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Sample records for single pill once-daily

  1. The quad pill, a once-daily combination therapy for HIV infection.

    Science.gov (United States)

    Johnson, Leonard B; Saravolatz, Louis D

    2014-01-01

    The quad pill is the newest single-pill, once-daily option for the treatment of human immunodeficiency virus (HIV) type 1 infection. In addition to tenofovir difumarate (TDF) and emtricitabine (FTC), the quad pill includes cobicistat (COBI; an inactivator of cytochrome P450 isoenzyme CYP3A without anti-HIV activity) and a new integrase inhibitor, elvitegravir (EVG). The quad does not have drug interactions with H2-receptor antagonists or proton pump inhibitors, does not cause central nervous system (CNS) side effects, and is pregnancy category B. It does have substantial drug interactions with medications that are metabolized using CYP3A and causes reversible declines in estimated glomerular filtration rate (eGFR) owing to inhibition of renal tubule transport of creatinine. In clinical trials, the virologic and immunologic efficacy of the quad pill is equivalent to that of other comparator regimens with low rates of discontinuation. The major side effect is nauseam which is self-limited, and the primary mutations associated with treatment failure frequently lead to cross-resistance with raltegravir (RAL).

  2. Preformulation and development of a once-daily sustained-release tenofovir vaginal tablet tablet containing a single excipient.

    Science.gov (United States)

    McConville, Christopher; Friend, David R; Clark, Meredith R; Malcolm, Karl

    2013-06-01

    Tenofovir is a nucleoside reverse-transcriptase inhibitor that is currently being investigated as a potential HIV microbicide candidate, with a recent phase IIb study of a 1% (w/w) tenofovir gel reducing HIV acquisition by 39% in sexually active women. However, not only does a HIV microbicidal product need to be safe and effective, it also needs to be cheap and easy to manufacture. In this study, we report the development of a tenofovir-loaded tablet, manufactured using a single sustained-release polymer, which has an acceptable hardness, friability and tenofovir release rate. Furthermore, by varying both the type and molecular weight of the sustained-release polymer, as well as the particle size of both tenofovir and the sustained-release polymer, we can vary the release rate of tenofovir from the tablets. Copyright © 2013 Wiley Periodicals, Inc.

  3. Legal, ethical, and economic implications of breaking down once-daily fixed-dose antiretroviral combinations into their single components for cost reduction.

    Science.gov (United States)

    Ramiro, Miguel A; Llibre, Josep M

    2014-11-01

    The availability of generic lamivudine in the context of the current economic crisis has raised a new issue in some European countries: breaking up the once-daily fixed-dose antiretroviral combinations (FDAC) of efavirenz/tenofovir/emtricitabine, tenofovir/emtricitabine, or abacavir/lamivudine, in order to administer their components separately, thereby allowing the use of generic lamivudine instead of branded emtricitabine or lamivudine. The legal, ethical, and economic implications of this potential strategy are reviewed, particularly in those patients receiving a once-daily single-tablet regimen. An unfamiliar change in antiretroviral treatment from a successful patient-friendly FDAC into a more complex regimen including separately the components to allow the substitution of one (or some) of them for generic surrogates (in the absence of a generic bioequivalent FDAC) could be discriminatory because it does not guarantee access to equal excellence in healthcare to all citizens. Furthermore, it could violate the principle of non-maleficence by potentially causing harm both at the individual level (hindering adherence and favouring treatment failure and resistance), and at the community level (hampering control of disease transmission and transmission of HIV-1 resistance). Replacing a FDAC with the individual components of that combination should only be permitted when the substituting medication has the same qualitative and quantitative composition of active ingredients, pharmaceutical form, method of administration, dosage and presentation as the medication being replaced, and a randomized study has demonstrated its non-inferiority. Finally, a strict pharma-economic study supporting this change, comparing the effectiveness and the cost of a specific intervention with the best available alternative, should be undertaken before its potential implementation. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiolog

  4. A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

    Science.gov (United States)

    Blume-Peytavi, Ulrike; Hillmann, Kathrin; Dietz, Ekkehart; Canfield, Douglas; Garcia Bartels, Natalie

    2011-12-01

    Although twice-daily application of propylene glycol-containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol-free formulation may improve efficacy and reduce unpleasant side effects. We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia. A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics. After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with "the treatment does not interfere with styling my hair" (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS. Because of differences in the formulations tested, study participants were not blinded to treatment. Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  5. Effect of once-daily, modified-release hydrocortisone versus standard glucocorticoid therapy on metabolism and innate immunity in patients with adrenal insufficiency (DREAM): a single-blind, randomised controlled trial.

    Science.gov (United States)

    Isidori, Andrea M; Venneri, Mary Anna; Graziadio, Chiara; Simeoli, Chiara; Fiore, Daniela; Hasenmajer, Valeria; Sbardella, Emilia; Gianfrilli, Daniele; Pozza, Carlotta; Pasqualetti, Patrizio; Morrone, Stefania; Santoni, Angela; Naro, Fabio; Colao, Annamaria; Pivonello, Rosario; Lenzi, Andrea

    2018-03-01

    Conventional treatment of patients with adrenal insufficiency involves administration of glucocorticoids multiple times a day and has been associated with weight gain and metabolic impairment. The optimal glucocorticoid replacement therapy for these patients is highly debated because of the scarcity of evidence from randomised trials. We aimed to establish whether the timing and pharmacokinetics of glucocorticoid replacement therapy affect the metabolism and immune system of patients with adrenal insufficiency. We did a single-blind randomised controlled trial at two reference university hospitals in Italy. Eligible patients (aged 18-80 years) with adrenal insufficiency were on conventional glucocorticoid therapy and had been stable for at least 3 months before enrolment. Patients were randomly assigned (1:1) with a computer-generated random sequence stratified by type of adrenal insufficiency and BMI to continue conventional glucocorticoid therapy (standard treatment group) or to switch to an equivalent dose of once-daily, modified-release oral hydrocortisone (switch treatment group). Outcome assessors were masked to treatment allocation. The primary outcome was bodyweight change from baseline to 24 weeks. Secondary outcomes included immune cell profiles, susceptibility to infections, and quality of life. Efficacy analyses included all patients who received at least one dose of the study drug. This trial is registered with ClinicalTrials.gov, NCT02277587. Between March 1, 2014, and June 30, 2016, 89 patients with adrenal insufficiency were randomly assigned to continue standard glucocorticoid therapy (n=43) or to switch to once-daily, modified-release hydrocortisone (n=46). At 24 weeks, bodyweight reduction was superior in patients in the once-daily hydrocortisone group compared with those in the standard treatment group (-2·1 kg [95% CI -4·0 to -0·3] vs 1·9 kg [-0·1 to 3·9]; treatment difference -4·0 kg, 95% CI -6·9 to -1·1; p=0·008). Additionally

  6. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain.

    Science.gov (United States)

    Wen, Warren; Sitar, Steve; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

    2015-01-01

    This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed. Out of 905 patients who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 - 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated. HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.

  7. Effectiveness of Antiretroviral Therapy in Individuals Who for Economic Reasons Were Switched From a Once-Daily Single-Tablet Regimen to a Triple-Tablet Regimen

    DEFF Research Database (Denmark)

    Engsig, Frederik N; Gerstoft, Jan; Helleberg, Marie

    2014-01-01

    BACKGROUND: To assess the impact on virological outcomes of a switch from branded single-tablet regimen (STR) including tenofovir, efavirenz, and emtricitabine (STR-TEE) to generic triple-tablet regimen (TTR), including tenofovir, efavirenz, and lamivudine (TTR-TEL), which was implemented on April...... April 1, 2011 to March 31, 2012 (n = 56) and cART-experienced HIV patients who were on STR-TEE from April 1, 2010 (n = 356) or were switched from STR-TEE to TTR-TEL after April 1, 2011 (n = 512). We estimated the fraction with detectable HIV-RNA, development of the 184V/I resistance mutations, and time...... to switch of cART. Approximately 96.2% of cART-experienced patients on STR-TEE were shifted to TTR-TEL after April 1, 2011. For the naive STR-TEE and TTR-TEL patients, the fractions with detectable HIV-RNA at week 48 were 7.0% and 8.3% and for the cART experienced 4.0% and 4.4%, respectively. The 184V...

  8. Didanosine once daily: potential for expanded use.

    Science.gov (United States)

    Pollard, R B

    2000-11-10

    Factors affecting patient adherence to therapy, such as frequent daily dosing and complex dosing schedules, are widely understood to be key obstacles to the durability of effective anti-HIV therapy. Didanosine, a nucleoside analogue reverse transcriptase inhibitor (NRTI) that is a core component of combination antiretroviral regimens, is currently indicated for twice-daily dosing. However, the active metabolite of didanosine (2',3'-dideoxyadenosine-5'-triphosphate) has a long intracellular half-life that supports the use of didanosine in a more patient-friendly, once-daily dosing schedule. Clinical studies in which didanosine was administered either once or twice daily, as monotherapy or in combination with another NRTI, have demonstrated the equivalence of both dosing schedules, with respect to safety and tolerability, virologic and immunologic endpoints, and short-term clinical effects (e.g., weight gain). Preliminary results from recent studies support the clinical efficacy and utility of once-daily didanosine in combination antiretroviral regimens that provide maximal drug exposure, while allowing for once- or twice-daily dosing of all component drugs.

  9. The pharmacology of antiretroviral nucleoside and nucleotide reverse transcriptase inhibitors: implications for once-daily dosing.

    Science.gov (United States)

    Back, David J; Burger, David M; Flexner, Charles W; Gerber, John G

    2005-08-01

    The trend toward once-daily dosing in HIV antiretroviral therapy is based on the association between adherence, treatment outcome, and patient preferences. Patients prefer simpler treatments, fewer pills, less frequent dosing, and no food restrictions. When a regimen meets a patient's preferences, the patient is more likely to be adherent, and with good adherence, the regimen is more likely to be effective. Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) have been a prime focus for developing once-daily therapies primarily because they form the backbone of most current regimens. Within the NRTI class, however, drugs differ in their pharmacokinetic properties, such as plasma and intracellular half-lives, and thus in their suitability for once-daily dosing. For example, newer NRTIs, such as tenofovir and emtricitabine, combine longer plasma half-lives with longer intracellular half-lives, prolonging exposure and the period of pharmacologic activity. Of equal importance, the clinical impact of systemic and intracellular interactions between concomitant drugs defines which once-daily drugs may be combined in once-daily regimens. To construct simplified and effective therapies for individual patients, clinicians require an understanding of the plasma and intracellular pharmacokinetic properties of NRTIs and how these properties determine a drug's appropriateness for once-daily dosing and placement within a once-daily regimen.

  10. Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Single- and multiple-dose Once-daily Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, in Chinese Patients With Type 2 Diabetes Mellitus.

    Science.gov (United States)

    Zhao, Xia; Cui, Yimin; Zhao, Shuai; Lang, Benjamin; Broedl, Uli C; Salsali, Afshin; Pinnetti, Sabine; Macha, Sreeraj

    2015-07-01

    The aim of this study was to investigate the pharmacokinetic and pharmacodynamic properties and tolerability of the oral once-daily sodium glucose cotransporter 2 inhibitor empagliflozin, given in single and multiple 10 and 25 mg doses in Chinese patients with type 2 diabetes mellitus (T2DM). In a double-blind, placebo-controlled, parallel-group study, Chinese patients with T2DM were randomly assigned to receive a single dose of empagliflozin 10 or 25 mg or placebo on day 1 and once daily on days 3 to 9. A total of 24 patients were enrolled (14 men, 10 women; median age, 53.5 years; empagliflozin 10 mg, n = 9; empagliflozin 25 mg, n = 9; and placebo, n = 6). After both single- and multiple-dose administration, empagliflozin 10 and 25 mg were rapidly absorbed, reaching peak plasma concentrations within 1 to 1.5 hours (median), with plasma levels declining biphasically. Empagliflozin exposure increased roughly dose proportionally between 10 and 25 mg. Mean terminal elimination half-life values at steady state were 13.9 and 12.1 hours with empagliflozin 10 and 25 mg, respectively. Mean (SD) changes from baseline in 24-hour urinary glucose excretion (UGE) on day 1 were +87.7 (22.9) and +82.8 (18.8) g with empagliflozin 10 and 25 mg, respectively, compared with -1.0 (2.8) g with placebo, and on day 9 were +95.8 (24.1), +82.6 (34.8) g with empagliflozin 10 and 25 mg, respectively, compared with -4.1 (6.4) g with placebo. Mean (SD) changes from baseline in fasting plasma glucose (FPG) on day 2 were -18.7 (17.2) mg/dL and -25.8 (19.6) mg/dL with empagliflozin 10 and 25 mg, respectively, compared with -4.2 (15.2) mg/dL with placebo, and on day 9, were -25.6 (20.7) mg/dL and -31.4 (26.9) mg/dL with empagliflozin 10 and 25 mg, respectively, compared to -3.7 (7.5) mg/dL with placebo. On day 10, mean changes in weight were -1.1, -1.6, and +0.5 kg with empagliflozin 10 and 25 mg and placebo, respectively. Overall, empagliflozin 10 and 25 mg had safety profiles similar to that of

  11. Once-daily dose regimen of ribavirin is interchangeable with a twice-daily dose regimen: randomized open clinical trial

    Directory of Open Access Journals (Sweden)

    Balk JM

    2015-08-01

    .05. No significant differences in the hematological profile were observed (P>0.05. Conclusion: The standard twice-daily RBV regimen is interchangeable with the once-daily regimen. The once-daily regimen will improve compliance and opens the opportunity to combine RBV with other drugs dosed once a day, in a single pill. Keywords: hepatitis C, dose regimen, ribavirin, pegylated interferon

  12. Effect of once-daily FDC treatment era on initiation of cART

    Directory of Open Access Journals (Sweden)

    David M Mosen

    2010-02-01

    Full Text Available David M Mosen1, Michael Horberg2, Douglas Roblin3, Christina M Gullion1, Richard Meenan1, Wendy Leyden2, Weiming Hu11Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA; 2Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; 3Center for Health Research, Kaiser Permanente Georgia, Atlanta, GA, USAObjectives: Combination antiretroviral therapy (cART is associated with increased survival among HIV-infected persons. Yet, no research to date has examined whether introduction of once-daily fixed-dosed combinations (FDC affects the likelihood of cART initiation. We aimed to determine whether implementation of once-daily FDC regimens was associated with changes to cART initiation. We also identified clinical, treatment regimen, and provider characteristics possibly associated with cART initiation. Study design: Retrospective observational analysis.Methods: We queried electronic medical records between July 1999–June 2006 to identify incident cases of detectable HIV infection in antiretroviral-naïve adults. Cox regression with time-dependent covariates was used to examine the effects of once-daily FDC era, clinical, provider, and treatment regimen characteristics on cART initiation.Results: Once-daily FDC availability did not change the likelihood of cART initiation, but other characteristics were associated with an increased likelihood: AIDS diagnosis, above-median daily pill consumption, and 16+ yrs of physician HIV experience. Decreased likelihood of cART initiation was associated with CD4 201–350 cells/µL, HIV RNA < 100,000 copies/mL, and with CD4 > 350 cells/µL (any HIV RNA level, compared to CD4 ≤ 200 cells/µL.Conclusion: Availability of once-daily FDC-based regimens did not affect likelihood of cART initiation. Patient clinical characteristics appear to be more important predictors of cART initiation.Keywords: ARV treatment, once-daily FDC therapies, ARV-naïve

  13. Maintaining remission in ulcerative colitis – role of once daily extended-release mesalamine

    Directory of Open Access Journals (Sweden)

    Lilliana Oliveira

    2011-02-01

    Full Text Available Lilliana Oliveira, Russell D CohenThe Department of Medicine, Section of Gastroenterology, University of Chicago Medical Center, Chicago, IL, USAAbstract: The aminosalicylates (5-ASA; also referred to as mesalamine-based agents are considered as first-line in the maintenance of remission of mild to moderate ulcerative colitis (UC. Traditionally these agents have required a large pill burden and multiple daily dosing regimens which may account for the low adherence rates, especially in patients in remission. Extended-release mesalamine is the first once daily mesalamine product approved by the Food and Drug Administration for the maintenance of UC remission. This review will examine the pharmacokinetics, dosing, efficacy, and safety data of extended-release mesalamine, and discuss the potential role of improving medication compliance and decreasing costs in UC maintenance.Keywords: ulcerative colitis, 5-ASA, mesalamine, adherence, compliance, quality of life, costs

  14. Tedizolid: The First Once-Daily Oxazolidinone Class Antibiotic.

    Science.gov (United States)

    Burdette, Steven D; Trotman, Robin

    2015-10-15

    Tedizolid phosphate is the second commercially available oxazolidinone antibiotic, although the first one in class that is dosed once daily. It is a prodrug that is rapidly converted to the active compound tedizolid. Tedizolid has activity against a wide range of gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. It is approved to treat acute bacterial skin and skin structure infections (ABSSSIs). In 2 randomized controlled phase 3 trials, 6 days of tedizolid (200 mg once daily) has been proven to be noninferior to 10 days of linezolid (600 mg twice daily). These 2 ABSSSI studies have positioned tedizolid among the growing armamentarium of newer, novel, anti-gram-positive agents. Tedizolid appears to differ from linezolid in the incidence of gastrointestinal and hematologic side effects and appears to lack drug interactions with selective serotonin reuptake inhibitors. Conditions other than ABSSSI are currently being evaluated in clinical studies. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  15. Antiretroviral activity and safety of once-daily etravirine in treatment-naive HIV-infected adults: 48-week results.

    Science.gov (United States)

    Floris-Moore, Michelle A; Mollan, Katie; Wilkin, Aimee M; Johnson, Marc A; Kashuba, Angela Dm; Wohl, David A; Patterson, Kristine B; Francis, Owen; Kronk, Catherine; Eron, Joseph J

    2016-01-01

    Etravirine (ETR), a non-nucleoside reverse transcriptase inhibitor approved for 200 mg twice-daily dosing in conjunction with other antiretrovirals (ARVs), has pharmacokinetic properties which support once-daily dosing. In this single-arm, open-label study, 79 treatment-naive HIV-infected adults were assigned to receive ETR 400 mg plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300/200 mg once daily to assess antiviral activity, safety and tolerability. ARV activity at 48 weeks was determined by proportion of subjects with HIV-1 RNAE138K (one alone and one with additional mutations). Median (95% CI) CD4(+) cell count increase was 163 (136, 203) cells/µl. Fifteen (19.0%) participants reported a new sign/symptom or lab abnormality ≥ Grade 3 and three participants (3.8%) permanently discontinued ETR due to toxicity. Two participants had psychiatric symptoms of any grade. There were no deaths. In this study of ARV-naive HIV-positive adults, once-daily ETR with TDF/FTC had acceptable antiviral activity and was well-tolerated. Once-daily ETR may be a plausible option as part of a combination ARV regimen for treatment-naive individuals. ClinicalTrials.gov NCT00959894.

  16. Empagliflozin/linagliptin single-pill combination therapy for patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Jain, Rajeev Kumar

    2017-04-01

    Type 2 diabetes mellitus (T2DM) is typically progressive, with sequential addition of therapies often needed to address increasing hyperglycemia over the disease course. Using treatments in combination may be preferred to sequential addition, as a means of providing a more rapid clinical response and potentially avoiding clinical inertia. In such cases, a single-pill combination can help to reduce pill burden. Although various single-pill combinations of oral glucose-lowering agents are available, empagliflozin/linagliptin was the first approved combination of a sodium glucose co-transporter 2 (SGLT2) inhibitor with a dipeptidyl peptidase 4 (DPP-4) inhibitor in the United States. Areas covered: Two publications of the clinical trial investigating the efficacy and safety of single-pill combinations of empagliflozin/linagliptin in treatment-naive or metformin-treated patients with T2DM (NCT01422876) are reviewed, and their potential impact on clinical practice is discussed. Expert opinion: The study discussed provides evidence for the efficacy and safety of empagliflozin/linagliptin single pills. Addition of an empagliflozin/linagliptin single pill may be considered in patients with inadequate glycemic control on metformin, or as an alternative to first-line treatment with empagliflozin or linagliptin when metformin is not suitable, particularly in patients with very poor glycemic control, or those who need to achieve target more quickly.

  17. Comparison of health care resource utilization and costs among patients with GERD on once-daily or twice-daily proton pump inhibitor therapy.

    Science.gov (United States)

    Mody, Reema; Eisenberg, Debra; Hou, Likun; Kamat, Siddhesh; Singer, Joseph; Gerson, Lauren B

    2013-01-01

    The purpose of this study was to assess differences in health care resource utilization and costs associated with once-daily and twice-daily proton pump inhibitor (PPI) therapy. Most patients with gastroesophageal reflux disease (GERD) achieve symptom control on once-daily PPI therapy, but approximately 20%-30% require twice-daily dosing. Patients were ≥18 years of age with at least one medical claim for GERD and at least two PPI claims from HealthCore's Integrated Research Database (HIRD(SM)) during 2004-2009. Patients were continuously eligible for 12 months before and after the index date (date of first PPI claim). Based on PPI dosing throughout the post-index period (quantity of medication dispensed/number of days supply), patients were classified as once-daily (dose ≤ 1.5 pills per day) or twice-daily (≥1.5) PPI users. The study cohort included 248,386 patients with GERD (mean age 52.8 ± 13.93 years, 56% females) of whom 90% were once-daily and 10% were twice-daily PPI users. The Deyo-Charlson Comorbidity Index for once-daily and twice-daily PPI users was 0.70 ± 1.37 and 0.89 ± 1.54, respectively (P < 0.05). More once-daily patients had claims for Barrett's esophagus (5% versus 2%, P < 0.0001) than twice-daily patients. Post-index, higher proportions of twice-daily patients had at least one GERD-related inpatient visit (7% versus 5%), outpatient visit (60% versus 49%), and office visit (48% versus 38%) versus once-daily patients (P < 0.0001). Mean total GERD-related health care costs were $2065 ± $6636 versus $3749 ± $11,081 for once-daily and twice-daily PPI users, respectively (P < 0.0001). Patients receiving twice-daily PPI therapy were likely to have more comorbid conditions and greater health care utilization and overall costs compared with patients using once-daily PPI therapy.

  18. Comparison of health care resource utilization and costs among patients with GERD on once-daily or twice-daily proton pump inhibitor therapy

    Directory of Open Access Journals (Sweden)

    Mody R

    2013-04-01

    Full Text Available Reema Mody,1 Debra Eisenberg,2 Likun Hou,2 Siddhesh Kamat,2 Joseph Singer,2 Lauren B Gerson3 1Takeda Pharmaceuticals International Inc, Deerfield, IL, 2HealthCore Inc, Wilmington, DE, 3Stanford University School of Medicine, Stanford, CA, USA Background: The purpose of this study was to assess differences in health care resource utilization and costs associated with once-daily and twice-daily proton pump inhibitor (PPI therapy. Most patients with gastroesophageal reflux disease (GERD achieve symptom control on once-daily PPI therapy, but approximately 20%–30% require twice-daily dosing. Methods: Patients were ≥18 years of age with at least one medical claim for GERD and at least two PPI claims from HealthCore's Integrated Research Database (HIRDSM during 2004–2009. Patients were continuously eligible for 12 months before and after the index date (date of first PPI claim. Based on PPI dosing throughout the post-index period (quantity of medication dispensed/number of days supply, patients were classified as once-daily (dose ≤ 1.5 pills per day or twice-daily (≥1.5 PPI users. Results: The study cohort included 248,386 patients with GERD (mean age 52.8 ± 13.93 years, 56% females of whom 90% were once-daily and 10% were twice-daily PPI users. The Deyo-Charlson Comorbidity Index for once-daily and twice-daily PPI users was 0.70 ± 1.37 and 0.89 ± 1.54, respectively (P < 0.05. More once-daily patients had claims for Barrett's esophagus (5% versus 2%, P < 0.0001 than twice-daily patients. Post-index, higher proportions of twice-daily patients had at least one GERD-related inpatient visit (7% versus 5%, outpatient visit (60% versus 49%, and office visit (48% versus 38% versus once-daily patients (P < 0.0001. Mean total GERD-related health care costs were $2065 ± $6636 versus $3749 ± $11,081 for once-daily and twice-daily PPI users, respectively (P < 0.0001. Conclusion: Patients receiving twice-daily PPI therapy were likely to have more

  19. A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

    Directory of Open Access Journals (Sweden)

    Segura J

    2013-09-01

    Full Text Available Julian Segura, Luis Miguel Ruilope Department of Nephrology, Hospital 12 de Octubre, Madrid, Spain Abstract: This review discusses the rationale for earlier use of single-pill combinations (SPCs of antihypertensive drugs, with a focus on telmisartan/amlodipine (T/A and telmisartan/hydrochlorothiazide (T/H SPCs. Compared with the respective monotherapies, the once-daily T/A and T/H SPCs have been shown to result in significantly higher blood pressure (BP reductions, BP goal rates, and response rates in patients at all stages of hypertension. As expected, BP reductions are highest with the highest dose (T80/A10 and T80/H25 SPCs. Subgroup analyses of the telmisartan trials have reported the efficacy of both SPCs to be consistent, regardless of the patients' age, race, and coexisting diabetes, obesity, or renal impairment. In patients with mild-to-moderate hypertension, the T/A combination provides superior 24-hour BP-lowering efficacy compared with either treatment administered as monotherapy. Similarly, the T/H SPC treatment provides superior 24-hour BP-lowering efficacy, especially in the last 6 hours relative to other renin–angiotensin system inhibitor-based SPCs. The T/A SPC is associated with a lower incidence of edema than amlodipine monotherapy, and the T/H SPC with a lower incidence of hypokalemia than hydrochlorothiazide monotherapy. Existing evidence supports the use of the T/A SPC for the treatment of hypertensive patients with prediabetes, diabetes, or metabolic syndrome, due to the metabolic neutrality of both component drugs, and the use of the T/H SPC for those patients with edema or in need of volume reduction. Keywords: calcium-channel blocker, essential hypertension, diuretic, primary care physician, renin-angiotensin system inhibitor

  20. A single-pill combination of amlodipine besylate and atorvastatin calcium.

    Science.gov (United States)

    Blank, Roy

    2006-03-01

    This review describes the clinical profile and rationale for the development of a single-pill formulation of the calcium channel blocker amlodipine besylate, a blood pressure-lowering agent with pleiotropic effects, and atorvastatin calcium, a statin with lipid-lowering as well as pleiotropic anti-atherosclerotic properties. Amlodipine and atorvastatin have been demonstrated in numerous clinical trials to be highly effective in lowering blood pressure and low-density lipoprotein cholesterol (LDL-C). Furthermore, both amlodipine and atorvastatin have been demonstrated to reduce cardiovascular events in a broad range of patients. The amlodipine/atorvastatin single pill has been shown to improve patients' achievement of national guideline-recommended blood pressure and lipid target levels and exhibits a safety profile consistent with its parent compounds. The combination pill is available in formulations appropriate for administration across therapeutic dose ranges targeted to a wide variety of hypertensive patients with additional risk factors and differing degrees of cardiovascular risk, or with manifest cardiovascular disease. Single-pill amlodipine/atorvastatin has the potential to improve the management of hypertensive patients with additional cardiovascular risk factors, especially dyslipidemia, by reducing pill burden and prescription costs. This potential has important implications because hypertensive patients with additional risk factors represent a large proportion of those at risk for cardiovascular events. Copyright 2006 Prous Science.

  1. Single-pill combination therapy for type 2 diabetes mellitus: linagliptin plus empagliflozin.

    Science.gov (United States)

    Aronson, Ronnie

    2015-05-01

    Treatment of type 2 diabetes mellitus invariably requires the use of multiple daily medications which can impact negatively on patient adherence. As a result, there is growing interest in the use of single-pill combinations that can reduce the pill burden. Many such formulations incorporate metformin, although this agent is not suitable for all patients. The single-pill combination of the dipeptidyl peptidase-4 inhibitor linagliptin with the sodium glucose co-transporter 2 inhibitor empagliflozin offers a new and attractive option, given their complementary mechanisms of action. Publications with titles containing the keywords 'linagliptin' or 'empagliflozin' were identified from a non-systematic search of PubMed without date restrictions, together with abstracts presented at the annual meetings of the American Diabetes Association and the European Association for the Study of Diabetes 2012-2014. ClinicalTrials.gov was searched for entries containing these two keywords. Additional references known to the author were included. The efficacy and safety of linagliptin and empagliflozin as monotherapy or in combination with other oral antidiabetic drugs has been established through extensive clinical trial programs. Studies specifically evaluating the efficacy/safety of a dipeptidyl peptidase-4 inhibitor/sodium glucose co-transporter 2 inhibitor in combination are limited, but do include two studies of linagliptin/empagliflozin of up to 52 weeks in duration. These studies show that the single-pill combination of linagliptin and empagliflozin produced clinical improvements in glycemic control that were generally superior to the improvements seen with linagliptin and empagliflozin alone, but with a safety profile comparable to that of the individual constituents. The single-pill combination of linagliptin and empagliflozin, with their complementary mechanisms of action, is a promising treatment option for patients with type 2 diabetes mellitus. It would reduce the daily

  2. Update on the clinical utility of once-daily tacrolimus in the management of transplantation

    Directory of Open Access Journals (Sweden)

    Posadas Salas MA

    2014-09-01

    Full Text Available Maria Aurora Posadas Salas, Titte R Srinivas Division of Nephrology and Hypertension, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA Abstract: Adherence to immunosuppression and minimizing variability in drug exposure are important considerations in preventing rejection and maximizing overall transplant outcomes. The availability of once-daily tacrolimus may confer potential benefit by simplifying immunosuppressive regimens, thereby improving medication adherence among transplant recipients. Pharmacokinetic studies in healthy normal volunteers and stable transplant recipients suggest that once-daily tacrolimus is bioequivalent to twice-daily tacrolimus. Efficacy studies suggest that once-daily tacrolimus is noninferior to twice-daily tacrolimus with a concentration-dependent rejection risk. The incidence of biopsy-proven acute rejection, graft survival, and patient survival are more or less comparable between the two tacrolimus formulations. Once-daily tacrolimus has also been reported to have favorable effects on blood pressure, lipid profile, and glucose tolerance. Once-daily tacrolimus may be a viable option to consider for de novo immunosuppression or for conversion from conventional tacrolimus. Keywords: pharmacokinetics, toxicity, immunosuppression, adherence

  3. Azelaic acid 15% gel once daily versus twice daily in papulopustular rosacea.

    Science.gov (United States)

    Thiboutot, Diane M; Fleischer, Alan B; Del Rosso, James Q; Graupe, Klaus

    2008-06-01

    Twice-daily azelaic acid (AzA) is the conventional regimen for papulopustular rosacea, but once-daily AzA may be equally effective, with greater convenience and dosing flexibility. In order to test this hypothesis, an exploratory study was conducted. The evaluable efficacy population of this 12-week double-blind, parallel-group study included 72 patients and the population that was used to report safety results included 92 patients. Baseline characteristics were comparable between the once-daily and twice-daily study groups. Evaluations were performed at baseline and at weeks 4, 8, and 12. No significant difference was found between the once-daily and twice-daily groups at the end of study therapy in mean investigator global assessment (IGA) scores, treatment success, or treatment response. The mean number of inflammatory lesions, the intensity of erythema intensity, and the intensity of telangiectasia at treatment end were likewise not significantly different (P>.205 for all). More than 90% of subjects in each group rated cosmetic acceptability of this AzA gel as satisfactory or better. Based on these findings and those of prior studies, once-daily AzA 15% gel can therefore be utilized as a safe, effective, and economical dosing option for the treatment of mild-to-moderate papulopustular rosacea. Once-daily dosing of AzA 15% gel was well accepted by patients and can offer considerable dosing flexibility and convenience for the patient as well as for the dermatologist.

  4. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    LENUS (Irish Health Repository)

    Ní Ainle, Fionnuala

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU\\/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU\\/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered

  5. A single-pill combination of amlodipine besylate and atorvastatin calcium (update).

    Science.gov (United States)

    Blank, Roy; Hobbs, F D Richard; Zamorano, Jose; Girerd, Xavier

    2007-03-01

    This review describes the clinical profile and rationale for the development of a single-pill formulation of the calcium channel blocker amlodipine besylate, a blood-pressure--lowering agent, and atorvastatin calcium, a statin with lipid-lowering antiatherosclerotic properties. Amlodipine and atorvastatin have been demonstrated in numerous clinical trials to be highly effective in lowering blood pressure and low-density lipoprotein cholesterol. Furthermore, both amlodipine and atorvastatin have been demonstrated to reduce cardiovascular events in a broad range of patients' in hypertensive patients with three concomitant cardiovascular risk factors but normal to mildly elevated cholesterol levels, amlodipine combined with atorvastatin demonstrated a reduction in cardiovascular events. The amlodipine/atorvastatin single pill has been shown to improve patients; achievement of national-guideline-recommended blood pressure and lipid target levels and exhibits a safety profile consistent with its parent compounds. The combination pill is now available in parts of Europe in formulations containing either 5 or 10 mg amlodipine and 10 mg atorvastatin. Amlodipine combined with atorvastatin has been demonstrated to reduce cardiovascular events in hypertensive patients at high cardiovascular risk, and the single-pill formulation has the potential to improve adherence and decrease prescription costs. These potential benefits are associated with important implications because hypertensive patients with additional risk factors represent a large proportion of those at risk for cardiovascular events. (c) 2007 Prous Science.

  6. Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma

    DEFF Research Database (Denmark)

    Oliver, Amanda J.; Covar, Ronina A.; Goldfrad, Caroline H.

    2016-01-01

    Objective To evaluate the dose-response, efficacy, and safety of fluticasone furoate (FF; 25 µg, 50 µg, and 100 µg), administered once daily in the evening during a 12-week treatment period to children with inadequately controlled asthma. Study design This was a Phase IIb, multicenter, stratified...

  7. Risk factors of cellulitis treatment failure with once-daily intravenous cefazolin plus oral probenecid.

    Science.gov (United States)

    Bader, Mazen S; Twells, Laurie; Hawboldt, John

    2011-12-01

    Once-daily intravenous cefazolin with probenecid is used commonly to treat cellulitis. The primary objective of this study was to determine the risk factors of treatment failure with this regimen. This was a retrospective cohort study of adult outpatients with cellulitis who were initially treated with once-daily intravenous cefazolin plus probenecid. Treatment failure is defined as inadequate improvement that necessitates either hospital admission or a change in antibiotic therapy to a different intravenous regimen. A stepwise logistic regression analysis was performed to determine the risk factors for regimen failure. From January 2003 to December 2008, 159 patients with cellulitis were initially treated with once daily intravenous cefazolin plus probenecid. Thirty-five (22%) patients had treatment failure. The treatment for 53% (9/17) of the patients with a history of chronic venous disease (CVD) failed, whereas the treatment for 18% (26/142) of patients without CVD failed (P = 0.001). Multivariate analysis identified the presence of CVD as the only risk factor associated with treatment failure (odds ratio 4.4, 95% confidence interval 1.5-13; P = .007). Patients with cellulitis and CVD who are being treated with once-daily intravenous cefazolin plus probenecid should be monitored closely for treatment failure.

  8. Effects of Once-Daily Oral and Transdermal Methylphenidate on Sleep Behavior of Children with ADHD

    Science.gov (United States)

    Faraone, Stephen V.; Glatt, Stephen J.; Bukstein, Oscar G.; Lopez, Frank A.; Arnold, L. Eugene; Findling, Robert L.

    2009-01-01

    Objective: Methylphenidate is a leading first-line treatment for ADHD (AD/HD). This stimulant has long been suspected to adversely affect sleeping patterns of treated individuals, especially children. There are few studies on the effects of recently developed longer-acting methylphenidate treatments, such as once-daily oral or transdermal…

  9. Clinical efficacy of levofloxacin 500 mg once daily for 7 days for patients with non-gonococcal urethritis.

    Science.gov (United States)

    Takahashi, Satoshi; Ichihara, Kohji; Hashimoto, Jiro; Kurimura, Yuichiro; Iwasawa, Akihiko; Hayashi, Kenji; Sunaoshi, Kenichi; Takeda, Koichi; Suzuki, Nobukazu; Satoh, Takashi; Tsukamoto, Taiji

    2011-06-01

    To confirm the efficacy of the treatment regimen with oral levofloxacin (LVFX) 500 mg once daily for 7 days for patients with non-gonococcal urethritis (NGU), we evaluated the microbiological and clinical outcomes of the regimen in those patients. We finally evaluated 53 patients with symptomatic NGU and 5 patients with asymptomatic NGU. As a result of microbiological examinations, 19 of the symptomatic patients were diagnosed as having non-gonococcal chlamydial urethritis (NGCU); 13 had non-gonococcal non-chlamydial urethritis (NGNCU), and 21 had urethritis without any microbial detection. Five of the asymptomatic patients were diagnosed as having NGCU. Microbiological cure was achieved in 91% of the 32 patients with symptomatic NGU and in 80% of the 5 patients with asymptomatic NGCU. Clinical cure was obtained in 92% of the 53 patients with symptomatic NGU. The microbiological eradication rate for Chlamydia trachomatis was 92% in 24 patients. As for other organisms, the microbiological eradication rate for Mycoplasma genitalium was 60% in 5 patients and that for Ureaplasma urealyticum was 100% in 10. The microbiological and clinical efficacy of oral LVFX 500 mg once daily for 7 days for the patients with NGU was the same for the azithromycin (AZM) 1,000 mg single dose that we previously reported. The eradication rates of C. trachomatis and U. urealyticum in the treatment regimen with LVFX 500 mg were high enough in the clinical setting; however, for M. genitalium, the rate was relatively inferior to that with AZM.

  10. The antianginal efficacy and tolerability of controlled-release metoprolol once daily

    DEFF Research Database (Denmark)

    Egstrup, K; Gundersen, T; Härkönen, R

    1988-01-01

    In a randomized, double-blind, cross-over study treatment with a new controlled-release (CR) preparation of metoprolol, given once daily, was compared with treatment with conventional metoprolol tablets, given twice daily, in 115 patients with stable effort angina pectoris. The patients were...... questionnaire. When all patients were analysed together there were no differences in antianginal efficacy between the two treatment regimens. However, when the group taking 200 mg daily was analysed separately better exercise tolerance was found during metoprolol CR therapy, as measured by onset of chest pain...... and ST-segment change, compared with conventional metoprolol therapy. The two formulations were well tolerated. When given once daily in a total daily dose of 100 mg, the CR preparation induced less adverse effects than the conventional tablets, 50 mg twice daily. It was concluded that the new metoprolol...

  11. Update on the clinical utility of once-daily tacrolimus in the management of transplantation

    Directory of Open Access Journals (Sweden)

    Revollo J

    2015-05-01

    Full Text Available Jane Revollo Department of Pharmacy, Jackson Memorial Hospital, University of Miami Leonard M Miller School of Medicine Miami, FL, USAThe review by Posadas Salas and Srinivas of the clinical utility of once-daily tacrolimus formulations in the management of transplant patients1 was timely and relevant. It is worth noting, however, the data were presented in a way that overlooked several key differences between two distinct once-daily tacrolimus formulations. These formulations differ in bioavailability, Cmax, Tmax, dose required to achieve target trough levels, and time to reach target trough. The specific formulation and dosing information of one product was detailed in this review (described as modified release 4 [MR-4]; Astagraf®, Astellas Pharma Inc., Tokyo, Japan, but no formulation or dosing details were provided for a very different once-daily tacrolimus formulation (LCP-Tacro™; Veloxis Pharmaceuticals A/S, Hørsholm, Denmark for which a thorough review was recently published.2 The latter product is currently approved in Europe and under review by the US Food and Drug Administration in the US. In presenting data in this review, the authors did not identify which product was investigated in each of the studies discussed. This could easily lead to misinterpretation of results or erroneous conclusions, ie, that both once-daily formulations are the same. In fact, a careful parsing of the data clearly demonstrates that they are not equivalent. Misunderstanding of this point could have a potentially serious impact on appropriate dosing, safety, and patient management in the post-transplant setting. Differentiation between the two products is needed to clarify what appear to be conflicting results of the studies presented in this review.View original paper by Posadas Salas and Srinivas

  12. Liraglutide: a once-daily GLP-1 analogue for the treatment of type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Vilsbøll, Tina

    2007-01-01

    properties that are suitable for once-daily dosing. Liraglutide has demonstrated lasting improvement of HbA(1c )levels, weight reduction and improved beta-cell function in patients with Type 2 diabetes mellitus. Liraglutide is well tolerated; the adverse events that are most frequently reported being...... transient nausea and diarrhoea. This article reviews the mechanisms of action and efficacy of liraglutide for the treatment of Type 2 diabetes mellitus. This agent is presently in Phase III clinical development....

  13. Fixed combinations in the pragmatic management of hypertension: focus on aliskiren and hydrochlorothiazide as a single pill

    Directory of Open Access Journals (Sweden)

    Michel Burnier

    2010-05-01

    Full Text Available Michel BurnierService of Nephrology and Hypertension, University Hospital, Lausanne, SwitzerlandAbstract: A majority of hypertensive patients need more than one antihypertensive drug to control their blood pressure. For this reason, most guidelines have introduced the possibility of prescribing fixed-dose combination therapies as first-line treatment in hypertension. Today, the concept of fixed-dose combinations has evolved and the term single pill combination might become more appropriate to reflect the large choice of drug combinations available on the market. Recently, a new single pill combination has been launched which combines the first direct renin inhibitor aliskiren and low doses of hydrochlorothiazide. This paper reviews the potential advantages of single pill combinations and presents the first results obtained with the aliskiren/HCTZ single pill combination in hypertension.Keywords: hypertension, drug adherence, combination therapies, diuretics, renin inhibition

  14. Tadalafil once daily in the management of erectile dysfunction: patient and partner perspectives

    Directory of Open Access Journals (Sweden)

    Pierre Costa

    2009-04-01

    Full Text Available Pierre Costa1, Thierry Grivel2, Naji Gehchan31Service d’Urologie–Andrologie, Hôpital Caremeau, Nîmes, France; 2159, Avenue Sainte-Marguerite, Nice, France; 3Eli Lilly and Company, Lilly France – Medical Division, Suresnes, FranceAbstract: Erectile dysfunction (ED is a prevalent condition that affects men and their partners. Significant improvements in the sexual lives of these couples have been achieved with the introduction of phosphodiesterase 5 (PDE5 inhibitors. A PDE5 inhibitor is now widely recognized as the first-line therapy for the majority of men with ED. Currently, three PDE5 inhibitors – sildenafil, tadalafil and vardenafil – are approved to be taken as needed in anticipation of sexual activity, but only one of these, tadalafil, has been approved to be taken once daily. The primary aims of this review are to summarize the patients’ and partners’ viewpoints of ED management with PDE5 inhibitors, and to determine whether once-daily tadalafil can contribute to improving some psychological aspects of ED (such as sexual self-confidence, spontaneity and time concerns compared with on-demand tadalafil or other PDE5 inhibitors taken by patients with ED.Keywords: erectile dysfunction, once-daily treatment, patient and partner perspectives, phosphodiesterase 5 (PDE5 inhibitor

  15. Effectiveness of once-daily high-dose ACTH for infantile spasms.

    Science.gov (United States)

    Hodgeman, Ryan M; Kapur, Kush; Paris, Ann; Marti, Candice; Can, Afra; Kimia, Amir; Loddenkemper, Tobias; Bergin, Ann; Poduri, Annapurna; Libenson, Mark; Lamb, Nathan; Jafarpour, Saba; Harini, Chellamani

    2016-06-01

    There is insufficient evidence to recommend a specific protocol for treatment of infantile spasms (IS) and a lack of standardization among, and even within, institutions. Twice-daily dosing (for the first two weeks) of high-dose natural ACTH for IS is used by many centers and recommended by the National Infantile Spasms Consortium (NISC). Conversely, it is our practice to use once-daily dosing of high-dose natural ACTH for IS. In order to determine the effectiveness of our center's practice, we retrospectively reviewed 57 cases over the past four years at Boston Children's Hospital (BCH). We found that 70% of infants were spasm-free at 14days from ACTH initiation and 54% continued to be spasm-free at 3-month follow-up. Electroencephalogram showed resolution of hypsarrhythmia (when present on the pretreatment EEG) in all responders. Additionally, once-daily dosing of ACTH was well tolerated. We performed a meta-analysis to compare our results against the reports of published literature using twice-daily high-dose ACTH for treatment of IS. The meta-analysis revealed that our results were comparable to previously published outcomes using twice-daily ACTH administration for IS treatment. Our experience shows that once-daily dosing of ACTH is effective for treatment of IS. If larger prospective trials can confirm our findings, it would obviate the need for additional painful injections, simplify the schedule, and support a universal standardized protocol. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients.

    Science.gov (United States)

    Staatz, Christine E; Tett, Susan E

    2015-10-01

    Tacrolimus is a pivotal immunosuppressant agent used in solid-organ transplantation. It was originally formulated for oral administration as Prograf(®), a twice-daily immediate-release capsule. In an attempt to improve patient adherence, retain manufacturer market share and/or reduce health care costs, newer once-daily prolonged-release formulations of tacrolimus (Advagraf(®) and Envarsus(®) XR) and various generic versions of Prograf(®) are becoming available. Tacrolimus has a narrow therapeutic index. Small variations in drug exposure due to formulation differences can have a significant impact on patient outcomes. The aim of this review is to critically analyse the published data on the clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients. Forty-three traditional (non-compartmental) and five population pharmacokinetic studies were identified and evaluated. On the basis of the stricter criteria for narrow-therapeutic-index drugs, Prograf(®), Advagraf(®) and Envarsus(®) XR are not bioequivalent [in terms of the area under the concentration-time curve from 0 to 24 h (AUC0-24) or the minimum concentration (C min)]. Patients may require a daily dosage increase if converted from Prograf(®) to Advagraf(®), while a daily dosage reduction appears necessary for conversion from Prograf(®) to Envarsus(®) XR. Prograf(®) itself, or generic immediate-release tacrolimus, can be administered in a once-daily regimen with a lower than double daily dose being reported to give 24-h exposure equivalent to that of a twice-daily regimen. Intense clinical and concentration monitoring is prudent in the first few months after any conversion to once-daily tacrolimus dosing; however, there is no guarantee that therapeutic drug monitoring strategies applicable to one formulation (or twice-daily dosing) will be equally applicable to another. The correlation between the tacrolimus AUC0-24 and C min is variable and not strong for all three

  17. Pharmacokinetics of once daily prolonged-release formulation of tacrolimus in children with primary nephrotic syndrome.

    Science.gov (United States)

    Han, Y; DU, S Q; Xiao, H J; Zhou, Y; Ding, J; Ding, J J; Cui, Y M

    2017-10-18

    Tacrolimus prolonged-release(PR) formulation is a new once-daily formulation of the calcineurin inhibitor tacrolimus, which is currently used in adult liver or kidney transplant patients,and is also gradually widely used in children with nephrotic syndrome.The present study was undertaken to preliminarily investigate the pharmacokinetic characteristics of tacrolimus PR in pediatric nephrotic syndrome recipients. This single-center open-label prospective study was performed in pediatric nephrotic syndrome recipients. Pharmacokinetic samples were collected from eight pediatric subjects with nephrotic syndrome from Department of Pediatric Nephrology in Peking University First Hospital between June and August 2011. They followed administration of single oral doses of tacrolimus PR formulation at 0.02 mg/kg (n=2), 0.05 mg/kg (n=2) and 0.10 mg/kg (n=4). Blood samples were taken before the dose and 1, 2, 4, 6, 8, 10, 12 and 24 h after drug intake. No other medicines or interacting food or drinks were taken during the study period. Blood concentrations were measured using an enzyme multiplied immunoassay technique. Pharmacokinetic analysis was performed using WinNolin Phoenix software Version 6.0(Pharsight, Cary, NC,USA). The pharmacokinetic data were best described by a non-compartment model. Pharmacokinetic parameters of tacrolimus PR formulation in the 3 ascending doses groups (0.02 mg/kg,0.05 mg/kg and 0.10 mg/kg) were as follows: the maximum drug concentrations (C max /D) were (1.7±1.0) μg/L, (3.1±1.9) μg/L, (8.0±3.5) μg/L, respectively; Areas under the drug concentration-time curve(AUC 0-∞ /D) were (47.2±47.1) h×μg/L, (84.0±13.1) h×μg/L, (175.6±107.1) h×μg/L, respectively; Oral clearance rates were (0.8±0.9) L/(h×kg), (0.4±0.1) L/(h×kg), (1.9±1.3) L/(h×kg), respectively; Body weight normalized distribution volumes were (7.0±3.4) L/kg, (12.4±8.4) L/kg and (73.6±68.6) L/kg, respectively. Both mean C max normalized level for the administered

  18. Real-world utilization of once-daily extended-release abuse deterrent formulation of hydrocodone: a comparison with the pre-approval randomized clinical trials.

    Science.gov (United States)

    Taber, Louise; Bond, T Christopher; Wang, Xuezhe; Kadakia, Aditi; Mayne, Tracy J

    2017-01-01

    Hydrocodone bitartrate extended release (Hysingla ® ER, HYD) was previously studied in a 12-week randomized, double-blind, placebo-controlled trial and a 52-week open-label safety study. Both of these preapproval studies allowed dose titration to efficacy. The purpose of the present analysis was to compare dosing and utilization patterns in these previous clinical trials with real-world data (RWD) usage in a retrospective claim analysis performed 12-14 months post approval in the US. In the claim analysis (Truven Health Analytics MarketScan ® Research Database), patients prescribed HYD between January 1, 2015, and April 30, 2016, were followed for up to 6 months of continuous HYD use. Daily average consumption (DACON), initial dose, rescue opioid use and total milligram dose over time were also evaluated. HYD daily dose stabilized at ~60 mg dose once daily across all three studies. There was also a reduced need for rescue medication with HYD, resulting in a lower total opioid milligram dose over time. In the claim analysis, the mean monthly HYD dose increased from 49 to 55 mg in month 2 and then remained stable through month 6. The mean (standard deviation [SD]) time on drug was 79.5 days (61.42 days), and DACON was 1.04 pills/day, corresponding to the approved full prescribing information (FPI) and once-daily dosing. In 12-14 months post approval, real-world dosing and utilization of HYD mirrored registration and open-label study findings, with stable once-daily dosing of ~60 mg and no increase in rescue medicine utilization.

  19. Cost-effectiveness analysis of low density lipoprotein cholesterol-lowering therapy in hypertensive patients with type 2 diabetes in Korea: single-pill regimen (amlodipine/atorvastatin versus double-pill regimen (amlodipine+atorvastatin

    Directory of Open Access Journals (Sweden)

    Ji-Hyun Park

    2015-02-01

    Full Text Available OBJECTIVES: Single-pill combination therapy (amlodipine/atorvastatin might be more effective than double-pill therapy (amlodipine+atorvastatin in patients with diabetes and concomitant hypertension requiring statin therapy. We compared the cost-effectiveness of a single-pill with that of double-pill for control of low density lipoprotein cholesterol (LDL-C levels, with the ultimate goal of cardiovascular disease prevention, in these patients using a cost-effectiveness analysis model that considered medication adherence. METHODS: Effectiveness was defined as the percentage (% attainment of target LDL-C levels (<100 mg/dL based on adherence for each therapy. Adherence was defined as compliance to medication (≥80% proportion of days covered. A systematic review of the literature was conducted to determine the proportion of patients who were adherent and target goal attainment based on adherence level. The annual medication costs were based on the adherence levels for each regimen. The average cost-effectiveness ratio (ACER was calculated as the cost per % attainment of the target LDL-C level. RESULTS: The ACER for the single-pill regimen was lower than for the double-pill regimen (4,123 vs. 6,062 Korean won per 1% achievement of target goal. Compared with the double-pill, the medication costs were approximately 32% lower with the single-pill. CONCLUSION:A single-pill for reductions in LDL-C is cost-effective compared with double-pill in hypertensive patients with type 2 diabetes.

  20. Once-daily versus multiple-daily dosing with intravenous aminoglycosides for cystic fibrosis.

    Science.gov (United States)

    Smyth, Alan R; Bhatt, Jayesh; Nevitt, Sarah J

    2017-03-27

    People with cystic fibrosis, who are chronically colonised with the organism Pseudomonas aeruginosa, often require multiple courses of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations. The properties of aminoglycosides suggest that they could be given in higher doses less often. This is an update of a previously published review. To assess the effectiveness and safety of once-daily versus multiple-daily dosing of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations in cystic fibrosis. We searched the Cystic Fibrosis Specialist Register held at the Cochrane Cystic Fibrosis and Genetic Disorders Group's editorial base, comprising references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings.Date of the most recent search: 24 June 2016. All randomised controlled trials, whether published or unpublished, in which once-daily dosing of aminoglycosides has been compared with multiple-daily dosing in terms of efficacy or toxicity or both, in people with cystic fibrosis. The two authors independently selected the studies to be included in the review and assessed the risk of bias of each study; authors also assessed the quality of the evidence using the GRADE criteria. Data were independently extracted by each author. Authors of the included studies were contacted for further information. As yet unpublished data were obtained for one of the included studies. Fifteen studies were identified for possible inclusion in the review. Four studies reporting results from a total of 328 participants (aged 5 to 50 years) were included in this review. All studies compared once-daily dosing with thrice-daily dosing. One study had a low risk of bias for all criteria assessed; the remaining three included studies had a high risk of bias from blinding, but for other criteria were judged to have either an unclear or a low risk

  1. Liraglutide: a once-daily GLP-1 analogue for the treatment of type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Vilsbøll, Tina

    2007-01-01

    The incretin hormones are intestinal peptides that enhance insulin secretion following ingestion of nutrients. Liraglutide is a glucagon-like peptide-1 receptor analogue, which is obtained by derivatising glucagon-like peptide-1 with a fatty acid, providing a compound with pharmacokinetic propert...... transient nausea and diarrhoea. This article reviews the mechanisms of action and efficacy of liraglutide for the treatment of Type 2 diabetes mellitus. This agent is presently in Phase III clinical development....... properties that are suitable for once-daily dosing. Liraglutide has demonstrated lasting improvement of HbA(1c )levels, weight reduction and improved beta-cell function in patients with Type 2 diabetes mellitus. Liraglutide is well tolerated; the adverse events that are most frequently reported being...

  2. Comparisons between twice-daily and once-daily training sessions in male weight lifters.

    Science.gov (United States)

    Hartman, Michael J; Clark, Brandon; Bembens, Debra A; Kilgore, J Lon; Bemben, Michael G

    2007-06-01

    Many elite athletes use increased daily training frequencies as a means to increase training load without substantial published literature to support this practice. To compare the physiological responses to twice- and once-daily training sessions with similar training volumes. Ten nationally competitive male weightlifters (age 20.5 +/- 1.2 y, body mass 92.9 +/- 23.6 kg, training history 5.5 +/- 1.5 y) were matched on body mass and training experience, then randomly assigned to train either once or twice daily for 3 wk. Isometric knee-extension strength (ISO), muscle cross-sectional area, vertical-jump peak power, resting hormone concentrations, neuromuscular activation (EMG), and weightlifting performance were obtained before and after the experimental training period. All dependent measures before the training intervention were similar for both groups. A 2-way repeated-measures ANOVA did not reveal any significant main effects (group or trial) or interaction effects (group x trial) for any of the dependent variables. There were also no significant group differences when parameters were expressed as percentage change, but the twice-daily training group had a greater percentage change in ISO (+5.1% vs +3.2%), EMG (+20.3% vs +9.1%), testosterone (+10.5% vs +6.4%), and testosterone:cortisol ratio (-10.5% vs +1.3%) than did the once-daily training group. There were no additional benefits from increased daily training frequency in national-level male weightlifters, but the increase in ISO and EMG activity for the twice-daily group might provide some rationale for dividing training load in an attempt to reduce the risk of overtraining.

  3. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne.

    Science.gov (United States)

    Jones, Terry M; Ellman, Herman; deVries, Tina

    2017-10-01

    To characterize minocycline pharmacokinetics and relative bioavailability following multiple-dose topical administration of minocycline hydrochloride (HCl) foam 4% (FMX101 4%) as compared with single-dose oral administration of minocycline HCl extended-release tablets (Solodyn®) in subjects with moderate-to-severe acne. A Phase 1, single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment crossover clinical study. The study included 30 healthy adults (mean age, 22.6 years; 90% white, and 60% females) who had moderate-to-severe acne. Subjects were assigned to first receive a single oral dose of a minocycline HCl extended-release tablet (approximately 1 mg/kg). At 10 days after the oral minocycline dose, topical minocycline foam 4% was applied, once daily for 21 days. Serial blood samples were obtained before and after administration of oral minocycline and each topical application of minocycline foam 4% on days 1, 12, and 21. Following oral administration of minocycline (approximately 1 mg/kg), plasma minocycline concentration increased until 3 hours, followed by a log-linear decrease over the remainder of the 96-hour sampling period. Following topical application of a 4-g maximal-use dose of minocycline foam 4% for 21 days, plasma minocycline concentration was very low, with geometric mean Cmax values ranging from 1.1 ng/mL to 1.5 ng/mL. Steady state was achieved by day 6. Overall, minocycline exposure with topical minocycline foam 4% was 730 to 765 times lower than that with oral minocycline. There was no evidence of minocycline accumulation over the 21 days of topical application of minocycline foam 4%. Topical minocycline foam 4% appeared to be safe and well tolerated, with no serious treatment-emergent adverse events (TEAEs), treatment-related TEAEs, or TEAEs that led to treatment discontinuation. Once-daily topical application of minocycline foam 4% did not lead to significant systemic exposure to minocycline. It appears to be a well

  4. Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.

    Science.gov (United States)

    Orbelo, Diana M; Enders, Felicity T; Romero, Yvonne; Francis, Dawn L; Achem, Sami R; Dabade, Tushar S; Crowell, Michael D; Geno, Debra M; DeJesus, Ramona S; Namasivayam, Vikneswaran; Adamson, Steven C; Arora, Amindra S; Majka, Andrew J; Alexander, Jeffrey A; Murray, Joseph A; Lohse, Matthew; Diehl, Nancy N; Fredericksen, Mary; Jung, Kee Wook; Houston, Margaret S; O'Neil, Angela E; Katzka, David A

    2015-01-01

    Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

  5. Gabapentin for once-daily treatment of post-herpetic neuralgia: a review

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    Beal B

    2012-07-01

    Full Text Available Benjamin Beal,1 Tobias Moeller-Bertram,1,2 Jan M Schilling,1 Mark S Wallace11Division of Pain Medicine, Department of Anesthesiology, University of California, 2VA San Diego Healthcare System, San Diego, CA, USAAbstract: Post-herpetic neuralgia is a neuropathic pain syndrome resulting from an insult to the peripheral and central nervous systems caused by the varicella zoster virus. Spontaneous pain may result in the persistent sensation of burning, tingling, or aching and may be associated with thermally or mechanically provoked pain, resulting in hyperalgesia or allodynia. The majority of cases occur in patients over the age of 50 years. Gabapentin is a structural analog of gamma aminobutyric acid that binds to the α2-δ site of voltage-dependent calcium channels and modulates the influx of calcium, with a resulting reduction in excitatory neurotransmitter release. Gabapentin is effective in reducing neuropathic pain due to post-herpetic neuralgia when given at least three times per day, due to its short half-life, resulting in demonstrable fluctuations in plasma levels. Gabapentin has dose-limiting side effects that prevent some patients from achieving therapeutic plasma levels, such as somnolence (27.4%, dizziness (23.9%, and ataxia (7.1%. Gralise™ is a once-daily extended-release formulation of gabapentin that has been developed using AcuForm™ technology. AcuForm is a polymer-based drug delivery system that retains the tablet in the stomach and upper gastrointestinal tract for a sustained period of time. Once-daily dosing has been shown to provide comparable drug exposure with an identical daily dose of the immediate-release formulation when administered three times daily. Participants given Gralise 1800 mg daily had a statistically significant reduction in average daily pain intensity scores compared with placebo, reduced sleep interference due to pain, and a greater percent of participants reporting being much or very much improved on

  6. The emergence of oral tadalafil as a once-daily treatment for pulmonary arterial hypertension

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    Jeremy A Falk

    2010-04-01

    Full Text Available Jeremy A Falk, Kiran J Philip, Ernst R SchwarzCedars Sinai Women’s Guild Lung Institute, Cedars Sinai Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA, USAAbstract: Pulmonary hypertension (PH is found in a vast array of diseases, with a minority representing pulmonary arterial hypertension (PAH. Idiopathic PAH or PAH in association with other disorders has been associated with poor survival, poor exercise tolerance, progressive symptoms of dyspnea, and decreased quality of life. Left untreated, patients with PAH typically have a progressive decline in function with high morbidity ultimately leading to death. Advances in medical therapy for PAH over the past decade have made significant inroads into improved function, quality of life, and even survival in this patient population. Three classes of pulmonary artery-specific vasodilators are currently available in the United States. They include prostanoids, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE5 inhibitors. In May 2009, the FDA approved tadalafil, the first once-daily PDE5 inhibitor for PAH. This review will outline the currently available data on tadalafil and its effects in patients with PAH.Keywords: PDE-5 inhibition, pulmonary hypertension, tadalafil

  7. Effect of alfaprostol, lasalocid, and once-daily suckling on postpartum interval in Brahman and Brahman crossbred cattle.

    Science.gov (United States)

    Del Vecchio, R P; Randel, R D; Neuendorff, D A; Peterson, L A

    1988-10-01

    Brahman cows (n = 49) and primiparous heifers (n = 11), Brahman x Hereford primiparous F1 heifers (n = 86) and Simmental x Brahman primiparous F1 heifers (n = 13) were randomly allotted by breed, age and date of calving to one of eight treatment groups: 1) control; 2) once-daily suckling; 3) lasalocid (200 mg/hd/d); 4) alfaprostol (5 mg intermuscular injections on Days 21 and 32 post partum); 5) lasalocid + once-daily suckling; 6) alfaprostol + once daily suckling; 7) alfaprostol + lasalocid; 8) alfaprostol + lasalocid + once daily suckling. All animals received 2.3 kg/hd/d of a concentrate (6 corn : 1 cottonseed meal) and lasalocid was mixed and fed in the concentrate. Body weights and condition scores were taken on Day 1 post partum and every 28 d thereafter. All animals were maintained with sterile marker bulls with Brahman and Simmental x Brahman cattle artificially inseminated at first estrus. Blood samples were collected at weekly intervals starting on Day 21 post partum until estrus and at nine to twelve days post estrus when the ovaries were palpated for corpora lutea. After the first postpartum estrus with a corpora lutea, cows were placed with fertile bulls. Mean serum progesterone concentrations were below 0.5 ng/ml prior to treatment. Calf weight gains to 90 d were not affected by age (P > 0.10) but were lower in the once-daily suckling group (P 0.10). Cows had a shorter postpartum interval (P 0.10) but did increase the cumulative frequency of return to estrus by 90 d post partum (P 0.10). Both once-daily suckling and alfaprostol were effective in increasing the numbers of animals inseminated by 90 d post partum. The once-daily suckling + alfaprostol treatment resulted in the shortest postpartum interval.

  8. Real-world utilization of once-daily extended-release abuse deterrent formulation of hydrocodone: a comparison with the pre-approval randomized clinical trials

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    Taber L

    2017-07-01

    Full Text Available Louise Taber,1 T Christopher Bond,2 Xuezhe Wang,2 Aditi Kadakia,2 Tracy J Mayne2 1Arizona Research Center, Phoenix, AZ, USA; 2Purdue Pharma L.P., Stamford, CT, USA Background and objective: Hydrocodone bitartrate extended release (Hysingla® ER, HYD was previously studied in a 12-week randomized, double-blind, placebo-controlled trial and a 52-week open-label safety study. Both of these preapproval studies allowed dose titration to efficacy. The purpose of the present analysis was to compare dosing and utilization patterns in these previous clinical trials with real-world data (RWD usage in a retrospective claim analysis performed 12–14 months post approval in the US.Methods: In the claim analysis (Truven Health Analytics MarketScan® Research Database, patients prescribed HYD between January 1, 2015, and April 30, 2016, were followed for up to 6 months of continuous HYD use. Daily average consumption (DACON, initial dose, rescue opioid use and total milligram dose over time were also evaluated.Results: HYD daily dose stabilized at ~60 mg dose once daily across all three studies. There was also a reduced need for rescue medication with HYD, resulting in a lower total opioid milligram dose over time. In the claim analysis, the mean monthly HYD dose increased from 49 to 55 mg in month 2 and then remained stable through month 6. The mean (standard deviation [SD] time on drug was 79.5 days (61.42 days, and DACON was 1.04 pills/day, corresponding to the approved full prescribing information (FPI and once-daily dosing.Conclusion: In 12–14 months post approval, real-world dosing and utilization of HYD mirrored registration and open-label study findings, with stable once-daily dosing of ~60 mg and no increase in rescue medicine utilization. Keywords: chronic low back pain, hydrocodone, bitartrate extended release, opioid, Hysingla ER, NCT01452529, NCT01400139 

  9. Long-term outcome of once daily nasal irrigation for the treatment of pediatric chronic rhinosinusitis.

    Science.gov (United States)

    Pham, Vinh; Sykes, Kevin; Wei, Julie

    2014-04-01

    Chronic rhinosinusitis(CRS) results in significant morbidity and health care expenditure. Safety and efficacy of nasal irrigation use in the treatment of pediatric CRS have been demonstrated, but long-term outcomes are unknown. We reviewed characteristics and treatment outcomes after 6 weeks of once daily nasal irrigation in pediatric CRS based on computed tomography (CT) scans, and summarized parental reports of subsequent use of nasal irrigation for recurring symptoms Retrospective cohort study and cross-sectional survey. Review and survey of 144 pediatric CRS patients diagnosed between July 2003 and January 2012. One hundred four patients were reviewed. Mean age was 8.0 years, and 65.4% were male. Presenting symptoms included congestion (95.2%), cough (79.8%), rhinorrhea (60.6%), headache (48.1%), and fatigue (40.4%). Comorbidities included positive allergy test (50%), asthma (57.3%), and gastroesophageal reflux disease (28.2%). After 6 weeks, 57.7% of patients reported complete resolution of symptoms. Reductions in Lund-Mackay CT scores were 4.14 and 4.38 on the left and right sides, respectively (P irrigation again in the past 12 months (median = 1, interquartile range = 3). Only nine patients underwent functional endoscopic sinus surgery (FESS) after the initial 6 weeks. Patients requiring FESS were, on average, 3.6 years older than those who did not receive FESS (P = 0.0005). Median length of follow-up was 48 months (range = 20-113). There were no significant differences in age, Lund-MacKay score changes, and symptom resolution proportions between those who completed the survey and those who did not. Nasal irrigation is effective as a first-line treatment for pediatric CRS and subsequent nasal symptoms, and reduces the need for FESS and CT imaging. 2b. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

  10. Once-daily cefazolin and probenecid for skin and soft tissue infections.

    Science.gov (United States)

    Cox, Victoria C; Zed, Peter J

    2004-03-01

    To review the pharmacokinetic and clinical evidence for the use of once-daily cefazolin and probenecid in the treatment of skin and soft tissue infections (SSTI). MEDLINE (1966-July 2003), EMBASE (1980-July 2003), and PubMed (1966-July 2003) databases for English language, human reports were searched. Search terms included cefazolin, probenecid, cellulitis, and soft tissue infections. Studies that described pharmacokinetic and clinical outcomes that evaluated the use of cefazolin in conjunction with probenecid for SSTI were included. All studies were evaluated independently by both authors. For pharmacokinetic studies, the effect of probenecid on the pharmacokinetics of cefazolin was evaluated. For clinical trials, efficacy and safety endpoints were evaluated. For efficacy endpoints, definition of cure was used as defined by each trial. In all 3 pharmacokinetic studies identified, the addition of probenecid to cefazolin therapy prolonged the half-life and increased serum concentrations of cefazolin. This process allowed serum concentrations to be above the minimal inhibitory concentrations (MIC) for the most likely skin pathogens (Staphylococcus aureus, beta-hemolytic streptococci) at the end of the dosing interval. In the first of 2 clinical trials, 7 (7%) of 96 patients receiving intravenous ceftriaxone 2 g and oral probenecid 1 g daily were reported to fail therapy compared with 8 (8%) of 98 patients receiving intravenous cefazolin 2 g and oral probenecid 1 g daily. In the second clinical trial, clinical success was reported in 51 (86%) of 59 patients receiving the same doses of cefazolin and probenecid as above compared with 55 (96%) of 57 patients receiving intravenous ceftriaxone 1 g and oral placebo daily. Limited pharmacokinetic and clinical data suggest that intravenous cefazolin 2 g and oral probenecid 1 g daily is an effective regimen in the treatment of SSTI.

  11. A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy

    Directory of Open Access Journals (Sweden)

    Samuel L Washington III

    2010-08-01

    Full Text Available Samuel L Washington III1, Alan W Shindel21School of Medicine, University of California at San Francisco, San Francisco, California, USA; 2Department of Urology, University of California at San Francisco, San Francisco, California, USAAbstract: Selective phosphodiesterase type 5 inhibitors (PDE5Is have revolutionized the ­treatment of erectile dysfunction (ED in men. As an on-demand treatment, PDE5Is have excellent efficacy and safety in the treatment of ED due to a broad spectrum of etiologies. Nevertheless, these drugs do have side-effect profiles that are troublesome to some patients, eg, headache, dyspepsia, myalgia, etc. Furthermore, many patients and their partners dislike the necessity of on-demand treatment for ED, citing a desire for greater spontaneity with sexual interactions. In 2008, approximately 10 years after the release of the first commercially available PDE5I, a paradigm shift in the management of ED occurred with the approval of once-daily dose of tadalafil by the US Food and Drug Administration for the management of ED. The prolonged half-life of tadalafil lends itself well to this dosing regimen and conveys the advantage of separating medication from sexual interactions; lower dose therapy also carries the theoretical benefit of lower incidence of side effects. In this study, we review the current state of the art with respect to this new management strategy for ED, highlighting published reports of the efficacy and tolerability of the daily dose tadalafil regimen.Keywords: PDE5 inhibitor, on-demand therapy, side effects, daily dosing

  12. Comparison of twice-daily vs once-daily deferasirox dosing in a gerbil model of iron cardiomyopathy

    Science.gov (United States)

    Otto-Duessel, Maya; Aguilar, Michelle; Nick, Hanspeter; Moats, Rex; Wood, John C.

    2010-01-01

    Objective Despite the availability of deferoxamine chelation therapy for more than 20 years, iron cardiomyopathy remains the leading cause of death in thalassemia major patients. Effective chelation of cardiac iron is difficult; cardiac iron stores respond more slowly to chelation therapy and require a constant gradient of labile iron species between serum and myocytes. We have previously demonstrated the efficacy of once-daily deferasirox in removing previously stored cardiac iron in the gerbil, but changes in cardiac iron were relatively modest compared with hepatic iron. We postulated that daily divided dosing, by sustaining a longer labile iron gradient from myocytes to serum, would produce better cardiac iron chelation than a comparable daily dose. Methods Twenty-four 8- to 10-week-old female gerbils underwent iron dextran—loading for 10 weeks, followed by a 1-week iron equilibration period. Animals were divided into three treatment groups of eight animals each and were treated with deferasirox 100 mg/kg/day as a single dose, deferasirox 100 mg/kg/day daily divided dose, or sham chelation for a total of 12 weeks. Following euthanasia, organs were harvested for quantitative iron and tissue histology. Results Hepatic and cardiac iron contents were not statistically different between the daily single-dose and daily divided-dose groups. However, the ratio of cardiac to hepatic iron content was lower in the divided-dose group (0.78% vs 1.11%, p = 0.0007). Conclusion Daily divided dosing of deferasirox changes the relative cardiac and liver iron chelation profile compared with daily single dosing, trading improvements in cardiac iron elimination for less-effective hepatic chelation. PMID:17588475

  13. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson’s Disease

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    Ji Young Yun

    2017-01-01

    Full Text Available This open-label study aimed to compare once-daily and twice-daily pramipexole extended release (PER treatment in Parkinson’s disease (PD. PD patients on dopamine agonist therapy, but with unsatisfactory control, were enrolled. Existing agonist doses were switched into equivalent PER doses. Subjects were consecutively enrolled into either once-daily-first or twice-daily-first groups and received the prescribed amount in one or two, respectively, daily doses for 8 weeks. For the second period, subjects switched regimens in a crossover manner. The forty-four patients completed a questionnaire requesting preference during their last visit. We measured the UPDRS-III, Hoehn and Yahr stages (H&Y in medication-on state, Parkinson’s disease sleep scale (PDSS, and Epworth Sleepiness Scale. Eighteen patients preferred a twice-daily regimen, 12 preferred a once-daily regimen, and 14 had no preference. After the trial, 14 subjects wanted to be on a once-daily regimen, 25 chose a twice-daily regimen, and 5 wanted to maintain the prestudy regimen. Main reasons for choosing the twice-daily regimen were decreased off-duration, more tolerable off-symptoms, and psychological stability. The mean UPDRS-III, H&Y, and PDSS were not different. Daytime sleepiness was significantly high in the once-daily regimen, whereas nocturnal hallucinations were more common in the twice-daily. Multiple dosing should be considered if once-daily dosing is unsatisfactory. This study is registered as NCT01515774 at ClinicalTrials.gov.

  14. Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus

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    Petersen AB

    2013-06-01

    Full Text Available Andreas B Petersen,1 Mikkel Christensen1,21Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark; 2Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, DenmarkAbstract: The glucagon-like peptide (GLP-1 receptor agonist lixisenatide (Lyxumia® was approved for marketing by the European Medicines Agency in February 2013 and has been evaluated in a clinical study program called GetGoal. Lixisenatide activates the GLP-1 receptor and thereby exercises the range of physiological effects generated by GLP-1, which consist of increased insulin secretion, inhibition of glucagon secretion, and decreased gastrointestinal motility alongside the promotion of satiety. In the GetGoal study program, lixisenatide demonstrated significant reductions in glycated hemoglobin (HbA1c, and fasting and postprandial plasma glucose compared with placebo. The effect on glycemia was evident, with both monotherapy and in combination with insulin and various oral antidiabetic agents. Furthermore, a general trend towards reduced bodyweight was reported. In head-to-head trials with the other GLP-1 receptor agonists (exenatide and liraglutide on the market, lixisenatide demonstrated a superior effect with respect to reduction in postprandial plasma glucose and had a tendency towards fewer adverse events. However, lixisenatide seemed to be less efficient or at best, equivalent to exenatide and liraglutide in reducing HbA1c, fasting plasma glucose, and bodyweight. The combination of a substantial effect on postprandial plasma glucose and a labeling with once daily administration separates lixisenatide from the other GLP-1 receptor agonists. The combination of basal insulin, having a lowering effect on fasting plasma glucose, and lixisenatide, curtailing the postprandial glucose excursions, makes sense from a clinical point of view. Not surprisingly, lixisenatide is undergoing clinical development as a combination

  15. Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500/100 mg together with 2 nucleos(tide reverse transcriptase inhibitors in real life: a multicentre prospective study

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    Terrón Alberto

    2010-03-01

    Full Text Available Abstract Background Ritonavir-boosted saquinavir (SQVr is nowadays regarded as an alternative antiretroviral drug probably due to several drawbacks, such as its high pill burden, twice daily dosing and the requirement of 200 mg ritonavir when given at the current standard 1000/100 mg bid dosing. Several once-daily SQVr dosing schemes have been studied with the 200 mg SQV old formulations, trying to overcome some of these disadvantages. SQV 500 mg strength tablets became available at the end of 2005, thus facilitating a once-daily regimen with fewer pills, although there is very limited experience with this formulation yet. Methods Prospective, multicentre study in which efficacy, safety and pharmacokinetics of a regimen of once-daily SQVr 1500/100 mg plus 2 NRTIs were evaluated under routine clinical care conditions in either antiretroviral-naïve patients or in those with no previous history of antiretroviral treatments and/or genotypic resistance tests suggesting SQV resistance. Plasma SQV trough levels were measured by HPLV-UV. Results Five hundred and fourteen caucasian patients were included (47.2% coinfected with hepatitis C and/or B virus; 7.8% with cirrhosis. Efficacy at 52 weeks (plasma RNA-HIV 95: 63.6 - 71.7% by intention-to-treat, and 92.2% (CI95: 89.8 - 94.6% by on-treatment analysis. The reasons for failure were: dropout or loss to follow-up (18.4%, virological failure (7.8%, adverse events (3.1%, and other reasons (4.6%. The high rate of dropout may be explained by an enrollement and follow-up under routine clinical care condition, and a population with a significant number of drug users. The median SQV Cmin (n = 49 was 295 ng/ml (range, 53-2172. The only variable associated with virological failure in the multivariate analysis was adherence (OR: 3.36; CI95, 1.51-7.46, p = 0.003. Conclusions Our results suggests that SQVr (1500/100 mg once-daily plus 2 NRTIs is an effective regimen, without severe clinical adverse events or

  16. Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500/100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life: a multicentre prospective study.

    Science.gov (United States)

    López-Cortés, Luis F; Viciana, Pompeyo; Ruiz-Valderas, Rosa; Pasquau, Juan; Ruiz, Josefa; Lozano, Fernando; Merino, Dolores; Vergara, Antonio; Terrón, Alberto; González, Luis; Rivero, Antonio; Muñoz-Sanz, Agustin

    2010-03-17

    Ritonavir-boosted saquinavir (SQVr) is nowadays regarded as an alternative antiretroviral drug probably due to several drawbacks, such as its high pill burden, twice daily dosing and the requirement of 200 mg ritonavir when given at the current standard 1000/100 mg bid dosing. Several once-daily SQVr dosing schemes have been studied with the 200 mg SQV old formulations, trying to overcome some of these disadvantages. SQV 500 mg strength tablets became available at the end of 2005, thus facilitating a once-daily regimen with fewer pills, although there is very limited experience with this formulation yet. Prospective, multicentre study in which efficacy, safety and pharmacokinetics of a regimen of once-daily SQVr 1500/100 mg plus 2 NRTIs were evaluated under routine clinical care conditions in either antiretroviral-naïve patients or in those with no previous history of antiretroviral treatments and/or genotypic resistance tests suggesting SQV resistance. Plasma SQV trough levels were measured by HPLV-UV. Five hundred and fourteen caucasian patients were included (47.2% coinfected with hepatitis C and/or B virus; 7.8% with cirrhosis). Efficacy at 52 weeks (plasma RNA-HIV <50 copies/ml) was 67.7% (CI95: 63.6 - 71.7%) by intention-to-treat, and 92.2% (CI95: 89.8 - 94.6%) by on-treatment analysis. The reasons for failure were: dropout or loss to follow-up (18.4%), virological failure (7.8%), adverse events (3.1%), and other reasons (4.6%). The high rate of dropout may be explained by an enrollment and follow-up under routine clinical care condition, and a population with a significant number of drug users. The median SQV Cmin (n = 49) was 295 ng/ml (range, 53-2172). The only variable associated with virological failure in the multivariate analysis was adherence (OR: 3.36; CI95, 1.51-7.46, p = 0.003). Our results suggests that SQVr (1500/100 mg) once-daily plus 2 NRTIs is an effective regimen, without severe clinical adverse events or hepatotoxicity, scarce lipid

  17. The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals

    NARCIS (Netherlands)

    van Heeswijk, R. P.; Veldkamp, A. I.; Mulder, J. W.; Meenhorst, P. L.; Wit, F. W.; Lange, J. M.; Danner, S. A.; Foudraine, N. A.; Kwakkelstein, M. O.; Reiss, P.; Beijnen, J. H.; Hoetelmans, R. M.

    2000-01-01

    OBJECTIVE: To investigate and to compare the steady-state plasma pharmacokinetics of nevirapine in a dosing regimen of 400 mg once daily versus 200 mg twice daily in HIV-1-infected individuals. DESIGN: Open-label, randomized, cross-over study. METHODS: Twenty HIV-1-infected individuals who already

  18. Once-daily dosing of saquinavir and low-dose ritonavir in HIV-1-infected individuals: a pharmacokinetic pilot study

    NARCIS (Netherlands)

    van Heeswijk, R. P.; Veldkamp, A. I.; Mulder, J. W.; Meenhorst, P. L.; Lange, J. M.; Beijnen, J. H.; Hoetelmans, R. M.

    2000-01-01

    To investigate the steady-state pharmacokinetics of a once-daily dosing regimen of saquinavir soft gelatin capsules in combination with a low dose of ritonavir in HIV-1-infected individuals. Open-label, multi-dose, pharmacokinetic pilot study. Seven HIV-1-infected individuals who were treated with

  19. Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    S Yu Vorotnikova

    2012-09-01

    Full Text Available Реферат по статье: Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus Juliana Levy, Roberta A Cobas, Marilia B Gomes. Diabetol Metab Syndr. 2010 Mar 18; 2:16.

  20. Pharmacokinetic evaluation of a sprinkle-dose regimen of a once-daily, extended-release morphine formulation.

    Science.gov (United States)

    Eliot, Lise; Butler, Jackie; Devane, John; Loewen, Gordon

    2002-02-01

    Morphine sulfate extended-release (MSER) uses a drug-delivery technology that allows once-daily dosing. It is possible to open the MSER capsule and sprinkle the contents on soft food, a potentially useful alternative to the intact capsule in patients who have difficulty swallowing. This study compared the bioavailability of MSER and its metabolites morphine-3-glucuronide and morphine-6-glucuronide after administration of MSER in a sprinkle-dose regimen relative to an intact capsule swallowed whole. This was a randomized, open-label, single-dose, crossover study, with a 7-day washout period between the 2 dosing days. Healthy volunteers were randomized to receive an intact 60-mg MSER capsule swallowed whole or the contents of a 60-mg MSER capsule sprinkled on applesauce. Blood samples were collected and analyzed for concentrations of morphine and its active glucuronide metabolites. Pharmacokinetic (PK) parameters were calculated and bioequivalence assessed. Bioequivalence was concluded if the 90% CIs of the ratio of log-transformed values for maximum concentration (Cmax) and area under the plasma concentration-time curve (AUC) were within 80% to 125%. Of 30 subjects enrolled, 28 completed the study and were eligible for PK evaluation. Two subjects were withdrawn for reasons unrelated to study treatment. The plasma concentration-time profiles of morphine and its metabolites were superimposable after administration of the 2 regimens. Cmax and total systemic exposure-based on AUC from time 0 to the last quantifiable concentration (AUC(last)) and AUC from time 0 to infinity (AUC(infinity))-were comparable between treatments. The 90% CIs for morphine AUC(last), AUC, and Cmax ratios were 98 to 109, 96 to 106, and 95 to 117, respectively. Similar 90% CIs were obtained for the morphine metabolites. In this study in healthy volunteers, sprinkling the entire contents of an MSER capsule onto applesauce and swallowing without chewing was bioequivalent to swallowing an intact

  1. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action.

    Science.gov (United States)

    Heise, Tim; Korsatko, Stefan; Nosek, Leszek; Coester, Hans Veit; Deller, Sigrid; Roepstorff, Carsten; Segel, Stine; Kapur, Rahul; Haahr, Hanne; Hompesch, Marcus

    2016-01-01

    Various factors influence the pharmacokinetic and pharmacodynamic properties of insulin analogs. The aim of the present study was to determine time to steady state of insulin degludec (IDeg), a basal insulin analog with an ultralong duration of action, after once-daily subcutaneous administration in subjects of varying age, diabetes type, and ethnicity. Time to steady state was analyzed in 195 subjects across five Phase I randomized single-center double-blind studies: three in subjects with type 1 diabetes (T1DM), including one in elderly subjects, and two in subjects with type 2 diabetes (T2DM), including one with African American and Hispanic/Latino subpopulations. Subjects received once-daily IDeg (100 U/mL, s.c.) at doses of 0.4-0.8 U/kg for 6-12 days. Time to clinical steady state was measured from first dose until the serum IDeg trough concentration exceeded 90% of the final plateau level. The IDeg concentrations were log-transformed and analyzed using a mixed-effects model with time from first dose and dose level (where applicable) as fixed effects, and subject as a random effect. Steady state serum IDeg concentrations were reached after 2-3 days in all subjects. In trials with multiple dose levels, time to steady state was independent of dose level in T1DM (P = 0.51) and T2DM (P = 0.75). Serum IDeg concentrations reached steady state within 2-3 days of once-daily subcutaneous administration in all subjects with T1DM or T2DM, including elderly and African American and Hispanic/Latino subjects. At steady state, serum IDeg concentrations were unchanged from day to day. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  2. Pharmacokinetics and Pharmacodynamics of Twice Daily and Once Daily Regimens of Empagliflozin in Healthy Subjects.

    Science.gov (United States)

    Macha, Sreeraj; Brand, Tobias; Meinicke, Thomas; Link, Jasmin; Broedl, Uli C

    2015-08-01

    This study was undertaken to compare the steady-state pharmacokinetic and pharmacodynamic properties of empagliflozin 5 mg twice daily (BID) and 10 mg once daily (QD) in healthy subjects. In an open-label, 2-way crossover study, subjects (n = 16) received empagliflozin 5 mg BID for 5 days and empagliflozin 10 mg QD for 5 days in a randomized order, with a washout period of ≥6 days between each treatment. The primary objective was the comparison of the overall exposure during a 24-hour period at steady state (AUC0-24,ss) for empagliflozin, based on standard bioequivalence criteria, with BID and QD dose regimens. The study population comprised 7 (43.8%) men and 9 (56.3%) women with a baseline median age of 38.0 years (range, 23-47 years) and a median body mass index of 23.3 kg/m(2) (range, 19.8-27.8 kg/m(2)). Based on standard bioequivalence criteria, there was no difference in the overall exposure of empagliflozin between BID and QD dose regimens (geometric mean ratio of AUC0-24,ss for empagliflozin 5 mg BID compared with empagliflozin 10 mg QD = 99.36%; 90% CI, 94.29-104.71). For empagliflozin 10 mg QD, mean (%CV) AUC during the dosing interval was 1900 nmol · h/L (20.6%), mean (%CV) Cmax,ss was 330 nmol/L (25.3%), and median (range) Tmax,ss was 1.0 hour (0.7-2.0 hours). For empagliflozin 5 mg BID, mean (%CV) AUC during the dosing interval was 1010 nmol · h/L (15.1%) and 867 nmol · h/L (18.6%) after the morning and evening dose, respectively, mean (%CV) Cmax,ss was 193 nmol/L (16.5%) and 120 nmol/L (21.0%), respectively, and median Tmax,ss was 1.0 hour (range, 0.7-2.0 hours) and 2.0 hours (range, 1.0-4.0 hours), respectively. The mean (%CV) cumulative amount of glucose excreted in urine during 24 hours was 52.1 g (32.1%) with empagliflozin 5 mg BID and 43.9 g (30.3%) with empagliflozin 10 mg QD. Adverse events were reported in six subjects (37.5%) receiving empagliflozin 5 mg BID and four (25.0%) receiving empagliflozin 10 mg QD. Headache was the most frequent

  3. Is Time an Important Problem in Management of Hypertension and Hypercholesterolemia by Using an Amlodipine-Atorvastatin Single Pill Combination?

    Science.gov (United States)

    Zeng, Rui; Wang, Mian; Zhang, Li

    2016-07-26

    BACKGROUND Is the timing of dosing for amlodipine and atorvastatin important with regard to therapeutic efficacy? To answer this question, we designed an outpatient, practice-based, case-control study lasting 8 weeks. MATERIAL AND METHODS Two hundred patients were divided into 2 groups: in Group I, patients were provided with a single pill containing amlodipine/atorvastatin (5/20 mg) to be taken each night at 10 pm, and in Group II, patients were taking amlodipine (5 mg) and atorvastatin (20 mg) each morning at 7 am. RESULTS Our results indicated no obvious difference in blood pressure control between the 2 groups. Taking amlodipine at night not only lowered blood pressure, but it also provided better control during the peak blood pressure in the morning. Hypercholesterolemia control in the 2 groups was also not significantly different, taking atorvastatin in the morning was as effective as dosing at night in patients with hypercholesterolemia. While the carotid IMT, hs-CRP, and LVMI were significantly lower after treatment, no differences were found between the 2 groups. Although no obvious difference was found in adverse drug reactions between the 2 groups, compliance was much better in the single-pill group than in patients taking the 2 medications separately. CONCLUSIONS In conclusion, single-pill amlodipine-atorvastatin taken at night can lower blood pressure and reduce the morning peak blood pressure levels the next day. Additionally, this dosing method could improve patient adherence to the therapy.

  4. Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.

    Science.gov (United States)

    McCracken, James T; Biederman, Joseph; Greenhill, Laurence L; Swanson, James M; McGough, James J; Spencer, Thomas J; Posner, Kelly; Wigal, Sharon; Pataki, Caroly; Zhang, Yuxin; Tulloch, Simon

    2003-06-01

    This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381. This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period. SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo. These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.

  5. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris.

    Science.gov (United States)

    Jarratt, Michael T; Jones, Terry M; Chang-Lin, Joan-En; Tong, Warren; Berk, David R; Lin, Vince; Kaoukhov, Alexandre

    2016-10-01

    Reducing the dosing frequency of topical acne treatments to once daily may improve adherence. Evaluate pharmacokinetics (PK), safety, and tolerability of 3 formulations of once-daily dapsone gel, 7.5% and of twice-daily dapsone gel, 5% over 28 days in patients with moderate acne vulgaris. This phase 1, multicenter, parallel-group study randomized males and females aged 16 to 35 years to 1 of 3 dapsone gel, 7.5% formulations (DAP-11078, DAP-11079, or DAP-11080 double-blind; applied once daily) or to dapsone gel, 5% (investigator-blinded only, applied twice-daily). Blood samples were collected for PK assessments of dapsone and its metabolites, N-acetyl dapsone (NAD) and dapsone hydroxylamine (DHA), before the morning dose on days 1, 7, 14, 18, 21, 26, 27, and 28, and at several follow-up time points (days 29-32). Safety profile assessments included adverse events (AEs), physical examinations, laboratory tests, and local tolerability assessments. Steady-state dapsone, NAD, and DHA concentrations were reached within 7 days of the first dose in all treatment groups. Daily systemic exposures of the 3 dapsone gel, 7.5% formulations were approximately 25% to 40% lower than that for dapsone gel, 5%, and these differences were statistically significant. Among the 3 dapsone gel, 7.5% formulations, the highest daily exposure of dapsone (per the AUC) was observed with DAP-11080, with respective Cmax and AUC0-24 being approximately 28.6% and 28.7% lower relative to dapsone gel, 5%. Most AEs were mild to moderate in intensity. The safety profiles for all 3 formulations of once-daily dapsone, 7.5% gel and twice-daily dapsone gel, 5% were similar following 28 days of topical administration. All 4 dapsone formulations were well tolerated. This study demonstrated lower systemic exposure with all 3 once-daily dapsone gel, 7.5% formulations than with twice-daily dapsone gel, 5%. All 4 formulations were well tolerated and demonstrated similar safety profiles. J Drugs Dermatol. 2016;15(10):1250-1259.

  6. Bioavailability of oxycodone after administration of a new prolonged-release once-daily tablet formulation in healthy subjects, in comparison to an established twice-daily tablet
.

    Science.gov (United States)

    Scheidel, Bernhard; Maritz, Martina A; Gschwind, Yves J; Steigerwald, Kerstin; Guth, Volker; Kovacs, Peter; Rey, Helene

    2017-11-01

    To evaluate and to compare the bioavailability, the influence of food intake on the bioavailability, and the safety and tolerability of a newly-developed oxycodone once-daily (OOD) prolonged-release tablet with an established oxycodone twice-daily (OTD) prolonged-release tablet after single-dose administration under fasting or fed conditions as well as after multiple-dose administration. Three single-center, open-label, randomized, balanced, two-treatment, two-period, two-sequence crossover studies were conducted. In each study, 36 healthy volunteers were randomized to receive 10 mg oxycodone daily as OOD (oxycodone HCL 10-mg PR tablets XL (Develco Pharma Schweiz AG, Pratteln, Switzerland); administration of 1 tablet in the morning) or as OTD (reference formulation: oxygesic 5-mg tablets (Mundipharma GmbH, Limburg an der Lahn, Germany); administration of 1 tablet in the morning and 1 tablet in the evening). Tablets were administered once daily or twice daily under fasting conditions (study 1) or under fed conditions (study 2) as well as after multiple-dose administration (study 3). A sufficient number of blood samples were taken for describing plasma profiles and for calculation of pharmacokinetic parameters. Plasma concentrations of oxycodone were determined by LC-MS/MS. Safety and tolerability were monitored and assessed in all three studies. Plasma profiles of OOD reveal sustained concentrations of oxycodone over the complete dosing interval of 24 hours. In comparison to the OTD reference formulation, the OOD test formulation showed a slightly slower increase of concentrations within the absorption phase and similar plasma concentrations at the maximum and at the end of the dosing interval (24 hours). Extent of bioavailability (AUC), maximum plasma concentrations (Cmax), and plasma concentrations at the end of the dosing interval (Cτ,ss,24h) of OOD could be classified as comparable to OTD considering 90% confidence intervals (CIs) and acceptance limits of 80

  7. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone.

    Science.gov (United States)

    Bateman, Eric D; O'Byrne, Paul M; Busse, William W; Lötvall, Jan; Bleecker, Eugene R; Andersen, Leslie; Jacques, Loretta; Frith, Lucy; Lim, Jessica; Woodcock, Ashley

    2014-04-01

    Combination therapy with an inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma. To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in patients with uncontrolled asthma. This randomised double-blind comparative study of variable duration (≥ 24-78 weeks) was designed to finish after 330 events (each patient's first on-treatment severe asthma exacerbation). 2019 patients with asthma aged ≥ 12 years with ≥ 1 recorded exacerbation within 1 year were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening. The primary endpoint was time to first severe exacerbation; secondary endpoints were rate of severe asthma exacerbations per patient per year and change in trough evening forced expiratory volume in 1 s (FEV1) from baseline. Compared with FF, FF/VI delayed the time to first severe exacerbation (HR 0.795, 95% CI 0.642 to 0.985) and reduced the annualised rate of severe exacerbations (rate reduction 25%, 95% CI 5% to 40%). Significantly greater improvements in trough FEV1 (pFF/VI than with FF at weeks 12, 36, 52 and at endpoint. Both treatments were well tolerated with similar rates of treatment-related adverse events and on-treatment serious adverse events. Once-daily FF/VI reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone, with good tolerability and safety profile in adolescents and adults with asthma currently receiving ICS. NCT01086384.

  8. Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months

    DEFF Research Database (Denmark)

    NN, NN; Valerius, Niels Henrik

    2010-01-01

    BACKGROUND: Once-daily dosing of abacavir and lamivudine has been approved for adults, but paediatric data are insufficient. We conducted a pharmacokinetic study of once-daily and twice-daily abacavir and lamivudine in children aged 3-... levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/kg) underwent plasma pharmacokinetic sampling. Children then switched to once-daily abacavir (16 mg/kg) with or without lamivudine (8 mg/kg), and sampling was repeated 4 weeks later. The area under......-pharmacokinetic data for abacavir (17 for lamivudine). The GMR of AUC(0-24), once-daily versus twice-daily, was 1.07 (90% CI 0.92-1.23) for abacavir and 0.91 (90% CI 0.79-1.06) for lamivudine. C(max) almost doubled on once-daily versus twice...

  9. Once-daily delayed-release metformin lowers plasma glucose and enhances fasting and postprandial GLP-1 and PYY: results from two randomised trials.

    Science.gov (United States)

    DeFronzo, Ralph A; Buse, John B; Kim, Terri; Burns, Colleen; Skare, Sharon; Baron, Alain; Fineman, Mark

    2016-08-01

    Delayed-release metformin (Metformin DR) was developed to maximise gut-based mechanisms of metformin action by targeting the drug to the ileum. Metformin DR was evaluated in two studies. Study 1 compared the bioavailability and effects on circulating glucose and gut hormones (glucagon-like peptide-1, peptide YY) of Metformin DR dosed twice-daily to twice-daily immediate-release metformin (Metformin IR). Study 2 compared the bioavailability and glycaemic effects of Metformin DR dosages of 1,000 mg once-daily in the morning, 1,000 mg once-daily in the evening, and 500 mg twice-daily. Study 1 was a blinded, randomised, crossover study (three × 5 day treatment periods) of twice-daily 500 mg or 1,000 mg Metformin DR vs twice-daily 1,000 mg Metformin IR in 24 participants with type 2 diabetes conducted at two study sites (Celerion Inc.; Tempe, AZ, and Lincoln, NE, USA). Plasma glucose and gut hormones were assessed over 10.25 h at the start and end of each treatment period; plasma metformin was measured over 11 h at the end of each treatment period. Study 2 was a non-blinded, randomised, crossover study (three × 7 day treatment periods) of 1,000 mg Metformin DR once-daily in the morning, 1,000 mg Metformin DR once-daily in the evening, or 500 mg Metformin DR twice-daily in 26 participants with type 2 diabetes performed at a single study site (Celerion, Tempe, AZ). Plasma glucose was assessed over 24 h at the start and end of each treatment period, and plasma metformin was measured over 30 h at the end of each treatment period. Both studies implemented centrally generated computer-based randomisation using a 1:1:1 allocation ratio. A total of 24 randomised participants were included in study 1; of these, 19 completed the study and were included in the evaluable population. In the evaluable population, all treatments produced similar significant reductions in fasting glucose (median reduction range, -0.67 to -0.81 mmol/l across treatments) and

  10. Clinical impact of laboratory error on therapeutic drug monitoring of once-daily tobramycin in cystic fibrosis: Case series

    Directory of Open Access Journals (Sweden)

    William A Prescott

    2014-01-01

    Full Text Available Once-daily dosing intravenous tobramycin is commonly used to treat cystic fibrosis pulmonary exacerbations. Clinicians often utilize historical therapeutic drug monitoring data to individualize the dose among patients who have been treated with tobramycin previously. This case series involves three patients with cystic fibrosis who had supra-therapeutic tobramycin levels despite use of a once-daily dosing that produced therapeutic drug levels during a previous hospital admission, raising questions about the validity of these levels. Investigation into several potential sources of error led to the discovery of an analyzer error in the laboratory. Once the laboratory’s tobramycin analyzer was recalibrated, the reported levels were comparable to historical levels. This case series emphasizes the clinical importance of critically analyzing reported levels, and specifically, the importance of utilizing past therapeutic drug monitoring data, if available, for all patients treated with intravenous tobramycin. If a patient was therapeutic on a similar dose of tobramycin during a previous admission, a dose adjustment may not be necessary, and clinicians should consider repeating levels while pursuing alternative explanations for the discrepant serum levels.

  11. Once-Daily Tacrolimus Extended-Release Formulation: 1 Year after Conversion in Stable Pediatric Kidney Transplant Recipients

    Directory of Open Access Journals (Sweden)

    Lars Pape

    2011-01-01

    Full Text Available It is speculated that a once-daily dosage of immunosuppression can increase adherence and thereby graft survival. Until now, there have been no studies on once-daily use of Tacrolimus extended-release formulation (TAC-ER in children following pediatric kidney transplantation. In 11 stable pediatric kidney recipients >10 years, efficacy, safety, and tolerability of a switch to TAC-ER were observed over one year. Adherence was determined by use of the BAASIS-Scale Interview and comparison of individual variability of Tacrolimus trough levels. Over the observation period, two acute rejections were observed in one girl with nonadherence and repeated Tacrolimus trough levels of 0 ng/m. Beside this, there were no acute rejections in this trial. TAC dose was increased in 3/11 patients and decreased in 2/11 patients within the course of the study. Six patients did not require a dose adjustment. All but one patient had a maximum of 1 dose change during therapy. Mean Tacrolimus dose, trough levels, and Glomerular filtration rates were also stable. Adherence, as measured by BAASIS-Scale Interview and coefficient of variation of Tacrolimus trough levels, was good at all times. It is concluded that conversion to Tac-ER is safe in low-risk children following pediatric kidney transplantation.

  12. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis.

    Science.gov (United States)

    Lee, Laurie A; Sterling, Richard; Máspero, Jorge; Clements, Diane; Ellsworth, Anna; Pedersen, Soren

    2014-01-01

    The effect of fluticasone furoate nasal spray (FFNS) on growth in prepubescent children has not been evaluated. To characterize the difference in mean prepubescent growth velocities, as determined by stadiometry, between patients treated continuously for 1 year with FFNS 110 mcg once daily and placebo nasal spray. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group 76-week safety study. Nasal symptom assessments were used as a measure of adherence. Eligible patients were ages 5 to velocity was 5.19 cm/y for the FFNS group and 5.46 cm/y for the placebo group; mean difference, -0.270 cm/y (95% CI, -0.48 to -0.06 cm/y). Other safety assessments, including 24-hour urinary cortisol excretion, were comparable between the treatment groups. Daily reflective total nasal symptom scores declined similarly in both the FFNS and placebo groups. Once-daily treatment with FFNS over 52 weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo. Clinicians will need to balance the reduction in growth observed with FFNS to its potential for clinical benefit. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  13. Comparing the effect of multiple-dose and once-daily regimens of gentamicin therapy on fraction excretion of magnesium

    Directory of Open Access Journals (Sweden)

    Hossein Khalili

    2006-05-01

    Full Text Available This study was designed to compare the influence of ordinary (multiple-dose and once-daily administration of gentamicin on tubular nephrotoxicity based on the urinary excretion of magnesium (Mg as an indicator for this type of side effect. Thirty-two hospitalized patients, who were assigned to receive at least 5-days treatment with gentamicin at the infectious disease ward of Imam Hospital in Tehran, were prospectively studied. Seventeen patients received multiple-doses of gentamicin per day and 15 patients received once-daily regimen. At the beginning and at the end of of gentamicin therapy, blood urea, serum creatinine (Cr and Mg levels were measured. Additionally 24-hour urine samples were collected for measurement of urinary volume, creatinine and Mg excretions. In both treatment groups serum Mg concentration was significantly lower and fraction excretion of (FEMg were considerably higher at the end of gentamicin therapy compared with the beginning of the treatment. However, the serum and urinary creatinine levels did not change significantly in the two groups

  14. Randomized Comparative Study of the Effects of Treatment with Once-Daily, Niacin Extended-Release/Lovastatin and with Simvastatin on Lipid Profile and Fibrinolytic Parameters in Taiwan

    Directory of Open Access Journals (Sweden)

    Tsung-Hsien Lin

    2006-06-01

    Full Text Available Hyperlipidemia can be effectively treated either with niacin or HMG-CoA reductase inhibitor (statin, or a combination of both. Few reports showed the effects of the combination regimen with niacin and statin on hemostatic functions. We conducted a single-center, double-blind, double-dummy, randomized, two-arm study to assess the effects of the niacin extended-release/lovastatin therapy in a fixed-dose formulation and of simvastatin on lipid lowering and two fibrinolytic parameters, fibrinogen and d-dimer. All patients were enrolled according to NCEP-ATP III guidelines and underwent a placebo run-in period of 4 weeks before being randomized to either niacin extended-release/lovastatin tablets (500/20 mg once daily (n = 36 or simvastatin capsule (20 mg once daily (n = 34. After 16 weeks of treatment, both groups of patients showed significantly reduced low-density lipoprotein cholesterol and total cholesterol (LDL-C, p < 0.001 and < 0.001, respectively, p = 0.159 between the groups; TC, p < 0.001 and < 0.001, respectively, p = 0.018 between the groups. Both drugs were well tolerated. Only in the group treated with niacin extended-release/lovastatin was fibrinogen concentration significantly reduced after treatment (2.48 ± 0.65 to 1.99 ± 0.62 g/L, p = 0.008. No difference was found with d-dimer in either group. This study shows that both niacin extended-release/ lovastatin and simvastatin are effective and well-tolerated lipid-lowering drugs in Taiwanese patients with dyslipidemia. A combinational treatment with niacin extended-release/lovastatin may provide additional benefit in fibrinolysis.

  15. Efficacy and safety of empagliflozin twice daily versus once daily in patients with type 2 diabetes inadequately controlled on metformin: a 16-week, randomized, placebo-controlled trial.

    Science.gov (United States)

    Ross, S; Thamer, C; Cescutti, J; Meinicke, T; Woerle, H J; Broedl, U C

    2015-07-01

    Patients with type 2 diabetes mellitus (T2DM) with a glycated haemoglobin (HbA1c) level ≥7 and ≤10% were randomized to receive empagliflozin 12.5 mg twice daily (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once daily (n = 220), or placebo (n = 107) as add-on to stable-dose metformin immediate release (IR) twice daily for 16 weeks. The primary endpoint was change from baseline in HbA1c at week 16. At week 16, change from baseline in HbA1c with empagliflozin twice daily was non-inferior to empagliflozin once daily and vice versa. The adjusted mean (95% confidence interval) difference in change from baseline in HbA1c with empagliflozin 12.5 mg twice daily versus 25 mg once daily was -0.11% (-0.26, 0.03), and with empagliflozin 5 mg twice daily versus 10 mg once daily it was -0.02% (-0.16, 0.13). All empagliflozin regimens were well tolerated; thus, when used as add-on to metformin IR in patients with T2DM, the therapeutic effect of empagliflozin twice-daily and once-daily regimens can be considered equivalent. © 2015 John Wiley & Sons Ltd.

  16. Accelerated partial breast irradiation using once-daily fractionation: analysis of 312 cases with four years median follow-up

    Directory of Open Access Journals (Sweden)

    Shaikh Arif Y

    2012-02-01

    Full Text Available Abstract Background There are limited data on accelerated partial breast irradiation (APBI using external beam techniques. Moreover, there are recent reports of increased fibrosis and unacceptable cosmesis with APBI using external beam with BID fractionation. We adopted a once daily regimen of APBI with fractionation similar to that shown to be effective in a Canadian randomized trial of whole breast irradiation. It is unclear whether patients with DCIS or invasive lobular carcinoma (ILC are suitable for APBI. Methods The retrospective cohort included 310 patients with 312 tumors of T1-T2N0-N1micM0 invasive ductal carcinoma (IDC, ILC, or Tis (DCIS treated with APBI via external beam. Most patients were treated using IMRT with 16 daily fractions of 270 cGy to a dose of 4320 cGy. The target volume included the lumpectomy cavity plus 1.0 cm to account for microscopic disease and an additional 0.5 to 1.0 cm for setup uncertainty and breathing motion. Ipsilateral breast failure (IBF was pathologically confirmed as a local failure (LF or an elsewhere failure (EF. Results Median follow-up was 49 months. Among the 312 cases, 213 were IDC, 31 ILC, and 68 DCIS. Median tumor size was 1.0 cm. There were 9 IBFs (2.9% including 5 LFs and 4 EFs. The IBF rates among patients with IDC, ILC, and DCIS were 2.4%, 3.2%, and 4.4%, respectively, with no significant difference between histologies. When patients were analyzed by the ASTRO APBI consensus statement risk groups, 32% of treated cases were considered suitable, 50% cautionary, and 18% unsuitable. The IBF rates among suitable, cautionary, and unsuitable patients were 4.0%, 2.6%, and 1.8%, respectively, with no significant difference between risk groups. Acute skin reactions were rare and long-term cosmetic outcome was very good to excellent. Conclusions External beam APBI with once daily fractionation has a low rate of IBF consistent with other published APBI studies. The ASTRO risk stratification did not

  17. Comparative steady-state pharmacokinetic evaluation of immediate-release topiramate and USL255, a once-daily extended-release topiramate formulation.

    Science.gov (United States)

    Bialer, Meir; Shekh-Ahmad, Tawfeeq; Braun, Tricia L; Halvorsen, Mark B

    2013-08-01

    Compare the pharmacokinetic (PK) profiles of immediate- and extended-release formulations of topiramate (TPM) in healthy subjects following multiple dosing, and evaluate maintenance of topiramate exposures after switching formulations. A randomized, open-label, single-center, two-way crossover, multiple-dose study comparing the steady-state PK profile of once-daily extended-release topiramate (USL255) to immediate-release topiramate (TPM-IR) administered twice-daily. The TPM PK profile was evaluated using standard PK parameters (e.g., AUC0-24 , Cmax , Cmin ) as well as less common PK criteria such as fluctuation index (FI), peak occupancy time (POT), and percent coefficient of variation (%CV). In addition, partial AUC (AUCp ) analyses provided comparisons of the AUC profiles over predetermined time intervals between TPM-IR and USL255. Pharmacokinetic equivalence between formulations was defined as containment of the 90% confidence intervals (CIs) of the USL255/TPM-IR geometric least-squares mean (GLSM) ratio within the equivalence limits of 80-125%. The effect of switching between treatments was assessed by evaluating equivalence of PK parameters between the day prior to formulation switch and the day immediately following formulation switch. Maintenance of steady state after switching formulations was also evaluated by comparing the slope between Cmin values at formulation switch and 24 h postswitch. Tolerability was evaluated through adverse event monitoring, vital sign measurements, and clinical laboratory evaluations. USL255 was well tolerated and provided TPM plasma exposure equivalent to TPM-IR at various time intervals. USL255 also demonstrated a significantly lower Cmax (p TPM-IR. Further, switching between TPM-IR and USL255 did not affect TPM concentrations, including Cmin , immediately after transitioning and at steady state. As compared with TPM-IR, USL255 provided equivalent plasma exposure with an extended absorption profile. Therefore, USL255 offers a

  18. An open-label, 1-year extension study of the long-term safety and efficacy of once-daily OROS® hydromorphone in patients with chronic cancer pain

    Directory of Open Access Journals (Sweden)

    Tuca Alberto

    2009-09-01

    Full Text Available Abstract Background Opioid analgesics have proven efficacy in the short-term management of chronic cancer pain, but data on their long-term use is more limited. OROS® hydromorphone is a controlled-release formulation of oral hydromorphone that may be particularly well suited to long-term management of chronic cancer pain because it provides stable plasma concentrations and consistent analgesia with convenient once-daily dosing. The objective of this study (DO-118X was to characterise the pain control achieved with long-term repeated dosing of OROS® hydromorphone in patients with chronic cancer pain. Methods In this multicentre, phase III, open-label, single treatment, 1-year extension study, OROS® hydromorphone was administered to 68 patients with moderate-to-severe chronic cancer pain, who had successfully completed a short-term equivalence study, and whose pain was controlled with a stable dose of medication (≥ 8 mg OROS® hydromorphone or equivalent controlled-release morphine. Patients were started on the dose of OROS® hydromorphone equivalent to the opioid dose on which they achieved dose-stable pain control in the equivalence study; dose adjustments were made as necessary and breakthrough pain medication was permitted. Efficacy was assessed with the Brief Pain Inventory (BPI and patient and investigator global evaluations of treatment effectiveness. No formal statistical analysis was done. Results The mean (standard deviation duration of exposure to study medication was 139 (129.9 days and the mean (standard deviation average daily consumption of OROS® hydromorphone was 43.7 (28.14 mg/day. All scores were maintained at a mild to moderate severity throughout the study; however, BPI scores for pain at its worst, pain at its least, pain on average, pain right now, and pain relief were slightly worsened at end point compared with baseline. Mean BPI pain interference with daily activities and patient and investigator global evaluation

  19. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients.

    Science.gov (United States)

    Davidson, Geoffrey; Wenzl, Tobias G; Thomson, Michael; Omari, Taher; Barker, Peter; Lundborg, Per; Illueca, Marta

    2013-09-01

    To evaluate the efficacy and safety of proton pump inhibitors in infants aged esomeprazole 0.5 mg/kg or placebo once daily for up to 14 days. Change from baseline in the total number of GERD symptoms (from video monitoring) and GERD-related signs (from cardiorespiratory monitoring) was assessed with simultaneous esophageal pH, impedance, cardiorespiratory, and 8-hour video monitoring. There were no significant differences between the esomeprazole and placebo groups in the percentage change from baseline in the total number of GERD-related signs and symptoms (-14.7% vs -14.1%, respectively). Mean change from baseline in total number of reflux episodes was not significantly different between esomeprazole and placebo (-7.43 vs -0.2, respectively); however, the percentage of time pH was 5 minutes in duration was significantly decreased with esomeprazole vs placebo (-10.7 vs 2.2 and -5.5 vs 1.0, respectively; P ≤ .0017). The number of patients with adverse events was similar between treatment groups. Signs and symptoms of GERD traditionally attributed to acidic reflux in neonates were not significantly altered by esomeprazole treatment. Esomeprazole was well tolerated and reduced esophageal acid exposure and the number of acidic reflux events in neonates. Copyright © 2013 Mosby, Inc. All rights reserved.

  20. NRPB 'pill'

    International Nuclear Information System (INIS)

    Martin, S.; Arnott, D.

    1985-01-01

    The National Radiological Protection Board circulated a leaflet entitled 'Advice for general practitioners in the event of a civil nuclear emergency' in July 1985 to doctors' surgeries in the vicinity of nuclear power stations in England and Wales. The leaflet is reviewed and the scientific background to the 'anti-radiation' potassium iodate pill is explained. (author)

  1. Can combining different risk interventions into a single formulation contribute to improved cardiovascular disease risk reduction? The single pill of amlodipine/atorvastatin

    Directory of Open Access Journals (Sweden)

    FD Richard Hobbs

    2007-11-01

    Full Text Available FD Richard HobbsUniversity of Birmingham, Edgbaston, Birmingham B15 2TT, UK.Abstract: In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program investigated the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients. The JEWEL program consisted of two 16-week, international, openlabel, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The two studies differed based on country of enrollment and certain tertiary endpoints, but the overall designs were very similar. Patients were enrolled from 255 centers across Canada and 13 European countries. The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single pill therapy in a real-world setting. Patients were initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and were uptitrated as necessary. The primary efficacy parameter was the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II and the same single goal for LDL-C across all study participants (JEWEL I and II. The program utilized a newly developed questionnaire to gain better understanding of participants’ beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850

  2. Profile of once-daily darunavir/cobicistat fixed-dose combination for the treatment of HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Navarro J

    2016-10-01

    Full Text Available Jordi Navarro, Adrian Curran Infectious Diseases Department, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain Abstract: Efficacy is the main objective of antiretroviral treatment and adherence is one of the cornerstones to achieve it. For this reason, treatment simplification is of key importance with regard to antiretroviral regimens. Rezolsta® (darunavir/cobicistat is the first fixed-dose combination containing a protease inhibitor approved for HIV treatment. This coformulation includes darunavir, a protease inhibitor that has shown its efficacy and safety in naïve and treatment-experienced patients, and cobicistat, the new pharmacokinetic enhancer that is expected to replace ritonavir. Bioequivalence between ritonavir and cobicistat as darunavir boosters has been shown in studies involving healthy volunteers. Furthermore, efficacy and safety of darunavir/cobicistat observed in phase III studies, including naïve and pretreated patients without darunavir-associated resistance mutations, are comparable to historical data of darunavir/ritonavir 800/100 mg once-daily formulation. Adverse events with darunavir/cobicistat are scarce and mild, and basically include skin reactions and gastrointestinal disturbances. Although small increases in plasma creatinine are expected in patients receiving cobicistat due to the inhibition of creatinine transporters in kidney tubules, actual glomerular filtrate rate remains unaltered. Cobicistat does not have an inducer effect on metabolic pathways and shows much more selective inhibition than ritonavir. Therefore, isoenzyms different from CYP3A4 are supposed to be less affected by cobicistat, and thus fewer drug–drug interactions are expected. Keywords: darunavir, cobicistat, fixed-dose combination, HIV infection, antiretroviral treatment

  3. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing.

    Science.gov (United States)

    Kempsford, Rodger D; Oliver, Amanda; Bal, Joanne; Tombs, Lee; Quinn, Dean

    2013-12-01

    To investigate the effect of time of day of dosing (morning or evening) on lung function following administration of fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg. Double-blind, placebo-controlled, randomised, three-way crossover study. Subjects with persistent asthma (N = 26) received FF/VI (morning or evening) or matching placebo once-daily for 14 (± 2 days) via dry powder inhaler (DPI). Weighted mean (0-24h) and pre-treatment FEV1 (morning and evening) were determined after the Day 14 evening dose, together with mean pre-treatment (morning and evening) peak expiratory flow (PEF) on Days 2-12. FF/VI 100/25 administered morning or evening produced clinically significant increases in weighted mean FEV1: the differences [95% confidence interval (CI)] from placebo were 377 mL [293, 462] and 422 mL [337, 507], respectively; the difference between morning and evening dosing was -44 mL [-125, 36]. Day 14 pre-treatment morning FEV1 differences [95% CI] from placebo were 403 mL [272, 533] and 496 mL [369, 624] after morning and evening dosing, respectively; the morning:evening treatment difference was -94 mL [-221, 34]. Pre-treatment evening FEV1 differences [95% CI] from placebo were 275 mL [169, 380] and 309 mL [205, 413] after morning and evening dosing, respectively; the morning:evening treatment difference was -34 mL [-138, 70]. FF/VI (morning or evening) produced rapid increases in PEF with the full effect apparent after the first dose and maintained throughout the 14-day treatment period. FF/VI 100/25 produces comparable improvements in lung function whether dosed in the morning or evening in subjects with persistent asthma. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Automated telecommunication-based reminders and adherence with once-daily glaucoma medication dosing: the automated dosing reminder study.

    Science.gov (United States)

    Boland, Michael V; Chang, Dolly S; Frazier, Travis; Plyler, Ryan; Jefferys, Joan L; Friedman, David S

    2014-07-01

    Topical glaucoma medications lower intraocular pressure and alter the course of the disease. Because adherence with glaucoma medications is a known problem, interventions are needed to help those patients who do not take their medications as prescribed. To assess the ability of an automated telecommunication-based intervention to improve adherence with glaucoma medications. We performed a prospective cohort study of medication adherence, followed by a randomized intervention for those found to be nonadherent, of individuals recruited from a university-based glaucoma subspecialty clinic. A total of 491 participants were enrolled in the initial assessment of adherence. Of those, 70 were nonadherent with their medications after 3 months of electronic monitoring and randomized to intervention and control groups. A personal health record was used to store the list of patient medications and reminder preferences. On the basis of those data, participants randomized to the intervention received daily messages, either text or voice, reminding them to take their medication. Participants randomized to the control group received usual care. Difference in adherence before and after initiation of the intervention. Using an intent-to-treat analysis, we found that the median adherence rate in the 38 participants randomized to the intervention increased from 53% to 64% (P telecommunication-based reminders linked to data in a personal health record improved adherence with once-daily glaucoma medications. This is an effective method to improve adherence that could realistically be implemented in ophthalmology practices with a minimum amount of effort on the part of the practice or the patient.

  5. Twice-daily versus once-daily antiretroviral therapy and coformulation strategies in HIV-infected adults: benefits, risks, or burden?

    Directory of Open Access Journals (Sweden)

    Nachega JB

    2011-12-01

    Full Text Available Jean B Nachega1–3, Bernd Rosenkranz4, Paul A Pham51Department of International Health, 2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 3Department of Medicine and Centre for Infectious Diseases, 4Division of Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Stellenbosch, Capetown, South Africa; 5Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USAAbstract: The recent development of once-daily antiretroviral agents and fixed-dose combination formulations has been an important development in antiretroviral regimen simplification. Recent studies indicate that once-daily antiretroviral regimens improve adherence, especially in antiretroviral-naïve patients and in difficult-to-treat populations, such as the homeless or marginally housed. However, there are potential risks with the higher peak and lower trough plasma drug concentrations that may result from certain once-daily formulations. Due to the multifactorial and complex nature of adherence behavior, clinicians’ efforts to improve patient adherence should not be limited to prescribing once-daily regimens, but should also consider social support, side effect management, and adherence support tools, such as pillbox organizers and other targeted interventions. Additional research will clarify the benefits of once-daily and fixed-dose combination regimens on clinical and virologic outcomes. Comprehensive cost-benefit analysis of regimen simplification could help facilitate evidence-based decisions regarding antiretroviral regimen choices.Keywords: regimen adherence, regimen simplification, health care costs, fixed-dose combination, once-daily antiretroviral drugs

  6. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use).

    Science.gov (United States)

    Philis-Tsimikas, Athena; Brod, Meryl; Niemeyer, Marcus; Ocampo Francisco, Ann Marie; Rothman, Jeffrey

    2013-06-01

    Insulin degludec (IDeg) is a new basal insulin in development with a flat, ultra-long action profile that may permit dosing using a simplified titration algorithm with less frequent self-measured blood glucose (SMBG) measurements and more simplified titration steps than currently available basal insulins. This 26-week, multi-center, open-label, randomized, treat-to-target study compared the efficacy and safety of IDeg administered once-daily in combination with metformin in insulin-naïve subjects with type 2 diabetes using two different patient-driven titration algorithms: a "Simple" algorithm, with dose adjustments based on one pre-breakfast SMBG measurement (n = 111) versus a "Step-wise" algorithm, with adjustments based on three consecutive pre-breakfast SMBG values (n = 111). IDeg was administered using the FlexTouch® insulin pen (Novo Nordisk A/S, Bagsværd, Denmark), with once-weekly dose titration in both groups. Glycosylated hemoglobin (HbA1c) decreased from baseline to week 26 in both groups (-1.09%, IDegSimple; -0.93%, IDegStep-wise). IDegSimple was non-inferior to IDegStep-wise in lowering HbA1c [estimated treatment difference (IDegSimple - IDegStep-wise): -0.16% points (-0.39; 0.07)95% CI]. Fasting plasma glucose was reduced (-3.27 mmol/L, IDegSimple; -2.68 mmol/L, IDegStep-wise) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDegSimple; 1.17, IDegStep-wise events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDegSimple; 0.10, IDegStep-wise events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDegSimple) and 0.50 U/kg (IDegStep-wise). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDegSimple; +1.1 kg, IDegStep-wise), and there were no clinically relevant differences in adverse event profiles. IDeg was effective and well tolerated using either the Simple or Step-wise titration

  7. Blood Pressure Control with a Single-Pill Combination of Indapamide Sustained-Release and Amlodipine in Patients with Hypertension: The EFFICIENT Study

    OpenAIRE

    Jadhav, Uday; Hiremath, Jagdish; Namjoshi, Deepak J.; Gujral, Vinod K.; Tripathi, Kamlakar K.; Siraj, Mohammad; Shamanna, Paramesh; Safar, Michel

    2014-01-01

    OBJECTIVE: Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release (SR) indapamide, a thiazide-like diuretic, and amlodipine, a calcium channel blocker (CCB), in the management of hypertension. METHODS: Patients who were previously uncontrolled on CCB monotherapy (BP≥140/90 mm Hg) or were previousl...

  8. Tamsulosin 0.4 mg once daily: effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction

    NARCIS (Netherlands)

    Höfner, K.; Claes, H.; de Reijke, T. M.; Folkestad, B.; Speakman, M. J.

    1999-01-01

    To evaluate the effect of tamsulosin, 0.4 mg once daily, on sexual function in comparison with placebo and alfuzosin, 2.5 mg three times daily, in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). Data from 830 patients randomized into three European

  9. Pharmacodynamics and Pharmacokinetics Following Once-Daily and Twice-Daily Dosing of Tiotropium Respimat(®) in Asthma Using Standardized Sample-Contamination Avoidance

    DEFF Research Database (Denmark)

    Beeh, Kai-Michael; Kirsten, Anne-Marie; Dusser, Daniel

    2016-01-01

    BACKGROUND: This study was conducted to confirm the 24-hour bronchodilator efficacy and pharmacokinetic profile of once-daily tiotropium Respimat(®) 5 μg add-on to inhaled corticosteroids (ICS) in adults with symptomatic asthma. It used a trial protocol designed to minimize the risk of pharmacoki...

  10. 12-Month safety and effectiveness of once-daily hydrocodone tablets formulated with abuse-deterrent properties in patients with moderate to severe chronic pain.

    Science.gov (United States)

    Wen, Warren; Taber, Louise; Lynch, Shau Yu; He, Ellie; Ripa, Steven

    2015-01-01

    To characterize the long-term safety and effectiveness of Hysingla™ ER, single-entity, once-daily, extended-release hydrocodone bitartrate tablets formulated with abuse-deterrent properties (HYD), offering a new treatment option for appropriate patients with chronic pain. An open-label study with a dose-titration period (up to 45 days) and a maintenance period (12 months). A total of 922 patients with chronic nonmalignant and non-neuropathic moderate to severe pain received open-label HYD tablets 20-120 mg; 728 of these achieved a stabilized dose of HYD at the end of dose-titration and entered the maintenance period. The safety profile was similar to that of other oral opioid analgesics, without new or unexpected safety concerns. The most frequent treatment-emergent adverse events (AEs; ≥ 5 percent) were those commonly associated with the use of systemic µ-opioid analgesics, including nausea, constipation, vomiting, fatigue, dizziness, somnolence, and headache. There were 77 (8 percent) patients with a total of 109 nonfatal treatment-emergent serious AEs. Few patients discontinued due to lack of therapeutic effect overall (6 percent), especially during the 12-month maintenance period (4 percent). Pain relief, sleep, functional health, and activities of daily living all improved at the end of the dose-titration period with HYD. These improvements were maintained through the 12-month maintenance period with stable HYD doses and without increase in concomitant supplemental analgesic medications. This long-term study demonstrated the safety and long-term maintenance of analgesic effect of HYD without continued need for dose increase.

  11. Adherence to GLP-1 receptor agonist therapy administered by once-daily or once-weekly injection in patients with type 2 diabetes in Germany

    Directory of Open Access Journals (Sweden)

    Qiao Q

    2016-06-01

    Full Text Available Qing Qiao,1 Mario JNM Ouwens,1 Susan Grandy,2 Kristina Johnsson,1 Karel Kostev3 1Global Medicines Development, AstraZeneca, Gothenburg, Sweden; 2Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA; 3Epidemiology and Evidence-Based Medicine, Real-World Evidence Solutions, IMS Health, Frankfurt am Main, Germany Aim: This study aimed to compare 6-month adherence to therapy with exenatide once weekly (Bydureon® vs liraglutide once daily (Victoza® in patients with type 2 diabetes under primary care in Germany.Methods: A nationwide longitudinal prescription database (LRx, (between January 2011 and September 2014 was used to analyze adherence to therapy. The proportion of days covered (PDC by prescription was used as a measure of adherence in the 6-month postindex period. Logistic regression analyses were performed to investigate the associations between glucagon-like peptide-1 receptor agonist therapy adjusting for age, sex, and cotherapy.Results: Therapy was initiated in 5,449 patients with exenatide once weekly (age: 59.7±11.8 years; 51.4% were male and in 24,648 patients with liraglutide once daily (age: 59.4±11.4 years; 49.7% were male. The median PDC was 0.88 for exenatide once weekly and 0.77 for liraglutide once daily (P<0.05. Once-weekly exenatide was associated with significantly higher adherence. Odds ratio (95% confidence interval for having a PDC of ≥0.80 was 1.78 (1.62–1.96 for exenatide once weekly compared with liraglutide once daily after adjusting for age, sex, and cotherapy.Conclusion: Adherence to treatment with exenatide once weekly was significantly increased compared to that with liraglutide once daily over 6 months in patients with type 2 diabetes. Keywords: type 2 diabetes, GLP-1 receptor agonists, adherence

  12. ABORTION PILL

    Directory of Open Access Journals (Sweden)

    Alenka Pretnar-Darovec

    2002-05-01

    Full Text Available Background. This contribution describes the history of the abortion pill, its introduction in the world and in our country. On the basis of the findings of the studies, carried out since the early ’80s, the authors provide the indications and contraindications for the application of the method.Conclusions. The most efficient method for termination of an early pregnancy with least adverse side effects is the combination of drugs, viz. 1 tablet of mifepristone (200 mg administered orally and 4 tablets (4 × 200 mcg of misoprostol applied vaginally.

  13. Birth control pills - combination

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000655.htm Birth control pills - combination To use the sharing features ... contain both progestin and estrogen. What Are Combination Birth Control Pills? Birth control pills help keep you ...

  14. Adherence to and Acceptance of Once-Daily Tacrolimus After Kidney and Liver Transplant: Results From OSIRIS, a French Observational Study.

    Science.gov (United States)

    Cassuto, Elisabeth; Pageaux, Georges P; Cantarovich, Diego; Rostaing, Lionel; Loupy, Alexandre; Roche, Bruno; Duvoux, Christophe; Moreau, Karine; Thervet, Eric; Mazouz, Hakim; Bourhis, Yann; Dharancy, Sébastien; Kessler, Michèle

    2016-10-01

    Adherence to immunosuppressive treatments is a major concern in transplanted patients. This 6-month French observational, longitudinal, prospective study aimed to assess patient adherence to and acceptance of once-daily tacrolimus (Advagraf) initiation in kidney and liver transplant recipients. Data from 1106 patients initiating once-daily tacrolimus during posttransplant follow-up were analyzed. Adherence and acceptance were assessed using self-administered questionnaires at inclusion and at 3 and 6 months. Mean age was 52.4 ± 13.2 years, 61.5% were men. For 94.9% of patients, once-daily tacrolimus was prescribed after switching from twice-daily tacrolimus. At inclusion, 20.9% of patients reported good treatment adherence, 72.0% minor nonadherence, and 7.1% were nonadherent. Mean general acceptance score (range, 0-100) was 77.7 (±24.7). At 3 months, adherence was improved in 21.1%, unchanged in 69.2%, and worsened in 9.7% of patients. Mean general acceptance score was 75.4 (±26.5). General acceptance score was improved in 28.0%, unchanged in 39.4%, and worsened in 32.7% of patients. At 6 months, similar changes in adherence and acceptance were observed. Higher general acceptance score at month 3 was significantly associated with better adherence at month 6. Conversion to once-daily tacrolimus led to an improved rate of adherence at month 3 in more than 20% of patients and a worsened rate of adherence in less than 10% of patients.

  15. Three-year outcomes of a once daily fractionation scheme for accelerated partial breast irradiation (APBI) using 3-D conformal radiotherapy (3D-CRT)

    International Nuclear Information System (INIS)

    Goyal, Sharad; Daroui, Parima; Khan, Atif J; Kearney, Thomas; Kirstein, Laurie; Haffty, Bruce G

    2013-01-01

    The aim of this study was to report 3-year outcomes of toxicity, cosmesis, and local control using a once daily fractionation scheme (49.95 Gy in 3.33 Gy once daily fractions) for accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT). Between July 2008 and August 2010, women aged ≥40 years with ductal carcinoma in situ or node-negative invasive breast cancer ≤3 cm in diameter, treated with breast-conserving surgery achieving negative margins, were accrued to a prospective study. Women were treated with APBI using 3–5 photon beams, delivering 49.95 Gy over 15 once daily fractions over 3 weeks. Patients were assessed for toxicities, cosmesis, and local control rates before APBI and at specified time points. Thirty-four patients (mean age 60 years) with Tis 0 (n = 9) and T1N0 (n = 25) breast cancer were treated and followed up for an average of 39 months. Only 3% (1/34) patients experienced a grade 3 subcutaneous fibrosis and breast edema and 97% of the patients had good/excellent cosmetic outcome at 3 years. The 3-year rate of ipsilateral breast tumor recurrence (IBTR) was 0% while the rate of contralateral breast events was 6%. The 3-year disease-free survival (DFS), overall survival (OS), and breast cancer-specific survival (BCSS) was 94%, 100%, and 100%, respectively. Our novel accelerated partial breast fractionation scheme of 15 once daily fractions of 3.33 Gy (49.95 Gy total) is a remarkably well-tolerated regimen of 3D-CRT-based APBI. A larger cohort of patients is needed to further ascertain the toxicity of this accelerated partial breast regimen

  16. An observational study evaluating tacrolimus dose, exposure, and medication adherence after conversion from twice- to once-daily tacrolimus in liver and kidney transplant recipients.

    Science.gov (United States)

    Bäckman, Lars; Persson, Carl-Axel

    2014-03-17

    Immunosuppression regimens in transplantation medicine are complex. Drugs with extended release action have simplified medication dosing without affecting efficacy. This prospective, observational, multicenter study, conducted in a routine medical practice setting, evaluated changes in tacrolimus daily dose and trough levels and patient-reported medication adherence at day 90 after 1:1 (mg: mg) conversion to once-daily tacrolimus in adult liver and kidney transplant recipients. Data from 224 recipients of a liver (n=19) or kidney (n=205) transplant, average age 51±14.5 years, were evaluated. The mean change in tacrolimus daily dose was +0.04 mg/day. Dose remained stable after conversion in 62.5%, was lower in 15.6%, and higher in 22% of patients. Trough level after conversion was lower in 62.6% and higher in 36.5%; generally, levels were 12.8% lower than pre-conversion levels. No acute rejection, graft loss, or serious safety events were observed. Two deaths occurred due to myocardial infarction. Conversion helped 19% to less frequently forget medications and 55% reported no difference in remembering to take the once-daily dose after conversion. The change in dosing frequency was identified as "better" for 55%. Tacrolimus daily dose remained stable while trough levels were significantly lower after conversion to once-daily dosing. Safety and efficacy were maintained; reduced dosing frequency had no apparent influence on patient-reported medication adherence.

  17. Birth Control Pill

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Birth Control Pill KidsHealth / For Teens / Birth Control Pill What's in this article? What Is ... español La píldora anticonceptiva What Is It? The birth control pill (also called "the Pill") is a ...

  18. Efficacy of twice-daily vs once-daily sessions of repetitive transcranial magnetic stimulation in the treatment of major depressive disorder: a retrospective study

    Directory of Open Access Journals (Sweden)

    Modirrousta M

    2018-01-01

    Full Text Available Mandana Modirrousta,1,2 Benjamin P Meek,2 Sara L Wikstrom2 1Department of Psychiatry, University of Manitoba, 2Mental Health, Saint Boniface General Hospital, Winnipeg, MB, Canada Purpose: There is no clinical consensus on the optimal protocol for the treatment of major depressive disorder (MDD using repetitive transcranial magnetic stimulation (rTMS. Accelerated protocols using more than a single session of treatment per day have been suggested as a means to reduce the overall length of time required for rTMS therapy. The objective of this study is to compare the treatment outcomes of patients with MDD who received two sessions of rTMS per day vs those who received one session per day, keeping the overall number of delivered pulses constant.Patients and methods: In a retrospective study, we compared treatment outcomes of 36 patients with MDD who received 30 sessions of high-frequency (10 Hz rTMS over the left dorsolateral prefrontal cortex. Patients received 3,000 pulses per session (5 s trains, 25 s intertrain interval at 110% of resting motor threshold using a figure-eight coil. Patients received either two rTMS sessions per day (n=17 or one session per day (n=19. Depression symptoms were assessed by a psychiatrist using the Hamilton Rating Scale for Depression at baseline and after every 10 sessions of rTMS.Results: The majority of patients in both groups responded to treatment, and there was a trend toward greater response rate in the twice-daily (TD group (82.4% compared to the once-daily (OD group (52.6%. TD stimulation was tolerable for patients and produced no adverse side effects. Patients in the TD group experienced an improvement in symptoms faster than the OD group due to the accelerated therapy period.Conclusion: Administration of two rTMS treatment sessions per day is tolerable for patients and does not seem to be inferior in efficacy to a OD protocol. TD administration has the benefit of producing symptom improvement over a

  19. Compliance, clinical outcome, and quality of life of patients with stable angina pectoris receiving once-daily betaxolol versus twice daily metoprolol: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Przemyslaw Kardas

    2007-05-01

    Full Text Available Przemyslaw KardasThe First Department of Family Medicine, Medical University of LodzBackground: A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris.Methods: One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life.Results: The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01, and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001. The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01. The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01, correct interdose intervals (77.4% v 53.1%, p < 0.0001, and therapeutic coverage (85.6% vs 73.7%, p < 0.001 were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions.Conclusions: The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris.Keywords: patient compliance, quality of life, stable angina pectoris, randomized controlled trial

  20. Once-daily trospium chloride 60 mg extended-release provides effective, long-term relief of overactive bladder syndrome symptoms.

    Science.gov (United States)

    Zinner, Norman R; Dmochowski, Roger R; Staskin, David R; Siami, Paul F; Sand, Peter K; Oefelein, Michael G

    2011-09-01

    Once-daily extended-release (XR) trospium chloride has been evaluated for the treatment of overactive bladder syndrome (OAB) in two 12-week randomized, double-blind, placebo-controlled studies. This pooled analysis of the 9-month open-label extensions to these studies evaluated the long-term efficacy and tolerability of trospium XR. Following double-blind treatment, subjects with OAB could enter the open-label period, during which they received trospium 60 mg XR once daily for 36 weeks. The primary efficacy variables were changes from baseline in the number of toilet voids and urgency urinary incontinence (UUI) episodes per day at Week 48. Adverse events (AEs) were also recorded. Of the 1,027 subjects who completed double-blind treatment, 944 (92%) continued into the open-label period (placebo-to-trospium, N = 483; trospium-to-trospium, N = 461); 332 (68.7%) and 335 (72.7%), respectively, completed the open-label period. At Week 48, the mean change from baseline in the number of toilet voids/day was -3.21 in the placebo-to-trospium group and -3.35 in the trospium-to-trospium group, and the median change from baseline in the number of UUI episodes/day was -2.33 in both groups. Efficacy was maintained relative to Week 12 in trospium-to-trospium subjects, while improvement was seen following trospium initiation in placebo-to-trospium subjects. Improvement from baseline was also observed on secondary efficacy parameters at Week 48. Trospium was well tolerated; dry mouth and constipation were the most common class treatment-emergent AEs. Central nervous system AEs were rare and did not increase with long-term treatment. Long-term treatment of OAB with once-daily trospium 60 mg XR is effective and well tolerated. Copyright © 2011 Wiley-Liss, Inc.

  1. Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial.

    Science.gov (United States)

    Palmieri, A; Imbimbo, C; Creta, M; Verze, P; Fusco, F; Mirone, V

    2012-04-01

    Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction. © 2011 The Authors. International Journal of Andrology © 2011 European Academy of Andrology.

  2. Protocol for the CONVERT trial-Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status.

    Science.gov (United States)

    Faivre-Finn, Corinne; Falk, Sally; Ashcroft, Linda; Bewley, Michelle; Lorigan, Paul; Wilson, Elena; Groom, Nicki; Snee, Michael; Fournel, Pierre; Cardenal, Felipe; Bezjak, Andrea; Blackhall, Fiona

    2016-01-20

    Concurrent ONce-daily VErsus twice-daily RadioTherapy (CONVERT) is the only multicentre, international, randomised, phase III trial open in Europe and Canada looking at optimisation of chemoradiotherapy (RT) in limited stage small cell lung cancer (LS-SCLC). Following on from the Turrisi trial of once-daily versus twice-daily (BD) concurrent chemoradiotherapy, there is a real need for a new phase III trial using modern conformal RT techniques and investigating higher once-daily radiation dose. This trial has the potential to define a new standard chemo-RT regimen for patients with LS-SCLC and good performance status. 447 patients with histologically or cytologically proven diagnosis of SCLC were recruited from 74 centres in eight countries between 2008 and 2013. Patients were randomised to receive either concurrent twice-daily RT(45 Gy in 30 twice-daily fractions over 3 weeks) or concurrent once-daily RT(66 Gy in 33 once-daily fractions over 6.5 weeks) both starting on day 22 of cycle 1. Patients are followed up until death. The primary end point of the study is overall survival and secondary end points include local progression-free survival, metastasis-free survival, acute and late toxicity based on the Common Terminology Criteria for Adverse Events V.3.0, chemotherapy and RTdose intensity. The trial received ethical approval from NRES Committee North West-Greater Manchester Central (07/H1008/229). There is a trial steering committee, including independent members and an independent data monitoring committee. Results will be published in a peer-reviewed journal and presented at international conferences. ISRCTN91927162; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Changes in body weight, blood pressure and selected metabolic biomarkers with an energy-restricted diet including twice daily sweet snacks and once daily sugar-free beverage

    OpenAIRE

    Nickols-Richardson, Sharon M.; Piehowski, Kathryn E.; Metzgar, Catherine J.; Miller, Debra L.; Preston, Amy G.

    2014-01-01

    BACKGROUND/OBJECTIVES The type of sweet snack incorporated into an energy-restricted diet (ERD) may produce differential effects on metabolic improvements associated with body weight (BW) loss. This study compared effects of incorporating either twice daily energy-controlled dark chocolate snacks plus once daily sugar-free cocoa beverage (DC) to non-chocolate snacks plus sugar-free non-cocoa beverage (NC) into an ERD on BW loss and metabolic outcomes. MATERIALS/METHODS In an 18-week randomize...

  4. Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2014-01-01

    BACKGROUND AND AIM: Long-acting bronchodilators are the preferred option for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the clinical efficacy of the once-daily fixed-dose du...... for chronic Obstructive Lung Disease [GOLD] spirometric criteria). Furthermore, a very recent study has shown that fixed-dose indacaterol/glycopyrronium improves exercise endurance time compared with placebo, although no significant difference was observed between fixed-dose indacaterol...

  5. Birth control pills - overview

    Science.gov (United States)

    ... from taking birth control pills include: Blood clots Heart attack High blood pressure Stroke Birth control pills without estrogen are much less likely to cause these problems. The risk is higher for women ...

  6. Birth control pill - slideshow

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/presentations/100108.htm Birth control pill - series—Normal female anatomy To use ... to produce a successful pregnancy. To prevent pregnancy, birth control pills affect how these organs normally function. ...

  7. Efficacy and safety of once-daily metronidazole 1% gel compared with twice-daily azelaic acid 15% gel in the treatment of rosacea.

    Science.gov (United States)

    Wolf, John E; Kerrouche, Nabil; Arsonnaud, Stephanie

    2006-04-01

    Rosacea is an inflammatory dermatologic disorder characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. The National Rosacea Society has established a classification system that identifies 4 distinct rosacea subtypes based on clinical presentation: erythematotelangiectatic, papulopustular, phymatous, and ocular. The goal of topical therapy for rosacea is to reduce inflammatory lesion counts; decrease intensity of erythema; and reduce symptoms such as stinging, burning, and pruritus. Metronidazole and azelaic acid are thought to reduce the inflammation associated with rosacea by inhibiting the production of reactive oxygen species produced by neutrophils. Both metronidazole 1% gel and azelaic acid 15% gel recently have been approved for the treatment of rosacea. The current study was conducted to compare the once-daily application of metronidazole 1% gel with twice-daily applications of azelaic acid 15% gel for the treatment of patients with moderate rosacea (N=160). Both treatments showed similar reductions in inflammatory lesion counts (77% for metronidazole 1% gel and 80% for azelaic acid 15% gel) and high success rates in both global severity (53.7% vs 56.4% for metronidazole 1% gel and azelaic acid 15% gel, respectively) and erythema (42.7% vs 42.3% for metronidazole 1% gel and azelaic acid 15% gel, respectively). On average, the efficacy (including reduction in erythema) of the once-daily application of metronidazole 1% gel and twice-daily applications of azelaic acid 15% gel were similar.

  8. Reduction in labile plasma iron during treatment with deferasirox, a once-daily oral iron chelator, in heavily iron-overloaded patients with β-thalassaemia

    Science.gov (United States)

    Daar, Shahina; Pathare, Anil; Nick, Hanspeter; Kriemler-Krahn, Ulrike; Hmissi, Abdel; Habr, Dany; Taher, Ali

    2009-01-01

    This subgroup analysis evaluated the effect of once-daily oral deferasirox on labile plasma iron (LPI) levels in patients from the prospective, 1-yr, multicentre ESCALATOR study. Mean baseline liver iron concentration and median serum ferritin levels were 28.6 ± 10.3 mg Fe/g dry weight and 6334 ng/mL respectively, indicating high iron burden despite prior chelation therapy. Baseline LPI levels (0.98 ± 0.82 μmol/L) decreased significantly to 0.12 ± 0.16 μmol/L, 2 h after first deferasirox dose (P=0.0006). Reductions from pre- to post-deferasirox administration were also observed at all other time points. Compared to baseline, there was a significant reduction in preadministration LPI that reached the normal range at week 4 and throughout the remainder of the study (P≤0.02). Pharmacokinetic analysis demonstrated an inverse relationship between preadministration LPI levels and trough deferasirox plasma concentrations. Once-daily dosing with deferasirox ≥20 mg/kg/d provided sustained reduction in LPI levels in these heavily iron-overloaded patients, suggesting 24-h protection from LPI. Deferasirox may therefore reduce unregulated tissue iron loading and prevent further end-organ damage. PMID:19191863

  9. Impact of antiretroviral dosing frequency and pill burden on adherence among newly diagnosed, antiretroviral-naive HIV patients.

    Science.gov (United States)

    Buscher, A; Hartman, C; Kallen, M A; Giordano, T P

    2012-05-01

    There are few data on the impact of antiretroviral therapy (ART) regimen factors on adherence in ART-naïve HIV patients on contemporary once- or twice-daily regimens. Ninety-nine newly diagnosed patients in a prospective observational cohort study completed a visual analogue scale to assess their ART adherence. Adherence by type of ART and dosing frequency were compared by Brown-Mood median tests. Participants taking once-daily regimens had higher adherence (n = 70, 99.5%) compared with participants taking twice-daily regimens (n = 29, 94%; P = 0.01). Adherence of participants taking the fixed dose combination efavirenz-emtricitabine-tenofovir (n = 34, 100%) compared with those taking once-daily regimens of two or more pills was no different (n = 36, 99.3%; P = 0.34). Among a cohort of newly diagnosed ART-naïve patients, once-daily dosing of ART resulted in higher adherence than twice-daily dosing. Pill burden among once-daily regimens did not predict adherence, suggesting that factors other than pill burden should drive regimen selection.

  10. Single-tablet regimens in HIV: does it really make a difference?

    Science.gov (United States)

    Aldir, Isabel; Horta, Ana; Serrado, Margarida

    2014-01-01

    Review of the available data on the currently available single-tablet regimens (STRs), from the analysis of efficacy and safety to the key points of value in terms of adherence, quality of life and pharmacoeconomic evaluation. For this narrative review, literature searches have been performed in PubMed, IndexRevMed and Cochrane, using the search terms HIV, single-tablet, one-pill, single dose, fixed-dose, and STR. These have been reviewed and complemented with the most recent publications of interest. Fixed-dose combinations are a significant advance in antiretroviral treatment simplification, contributing to an increase in compliance with complex chronic therapies, thus improving patients' quality of life. Reducing the number of pills and daily doses is associated with higher adherence and better quality of life. As a fixed-dose combination tablet given once daily, EFV/FTC/TDF was the first available STR combining efficacy, tolerability and convenience, with the simplest dosing schedule and smallest numbers of pills of any ART combination therapy. The RPV/FTC/TDF is a next-generation NNRTI-based STR, a once daily complete ART regimen for the treatment of HIV-1 infection. Recently the combination of EVG/COBI/FTC/TDF was also approved by the European Commission, and is the first integrase inhibitor-based STR. Receiving antiretroviral therapy as once daily STR is associated with both clinical and economic benefits, which confirms previous research. The associated benefits of STRs provide a valid strategy for the treatment of HIV-infected patients.

  11. Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study.

    Directory of Open Access Journals (Sweden)

    Uday Jadhav

    Full Text Available OBJECTIVE: Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP, notably high systolic blood pressure (SBP. The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release (SR indapamide, a thiazide-like diuretic, and amlodipine, a calcium channel blocker (CCB, in the management of hypertension. METHODS: Patients who were previously uncontrolled on CCB monotherapy (BP≥140/90 mm Hg or were previously untreated with grade 2 or 3 essential hypertension (BP≥160/100 mm Hg received a single-pill combination tablet containing indapamide SR 1.5 mg and amlodipine 5 mg daily for 45 days, in this multicenter prospective phase 4 study. The primary outcome was mean change in BP from baseline; percentage of patients achieving BP control (BP<140/90 mm Hg was a secondary endpoint. SBP reduction (ΔSBP versus diastolic BP reduction (ΔDBP was evaluated (ΔSBP/ΔDBP from baseline to day 45. Safety and tolerability were also assessed. RESULTS: Mean baseline BP of 196 patients (mean age 52.3 years was 160.2/97.9 mm Hg. After 45 days, mean SBP decreased by 28.5 mm Hg (95% CI, 26.4 to 30.6, while diastolic BP decreased by 15.6 mm Hg (95% CI, 14.5 to 16.7. BP control (<140/90 mm Hg was achieved in 85% patients. ΔSBP/ΔDBP was 1.82 in the overall population. Few patients (n = 3 [2%] reported side effects, and most (n = 194 [99%] adhered to treatment. CONCLUSION: In patients who were previously uncontrolled on CCB monotherapy or untreated with grade 2 or 3 hypertension, single-pill combination indapamide SR/amlodipine reduced BP effectively--especially SBP--over 45 days, and was safe and well tolerated. TRIAL REGISTRATION: Clinical Trial Registry-India CTRI/2010/091/000114.

  12. A novel once daily microparticulate dosage form comprising lansoprazole to prevent nocturnal acid breakthrough in the case of gastro-esophageal reflux disease: preparation, pharmacokinetic and pharmacodynamic evaluation.

    Science.gov (United States)

    Alai, Milind; Lin, Wen Jen

    2013-01-01

    The objective of this study was to formulate and evaluate the lansoprazole (LPZ)-loaded microparticles to prevent nocturnal acid breakthrough in the case of gastro-esophageal reflux disease (GERD). The microparticulate delivery system was prepared by solvent evaporation method using Eudragit RS100 as a matrix polymer followed by enteric coated with Eudragit S100 and hydroxypropyl methylcellulose phthalate HP55 using spray drying method. The enteric coated microparticles were stable in gastric pH condition. In vivo pharmacokinetic and pharmacodynamic studies in male Wistar rats demonstrated that enteric coated microparticles sustained release of LPZ and promoted ulcer healing activity. In other words, the microparticulate dosage form provided effective drug concentration for a longer period as compared to conventional extended release dosage form, and showed sufficient anti-acid secretion activity to treat acid related disorders including the enrichment of nocturnal acid breakthrough event based on a once daily administration.

  13. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial

    Directory of Open Access Journals (Sweden)

    D'Urzo Anthony

    2011-12-01

    Full Text Available Abstract Background NVA237 is a once-daily dry-powder formulation of the long-acting muscarinic antagonist glycopyrronium bromide in development for the treatment of chronic obstructive pulmonary disease (COPD. The glycopyrronium bromide in COPD airways clinical study 1 (GLOW1 evaluated the efficacy, safety and tolerability of NVA237 in patients with moderate-to-severe COPD. Methods Patients with COPD with a smoking history of ≥ 10 pack-years, post-bronchodilator forced expiratory volume in 1 second (FEV1 1/forced vital capacity 1 antagonists permitted in patients stabilized on them prior to study entry. The primary outcome measure was trough FEV1 at Week 12. Results A total of 822 patients were randomized to NVA237 (n = 552 or placebo (n = 270. Least squares mean (± standard error trough FEV1 at Week 12 was significantly higher in patients receiving NVA237 (1.408 ± 0.0105 L, versus placebo (1.301 ± 0.0137 L; treatment difference 108 ± 14.8 mL, p 1 were apparent at the end of Day 1 and sustained through Week 26. FEV1 was significantly improved in the NVA237 group versus placebo throughout the 24-hour periods on Day 1 and at Weeks 12 and 26, and at all other visits and timepoints. Transition dyspnoea index focal scores and St. George's Respiratory Questionnaire scores were significantly improved with NVA237 versus placebo at Week 26, with treatment differences of 1.04 (p Conclusions Once-daily NVA237 was safe and well tolerated and provided rapid, sustained improvements in lung function, improvements in dyspnoea, and health-related quality of life, and reduced the risk of exacerbations and the use of rescue medication. Trial registration ClinicalTrials.gov: NCT01005901

  14. Once-daily intramuscular amikacin for outpatient treatment of lower urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli in children

    Science.gov (United States)

    Polat, Meltem; Kara, Soner Sertan

    2017-01-01

    Background The rise in community-acquired urinary tract infections (UTIs) with extended-spectrum β-lactamase (ESBL)-producing Escherichia coli strains raises the question of how to treat these infections effectively in pediatric outpatients. Amikacin has shown promising in vitro activity against ESBL-producing urinary isolates of E. coli; however, clinical data are limited. Objective To investigate the clinical and microbiological outcomes of community-acquired lower UTIs caused by ESBL-producing E. coli treated with outpatient amikacin in children. Materials and methods A retrospective cohort study was performed on pediatric patients aged ≥2 to 18 years treated as outpatients with intramuscular amikacin (given at a dose of 15 mg/kg/day once daily) for community-acquired lower UTIs caused by ESBL-producing E. coli, between January 2015 and December 2016. Results A total of 53 pediatric patients (38 females) were enrolled in this study. The median age was 4.7 years (range 3–12 years). All E. coli isolates were susceptible to amikacin with minimum inhibitory concentrations of ≤4 mg/L. The median duration of amikacin treatment was 6 days (range 3–7 days). Favorable clinical and bacteriological responses were observed in 51 of 53 (96%) patients. Development of resistance during treatment with amikacin was seen in only 1 patient (2%), who failed to respond to amikacin treatment and developed acute pyelonephritis with bacteremia. Relapsed lower UTI after initial treatment response occurred in 1 patient (2%) 2 weeks after completion of amikacin treatment. All patients had normal serum creatinine values at baseline, and no significant nephrotoxicity or ototoxicity was observed in any of the patients. Conclusion Our study suggests that once-daily intramuscular amikacin could be an alternative option for outpatient treatment of community-acquired lower UTIs caused by amikacin-susceptible ESBL-producing E. coli in pediatric patients with normal renal function, when

  15. Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy

    Directory of Open Access Journals (Sweden)

    Albertson TE

    2016-12-01

    Full Text Available Timothy E Albertson,1–3 Samuel W Bullick,1,3 Michael Schivo,1 Mark E Sutter2,3 1Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, 2Department of Emergency Medicine, School of Medicine, UC Davis, Sacramento, 3Department of Medicine, Veterans Administration Northern California Health Care System, Mather, CA, USA Abstract: The use of inhaled corticosteroids (ICSs plays a key role in the treatment of asthmatic patients, and international guidelines have designated ICSs as an early maintenance therapy in controlling asthma symptoms. When asthmatic patients remain symptomatic on ICSs, one common option is to add a long-acting beta2 agonist (LABA to the maintenance treatment. Fixed combination inhalers that contain both an ICS and a LABA have been popular for both chronic obstructive pulmonary disease (COPD and asthma. Historically, these inhalers have been dosed twice daily. However, currently, there is a once-daily combination therapy with the ICS fluticasone furoate (FF and the LABA vilanterol trifenatate (VI with indications for use in both COPD and asthma. This dry powder inhaler (DPI comes in two doses of FF (100 or 200 µg both combined with VI (25 µg. This article reviews the clinical trial data for FF, VI and FF/VI combination inhalers and documents the efficacy and safety of once-daily inhaled maintenance therapy by DPI in asthmatic patients. Keywords: fluticasone furoate/vilanterol trifenatate, asthma, long-acting beta2 agonist, inhaled corticosteroid, combined inhaler, persistent asthma, dry powder inhaler  

  16. Pill power: The prequel

    OpenAIRE

    Edlund, Lena; Machado, Cecilia

    2011-01-01

    Goldin and Katz [2002], in an influential paper, argued that giving unmarried minors access to the contraceptive Pill was instrumental for women's professional advancement, because such access allowed marriage to be postponed. However, by 1960, married women could get the Pill and thence it is not clear why early marriage would interfere with the pursuit of professional interests. We explore the effects of this alternative, earlier, and common, route to the Pill. Using variation in state mini...

  17. Once-daily intramuscular amikacin for outpatient treatment of lower urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli in children

    Directory of Open Access Journals (Sweden)

    Polat M

    2017-11-01

    Full Text Available Meltem Polat,1,2 Soner Sertan Kara1 1Pediatric Infectious Diseases Department, Erzurum Research and Training Hospital, Erzurum, 2Pediatric Infectious Diseases Department, Pamukkale University Faculty of Medicine, Denizli, Turkey Background: The rise in community-acquired urinary tract infections (UTIs with extended-spectrum β-lactamase (ESBL-producing Escherichia coli strains raises the question of how to treat these infections effectively in pediatric outpatients. Amikacin has shown promising in vitro activity against ESBL-producing urinary isolates of E. coli; however, clinical data are limited. Objective: To investigate the clinical and microbiological outcomes of community-acquired lower UTIs caused by ESBL-producing E. coli treated with outpatient amikacin in children. Materials and methods: A retrospective cohort study was performed on pediatric patients aged ≥2 to 18 years treated as outpatients with intramuscular amikacin (given at a dose of 15 mg/kg/day once daily for community-acquired lower UTIs caused by ESBL-producing E. coli, between January 2015 and December 2016. Results: A total of 53 pediatric patients (38 females were enrolled in this study. The median age was 4.7 years (range 3–12 years. All E. coli isolates were susceptible to amikacin with minimum inhibitory concentrations of ≤4 mg/L. The median duration of amikacin treatment was 6 days (range 3–7 days. Favorable clinical and bacteriological responses were observed in 51 of 53 (96% patients. Development of resistance during treatment with amikacin was seen in only 1 patient (2%, who failed to respond to amikacin treatment and developed acute pyelonephritis with bacteremia. Relapsed lower UTI after initial treatment response occurred in 1 patient (2% 2 weeks after completion of amikacin treatment. All patients had normal serum creatinine values at baseline, and no significant nephrotoxicity or ototoxicity was observed in any of the patients. Conclusion: Our study

  18. Conversion from Twice-Daily to Once-Daily Tacrolimus Improves Graft Function but has no Influence on Proteinuria in Renal Transplant Recipients

    Directory of Open Access Journals (Sweden)

    Basic-Jukic Nikolina

    2016-12-01

    Full Text Available Introduction. Tacrolimus extended-release formulation enables once-daily use. Although an increasing number of patients have been converted from twice-daily (Tac- BID to once-daily (Tac-QD formulation, the available information regarding the initiation and follow-up of Tac- QD is sparse. In the present study we investigated influence of switch from Tac-BID or cyclosporine to Tac-QD on renal allograf function, proteinuria and protein-creatinine (P/C ratio. Methods. Between October 2012 and October 2014, the switch from Tac-BID or cyclosporine to tacrolimus extended-release formulation was done in 129(38% female, mean age 49 years renal transplant recipients at different time after transplantation. The analysis focused on markers of graft function (GFR, serum creatinine, proteinuria, P/C ratio, liver function (AST, ALT, γGT, alkaline phosphatase and blood glucose. Clinical data were obtained at baseline (before conversion, 1 month (V1, 6 months (V6 and 12 months (V12 after conversion. Results. Both serum creatinine and GFR showed a statistically significant improvement. With GFR, signifycant improvement was observed as early as V1 and it continued to increase throughout the study period up to V12 (all between-visit changes were statistically significant. With serum creatinine, mean levels were numerically decreasing throughout the follow-up period, but a significant improvement occurred at V6 and remained significant at V12 (both vs. V0 values. Proteinuria and P/C ratio did not show any significant change through the observation period. In the majority of patients, the baseline values of AST, ALT, GGT, AlP and glucose were within normal limits and did not change significantly through the observation period. Analysis of tacrolimus C0 showed a significant decrease throughout the follow-up period, at practically all visit. This finding was paralleled by a significant tacrolimus dose decrease from baseline to V6 and V12, as well as by a significant

  19. Birth control pills - progestin only

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000656.htm Birth control pills - progestin only To use the sharing ... have estrogen in them. What Are Progestin Only Birth Control Pills? Birth control pills help keep you ...

  20. Exploratory study of once-daily transcranial direct current stimulation (tDCS) as a treatment for auditory hallucinations in schizophrenia.

    Science.gov (United States)

    Fröhlich, F; Burrello, T N; Mellin, J M; Cordle, A L; Lustenberger, C M; Gilmore, J H; Jarskog, L F

    2016-03-01

    Auditory hallucinations are resistant to pharmacotherapy in about 25% of adults with schizophrenia. Treatment with noninvasive brain stimulation would provide a welcomed additional tool for the clinical management of auditory hallucinations. A recent study found a significant reduction in auditory hallucinations in people with schizophrenia after five days of twice-daily transcranial direct current stimulation (tDCS) that simultaneously targeted left dorsolateral prefrontal cortex and left temporo-parietal cortex. We hypothesized that once-daily tDCS with stimulation electrodes over left frontal and temporo-parietal areas reduces auditory hallucinations in patients with schizophrenia. We performed a randomized, double-blind, sham-controlled study that evaluated five days of daily tDCS of the same cortical targets in 26 outpatients with schizophrenia and schizoaffective disorder with auditory hallucinations. We found a significant reduction in auditory hallucinations measured by the Auditory Hallucination Rating Scale (F2,50=12.22, Phallucinations and the pronounced response in the sham-treated group in this study contrasts with the previous finding and demonstrates the need for further optimization and evaluation of noninvasive brain stimulation strategies. In particular, higher cumulative doses and higher treatment frequencies of tDCS together with strategies to reduce placebo responses should be investigated. Additionally, consideration of more targeted stimulation to engage specific deficits in temporal organization of brain activity in patients with auditory hallucinations may be warranted. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  1. Morning-After Pill

    Science.gov (United States)

    ... isn't recommended. Side effects of the morning-after pill typically last only a few days and may include: Nausea or vomiting Dizziness Fatigue ... pregnancy. If you have unprotected sex in the days and weeks after taking the morning-after pill, you're at risk of becoming pregnant. Be ...

  2. Localization of magnetic pills

    Science.gov (United States)

    Laulicht, Bryan; Gidmark, Nicholas J.; Tripathi, Anubhav; Mathiowitz, Edith

    2011-01-01

    Numerous therapeutics demonstrate optimal absorption or activity at specific sites in the gastrointestinal (GI) tract. Yet, safe, effective pill retention within a desired region of the GI remains an elusive goal. We report a safe, effective method for localizing magnetic pills. To ensure safety and efficacy, we monitor and regulate attractive forces between a magnetic pill and an external magnet, while visualizing internal dose motion in real time using biplanar videofluoroscopy. Real-time monitoring yields direct visual confirmation of localization completely noninvasively, providing a platform for investigating the therapeutic benefits imparted by localized oral delivery of new and existing drugs. Additionally, we report the in vitro measurements and calculations that enabled prediction of successful magnetic localization in the rat small intestines for 12 h. The designed system for predicting and achieving successful magnetic localization can readily be applied to any area of the GI tract within any species, including humans. The described system represents a significant step forward in the ability to localize magnetic pills safely and effectively anywhere within the GI tract. What our magnetic pill localization strategy adds to the state of the art, if used as an oral drug delivery system, is the ability to monitor the force exerted by the pill on the tissue and to locate the magnetic pill within the test subject all in real time. This advance ensures both safety and efficacy of magnetic localization during the potential oral administration of any magnetic pill-based delivery system. PMID:21257903

  3. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study.

    Science.gov (United States)

    Blume-Peytavi, Ulrike; Shapiro, Jerry; Messenger, Andrew G; Hordinsky, Maria K; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Olsen, Elise A

    2016-07-01

    A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss. Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage. Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was -0.3 hairs/cm2 (95% CI = -6.0, 5.4). Since the lower bound of the 95% CI was less than -5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated. Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met. ClinicalTrials.gov identifier: NCT01145625 J Drugs Dermatol. 2016;15(7):883-889.

  4. Impact of Statin Therapy on the Blood Pressure-Lowering Efficacy of a Single-Pill Perindopril/Amlodipine Combination in Hypertensive Patients with Hypercholesterolemia.

    Science.gov (United States)

    Sirenko, Yuriy; Radchenko, Ganna

    2017-03-01

    Several lines of research indicate that statins can lower blood pressure (BP) independently of their lipid-lowering effects when used as monotherapy and in combination with antihypertensive agents. This short-term, open-label study examined whether statin therapy had a synergistic effect on the BP-lowering efficacy of perindopril/amlodipine in a subgroup of patients in the PERSPECTIVA study with concomitant hypertension and hypercholesterolemia, with or without statin at baseline. The PERSPECTIVA study recruited 732 adults with untreated or uncontrolled hypertension. This subgroup analysis of PERSPECTIVA included 587 patients with concomitant hypertension and hypercholesterolemia (mean age 56.7 years) of whom 226 were receiving a statin at baseline (statin [+] group) and 361 were not (statin [-] group). All patients received treatment with single-pill combination perindopril/amlodipine at a dose of 5/5, 10/5 or 10/10 mg/day. The study duration was 60 days with follow-up visits for BP monitoring at 7, 15, 30 and 60 days. At day 60, BP control (hypercholesterolemia are significantly improved with a treatment regimen that combines perindopril/amlodipine with statin therapy, regardless of previous antihypertensive therapy. This subanalysis of the PERSPECTIVA study supports the synergistic BP-lowering effect of statins and perindopril/amlodipine.

  5. Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT

    Directory of Open Access Journals (Sweden)

    Ross Lisa L

    2008-03-01

    Full Text Available Abstract Background Once-daily (QD ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100 or atazanavir 300 mg (ATV/r100, plus tenofovir/emtricitabine (TDF/FTC 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3 randomly assigned to the FPV/r100 or ATV/r100 regimens. Results At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both], CD4+ count (mean, 176 vs 205 cells/mm3. At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA 3, p = 0.398 [Wilcoxon rank sum test]. Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL. FPV/r100-treated patients experienced fewer treatment-related grade 2–4 adverse events (15% vs 57%, with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to Conclusion The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2–4 adverse events.

  6. Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder.

    Science.gov (United States)

    Biederman, Joseph; Quinn, Declan; Weiss, Margaret; Markabi, Sabri; Weidenman, Meredith; Edson, Kathryn; Karlsson, Goeril; Pohlmann, Harald; Wigal, Sharon

    2003-01-01

    To evaluate the safety and efficacy of extended-release methylphenidate with a bimodal profile using SODAS technology (Ritalin LA ) compared with placebo in children aged 6-14 years with attention deficit hyperactivity disorder (ADHD). This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. Following titration and a 1-week placebo washout period, patients were randomized to 2 weeks of double-blind treatment with either Ritalin LA (10-40 mg/day) or placebo. The efficacy assessments used were the Conners' ADHD/DSM-IV Scales for teachers (CADS-T) and for parents (CADS-P), and the Clinical Global Impression-Improvement Scale (CGI-I) completed by the investigator. The primary efficacy variable was the change from baseline (end of placebo washout) to the final rating (end of 2-week double-blind treatment) in the CADS-T Total subscale score. One-hundred-and-sixty-one children were treated and 134 responders were included in the intent-to-treat analysis. Ritalin LA achieved a mean change from baseline (+/- SD) on the CADS-T Total subscale of -10.7 (+/-15.68) compared with 2.8 (+/-10.59) for placebo (p Ritalin LA was 0.90. Additionally, 69.8% of patients in the Ritalin LA group were rated as much or very much improved on the CGI-I at final assessment compared with 40% of patients in the placebo group (p = 0.0009). The adverse events reported were generally mild or moderate, and were similar in both groups. The results demonstrate that Ritalin LA administered once daily for up to 2 weeks achieved outcomes statistically superior to placebo in children with ADHD.

  7. Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin ® LA) in school children under daily practice conditions.

    Science.gov (United States)

    Haertling, Fabian; Mueller, Beate; Bilke-Hentsch, Oliver

    2015-06-01

    Long-acting (LA) preparations of methylphenidate allow for once-daily dosing; however, pharmacokinetics may vary and depend on food intake. The objective was to evaluate effectiveness of a two-phase release formulation (Ritalin(®) LA) under daily practice conditions. This was a prospective, multicenter, observational study in Germany. Eligibility and dosing were determined by the physician based on the drug label. Outcomes included changes over 3 months of treatment in assessments of effect duration, clinical global impression (CGI), and quality of life (ILK). In 101 sites, 262 patients (197 boys, 63 girls, and two unknown) with a mean age of 10.9 years were enrolled; 50 were treated for the first time; 212 switched medication to Ritalin(®) LA. After 3 months, CGI improved in 59.4 % of patients, and well-being overall was rated as good by 61.0 % of parents and 63.7 % of children. Based on parents' assessment, the proportion of children suffering from strong disease burden decreased from 40.7 to 15.1 %. In 123 insufficient responders to previous ADHD medications, benefit from Ritalin(®) LA was above average and effect duration was significantly prolonged as compared to pretreatment. Overall, 28 patients (10.7 %) had treatment-related adverse events with one case being serious; 23 patients (8.8 %) discontinued therapy, 7 (2.7 %) due to poor treatment response; and 212 patients (81 %) continued treatment beyond the study. In line with clinical trial data, Ritalin(®) LA provides significant benefit also under routine practice conditions.

  8. Effects of 50 mg vildagliptin twice daily vs. 50 mg sitagliptin once daily on blood glucose fluctuations evaluated by long-term self-monitoring of blood glucose.

    Science.gov (United States)

    Nomoto, Hiroshi; Kimachi, Kimihiko; Miyoshi, Hideaki; Kameda, Hiraku; Cho, Kyu Yong; Nakamura, Akinobu; Nagai, So; Kondo, Takuma; Atsumi, Tatsuya

    2017-04-29

    To date, several clinical trials have compared differences in glucose fluctuation observed with dipeptidyl peptidase-4 inhibitor treatment in patients with type 2 diabetes mellitus. However, most patients were assessed for limited periods or during hospitalization. The aim of the present study was to evaluate the effects of switching from sitagliptin to vildagliptin, or vice versa, on 12-week glucose fluctuations using self-monitoring of blood glucose in the standard care setting. We conducted a multicenter, prospective, open-label controlled trial in Japanese patients with type 2 diabetes. Thirty-two patients were treated with vildagliptin (50 mg) twice daily or sitagliptin (50 mg) once daily and were allocated to one of two groups: vildagliptin treatment for 12 weeks before switching to sitagliptin for 12 weeks, or vice versa. Daily profiles of blood glucose were assessed several times during each treatment period, and the mean amplitude of glycemic excursions and M-value were calculated. Metabolic biomarkers such as hemoglobin A1c (HbA1c), glycated albumin, and 1,5-anhydroglucitol were also assessed. With vildagliptin treatment, mean amplitude of glycemic excursions was significantly improved compared with sitagliptin treatment (57.9 ± 22.2 vs. 68.9 ± 33.0 mg/dL; p=0.0045). M-value (p=0.019) and mean blood glucose (p=0.0021) were also lower with vildagliptin, as were HbA1c, glycated albumin, and 1,5-anhydroglucitol. There were no significant differences in other metabolic parameters evaluated. Reduction of daily blood glucose profile fluctuations by vildagliptin was superior to that of sitagliptin in Japanese patients with type 2 diabetes.

  9. Once Daily Self-Monitoring of Blood Glucose (SMBG) Improves Glycemic Control in Oral Hypoglycemic Agents (OHA)-Treated Diabetes: SMBG-OHA Follow-Up Study.

    Science.gov (United States)

    Harashima, Shin-Ichi; Nishimura, Akiko; Ikeda, Kaori; Wang, Yu; Liu, Yanyan; Inagaki, Nobuya

    2015-10-01

    The aim of this study was to compare glycemic control between SMBG-continued and -discontinued subjects with type 2 diabetes in the SMBG-OHA study. Of the 96 subjects from the SMBG-OHA study, 59 were recruited for the 24-week, comparison follow-up study. The study outcomes were the differences in change in HbA1c levels at 24 weeks between the 2 groups, and change in SMBG frequency in SMBG-continued subjects. Although health insurance does not cover the cost of SMBG, 22.0% of subjects continued SMBG of their own will after the SMBG-OHA study was completed. HbA1c levels were maintained from 6.81 ± 0.55% to 6.64 ± 0.53% in SMBG-continued subjects. Conversely, HbA1c levels were increased from 7.18 ± 0.63% to 7.48 ± 0.84% in SMBG-discontinued subjects. HbA1c levels were significantly different by 0.83 ± 0.25% (95% CI: -1.33 to -0.36). The difference in change in HbA1c between the groups was -0.46% (95% CI: -0.78 to -0.15). SMBG frequency was decreased from 2.02 ± 1.06 to 1.53 ± 0.86 times a day. HbA1c levels were maintained in SMBG-continued subjects but increased in SMBG-discontinued subjects. The study implied that almost once daily SMBG is helpful to maintain glycemic control in non-insulin-treated type 2 diabetes. © 2015 Diabetes Technology Society.

  10. PGC-1beta is downregulated by training in human skeletal muscle: no effect of training twice every second day vs. once daily on expression of the PGC-1 family

    DEFF Research Database (Denmark)

    Mortensen, Ole Hartvig; Plomgaard, Peter; Fischer, Christian P

    2007-01-01

    be observed in the acute response to endurance exercise. Furthermore, we hypothesized that expression levels of the PGC-1 family differ with muscular fiber-type composition. Thus, before and after 10 wk of knee extensor endurance training, training one leg once daily and the other leg twice daily every second......We hypothesized that the peroxisome proliferator-activated receptor-gamma coactivator-1 (PGC-1) family of transcriptional coactivators (PGC-1alpha, PGC-1beta, and PRC) is differentially regulated by training once daily vs. training twice daily every second day and that this difference might...... of the PGC-1 family is independent of training protocol. Training decreased PGC-1beta in both legs, whereas PGC-1alpha was increased, but not significantly, in the leg training once daily. PRC did not change with training. Both PGC-1alpha and PRC were increased by acute exercise both before and after...

  11. A novel once-daily fixed-dose combination of memantine extended release and donepezil for the treatment of moderate to severe Alzheimer's disease: two phase I studies in healthy volunteers.

    Science.gov (United States)

    Boinpally, Ramesh; Chen, Laishun; Zukin, Stephen R; McClure, Natalie; Hofbauer, Robert K; Periclou, Antonia

    2015-07-01

    Combining two standard-of-care medications for Alzheimer's disease (AD) into a single once-daily dosage unit may improve treatment adherence, facilitate drug administration, and reduce caregiver burden. A new fixed-dose combination (FDC) capsule containing 28 mg memantine extended release (ER) and 10 mg donepezil was evaluated for bioequivalence with co-administered commercially available memantine ER and donepezil, and for bioavailability with regard to food intake. Two phase I, single-dose, randomized, open-label, crossover studies were conducted in 18- to 45-year-old healthy individuals. In MDX-PK-104 study, fasting participants (N = 38) received co-administered memantine ER and donepezil or the FDC. In MDX-PK-105 study, participants (N = 36) received three treatments: intact FDC taken while fasting or after a high-fat meal, or FDC contents sprinkled on applesauce while fasting. Standard pharmacokinetic parameters for memantine and donepezil were calculated from the plasma concentration time-curve using non-compartmental analyses. Linear mixed-effects models were used to compare: (a) FDC versus co-administered individual drugs; (b) FDC fasted versus with food; and (c) FDC sprinkled on applesauce versus FDC intact, both fasted. Safety parameters were also evaluated. The FDC capsule was bioequivalent to co-administered memantine ER and donepezil. There was no significant food effect on the bioavailability of the FDC components. There were no clinically relevant differences in time to maximum plasma concentration or safety profiles across treatments. An FDC capsule containing 28 mg memantine ER and 10 mg donepezil is bioequivalent to commercially available memantine ER and donepezil, and bioavailability is not affected by food intake or sprinkling of capsule contents on applesauce.

  12. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol

    Directory of Open Access Journals (Sweden)

    Roskell NS

    2014-07-01

    Full Text Available Neil S Roskell,1 Antonio Anzueto,2 Alan Hamilton,3 Bernd Disse,4 Karin Becker5 1Statistics, Bresmed Health Solutions Ltd, Sheffield, UK; 2School of Medicine, University of Texas Health Science Center, San Antonio, TX, USA; 3Medical Department, Boehringer Ingelheim (Canada Ltd, Burlington, ON, Canada; 4Medical Department, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany; 5Global Health Economics and Outcomes Research, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany Purpose: In the absence of head-to-head clinical trials comparing the once-daily, long-acting beta2-agonists olodaterol and indacaterol for the treatment of chronic obstructive pulmonary disease (COPD, an indirect treatment comparison by systematic review and synthesis of the available clinical evidence was conducted. Methods: A systematic literature review of randomized, controlled clinical trials in patients with COPD was performed to evaluate the efficacy and safety of olodaterol and indacaterol. Network meta-analysis and adjusted indirect comparison methods were employed to evaluate treatment efficacy, using outcomes based on trough forced expiratory volume in 1 second (FEV1, Transition Dyspnea Index, St George’s Respiratory Questionnaire total score and response, rescue medication use, and proportion of patients with exacerbations. Results: Eighteen trials were identified for meta-analysis (eight, olodaterol; ten, indacaterol. Olodaterol trials included patients of all severities, whilst indacaterol trials excluded patients with very severe COPD. Concomitant maintenance bronchodilator use was allowed in most olodaterol trials, but not in indacaterol trials. When similarly designed trials/data were analyzed for change from baseline in trough FEV1 (liters, the following mean differences (95% confidence interval were observed: trials excluding concomitant bronchodilator: indacaterol 75 mcg versus olodaterol 5 mcg, –0.005 (–0.077 to 0.067, and indacaterol 150 mcg

  13. Effectiveness and gastrointestinal tolerability during conversion and titration with once-daily OROS® hydromorphone extended release in opioid-tolerant patients with chronic low back pain

    Science.gov (United States)

    Hale, Martin E; Nalamachu, Srinivas R; Khan, Arif; Kutch, Michael

    2013-01-01

    Purpose To describe the efficacy and safety of hydromorphone extended-release tablets (OROS hydromorphone ER) during dose conversion and titration. Patients and methods A total of 459 opioid-tolerant adults with chronic moderate to severe low back pain participated in an open-label, 2- to 4-week conversion/titration phase of a double-blind, placebo-controlled, randomized withdrawal trial, conducted at 70 centers in the United States. Patients were converted to once-daily OROS hydromorphone ER at 75% of the equianalgesic dose of their prior total daily opioid dose (5:1 conversion ratio), and titrated as frequently as every 3 days to a maximum dose of 64 mg/day. The primary outcome measure was change in pain intensity numeric rating scale; additional assessments included the Patient Global Assessment and the Roland–Morris Disability Questionnaire scores. Safety assessments were performed at each visit and consisted of recording and monitoring all adverse events (AEs) and serious AEs. Results Mean (standard deviation) final daily dose of OROS hydromorphone ER was 37.5 (17.8) mg. Mean (standard error of the mean [SEM]) numeric rating scale scores decreased from 6.6 (0.1) at screening to 4.3 (0.1) at the final titration visit (mean [SEM] change, −2.3 [0.1], representing a 34.8% reduction). Mean (SEM) change in Patient Global Assessment was −0.6 (0.1), and mean change (SEM) in the Roland–Morris Disability Questionnaire was −2.8 (0.3). Patients achieving a stable dose showed greater improvement than patients who discontinued during titration for each of these measures (P < 0.001). Almost 80% of patients achieving a stable dose (213/268) had a ≥30% reduction in pain. Commonly reported AEs were constipation (15.4%), nausea (11.9%), somnolence (8.7%), headache (7.8%), and vomiting (6.5%); 13.0% discontinued from the study due to AEs. Conclusion The majority of opioid-tolerant patients with chronic low back pain were successfully converted to effective doses of

  14. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study

    NARCIS (Netherlands)

    Pratley, Richard E.; Nauck, Michael A.; Barnett, Anthony H.; Feinglos, Mark N.; Ovalle, Fernando; Harman-Boehm, Illana; Ye, June; Scott, Rhona; Johnson, Susan; Stewart, Murray; Rosenstock, Julio; Adamson, K.; Ahmann, A.; Ahn, C. W.; Ajani, D.; Akright, L.; Alwine, L.; Alzohaili, O.; Andrawis, N.; Arbañil Huaman, H.; Arora, S.; Bailey, T.; Barnett, A.; Baron, M.; Barreda Caceres, L.; Barrera, J.; Berg, J.; Bertenshaw, R.; Bode, B.; Bolton, D.; Brito, M.; Brock, S.; Brockmyre, A.; Broker, R.; Brusco, O.; Buynak, R.; Canadas-Zizzias, R.; Canas, G.; Capo, J.; Castillo Gamarra, M.; Cathcart, H.; Catindig, E. A.; Chilka, S.; Cho, Y. W.; Choi, D. S.; Chuck, L.; Cooper, M.; Corder, C.; Cruz, H.; Darzy, K.; de la Rosa, R.; de Teresa, L.; Degarmo, R.; D'Emden, M.; Denopol, M.; DiGiovanna, M.; Escalante, D.; Fakih, F.; Farris, N.; Feinglos, M.; Fillmore, R.; Fitz-Patrick, D.; Forker, A.; Fulcher, G.; Gabra, N.; Gabriel, J.; Gerstman, M.; Glaser, L.; Gnudi, L.; Gonzales Bravo, L.; Gonzalez, E.; Graf, R.; Greenwald, M.; Grunberger, G.; Harman-Boehm, I.; Herskovits, T.; Higgins, A.; Hoekstra, J.; Hollander, P.; Hubach, E.; Huff man, D.; Ison, R.; Jang, H. C.; Jimeno, C.; Jones, S.; Karl, J.; Kemp, S.; Ketels, C.; Kipnes, M.; Knopke, C.; Kolettis, E.; Lacour, A.; Ledesma, G.; Lee, D.; Lefebvre, G.; Liljenquist, D.; Lipetz, R.; Look, M.; Lucas, K.; Luna Figueroa, A.; Maletz, L.; Marar, I.; Mathur, R.; Mayeda, S.; McCartney, M.; McGill, J.; Metz, D.; Mihalyi, D.; Min, K. W.; Minuchin, O.; Mirasol, R.; Nelson, D.; Nolan, C.; Norwood, P.; Oberoi, M.; Ovalle, F.; Pace, D.; Pace, M.; Pappas, J.; Patel, N.; Patron, A.; Powell, S.; Pratley, R.; Proietto, J.; Rendell, M.; Roberts, A.; Rosen, R.; Rosenblit, P.; Rosenstock, J.; Rothman, J.; Ruoff, G.; Russell, A.; Samuels, B.; Sanderlin, D.; Sanders, R.; Schmidt, J.; Selam, J. L.; Severance, R.; Sewell, M.; Shachar, S.; Simpson, R.; Smith, T.; Solis Villanueva, J.; Soto, A.; Sparks, J.; Stephens, J.; Stewart, R.; Streja, D.; Strzinek, R.; Sy, R. A.; Teniola, S.; Tidman, R.; Toro, H.; Upender, R.; Urgeles Planella, J. R.; Valitutto, M.; Vishlitzky, V.; Wade, R.; Wahle, J.; Weissman, P.; Williams, D.; Yao, C.; Ygpuara, M. D. L.; Yue, D.; Zapata Rincón, L.

    2014-01-01

    Background As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes

  15. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study

    DEFF Research Database (Denmark)

    NN, NN

    2010-01-01

    AF who have a history of stroke or at least 2 additional independent risk factors for future stroke. Patients are randomly assigned to receive rivaroxaban, 20 mg once daily (od), or dose-adjusted warfarin titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive...

  16. Cost and quality-adjusted life year differences in the treatment of active ulcerative colitis using once-daily 4 g or twice-daily 2g mesalazine dosing

    NARCIS (Netherlands)

    Connolly, Mark P.; Kuyvenhoven, Johan P.; Postma, Maarten J.; Nielsen, Sandy K.

    2014-01-01

    BACKGROUND: Improved compliance in active ulcerative colitis (UC) is likely to improve healthcare efficiency by reducing time spent in active mild to moderate UC state. To establish whether once daily (OD) mesalazine offers economic advantages over twice daily (BD) dosing in active UC, we evaluated

  17. DRV concentrations and viral load in CSF in patients on DRV/r 600/100 or 800/100mg once daily plus two NRTI.

    Science.gov (United States)

    Di Yacovo, Silvana; Molto, Jose; Ferrer, Elena; Curran, Adrian; Else, Laura Jayne; Clotet, Bonaventura; Tiraboschi, Juan; Niubo, Jordi; Vila, Antonia; Podzamczer, Daniel

    2014-01-01

    Darunavir/r (DRV/r) is currently used at a dose of 800/100 mg once daily (OD) in a high proportion of patients. Pharmacokinetic data suggest that 600/100 OD may be effective, reducing toxicity and cost. However, drug concentrations in reservoirs such as cerebrospinal fluid (CSF) might not be adequate to inhibit viral replication. We aimed to evaluate concentrations of DRV and HIV-1 viral load (VL) in CSF patients receiving DRV 600/100 mg OD. DRV600 is an ongoing randomized open study comparing DRV/r 800/100 mg (DRV800) vs 600/100 mg (DRV600) OD plus TDF/FTC or ABC/3TC in 100 virologically suppressed patients (eudraCT 2011-006272-39). Here we present the results of a CSF sub-study. A lumbar puncture (LP) was performed in participating patients after at least six months of inclusion in the study, 20-28 hours after a dose of DRV/r. VL (PCR, LOD 40 copies/mL) was determined in CSF and in plasma. DRV concentrations were quantified in CSF by liquid chromatography mass spectrometry (LC/MS/MS) and in plasma using high-performance liquid chromatography (HPLC). Sixteen patients were included (eight in each arm). All DRV600 patients and four out of eight DRV800 patients received TDF/FTC, and the other four ABC/3TC. 75% were males, median (range) age was 48 (17-71) years, CD4 cell count 532 cells/mL (190-1,394). Median total time on DRV/r was 30 (11-57) months, and since the beginning of the study 8 (6-12) months in DRV800 and 10 (7-12) months in DRV600 patients. LP was performed a median of 26 (24-28) hours after the last DRV/r+TVD or KVX dose. In DRV600 patients the median DRV plasma levels were 1,674 (326-3,742) ng/mL, CSF levels 17.08 (5.79-30.19) ng/mL and DRV CSF:plasma ratio 0.0084 (0.0028-0.0388), while in the DRV800 arm, median DRV plasma levels were 1,707 (958-3,910) ng/mL, CSF levels 13.23 (3.47-32.98) ng/mL and DRV CSF:plasma ratio 0.0104 (0.0018-0.0262). All patients had VL100 mg or 600/100 mg OD. Low CSF DRV concentrations might be associated with viral escape in

  18. Efficacy of once-daily indacaterol 75 μg relative to alternative bronchodilators in COPD: A study level and a patient level network meta-analysis

    Directory of Open Access Journals (Sweden)

    Cope Shannon

    2012-06-01

    Full Text Available Abstract Background The objective of this study was to evaluate the comparative efficacy of indacaterol 75 μg once daily (OD, tiotropium 18 μg OD, salmeterol 50 μg twice daily (BID, formoterol 12 μg BID, and placebo for the treatment of chronic obstructive pulmonary disease (COPD based on individual patient data (IPD from randomized controlled trials (RCTs from the indacaterol trial program and aggregate data (AD identified from a systematic review of RCTs. Methods 22 RCTs were included in the AD analysis that evaluated: indacaterol 75 μg (n = 2 studies, indacaterol 150 μg n = 5 (i.e. salmeterol 50 μg (n = 5, indacaterol 300 μg (n = 2, tiotropium 18 μg (n = 10, salmeterol 50 μg (n = 7, and formoterol 12 μg (n = 4. All of the studies except for one head-to-head comparison (tiotropium vs. salmeterol were placebo controlled. Outcomes of interest were trough forced expiratory volume in 1 second (FEV1 and St. George’s Respiratory Questionnaire (SGRQ total score at week 12. The AD from all trials was analysed simultaneously using a Bayesian network meta-analysis (NMA and relative treatment effects between all regimens were obtained. In a separate analysis, the IPD available from the 6 indacaterol RCTs was analysed in a NMA. Treatment-by-covariate interactions were included in both analyses to improve similarity of the trials. Results All interventions compared were more efficacious than placebo regarding FEV1 at 12 weeks. Indacaterol 75 μg is expected to result in a comparable FEV1 at 12 weeks to tiotropium and salmeterol based on both IPD and AD analyses. In comparison to formoterol, the IPD and AD results indicate indacaterol 75 μg is more efficacious (IPD = 0.07 L difference; 95%Credible Interval (CrI 0.02 to 0.11; AD = 0.05 L difference; 95%CrI 0.01; 0.09. In terms of SGRQ total score at 12 weeks, indacaterol 75 μg and formoterol were more efficacious than

  19. Effectiveness and gastrointestinal tolerability during conversion and titration with once-daily OROS® hydromorphone extended release in opioid-tolerant patients with chronic low back pain

    Directory of Open Access Journals (Sweden)

    Hale ME

    2013-05-01

    Full Text Available Martin E Hale,1 Srinivas R Nalamachu,2 Arif Khan,3 Michael Kutch4,* 1Gold Coast Research, LLC, Weston, FL, USA; 2International Clinical Research Institute, Overland Park, KS, USA; 3MedNorthwest Clinical Research Center, Bellevue, WA, USA; Duke University Medical Center, Durham, NC, USA; 4Applied Clinical Intelligence, LLC, Bala Cynwyd, PA, USA *Affiliation at the time this work was completed. Michael Kutch is currently affiliated with Cytel Inc, Chesterbrook, PA, USA Purpose: To describe the efficacy and safety of hydromorphone extended-release tablets (OROS hydromorphone ER during dose conversion and titration. Patients and methods: A total of 459 opioid-tolerant adults with chronic moderate to severe low back pain participated in an open-label, 2- to 4-week conversion/titration phase of a double-blind, placebo-controlled, randomized withdrawal trial, conducted at 70 centers in the United States. Patients were converted to once-daily OROS hydromorphone ER at 75% of the equianalgesic dose of their prior total daily opioid dose (5:1 conversion ratio, and titrated as frequently as every 3 days to a maximum dose of 64 mg/day. The primary outcome measure was change in pain intensity numeric rating scale; additional assessments included the Patient Global Assessment and the Roland–Morris Disability Questionnaire scores. Safety assessments were performed at each visit and consisted of recording and monitoring all adverse events (AEs and serious AEs. Results: Mean (standard deviation final daily dose of OROS hydromorphone ER was 37.5 (17.8 mg. Mean (standard error of the mean [SEM] numeric rating scale scores decreased from 6.6 (0.1 at screening to 4.3 (0.1 at the final titration visit (mean [SEM] change, -2.3 [0.1], representing a 34.8% reduction. Mean (SEM change in Patient Global Assessment was -0.6 (0.1, and mean change (SEM in the Roland–Morris Disability Questionnaire was -2.8 (0.3. Patients achieving a stable dose showed greater improvement

  20. The Pills problem revisited | Brennan | Quaestiones Mathematicae

    African Journals Online (AJOL)

    We revisit the pills problem proposed by Knuth and McCarthy. In a bottle there are m large pills and n small pills. The large pill is equivalent to two small pills. ... Mathematics Subject Classification (2000): Primary: 05A15; Secondary: 60C05. Key words: Pills problem, recursions, harmonic numbers, generating functions.

  1. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial

    DEFF Research Database (Denmark)

    Bretzel, R.G.; Nuber, U.; Landgraf, W.

    2008-01-01

    BACKGROUND: As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycaemic c......, and greater patient satisfaction than was insulin lispro. FUNDING: Sanofi-Aventis Udgivelsesdato: 2008/3/29...

  2. Simultaneous Determination of Plasma Deferasirox and Deferasirox-Iron Complex Using an HPLC-UV System and Pharmacokinetics of Deferasirox in Patients With β-Thalassemia Major: Once-daily Versus Twice-daily Administration.

    Science.gov (United States)

    Lu, Meng-Yao; Wang, Ning; Wu, Wen-Hsin; Lai, Cheng-Wei; Kuo, Pei-Hsin; Chiang, Po-Hung; Lin, Kai-Hsin; Wu, Tzu-Hua

    2015-08-01

    Deferasirox (DEFR), when administered BID, improves iron overload and decreases DEFR-related adverse effects in patients with β-thalassemia major. However, the pharmacokinetic (PK) disposition of DEFR and the iron-DEFR complex (Fe-[DEFR]2) in this dosing strategy is unclear. Chromatographic analysis was performed using a solvent delivery system coupled to an HPLC-UV detector to determine the steady-state concentrations of DEFR (CDEFR) and Fe-(DEFR)2 (CFe-[DEFR]2) in β-thalassemia major patients (n = 8) following either once-daily or BID dosing, during which the PK parameters of the 2 dosing schedules were compared. An HPLC-UV system for the analysis of blood samples following solid-phase extraction was validated. Patients who received 40 mg/kg of DEFR had higher mean CDEFR and CFe-[DEFR]2 values at all sampling times. However, concentrations of iron-DEFR complex were similar in patients who received 30 or 40 mg/kg of DEFR in the once-daily group at the 6- to 24-hour sampling times. There was no significant difference in any of the PK parameters; however, DEFR administration BID increased the mean trough levels of DEFR (183.8 [157.5] μmol/L) compared with once daily (87.7 [56.8] μmol/L), whereas all the patients had increased peak levels per individual DEFR dose when they were switched from once daily to BID (139.0 [59.8] μmol/L vs 289.2 [145.8] μmol/L, respectively). Splitting the dose increased the peak levels of DEFR per unit dose in all patients and tends to increase drug exposures, but there were no significant differences in DEFR PK parameter estimates. Switching from once daily to BID may be considered for patients with an inadequate response to chelation therapy to achieve optimal drug levels. Further research is needed with a larger sample size to determine the clinical importance of the significant results due to the interindividual variability of DEFR. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  3. Bioequivalence study between a fixed-dose single-pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high-performance liquid chromatography coupled to tandem mass spectrometry.

    Science.gov (United States)

    Vespasiano, Celso Francisco Pimentel; Laurito, Tiago Luders; Iwamoto, Renan Donomae; Moreno, Ronilson Agnaldo; Mendes, Gustavo D; De Nucci, Gilberto

    2017-05-01

    Systemic arterial hypertension is a major risk factor for cerebrovascular disease. Therefore, adequate control of blood pressure is of enormous importance. One of the many fixed-dose single-pill antihypertensive formulations available on the market is the combination of nebivolol and hydrochlorothiazide. The objective of this study was to develop two distinct high-performance liquid chromatography coupled to tandem mass spectrometry methods to simultaneously quantify nebivolol and hydrochlorothiazide in human plasma. The methods were employed in a bioequivalence study, the first assay involving a nebivolol fixed-dose single-pill formulation based on healthy Brazilian volunteers. Nebilet HCT™ (nebivolol 5 mg + hydrochlorothiazide 12.5 mg tablet, manufactured by Menarini) was the test formulation. The reference formulations were Nebilet™ (nebivolol 5 mg tablet, manufactured by Menarini) and Clorana™ (hydrochlorothiazide 25 mg tablet, manufactured by Sanofi). For both analytes, liquid-liquid extraction was employed for sample preparation and the chromatographic run time was 3.5 min. The limits of quantification validated were 0.02 ng/mL for nebivolol and 1 ng/mL for hydrochlorothiazide. Since the 90% CI for C max , AUC (0-last) and AUC (0-inf) individual test/reference ratios were within the 80-125% interval indicative of bioequivalence, it was concluded that Nebilet HCT™ is bioequivalent to Nebilet™ and Clorana™. Copyright © 2016 John Wiley & Sons, Ltd.

  4. [A follow-up study on a randomized, single-blind control of King's Brain pills in treatment of memory disorder in elderly people with MCI in a Beijing community].

    Science.gov (United States)

    Tian, Jin-zhou; Zhu, Ai-hua; Zhong, Jian

    2003-10-01

    To evaluate the effect of King's Brain pills (Compound Chinese ginseng extract from herbs) on the treatment and the delaying of memory decline in the elderly with mild cognitive impairment (MCI) in a community by a year follow-up of neuropsychology. 75 patients with MCI were selected from Beixinqiao community of Beijing by a cutoff score of 0.0/0.5 on CDR and were randomly assigned into a treatment group (n = 30 cases), given 4 pills of a compound Chinese ginseng extract (King's Brain) with 2 placebo tablets, and a positive control group (n = 30 cases), given 2 tablets of Piracetam with 4 placebo tablets, as well as a placebo group (n = 15 cases), given a placebo of 4 tablets and 2 pills. All subjects took this medication 3 times a day for 3 months. Single-blind and double-moulding control were used in this study. At a baseline and a middlepoint (after 3 months), and a follow-up end (one year later) following a three months of medication therapeutics, all subjects were assessed using a battery consisting of MMSE and 5 memory items on BNPT battery. In the treatment group, MMSE score 27.50 +/- 1.68 was increased to 28.27 +/- 1.70 after 3 months but decreased to 26.90 +/- 1.90 after one year of the treatment. However, the latter score was higher than that in a placebo group 26.33 +/- 1.03 (P Brain spills and piracetam tablets have protective effect on cognitive and memory decline in elderly with MCI.

  5. Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials.

    Science.gov (United States)

    Stein Gold, Linda F; Jarratt, Michael T; Bucko, Alicia D; Grekin, Steven K; Berlin, Joshua M; Bukhalo, Michael; Weiss, Jonathan S; Berk, David R; Chang-Lin, Joan-En; Lin, Vince; Kaoukhov, Alexandre

    2016-05-01

    Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen. The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne. This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions. The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (Pdapsone gel, 7.5% and vehicle groups (all Pdapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of "none" for stinging/burning, dryness, scaling, and erythema scales at all time points. Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne. J Drugs Dermatol. 2016;15(5):553-561.

  6. Comparative efficacy of two once daily methylphenidate formulations (Ritalin LA and Concerta) and placebo in children with attention deficit hyperactivity disorder across the school day.

    Science.gov (United States)

    Lopez, Frank; Silva, Raul; Pestreich, Linda; Muniz, Rafael

    2003-01-01

    The primary objective was to compare the differences in clinical efficacy of the starting dose of Ritalin LA (20mg) to the starting dose of Concerta (18mg), in a laboratory school setting for the duration of an entire school day. Secondary objectives were to compare Ritalin LA 20mg with Concerta 36mg, and Ritalin LA and both Concerta doses versus placebo across the school day. Thirty-six children (29 males, 7 females), aged 6-12 years, with attention deficit hyperactivity disorder, previously stabilized on methylphenidate (MPH), completed this four-way, randomized, single-blind crossover, analog classroom study. Patients were evaluated on day 0 and randomized to receive treatment on days 7, 14, 21, and 28 (Ritalin LA 20mg, Concerta 18mg, Concerta 36mg, or placebo). Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale (SKAMP)-attention: The effect of Ritalin LA 20mg across the morning was statistically different from that of Concerta 18mg and 36mg, as demonstrated by the change in the area under the curve (AUC) during the first 4 hours (0-4) from pre-dose. AUC((0-4)) for RitalinLA was -2.48 versus -1.36 for Concerta 18mg (p = 0.015), and -1.55 for Concerta 36mg (p = 0.043). AUC((0-8)) change from pre-dose for Ritalin LA was -4.48 versus -2.72 for Concerta 18mg (p = 0.074), and -3.24 for Concerta 36mg (p = 0.208).SKAMP-deportment: AUC((0-4)) for Ritalin LA was -1.67 compared with -0.28 for Concerta 18mg (p Ritalin LA was -2.81 compared with -0.82 for Concerta 18mg (p = 0.018), and -1.34 for Concerta 36mg (p = 0.078).Combined: Mean AUC((0-4)) change from pre-dose for Ritalin LA was -2.05 compared with -0.78 for Concerta 18mg (p Ritalin LA was -3.58 compared with -1.70 for Concerta 18mg (p = 0.010), -2.22 for Concerta 36mg (p = 0.061). Math test-attempted: Mean pre-dose score for Ritalin LA was about 73 compared with 74, 90, and 81 for Concerta 18mg, 36mg, and placebo, respectively. Mean AUC((0-8)) change from pre-dose for Ritalin LA was 202 compared with 115 for

  7. Association between daily antiretroviral pill burden and treatment adherence, hospitalisation risk, and other healthcare utilisation and costs in a US medicaid population with HIV.

    Science.gov (United States)

    Cohen, Calvin J; Meyers, Juliana L; Davis, Keith L

    2013-08-01

    Lower pill burden leads to improved antiretroviral therapy (ART) adherence among HIV patients. Simpler dosing regimens have not been widely explored in real-world populations. We retrospectively assessed ART adherence, all-cause hospitalisation risk and costs, and other healthcare utilisation and costs in Medicaid enrollees with HIV treated with ART as a once-daily single-tablet regimen (STR) or two or more pills per day (2+PPD). Patients with an HIV diagnosis from 2005 to 2009 receiving complete ART (ie, two nucleoside/nucleotide reverse transcriptase inhibitors plus a third agent) for ≥60 days as STR or 2+PPD were selected and followed until the first of (1) discontinuation of the complete ART, (2) loss of enrolment or (3) end of database. Adherence was measured using the medication possession ratio. Monthly all-cause healthcare utilisation and costs were observed from regimen initiation until follow-up end. Of the 7381 patients who met inclusion criteria, 1797 were treated with STR and 5584 with 2+PPD. STR patients were significantly more likely to reach 95% adherence and had fewer hospitalisations than 2+PPD patients (both p<0.01). STR patients had mean (SD) total monthly costs of $2959 ($4962); 2+PPD patients had $3544 ($5811; p<0.001). Hospital costs accounted for 53.8% and pharmacy costs accounted for 32.5% of this difference. Multivariate analyses found that STR led to a 23% reduction in hospitalisations and a 17% reduction in overall healthcare costs. ART adherence appears to be a key mechanism mediating hospitalisation risk, as patients with ≥95% adherence (regardless of regimen type) had a lower hospitalisation rate compared with <95% adherence. While it was expected that STR patients would have lower pharmacy costs, we also found that STR patients had fewer hospitalisations and lower hospital costs than 2+PPD patients, resulting in significantly lower total healthcare costs for STR patients.

  8. Efficacy and tolerability of a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg according to age, gender, race, hypertension severity, and previous antihypertensive use: planned analyses of a randomized trial

    Directory of Open Access Journals (Sweden)

    Zhu D

    2013-04-01

    Full Text Available Dingliang Zhu,1 Harold Bays,2 Pingjin Gao,1 Michaela Mattheus,3 Birgit Voelker,3 Luis M Ruilope4 1Shanghai Ruijin Hospital, Shanghai, People’s Republic of China; 2Louisville Metabolic and Atherosclerosis Research Center Inc, Louisville, KY, USA; 3Boehringer Ingelheim International GmbH, Ingelheim, Germany; 4Hospital 12 de Octubre, Madrid, Spain Background: The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25 single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 100 mmHg in specific patient subpopulations. Methods: This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ≥ 65 years versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP 30 mmHg and >40 mmHg. Results: Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of >30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ≥65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients

  9. Herbal Weight Loss Pill Overdose: Sibutramine Hidden in Pepper Pill

    OpenAIRE

    Pamukcu Gunaydin, Gul; Dogan, Nurettin Ozgur; Levent, Sevcan; Kurtoglu Celik, Gulhan

    2015-01-01

    Supposedly herbal weight loss pills are sold online and are widely used in the world. Some of these products are found to contain sibutramine by FDA and their sale is prohibited. We report a case of a female patient who presented to the emergency department after taking slimming pills. 17-year-old female patient presented to the emergency room with palpitations, dizziness, anxiety, and insomnia. She stated that she had taken 3 pills named La Jiao Shou Shen for slimming purposes during the day...

  10. Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials.

    Science.gov (United States)

    Eichenfield, Lawrence F; Lain, Ted; Frankel, Ellen H; Jones, Terry M; Chang-Lin, Joan-En; Berk, David R; Ruan, Shiling; Kaoukhov, Alexandre

    2016-08-01

    Dapsone gel, 5% is administered twice daily for the treatment of acne vulgaris, and some patients may find adherence challenging. The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone. This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20-50 facial inflammatory lesions, 30-100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions. The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P<0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P<0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from "none" to "mild." Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment. J Drugs Dermatol. 2016;15(8):962-969.

  11. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

    Directory of Open Access Journals (Sweden)

    Koch A

    2014-07-01

    Full Text Available Andrea Koch,1 Emilio Pizzichini,2 Alan Hamilton,3 Lorna Hart,3 Lawrence Korducki,4 Maria Cristina De Salvo,5 Pierluigi Paggiaro6 1Medical Clinic III for Pneumology, Allergology, Sleep and Respiratory Medicine, University Hospital Bochum-Bergmannsheil, Bochum, Germany; 2NUPAIVA (Asthma Research Center, Universidade Federal de Santa Catarina, Santa Catarina, Brazil; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 5Centro Médico Dra. De Salvo, Fundación Respirar, Buenos Aires, Argentina; 6Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy Abstract: Two replicate, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III studies investigated the long-term efficacy and safety of once-daily olodaterol via Respimat® versus placebo and formoterol over 48 weeks in patients with moderate to very severe chronic obstructive pulmonary disease receiving usual-care background therapy. Patients received once-daily olodaterol 5 or 10 µg, twice-daily formoterol 12 µg, or placebo. Co-primary end points were forced expiratory volume in 1 second (FEV1 area under the curve from 0–3 hours response, FEV1 trough response, and Mahler transition dyspnea index total score after 24 weeks; secondary end points included St George's Respiratory Questionnaire. Overall, 904 (Study 1222.13 and 934 (Study 1222.14 patients received treatment. Olodaterol significantly improved FEV1 area under the curve from 0–3 hours versus placebo in both studies (with olodaterol 5 µg, 0.151 L and 0.129 L; with olodaterol 10 µg, 0.165 L and 0.154 L; for all comparisons P<0.0001 and FEV1 trough responses versus placebo (0.053–0.085 L; P<0.01, as did formoterol. Primary analysis revealed no significant difference in transition dyspnea index focal score for any active treatment versus placebo. Post hoc analysis using pattern mixture modeling (accounting for

  12. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial

    DEFF Research Database (Denmark)

    Bretzel, R.G.; Nuber, U.; Landgraf, W.

    2008-01-01

    BACKGROUND: As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycaemic...... control in adults with inadequately controlled type 2 diabetes mellitus taking oral hypoglycaemic agents. METHODS: In the 44-week, parallel, open study that was undertaken in 69 study sites across Europe and Australia, 418 patients with type 2 diabetes mellitus that was inadequately controlled by oral....... Randomisation was done with a central randomisation service. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00311818. FINDINGS: 205 patients were randomly assigned to insulin glargine and 210 to insulin lispro. Mean haemoglobin A(1c) decrease in the insulin glargine group...

  13. Fifteen-year results of a randomized prospective trial of hyperfractionated chest wall irradiation versus once-daily chest wall irradiation after chemotherapy and mastectomy for patients with locally advanced noninflammatory breast cancer

    International Nuclear Information System (INIS)

    Buchholz, Thomas A.; Strom, Eric A.; Oswald, Mary Jane; Perkins, George H.; Oh, Julia; Domain, Delora; Yu, Tse-Kuan; Woodward, Wendy A.; Tereffe, Welela; Singletary, S. Eva; Thomas, Eva; Buzdar, Aman U.; Hortobagyi, Gabriel N.; McNeese, Marsha D.

    2006-01-01

    Purpose: To analyze the results of a Phase III clinical trial that investigated whether a hyperfractionated radiotherapy (RT) schedule could reduce the risk of locoregional recurrence in patients with locally advanced breast cancer treated with chemotherapy and mastectomy. Methods and Materials: Between 1985 and 1989, 200 patients with clinical Stage III noninflammatory breast cancer were enrolled in a prospective study investigating neoadjuvant and adjuvant chemotherapy. Of the 179 patients treated with mastectomy after neoadjuvant chemotherapy, 108 participated in a randomized component of the trial that compared a dose-escalated, hyperfractionated (twice-daily, b.i.d.) chest wall RT schedule (72 Gy in 1.2-Gy b.i.d. fractions) with a once-daily (q.d.) schedule (60 Gy in 2-Gy q.d. fractions). In both arms of the study, the supraclavicular fossa and axillary apex were treated once daily to 50 Gy. The median follow-up period was 15 years. Results: The 15-year actuarial locoregional recurrence rate was 7% for the q.d. arm and 12% for the b.i.d. arm (p = 0.36). The rates of severe acute toxicity were similar (4% for q.d. vs. 5% for b.i.d.), but moist desquamation developed in 42% of patients in the b.i.d. arm compared with 28% of the patients in the q.d. arm (p = 0.16). The 15-year actuarial rate of severe late RT complications did not differ between the two arms (6% for q.d. vs. 11% for b.i.d., p = 0.54). Conclusion: Although the sample size of this study was small, we found no evidence that this hyperfractionation schedule of postmastectomy RT offered a clinical advantage. Therefore, we have concluded that it should not be further studied in this cohort of patients

  14. Morning and evening behavior in children and adolescents treated with atomoxetine once daily for Attention-Deficit/Hyperactivity Disorder (ADHD: Findings from two 24-week, open-label studies

    Directory of Open Access Journals (Sweden)

    Schacht Alexander

    2009-02-01

    Full Text Available Abstract Background The impact of once daily atomoxetine treatment on symptoms in children and adolescents with ADHD may vary over the day. In order to capture such variations, two studies were undertaken in children and adolescents with ADHD using two instruments that capture morning and evening behavior and ADHD-related difficulties over the day. This secondary measure analysis builds on two primary analyses that were conducted separately for children and adolescents and also published separately. Methods In two open-label studies, ADHD patients aged 6–17 years (n = 421, received atomoxetine in the morning (target-dose 0.5–1.2 mg/kg/day for up to 24 weeks. Morning and evening behavior was assessed using the investigator-rated Weekly Rating of Evening and Morning Behavior (WREMB-R scale. ADHD-related difficulties at various times of the day (morning, during school, during homework, evening were assessed using the Global Impression of Perceived Difficulties (GIPD scale, rated by patients, parents and physicians. Data from both studies were combined for this secondary measure analysis. Results Both WREMB-R subscores decreased significantly over time, the evening subscore from 13.7 (95% CI 13.2;14.2 at baseline to 8.0 (7.4;8.5 at week 2, the morning subscore from 4.3 (4.0;4.5 to 2.4 (2.2;2.6. Scores then remained stable until week 24. All GIPD items improved correspondingly. At all times of the day, patients rated ADHD-related difficulties as less severe than parents and physicians. Conclusion These findings from two open-label studies suggest that morning and evening behavior and ADHD-related difficulties in the mornings and evenings improve over time with once daily atomoxetine treatment.

  15. Pille Jänes 39

    Index Scriptorium Estoniae

    2004-01-01

    Pille Jänes sai tänavu rahvusvahelise teatripäeva peol Ugalas kunstnikuauhinna kujunduse eest Tallinna Linnateatri lavastusele "Tshapajev ja Pustota", Linnateter andis kunstnikule parima kunstniku aastaauhinna

  16. Anti-C.Diff Pill

    Energy Technology Data Exchange (ETDEWEB)

    Kumar, Anand [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2018-01-30

    The anti- C.diff pill is being developed for patients who are at high risk for Clostridium difficile, a bacterium that causes diarrhea and serious intestinal conditions like colitis. C-diff is deadly, killing over 30,000 people a year in the United States and costing an average of $42,000 per treatment. The most common treatment is a fecal transplant (FT). The anti- C.diff replaces the invasive and messy FT practice with a pill.

  17. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial.

    Science.gov (United States)

    Raffi, François; Jaeger, Hans; Quiros-Roldan, Eugenia; Albrecht, Helmut; Belonosova, Elena; Gatell, Jose M; Baril, Jean-Guy; Domingo, Pere; Brennan, Clare; Almond, Steve; Min, Sherene

    2013-11-01

    In the primary analysis of SPRING-2 at week 48, dolutegravir showed non-inferior efficacy to and similar tolerability to raltegravir in adults infected with HIV-1 and naive for antiretroviral treatment. We present the 96 week results. SPRING-2 is an ongoing phase 3, randomised, double-blind, active-controlled, non-inferiority study in treatment-naive adults infected with HIV-1 that started in Oct 19, 2010. We present results for the safety cutoff date of Jan 30, 2013. Patients had to be aged 18 years or older and have HIV-1 RNA concentrations of 1000 copies per mL or more. Patients were randomly assigned (1:1) to receive either dolutegravir (50 mg once daily) or raltegravir (400 mg twice daily), plus investigator-selected tenofovir-emtricitabine or abacavir-lamivudine. Prespecified 96 week secondary endpoints included proportion of patients with HIV-1 RNA less than 50 copies per mL, CD4 cell count changes from baseline, safety, tolerability, and genotypic or phenotypic resistance. We used an intention-to-treat exposed population (received at least one dose of study drug) for the analyses. Sponsor staff were masked to treatment assignment until primary analysis at week 48; investigators, site staff, and patients were masked until week 96. Of 1035 patients screened, 827 were randomly assigned to study group, and 822 received at least one dose of the study drug (411 patients in each group). At week 96, 332 (81%) of 411 patients in the dolutegravir group and 314 (76%) of 411 patients in the raltegravir group had HIV-1 RNA less than 50 copies per mL (adjusted difference 4∙5%, 95% CI -1∙1% to 10∙0%) confirming non-inferiority. Secondary analyses of efficacy such as per protocol (HIV RNA failure (93% without failure for dolutegravir; 91% for raltegravir) supported non-inferiority. Virological non-response occurred less frequently in the dolutegravir group (22 [5%] patients for dolutegravir vs 43 [10%] patients for raltegravir). Median increases in CD4 cell count

  18. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study.

    Science.gov (United States)

    Raffi, Francois; Rachlis, Anita; Stellbrink, Hans-Jürgen; Hardy, W David; Torti, Carlo; Orkin, Chloe; Bloch, Mark; Podzamczer, Daniel; Pokrovsky, Vadim; Pulido, Federico; Almond, Steve; Margolis, David; Brennan, Clare; Min, Sherene

    2013-03-02

    Dolutegravir (S/GSK1349572) is a once-daily HIV integrase inhibitor with potent antiviral activity and a favourable safety profile. We compared dolutegravir with HIV integrase inhibitor raltegravir, as initial treatment for adults with HIV-1. SPRING-2 is a 96 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began on Oct 19, 2010, at 100 sites in Canada, USA, Australia, and Europe. Treatment-naive adults (aged ≥ 18 years) with HIV-1 infection and HIV-1 RNA concentrations of 1000 copies per mL or greater were randomly assigned (1:1) via a computer-generated randomisation sequence to receive either dolutegravir (50 mg once daily) or raltegravir (400 mg twice daily). Study drugs were given with coformulated tenofovir/emtricitabine or abacavir/lamivudine. Randomisation was stratified by screening HIV-1 RNA (≤ 100,000 copies per mL or >100,000 copies per mL) and nucleoside reverse transcriptase inhibitor backbone. Investigators were not masked to HIV-1 RNA results before randomisation. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies per mL at 48 weeks, with a 10% non-inferiority margin. Main secondary endpoints were changes from baseline in CD4 cell counts, incidence and severity of adverse events, changes in laboratory parameters, and genotypic or phenotypic evidence of resistance. Our primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01227824. 411 patients were randomly allocated to receive dolutegravir and 411 to receive raltegravir and received at least one dose of study drug. At 48 weeks, 361 (88%) patients in the dolutegravir group achieved an HIV-1 RNA value of less than 50 copies per mL compared with 351 (85%) in the raltegravir group (adjusted difference 2·5%; 95% CI -2·2 to 7·1). Adverse events were similar between treatment groups. The most common events were nausea (59 [14%] patients in the dolutegravir group vs 53 [13

  19. Pharmacokinetic study of five ginsenosides using a sensitive and rapid liquid chromatography-tandem mass spectrometry method following single and multiple oral administration of Shexiang Baoxin pills to rats.

    Science.gov (United States)

    Peng, Chengcheng; Yang, Yongge; Lv, Chao; Jin, Huizi; Tao, Jianfei; Yuan, Xing; Huang, Huimei; Han, Lin; Chang, Wanlin; Liu, Runhui; Zhang, Weidong

    2015-03-01

    Shexiang Baoxin pills (SBP) are a traditional Chinese medicine that are used for treating coronary heart disease. Ginsenosides are the main effective components of SBP, but a comprehensive and deep pharmacokinetic study of ginsenosides in SBP, including multiple dosing and linear or nonlinear properties, is lacking. This study was designed to investigate and compare the pharmacokinetic characteristics of ginsenosides in SBP at a single dose and in multiple doses. A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous determination of the ginsenosides Rg1, Re, Rb3, Rc and Rb1 in rat plasma. Rats were randomly assigned to receive a single dose of 4, 8 or 12 g/kg and multiple doses (4 g/kg) of SBP for 8, 15 or 22 consecutive days. The results revealed that ginsenosides, following a single oral dose of 4 or 8 g/kg, were absorbed rapidly, with a Tmax ranging from 0.250 to 1.08 h. The AUC0-t and Cmax of the ppd-type ginsenosides Rb3, Rc and Rb1 were greater than those of the ppt-type ginsenosides Rg1 and Re. Nondose-dependent exposure was observed at doses of 4-12 g/kg for all of the ginsenosides. After multiple dosing, the plasma levels of the ppt-type ginsenosides decreased, whereas those of the ppd-type ginsenosides did not change significantly. In conclusion, the LC-MS/MS method was successfully applied to investigate the pharmacokinetics of ginsenosides after single and multiple oral administrations of SBP. The ginsenosides did not accumulate after multiple dosing. The ppd-type ginsenosides displayed more favorable pharmacokinetic properties compared with the ppt-type ginsenosides. Copyright © 2014 John Wiley & Sons, Ltd.

  20. Pilling Resistance of Knitted Fabrics

    Directory of Open Access Journals (Sweden)

    Gita BUSILIENĖ

    2011-09-01

    Full Text Available Knitted fabrics with different quantity of elastane, conspicuous by high viscosity and elasticity, having one of the most important performance properties - resistance to pilling are often used in the production of high quality sportswear. During technological process imitating operating conditions, the behaviour of knitted fabrics may be changed by different industrial softeners from 12 % to 20 % of active substance, for example fatty acid condensate (Tubingal 5051 or silicone micro emulsion (Tubingal SMF. The aim of this investigation is to define the influence of fibrous composition and chemical softeners to the propensity of fuzzing and pilling of plain and plated jersey pattern knitted fabrics. The results of investigations showed that fibrous composition and thickness of materials (up to 6 % and washing as well as softening (from 33 % to 67 % change the resistance of knitted fabrics to pilling.http://dx.doi.org/10.5755/j01.ms.17.3.597

  1. "Pills" and the air passages.

    Science.gov (United States)

    Küpeli, Elif; Khemasuwan, Danai; Lee, Pyng; Mehta, Atul C

    2013-08-01

    Aspiration of a medication in the airways in any form produces a variety of adverse effects, both local and systemic. Furthermore, specific reaction of the airways to each type of pill strongly affects the outcome. It is crucial for pulmonologists and emergency medicine specialists to acknowledge this clinical entity. In addition, airways have been increasingly used to deliver medications such as insulin and prostacycline. These aerosolized medications can also cause local as well as systemic side effects. We review the local and systemic reactions of these "pills" accessing the airways either by incidental aspiration or iatrogenic administration. We address clinical presentation, mechanism of injury, diagnosis, and management of complications of these pills in the air passages.

  2. Analysis of traditional Tibetan pills

    Science.gov (United States)

    Cesnek, Martin; Štefánik, Milan; Miglierini, Marcel; Kmječ, Tomáš; Sklenka, L'ubomír

    2017-11-01

    Traditional Tibetan medicine starts to be a very popular complementary medicine in USA and Europe. These pills contain many elements essential for the human body. However, they might also contain heavy metals such as mercury, iron, arsenic, etc. This paper focuses on elemental composition of two Tibetan pills and investigation of forms of iron in them. X-ray fluorescence spectroscopy and neutron activation analysis identified the presence of several heavy metals such as mercury, iron and copper. Mőssbauer spectroscopy revealed the possible presence of α - F e 2 O 3(hematite) and α - F e O O H(goethite) in both of the investigated samples.

  3. Oral Steroids (Steroid Pills and Syrups)

    Science.gov (United States)

    ... to learn more about steroids? How are steroid pills and syrups used? Steroid pills and syrups are ... in the body; some more steroid medicines; important dosing considerations; and our research on steroids. Learn more ...

  4. Rein Pill tegi fantastilise sõidu / Rein Pill

    Index Scriptorium Estoniae

    Pill, Rein

    2008-01-01

    Septembris Chernjahovskis peetud CS14 taseme rahvusvahelistel ratsutamise takistussõiduvõistlustel tegi Rein Pill ajalugu, võites hobusel A Big Boy võistluste Grand Prix 160 cm kõrgusel parkuuril ja täites Euroopa meistrivõistluste kvalifikatsiooninormi

  5. Herbal Weight Loss Pill Overdose: Sibutramine Hidden in Pepper Pill

    Directory of Open Access Journals (Sweden)

    Gul Pamukcu Gunaydin

    2015-01-01

    Full Text Available Supposedly herbal weight loss pills are sold online and are widely used in the world. Some of these products are found to contain sibutramine by FDA and their sale is prohibited. We report a case of a female patient who presented to the emergency department after taking slimming pills. 17-year-old female patient presented to the emergency room with palpitations, dizziness, anxiety, and insomnia. She stated that she had taken 3 pills named La Jiao Shou Shen for slimming purposes during the day. Her vital signs revealed tachycardia. On her physical examination, she was restless, her oropharynx was dry, her pupils were mydriatic, and no other pathological findings were found. Sibutramine intoxication was suspected. She was given 5 mg IV diazepam for restlessness. After supportive therapy and observation in emergency department for 12 hours there were no complications and the patient was discharged home. Some herbal pills that are sold online for weight loss have sibutramine hidden as an active ingredient, and their sale is prohibited for this reason. For people who use herbal weight loss drugs, sibutramine excessive intake should be kept in mind at all times.

  6. Antiretroviral pill count and clinical outcomes in treatment-naïve patients with HIV infection.

    Science.gov (United States)

    Young, J; Smith, C; Teira, R; Reiss, P; Jarrín Vera, I; Crane, H; Miro, J M; D'Arminio Monforte, A; Saag, M; Zangerle, R; Bucher, H C

    2018-02-01

    Treatment guidelines recommend single-tablet regimens for patients with HIV infection starting antiretroviral therapy. These regimens might be as effective and cost less if taken as separate drugs. We assessed whether the one pill once a day combination of efavirenz, emtricitabine and tenofovir reduces the risk of disease progression compared with multiple-pill formulations of the same regimen. We selected treatment-naïve patients starting one-, two- or three-pill formulations of this regimen in data from the Antiretroviral Therapy Cohort Collaboration. These patients were followed until an AIDS event or death or until they modified their regimen. We analysed these data using Cox regression models, then used our models to predict the potential consequences of exposing a future population to either a one-pill regimen or a three-pill regimen. Among 11 739 treatment-naïve patients starting the regimen, there were 386 AIDS events and 87 deaths. Follow-up often ended when patients switched to the same regimen with fewer pills. After the first month, two pills rather than one was associated with an increase in the risk of AIDS or death [hazard ratio (HR) 1.39; 95% confidence interval (CI) 1.01-1.91], but three pills rather than two did not appreciably add to that increase (HR 1.19; 95% CI 0.84-1.68). We estimate that 77 patients would need to be exposed to a one-pill regimen rather than a three-pill regimen for 1 year to avoid one additional AIDS event or death. This particular single-tablet regimen is associated with a modest decrease in the risk of AIDS or death relative to multiple-pill formulations. © 2017 British HIV Association.

  7. Unmarried Mother's Knowledge and Attitudes toward Emergency Contraceptive Pills

    Directory of Open Access Journals (Sweden)

    Gyeong Mi Lee

    2013-06-01

    Full Text Available PurposeThis study was conducted to identify relationships among knowledge and attitudes of unmarried mothers toward emergency contraceptive pills.MethodsData were collected through structured questionnaires from 135 unmarried mothers enrolled in 7 single mothers' facilities nationwide. Data were analyzed using the SPSS/WIN 17.0 program for descriptive statistics, t-test, ANOVA, Scheffe-test, and Pearson correlation coefficients.ResultsFor knowledge about emergency contraceptive pills, there were significant differences among who live with her before pregnancy, experience of past pregnancies, state of present pregnancy and preparation in using contraceptives. For attitude toward emergency contraceptive pills, there were significant differences according to age, education level and religion. There were significant positive relationships between knowledge and attitudes toward emergency contraceptive pills.ConclusionThe results of this study suggest that unmarried women should be better informed about emergency contraceptive pills, and reassured about their safety. Efforts are needed to disseminate up-to-date information to experts in sex education including nurses.

  8. A pill for every ill?

    OpenAIRE

    Buhagiar, Marc

    2015-01-01

    In the US, non-medical use of prescription drugs is second only to marijuana. Marc Buhagiar meets up with Prof. Marilyn Clark to investigate just how dangerous this problem is around Europe. Illustrations by Sonya Hallett. http://www.um.edu.mt/think/a-pill-for-every-ill/

  9. Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100 for 52 Weeks in Insulin-Naïve Patients with Type 2 Diabetes: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ajay Kumar

    Full Text Available The efficacy and safety of insulin degludec/insulin aspart (IDegAsp once daily (OD compared with insulin glargine U100 (IGlar OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM was investigated.In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1 to receive IDegAsp OD (breakfast, n = 266 or IGlar OD (as per label, n = 264. Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221. The primary endpoint was change from baseline to Week 26 in HbA1c.After 26 and 52 weeks, mean HbA1c decreased to similar levels in both groups. After 52 weeks, the mean estimated treatment difference was -0.08% (-0.26, 0.09 95%CI, confirming the non-inferiority of IDegAsp OD versus IGlar OD evaluated at Week 26. After 52 weeks, there was a similar reduction in mean fasting plasma glucose in both treatment groups. The rate of confirmed hypoglycemic episodes was 86% higher (p < 0.0001 whereas the rate of nocturnal hypoglycemia was 75% lower (p < 0.0001 for IDegAsp versus IGlar.Nocturnal-confirmed hypoglycemia was higher with IGlar whereas overall and diurnal hypoglycemia were higher with IDegAsp dosed at breakfast. These results highlight the importance of administration of IDegAsp with the main meal of the day, tailored to the individual patient's needs.ClinicalTrials.gov: NCT01045707 [core] and NCT01169766 [ext].

  10. Long-Term, Open-Label, Safety Study of Edivoxetine 12 to 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment.

    Science.gov (United States)

    Ball, Susan G; Atkinson, Sarah; Sparks, JonDavid; Bangs, Mark; Goldberger, Celine; Dubé, Sanjay

    2015-06-01

    Long-term safety, tolerability, and efficacy of adjunctive edivoxetine hydrochloride (hereafter edivoxetine), a highly selective and potent norepinephrine reuptake inhibitor, was assessed in patients with major depressive disorder (MDD) experiencing partial response to selective serotonin reuptake inhibitor treatment. Data are from a multicenter, 54-week, open-label trial of adjunctive edivoxetine 12 to 18 mg once daily in patients with MDD who had experienced partial response by history to 6 or more weeks of current selective serotonin reuptake inhibitor therapy and who had a 17-item GRID Hamilton Rating Scale for Depression total score 16 or higher at study entry. Safety measures included discontinuation rate, treatment-emergent adverse events, serious adverse events, and vital signs. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale. Of 608 patients, 328 (54%) completed the open-label adjunctive treatment. Study discontinuation due to adverse events occurred in 17.0%, and there were 13 serious adverse events (1 death). Treatment-emergent adverse events 5% or higher were nausea, hyperhidrosis, constipation, headache, dry mouth, dizziness, vomiting, insomnia, and upper respiratory tract infection. Mean increases were observed in systolic blood pressure (range, 0.0-2.3 mm Hg), diastolic blood pressure (range, 1.9-3.3 mm Hg), and pulse (range, 5.9-8.4 beats per minute). Mean improvements on the Montgomery-Åsberg Depression Rating Scale (-17.0) were observed from baseline to week 54. The safety profile from this study provides an overview of outcomes associated with edivoxetine and norepinephrine reuptake inhibition as an adjunctive treatment in patients with MDD who were treated up to 1 year.

  11. Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Maltais, François; O'Donnell, Denis; Gáldiz Iturri, Juan Bautista; Kirsten, Anne-Marie; Singh, Dave; Hamilton, Alan; Tetzlaff, Kay; Zhao, Yihua; Casaburi, Richard

    2018-01-01

    The TORRACTO ® study evaluated the effects of tiotropium/olodaterol versus placebo on endurance time during constant work-rate cycling and constant speed shuttle walking in patients with chronic obstructive pulmonary disease (COPD) after 12 weeks of treatment. The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12 weeks of treatment was also evaluated in a subset of patients. A total of 404 patients received treatment, with 165 participating in the ESWT substudy. A statistically significant improvement in endurance time during CWRCE was observed after 12 weeks (primary endpoint) with tiotropium/olodaterol 5/5 µg [14% ( p = 0.02)] but not with tiotropium/olodaterol 2.5/5 µg [9% ( p = 0.14)] versus placebo. In the ESWT substudy, a trend to improvement in endurance time during ESWT after 12 weeks (key secondary endpoint) was observed with tiotropium/olodaterol 5/5 µg [21% ( p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21% ( p = 0.056)] versus placebo. Tiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry versus placebo, with a strong tendency to also improve walking endurance time. [ ClinicalTrials.gov identifier: NCT01525615.].

  12. An update on the pill.

    Science.gov (United States)

    1983-01-01

    The discussion traces the development of the oral contraceptive (OC) pill and presents the most recent medical findings on OC and its effects. In 1959 the 1st combined OC, Enovid, was officially approved for use in the US after clinical trials in Los Angeles and Puerto Rico. By 1975, OCs were being used in the US by more than 1/3 of married women who practiced family planning and by an even higher percentage of unmarried contraceptive users. Retail pharmacy sales of OCs have declined by 40% during the 1975-79 period. The major reason given for the decline was the side effects or fear of side effects arising from OC use. Many OCs are available today because of an increasing variety of chemical combinations and the rapid increase in product names, according to "Oral Contraceptives: A Guide for Programs and Clinics," a Pathfinder Fund handbook. The authors classified OCs into 2 general groups -- combined pills and the mini-pills. OCs used in the combined preparation each contain 2 synthetic hormones -- estrogen and progestin. The combined OC is 99% effective when taken properly. The most popular belief now is that OCs act by interfering with the normal menstrual cycle. The mini-pills, which contain small doses of synthetic progestins, have a contraceptive effect by altering the cervical mucus and by altering the lining of the womb or endometrium. Absolute, strong relative, and other relative contraindications to pill use are listed. Side effects that are possibly life threatening include blood clots in the legs, pelvis (lower abdomen), lungs, heart, or brain. Women OC users over 40 have a higher risk of heart attack than younger users, and users over 40 who smoke have the highest risk of heart attack. Benign tumors of the liver, which have been found to be more common in women who use OCs, may cause rupture of the capsule of the liver, extensive bleeding, and even death. Rare tumors of the liver, hepatocelluar adenomas, are more likely to occur in long term OC users

  13. Study regarding the physical-mechanical properties of knits for garments – pilling performance

    Directory of Open Access Journals (Sweden)

    Coldea Alina Mihaela

    2017-01-01

    Full Text Available The effect of the pilling degradation results is an important decreasing in garment quality and a negative influence on the user’s comfort to wear. There are a lot factors, such as the yarn spinning system, fabric geometry and finishing operation, which affect the pilling performance. This research paper presents the investigation of fabric surface concerning pilling formation, especially knits, influenced by the fibrous composition. As samples were used knitted fabric panels, obtained from carded yarns, with fibers composition like cotton, wool or mixed one. Regarding fabric geometry 3 types were used – single jersey, 2x2 rib and moss stitch. In order to establish which of the yarns are most appropriate for knitting garments from the point of view of pilling resistance were realized tests using the standard SR EN ISO 12945-2.The tests were performed with the Nu-Martindale – Abrasion and Pilling Tester, Model 864.For assessment were used two methods – the first one is a comparison with visual standards, tested fabrics or photographs of fabrics, to find the degree of pilling on a scale from 5 (no pilling to 1 (very severe pilling and the second one by determination of mass loss percent.

  14. Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.

    Science.gov (United States)

    Dahl, Ronald; Engel, Michael; Dusser, Daniel; Halpin, David; Kerstjens, Huib A M; Zaremba-Pechmann, Liliana; Moroni-Zentgraf, Petra; Busse, William W; Bateman, Eric D

    2016-09-01

    Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma. To evaluate safety and tolerability of tiotropium delivered via the Respimat(®) device, compared with placebo, each as add-on to at least ICS therapy, in a pooled sample of adults with symptomatic asthma at different treatment steps. Data were pooled from seven Phase II and III, randomised, double-blind, parallel-group trials of 12-52 weeks' treatment duration, which investigated once-daily tiotropium Respimat(®) (5 μg, 2.5 μg) versus placebo as add-on to different background maintenance therapy including at least ICS. Adverse events (AEs) including serious AEs were assessed throughout treatment + 30 days after the last dose of trial medication. Of 3474 patients analysed, 2157 received tiotropium. The percentage of patients with AEs was comparable between treatment groups: tiotropium 5 μg, 60.8%; placebo 5 μg pool, 62.5%; tiotropium 2.5 μg, 57.1%; placebo 2.5 μg pool, 55.1%. Consistent with the disease profile, the most frequent AEs overall were asthma, decreased peak expiratory flow rate (both less frequent with tiotropium) and nasopharyngitis. Overall incidence of dry mouth, commonly associated with use of anticholinergics, was low: tiotropium 5 μg, 1.0%; placebo 5 μg pool, 0.5%; tiotropium 2.5 μg, 0.4%; placebo 2.5 μg pool, 0.5%. The percentage of cardiac disorder AEs was comparable between tiotropium and placebo: tiotropium 5 μg, 1.4%; placebo 5 μg pool, 1.4%; tiotropium 2.5 μg, 1.4%; placebo 2.5 μg pool, 1.1%. The proportions of patients with serious AEs were balanced across groups: tiotropium 5 μg, 4.0%; placebo 5 μg pool, 4.9%; tiotropium 2.5 μg, 2.0%; placebo 2.5 μg pool, 3.3%. Tiotropium Respimat(®) demonstrated safety and tolerability comparable with those of placebo, as add-on to at least

  15. Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Haruhiko Ogata

    2017-07-01

    Full Text Available Background/Aims: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD compared to another form of high-dose mesalazine.Methods: In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI at the end of the treatment period.Results: The change in the UC-DAI (mean±standard deviation in the per-protocol set was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134 and −1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129. The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidence interval, −1.3 to −0.1. The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1. The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups.Conclusions: Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.

  16. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

    Science.gov (United States)

    Goodman, Shaun G; Wojdyla, Daniel M; Piccini, Jonathan P; White, Harvey D; Paolini, John F; Nessel, Christopher C; Berkowitz, Scott D; Mahaffey, Kenneth W; Patel, Manesh R; Sherwood, Matthew W; Becker, Richard C; Halperin, Jonathan L; Hacke, Werner; Singer, Daniel E; Hankey, Graeme J; Breithardt, Gunter; Fox, Keith A A; Califf, Robert M

    2014-03-11

    This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767

  17. Pharmacodynamic analysis and clinical trial of amoxicillin sprinkle administered once daily for 7 days compared to penicillin V potassium administered four times daily for 10 days in the treatment of tonsillopharyngitis due to Streptococcus pyogenes in children.

    Science.gov (United States)

    Pichichero, M E; Casey, J R; Block, S L; Guttendorf, R; Flanner, H; Markowitz, D; Clausen, S

    2008-07-01

    An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time above the MIC (T >MIC; based on the MIC(90) of 0.06 microg/ml for Streptococcus pyogenes reported in the literature) was shown to be achievable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle). The daily T >MIC achieved with the QD amoxicillin sprinkle formulation was comparable to that achieved with a four-times-daily (QID) penicillin VK suspension. An investigator-blinded, randomized, parallel-group, multicenter study involving 579 children 6 months to 12 years old with acute streptococcal tonsillopharyngitis was then undertaken. Children were randomly assigned 1:1 to receive either the amoxicillin sprinkle (475 mg for ages 6 months to 4 years, 775 mg for ages 5 to 12 years) QD for 7 days or 10 mg/kg of body weight of penicillin VK QID for 10 days (up to the maximum dose of 250 mg QID). Unexpectedly, the rates of bacteriological eradication at the test of cure were 65.3% (132/202) for the amoxicillin sprinkle and 68.0% (132/194) for penicillin VK (95% confidence interval, -12.0% to 6.6%). Thus, neither antibiotic regimen met the minimum criterion of > or =85% eradication ordinarily required by the U.S. FDA for first-line treatment of tonsillopharyngitis due to S. pyogenes. The results of subgroup analyses across demographic characteristics and current infection characteristics and by age/weight categories were consistent with the primary-efficacy result. The clinical cure rates for amoxicillin sprinkle and penicillin VK were 86.1% (216/251) and 91.9% (204/222), respectively (95% confidence interval, -11.6% to -0.4%). The results of a post hoc PD analysis suggested that a requirement for 60% daily T >MIC(90) more accurately predicted the observed high failure rates for bacteriologic eradication with the amoxicillin sprinkle and penicillin VK suspension studied. Based on the association between

  18. Pharmacodynamic Analysis and Clinical Trial of Amoxicillin Sprinkle Administered Once Daily for 7 Days Compared to Penicillin V Potassium Administered Four Times Daily for 10 Days in the Treatment of Tonsillopharyngitis Due to Streptococcus pyogenes in Children▿

    Science.gov (United States)

    Pichichero, M. E.; Casey, J. R.; Block, S. L.; Guttendorf, R.; Flanner, H.; Markowitz, D.; Clausen, S.

    2008-01-01

    An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time above the MIC (T >MIC; based on the MIC90 of 0.06 μg/ml for Streptococcus pyogenes reported in the literature) was shown to be achievable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle). The daily T >MIC achieved with the QD amoxicillin sprinkle formulation was comparable to that achieved with a four-times-daily (QID) penicillin VK suspension. An investigator-blinded, randomized, parallel-group, multicenter study involving 579 children 6 months to 12 years old with acute streptococcal tonsillopharyngitis was then undertaken. Children were randomly assigned 1:1 to receive either the amoxicillin sprinkle (475 mg for ages 6 months to 4 years, 775 mg for ages 5 to 12 years) QD for 7 days or 10 mg/kg of body weight of penicillin VK QID for 10 days (up to the maximum dose of 250 mg QID). Unexpectedly, the rates of bacteriological eradication at the test of cure were 65.3% (132/202) for the amoxicillin sprinkle and 68.0% (132/194) for penicillin VK (95% confidence interval, −12.0% to 6.6%). Thus, neither antibiotic regimen met the minimum criterion of ≥85% eradication ordinarily required by the U.S. FDA for first-line treatment of tonsillopharyngitis due to S. pyogenes. The results of subgroup analyses across demographic characteristics and current infection characteristics and by age/weight categories were consistent with the primary-efficacy result. The clinical cure rates for amoxicillin sprinkle and penicillin VK were 86.1% (216/251) and 91.9% (204/222), respectively (95% confidence interval, −11.6% to −0.4%). The results of a post hoc PD analysis suggested that a requirement for 60% daily T >MIC90 more accurately predicted the observed high failure rates for bacteriologic eradication with the amoxicillin sprinkle and penicillin VK suspension studied. Based on the association between longer

  19. Emergency contraceptive pills (ECP) protocol.

    Science.gov (United States)

    1994-05-01

    Outlined is a protocol for the administration of emergency contraceptive pills. The indication for such treatment is unprotected intercourse within the past 72 hours. Absolute contraindications include the possibility of an existing pregnancy and a family history of stroke, heart attack, thrombophlebitis, breast or endometrial cancer, or liver tumor. Possibly excluded, depending on evaluation by a physician, are women with abnormal vaginal bleeding, active hepatitis, active gallbladder disease, high blood pressure, acute focal migraine, breastfeeding women, and those unable to understand instructions. The recommended regimen consists of six tablets of Ovral (two taken immediately, two more in 12 hours) or 12 tablets of Lo/Ovral, Nordette, or Levlen (four taken immediately, repeat dosage in 12 hours). The extra pills are to be used in cases of vomiting within three hours of pill ingestion. Women with a history of oral contraceptive-related nausea and vomiting should be provided with Compazine. Women should be informed that this method is effective in only about 92% of cases. All women who receive emergency contraception should be counseled that this is strictly a back-up method and helped to formulate a long-term birth control strategy.

  20. Ventricular tachycardia induced by weight loss pills

    DEFF Research Database (Denmark)

    Pareek, Manan; Hansson, Nils Henrik; Grove, Erik Lerkevang

    2013-01-01

    A previously healthy 29-year-old man was admitted with palpitations, dizziness, and near-syncope after he had recently started taking weight loss pills purchased on the internet. The pills contained caffeine and ephedrine. An electrocardiogram and telemetry revealed multiple episodes of non......-sustained monomorphic ventricular tachycardia, which was successfully treated with amiodarone. In conclusion, unauthorized weight loss pills can be harmful. In particular, ephedrine-containing drugs carry a risk of ventricular tachycardia and should be discouraged....

  1. [Mamy-boom and baby-flop, pill and pill].

    Science.gov (United States)

    Geraud, R

    1989-05-01

    Data from France's National Institute of Demographic Studies indicate that in 1986, 778,859 infants were born in France, including 80,874 to foreign mothers. France's total fertility rate was 1.83, higher than the 1.40 of the Federal Republic of Germany or the 1.35 of Italy but not high enough to ensure replacement. A 1988 survey by the National Institute of Demographic Studies indicated that almost 2/3 of fertile-aged French women used pills or IUDs. 7% had undergone sterilization, 4% were infertile, 13% had no partners, and 10% were pregnant or desired to become pregnant. All the developed countries, regardless of their form of government, have low fertility rates. The complete explanations of the trend to low fertility are not known. Economic and sociological explanations probably carry less weight than psychological factors. The desire for material goods, greater freedom of women, changing roles of men in the family and society, and fragility of marriages probably all play a part. The pill and to a lesser extent abortion have been blamed for the declining fertility, but do not furnish the complete explanation. Greater availability of RU 486 may cause further decline, but nobody can predict with assurance. Falling nuptiality, increased nonmarital cohabitation with its low fertility rates, the low rate of remarriage after divorce, and the greater life expectancy of women all affect France's population structure and prospects. By 2010, some 20% of the European population will be aged 65 and over. By 2035 almost 10 million persons will be over 70 years old in France, and nearly 2/3 of them will be female. This large cohort of elderly will require expensive care that the smaller young cohorts will be expected to finance. Intergenerational solidarity, however, already shows signs of strain. Serious conflicts will inevitably arise over the care and maintenance of this large elderly population group and will be exacerbated by the uneven population structure resulting

  2. Dynamically programmable electronic pill dispenser system.

    Science.gov (United States)

    Boquete, Luciano; Rodriguez-Ascariz, Jose Manuel; Artacho, Irene; Cantos-Frontela, Joaquin; Peixoto, Nathalia

    2010-06-01

    Compliance in medicine dispensation has proven critical for dosage control, diagnosis, and treatment. We have designed, manufactured, and characterized a novel dynamically programmable e-pill dispensing system. Our system is initially programmed remotely through a cell phone. After programming, the system may be reconfigured in order to adapt pill dispensation to new conditions. In this paper we describe the mechanics, electronics, control, and communication protocols implemented. Our dyn-e-pill devices can be actuated for over 350 h with two pill retrievals per hour. We challenged the charging circuit and demonstrated that the system has a lifetime longer than 6 h with a 30 min charging cycle, while it lasts for 14 h of uninterrupted use with a full charge.

  3. Radio pill antenna range test

    Science.gov (United States)

    Cummins, W. F.; Kane, R. J.

    1992-05-01

    In order to investigate the potential of a proposed 'radio pill' beacon transmitter, a range test experiment was devised and carried out in the VHF frequency range. Calculations and previous work indicated that optimum sensitivity and, thus, distance would be obtained in this frequency range provided body radio-frequency (RF) absorption was not too great. A ferrite-core loop antenna is compatible with a pill geometry and has better radiation efficiency than an air core loop. The ferrite core may be a hollow cylinder with the electronics and batteries placed inside. However, this range test was only concerned with experimentally developing test range data on the ferrite core antenna itself. A one turn strap loop was placed around a 9.5 mm diameter by 18.3 mm long stack of ferrite cores. This was coupled to a 50 Omega transmission line by 76 mm of twisted pair line and a capacitive matching section. This assembly was excited by a signal generator at output levels of -10 to +10 dBm. Signals were received on a VHF receiver and tape recorder coupled to a 14 element, circularly polarized Yagi antenna at a height of 2.5 m. Field strength measurements taken at ranges of 440, 1100, and 1714 m. Maximum field strengths referenced to 0 dBm transmitter level were -107 to -110 dB at 440 m, -124 to -127 dBm at 1100 m, and -116 to -119 dBm at 1714 m when the antenna cylinder was horizontal. Field strengths with a vertical antenna were about 6 dB below these values. The latter transmit site was elevated and had a clear line-of-site path to the receiving site. The performance of this test antenna was better than that expected from method-of-moment field calculations. When this performance data is scaled to a narrow bandwidth receiving system, ground level receiving ranges of a few to 10 km can be expected. Clear line-of-sight ranges where either or both the transmitter and receiver are elevated could vary from several km to 100 km.

  4. [A brief history of traditional Chinese medicinal pills].

    Science.gov (United States)

    Xu, X; Lu, X; Zhu, J P

    2016-05-01

    Traditional Chinese medicine pill, an archaic medicinal preparation form, is a kind of spherical or spherical-like preparation form produced by medicinal powders or extracts mixed with appropriate excipient or other accessories. It was originated in the Pre-Qin Dynasty, developed and enriched from the Han Dynasty to the Ming and Qing Dynasties. With the improvement of preparing process, honeyed pill, waxed pill, coating pill and wax-coating pill etc. appeared in succession. In modern times, with the progress of pharmaceutical machine, the medicinal pill is innovated constantly, and at present, it becomes the main form of Chinese patent medicine with batch production.

  5. The 2016 iodine pill distribution campaign

    International Nuclear Information System (INIS)

    Delmestre, A.; Le Guen, B.

    2016-01-01

    The last iodine pills were distributed in february 2009, they are now outdated and a new campaign has been launched. Each family will receive a voucher to recover iodine pills from the nearby pharmacy. The aim of this new campaign is of course to protect people in case of severe nuclear accident but also to develop a radiation protection culture among the population. During the previous campaign only 51% of the concerned people went to the pharmacy to get the pills. The 2016 campaign will involve the public and all the establishments open to the public in a range of 10 km around each of the 19 nuclear power plants. It concerns 500 municipalities, 375.000 households, 55.000 enterprises and public utilities and 275 pharmacies are involved in the campaign. (A.C.)

  6. A phase Ib trial of continuous once-daily oral afatinib plus sirolimus in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer and/or disease progression following prior erlotinib or gefitinib.

    Science.gov (United States)

    Moran, Teresa; Palmero, Ramón; Provencio, Mariano; Insa, Amelia; Majem, Margarita; Reguart, Noemí; Bosch-Barrera, Joaquim; Isla, Dolores; Costa, Enric Carcereny; Lee, Chooi; Puig, Marta; Kraemer, Sandrine; Schnell, David; Rosell, Rafael

    2017-06-01

    Dysregulation of the downstream PI3K/AKT/mTOR signaling pathway is a proposed mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). We investigated safety and antitumor activity of afatinib plus sirolimus as a potential combination to reverse acquired resistance to EGFR-TKIs in a phase IB trial in patients with EGFR mutation-positive non-small-cell lung cancer (EGFR mut NSCLC) and/or disease progression following prior erlotinib/gefitinib. Patients with EGFR mut NSCLC and/or disease progression following at least prior erlotinib/gefitinib were included in the trial. The primary endpoint was incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD). Four initial dose cohorts were proposed to evaluate DLTs. Other endpoints included tumor response, safety, progression-free survival (PFS) and pharmacokinetics. Thirty-nine patients received afatinib and sirolimus. Additional dose cohorts were added since the second cohort (afatinib 40mg/day and sirolimus 5mg/day) was considered to have excessive toxicity. All patients experienced adverse events (AE) [grade 3: 66.7%; serious AE: 56.4%]. The most frequent AEs were diarrhea (94.9%), mucosal inflammation (64.1%), asthenia (53.8%) and rash (53.8%). Discontinuations and dose reduction due to AEs occurred in 23.1% and 25.6% of patients. MTD was determined as afatinib 30mg and sirolimus 1mg. Responses were observed in 5 patients (12.8%) [2 (5.1%) with confirmed partial response (PR); 3 (7.7%) with unconfirmed PR], and stable disease in 18 patients (46.2%). Four of the 5 responses were at doses above MTD. PFS at 6 months was estimated in 33.3% (median PFS 3.4 months). Pharmacokinetic parameters of afatinib and sirolimus were similar after single administration or in combination. The combination of afatinib and sirolimus showed lower responses than expected. Together with increased AEs and poor tolerability, this precludes clinical use and further

  7. [Sex hormones: inexpensive pills to poor women].

    Science.gov (United States)

    Astrup, N

    1988-03-16

    The medical community in India is engaged in a strident debate on wither the sale of pills containing a high dose of the female sex hormones estrogen and progesterone should be forbidden by law. During the '50s and '60s pills with a high dose of estrogen and progesterone were used in the industrial nations as a means of pregnancy tests. The failure of a woman with delayed menses to respond to administration of a high dose of these hormones in a few days was an indication of pregnancy. Eventually evidence accumulated that use of these pills during the early stages of pregnancy caused malformations of the fetus, particularly hydrocephalus. In most countries sale of these pills was forbidden or at least subjected to strong controls. Today, however, sales continue in a large part of the Third World, which accounts for 87% of all estrogen and progesterone preparations in the world. Studies in southern India show that among women who have delivered malformed children, 31% had taken hormone pills during the first 3 months of pregnancy. In 1982 the Indian department of health forbade the sale of high dose combinations of estrogen and progesterone but gave manufacturers a half year to cease production and a year to cease sales. The manufacturers appealed the ruling to the Indian supreme court and sales have continued as hearings proceeded through the legal system. The deciding factor, however, is one of price. A urine pregnancy test is quicker and completely harmless but a urine tests costs $4-$5 while the pills cost less than $1.

  8. Smart pill dispenser for dependent people

    OpenAIRE

    Juan Grau, Guillermo de

    2015-01-01

    Many medical errors are due to the fact that people in charge of patient or elder’s medication have to deal with sorting huge amounts of pills each day. This paper consists on the conception, design and creation of a pillbox prototype intended to solve this deficiency in the medical area as it has the ability of sorting out the pills by itself as well as many other advanced features, with this device being intended to be used by hospitals or retirement homes. For the design of this device ope...

  9. Antiretroviral pill count and clinical outcomes in treatment-naive patients with HIV infection

    NARCIS (Netherlands)

    Young, J.; Smith, C.; Teira, R.; Reiss, P.; Jarrín Vera, I.; Crane, H.; Miro, J. M.; d'Arminio Monforte, A.; Saag, M.; Zangerle, R.; Bucher, H. C.; Boulle, Andrew; Stephan, Christoph; Cavassini, Matthias; del Amo, Julia; Fätkenheuer, Gerd; Gill, John; Guest, Jodie; Hans-Ulrich Haerry, David; Hogg, Robert; Justice, Amy; Shepherd, Leah; Obel, Neils; Sterling, Tim; Williams, Matthew

    2018-01-01

    ObjectivesTreatment guidelines recommend single-tablet regimens for patients with HIV infection starting antiretroviral therapy. These regimens might be as effective and cost less if taken as separate drugs. We assessed whether the one pill once a day combination of efavirenz, emtricitabine and

  10. The Contraceptive Pill-Current Status

    African Journals Online (AJOL)

    16 Okt 1974 ... the method and a certain amount of inherent risk, and nonetheless request it. The onus is therefore on the medical profession to select the most suitable type of pill for each type of patient. An attempt must be made to assess the risks in specific indi- viduals, and to prevent prescription of oral contra-. 2085 ...

  11. Contraception. Low-dose pill launched.

    Science.gov (United States)

    1993-01-01

    At a vibrant ceremony in Kampala, Uganda, the Minister of Women in Development, Youth and Culture launched the new low-dose oral contraceptive Pilplan which provides women more options for birth spacing. Diplomats, physicians, government officials, and business leaders attended the ceremony at the Sheraton Hotel Kampala. A dance group did an interpretation of "Women in Uganda: Gaining Momentum." The Minister considered the introduction of this new pill as a turning point for reproductive rights. A baseline survey among Ugandan women has shown that although almost all women were familiar with the pill, only 36% have ever used it and only 15% were currently using it. 80% thought that pill use was preferable to having an unplanned pregnancy. These findings convinced the Minister that ignorance and misconception keep women from using the pill. The government, health providers, and others need to educate women about Pilplan and how to use it correctly. A bilateral agreement between the Ministry of Health and USAID set in motion a social marketing project which has now launched two contraceptive methods: Pilplan in 1993 and the Protector condom in 1990. USAID vowed to continue to support Pilplan, particularly if men could also help in supporting birth spacing. A Uganda-based pharmaceutical firm will distribute Pilplan in Uganda through pharmacies, clinics, and health facilities. Pilplan targets all middle- to low-income women.

  12. Formulation and in Vitro Evaluation of Once Daily Sustained ...

    African Journals Online (AJOL)

    Purpose: The objective of the study was to develop matrix tablets for oral controlled release of aceclofenac using ethyl cellulose, guar gum and various grades of cellulose polymers. Methods: Possible drug-excipient interaction was evaluated by high performance liquid chromatography (HPLC) and Fourier infrared ...

  13. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.

    Science.gov (United States)

    Ahrén, Bo; Masmiquel, Luis; Kumar, Harish; Sargin, Mehmet; Karsbøl, Julie Derving; Jacobsen, Sanja Hald; Chow, Francis

    2017-05-01

    Semaglutide is a novel glucagon-like peptide-1 (GLP-1) analogue, suitable for once-weekly subcutaneous administration, in development for treatment of type 2 diabetes. We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both. We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries. Eligible patients were aged at least 18 years (or at least 20 years in Japan) and diagnosed with type 2 diabetes, with insufficient glycaemic control (HbA 1c 7·0-10·5% [53·0-91·0 mmol/mol]) despite stable treatment with metformin, thiazolidinediones, or both. We randomly assigned participants (2:2:1:1) using an interactive voice or web response system to 56 weeks of treatment with subcutaneous semaglutide 0·5 mg once weekly plus oral sitagliptin placebo once daily, subcutaneous semaglutide 1·0 mg once weekly plus oral sitagliptin placebo once daily, oral sitagliptin 100 mg once daily plus subcutaneous semaglutide placebo 0·5 mg once weekly, or oral sitagliptin 100 mg once daily plus subcutaneous semaglutide placebo 1·0 mg once weekly. The two oral sitagliptin 100 mg groups (with semaglutide placebo 0·5 mg and 1·0 mg) were pooled for the analyses. The primary endpoint was change in HbA 1c from baseline to week 56, assessed in the modified intention-to-treat population (all randomly assigned participants who received at least one dose of study drug); change in bodyweight from baseline to week 56 was the confirmatory secondary endpoint. Safety endpoints included adverse events and hypoglycaemic episodes. This trial is registered with ClinicalTrials.gov, number NCT01930188. Between Dec 2, 2013, and Aug 5, 2015, we randomly assigned 1231 participants; of the 1225 included in the modified intention

  14. Fatal Fentanyl: One Pill Can Kill.

    Science.gov (United States)

    Sutter, Mark E; Gerona, Roy R; Davis, M Thais; Roche, Bailey M; Colby, Daniel K; Chenoweth, James A; Adams, Axel J; Owen, Kelly P; Ford, Jonathan B; Black, Hugh B; Albertson, Timothy E

    2017-01-01

    The current national opioid epidemic is a public health emergency. We have identified an outbreak of exaggerated opioid toxicity caused by fentanyl adulterated tablets purchased on the street as hydrocodone/acetaminophen. Over an 8-day period in late March 2016, a total of 18 patients presented to our institution with exaggerated opioid toxicity. The patients provided a similar history: ingesting their "normal dose" of hydrocodone/acetaminophen tablets but with more pronounced symptoms. Toxicology testing and analysis was performed on serum, urine, and surrendered pills. One of the 18 patients died in hospital. Five patients underwent cardiopulmonary resuscitation, one required extracorporeal life support, three required intubation, and two received bag-valve-mask ventilation. One patient had recurrence of toxicity after 8 hours after naloxone discontinuation. Seventeen of 18 patients required boluses of naloxone, and four required prolonged naloxone infusions (26-39 hours). All 18 patients tested positive for fentanyl in the serum. Quantitative assays conducted in 13 of the sera revealed fentanyl concentrations of 7.9 to 162 ng/mL (mean = 52.9 ng/mL). Pill analysis revealed fentanyl amounts of 600-6,900 μg/pill. The pills are virtually indistinguishable from authentic hydrocodone/acetaminophen tablets and are similar in weight. To date, our county has reported 56 cases of fentanyl opioid toxicity, with 15 fatalities. In our institution, the outbreak has stressed the capabilities and resources of the emergency department and intensive care units. A serious outbreak of exaggerated opioid toxicity caused by fentanyl-adulterated tablets purchased on the street as hydrocodone/acetaminophen is under way in California. These patients required higher dosing and prolonged infusions of naloxone. Additionally, observation periods off naloxone were extended due to delayed, recurrent toxicity. The outbreak has serious ramifications for public health and safety, law

  15. The Pill vs. the Sword: Additional Considerations

    Science.gov (United States)

    Lottes, Ilsa L.

    2015-01-01

    In this paper, I present additional information for policy-makers and researchers to consider in response to the view proposed by Potts et al that "the pill is mightier than the sword." I identify states with both high rates of terrorism and a youth bulge and discuss correlates of both these societal characteristics. The research examined supports the view that factors other than access to family planning are more important in facilitating terrorism. PMID:26673473

  16. Effect of Zuogui Pill () on monoamine neurotransmitters and sex hormones in climacteric rats with panic attack.

    Science.gov (United States)

    Li, Xiao-Yu; Wang, Xiao-Yun

    2017-03-01

    To explore the effects of Chinese medicine prescription Zuogui Pill (, ZGP) on monoamine neurotransmitters and sex hormones in climacteric rats with induced panic attacks. Forty-eight climacteric female rats were randomized into 6 groups with 8 rats in each group: the control group, the model group, the low-, medium- and high-dose ZGP groups and the alprazolam group. Rats in the low-, medium- and high-dose ZGP groups were administered 4.725, 9.45, or 18.9 g/kg ZGP by gastric perfusion, respectively. The alprazolam group was treated by gastric perfusion with 0.036 mg/kg alprazolam. The control and model groups were treated with distilled water. The animals were pretreated once daily for 8 consecutive weeks. The behaviors of rats in the open fifield test and the elevated T-maze (ETM) were observed after induced panic attack, and the levels of brain monoamine neurotransmitters and the plasma levels of sex hormones were measured. Compared with the control group, the mean ETM escape time and the levels of 5-hydroxytryptamine (5-HT) and noradrenalin (NE) of the model group were signifificantly reduced (P<0.05), Compared with the model group, the mean ETM escape time and the 5-HT and NE levels of all the ZGP groups increased signifificantly (P<0.05 or P<0.01). However, no signifificant difference was observed in the levels of sex hormones between the groups. Pretreatment with ZGP in climacteric rats may improve the behavior of panic attack, which may be related to increased 5-HT and NE in the brain.

  17. Happy-People-Pills for All

    Directory of Open Access Journals (Sweden)

    Mark Walker

    2011-01-01

    Full Text Available

    It is argued that we have a moral duty to create, and make available, advanced pharmacological agents to boost the happiness of those in the normal, i.e., the non-depressed, range of happiness. Happiness, conceived as a propensity to positive moods, is a quantitative trait with a sizeable genetic component. One means to boost the happiness of those in the normal range is to test the efficacy of antidepressants for enhancement. A second possibility is to model new pharmacologicals based on the genetics of the happiest amongst us, that is, the hyperthymic. The suggestion, in other words, is to “reverse engineer” the hyperthymic: to investigate what makes the hyperthymic genetically and physiologically different and then put what they have into pill form. To the ‘Brave New World’ objection, that there is more to wellbeing than happiness and that taking happy-people-pills will require the sacrifice of these other aspects of wellbeing, it is countered that contemporary social science research supports the view that happiness promotes achievement in the ‘higher’ endeavors of humanity, including work, love and virtue. In other words, happiness promotes acquisition of traits valued by perfectionists. Those born with genes for hyperthymia, on average, tend to be doubly blessed: they are happier and achieve more than the rest of the population. Happy-people-pills are a means to allow everyone else to share in this good

  18. Improving access to emergency contraceptive pills.

    Science.gov (United States)

    1999-09-01

    This article focuses on the accessibility of emergency contraceptive pills (ECPs). The ECPs are safe, simple, and effective contraceptive agent that can reduce a woman's chance of becoming pregnant by 75%. It works by preventing or delaying ovulation, interfering with fertilization, or blocking implantation of a fertilized egg, depending on when in the menstrual cycle the pills are taken. The Population Council takes a multifaceted approach to expanding access to and knowledge on emergency contraception. Studies on innovations in service delivery are being conducted. In Mexico, one-tenth of women aged 13-55 who reported being raped during the 9-month study were counseled about ECPs. Results showed that pregnancies from reported rapes declined from 9.8% to 7.4% during the study. In Ho Chi Minh City, Vietnam, practitioners approved of the use of emergency contraception and desired more accurate knowledge so that they could provide it effectively. Moreover, in Zambia, researchers found out that giving women packages of ECPs in advance greatly reduced the length of time between having unprotected intercourse and beginning ECP treatment. Council researchers have also addressed the safety of offering ECPs without prescription. They have collaborated with leaders in the health care industry to increase method availability.

  19. Smoking, the oral contraceptive pill, and Crohn's disease.

    Science.gov (United States)

    Wakefield, A J; Sawyerr, A M; Hudson, M; Dhillon, A P; Pounder, R E

    1991-08-01

    Both cigarette smoking and the oral contraceptive pill have been implicated as aggravating factors in Crohn's disease. Based upon the recent demonstration of multifocal gastrointestinal infarction in Crohn's disease, a possible pathogenic mechanism for this condition, we propose how smoking and the oral contraceptive pill may potentiate a tendency for focal thrombosis and hence exacerbate the activity of Crohn's disease.

  20. Understanding gastric forces calculated from high-resolution pill tracking.

    Science.gov (United States)

    Laulicht, Bryan; Tripathi, Anubhav; Schlageter, Vincent; Kucera, Pavel; Mathiowitz, Edith

    2010-05-04

    Although other methods exist for monitoring gastrointestinal motility and contractility, this study exclusively provides direct and quantitative measurements of the forces experienced by an orally ingested pill. We report motive forces and torques calculated from real-time, in vivo measurements of the movement of a magnetic pill in the stomachs of fasted and fed humans. Three-dimensional net force and two-dimensional net torque vectors as a function of time data during gastric residence are evaluated using instantaneous translational and rotational position data. Additionally, the net force calculations described can be applied to high-resolution pill tracking acquired by any modality. The fraction of time pills experience ranges of forces and torques are analyzed and correlate with the physiological phases of gastric digestion. We also report the maximum forces and torques experienced in vivo by pills as a quantitative measure of the amount of force pills experience during the muscular contractions leading to gastric emptying. Results calculated from human data are compared with small and large animal models with a translational research focus. The reported magnitude and direction of gastric forces experienced by pills in healthy stomachs serves as a baseline for comparison with pathophysiological states. Of clinical significance, the directionality associated with force vector data may be useful in determining the muscle groups associated with gastrointestinal dysmotility. Additionally, the quantitative comparison between human and animal models improves insight into comparative gastric contractility that will aid rational pill design and provide a quantitative framework for interpreting gastroretentive oral formulation test results.

  1. Towards Automated and Objective Assessment of Fabric Pilling

    Directory of Open Access Journals (Sweden)

    Rocco Furferi

    2014-10-01

    Full Text Available Pilling is a complex property of textile fabrics, representing, for the final user, a non-desired feature to be controlled and measured by companies working in the textile industry. Traditionally, pilling is assessed by visually comparing fabrics with reference to a set of standard images, thus often resulting in inconsistent quality control. A number of methods using machine vision have been proposed all over the world, with almost all sharing the idea that pilling can be assessed by determining the number of pills or the area occupied by the pills on the fabric surface. In the present work a different approach is proposed: instead of determining the number of pills, a machine vision-based procedure is devised with the aim of extracting a number of parameters characterizing the fabric. These are then used to train an artificial neural network to automatically grade the fabrics in terms of pilling. Tested against a set of differently pilled fabrics, the method shows its effectiveness.

  2. [Tissue distribution of arsenic of liushen pills and realgar].

    Science.gov (United States)

    Zhang, Qing-Li; Wu, Qian; Xie, Yuan-Yuan; Shen, Lian-Zhong; Fan, Min-Wei; Liang, Qiong-Lin; Wang, Yi-Ming; Luo, Guo-An

    2011-06-01

    This study is to report the tissue distribution of arsenic after giving different doses of realgar and Liushen pills to Beagle dogs, in order to provide basis for the safety evaluation of Liushen pills. ICP-MS was used to measure arsenic concentration, and HPLC-ICP-MS was used to analyze arsenic speciation. The concentration of total arsenic and As(III) + DMA (arsenite + dimethylarsenic acid) increased with dosing of realgar. Total arsenic concentration in most tissues and As(III) + DMA concentration in all tissues of Liushen pills group are lower than that of realgar group, but AsB concentration in liver, spleen and kidney of Liushen pills group increased. The concentration of total arsenic showed a dose-dependent manner with dosage administered. It was indicated that components in Liushen pills can reduce solubility of arsenic in realgar, which may decrease toxicity of realgar.

  3. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days.

    Science.gov (United States)

    Bell, D; Duffin, A; Jacobs, A; Pediconi, C; Gruss, H J

    2014-03-01

    The 1R,2S stereoisomer of methoxamine hydrochloride, NRL001, is a highly selective α1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone. This study investigated the steady state pharmacokinetics (PK) and safety of 2 g rectal suppositories containing NRL001 in different strengths (7.5, 10, 12.5 or 15 mg). Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo. In each dose group nine participants received NRL001 and three received placebo. Blood samples to determine NRL001 concentrations were taken on Days 1, 7 and 14. Cardiovascular parameters were collected via electrocardiograms, Holter monitoring (three lead Holter monitor) and vital signs. Forty-eight volunteers were enrolled; 43 completed the study and were included in the PK analysis population. AUC and Cmax broadly increased with increasing dose, Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional, dose proportionality analysis did not provide evidence against dose proportionality as the log(dose) coefficients were not significantly < 1. NRL001 did not accumulate over time for any dose. Increasing NRL001 concentrations were related to changes in vital sign variables, most notably decreased heart rate. The most commonly reported adverse events (AEs) in the active treatment groups were paraesthesia and piloerection. Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time. Treatment was associated with changes in vital sign variables, most notably decreased heart rate. AEs commonly reported with NRL001 treatment were events indicative of a systemic α-adrenergic effect. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  4. Combining qualitative with quantitative approaches to study contraceptive pill use.

    Science.gov (United States)

    Oakley, D; Yu, M Y; Zhang, Y M; Zhu, X L; Chen, W H; Yao, L

    1999-03-01

    According to large-scale studies, oral contraceptive users become pregnant at rates that exceed ideal use failure rates. It is thought that a major cause is missed pills, but current research on consistent contraceptive pill taking is characterized by inadequate measures and a failure to investigate women's thinking about their own patterns of use. The purpose of this study was to gain some understanding about women's interpretations of consistency in their own pill taking through combining qualitative with quantitative data. The study was conducted in China, where contraception is free and widely available. Five urban and five rural oral contraceptive users were followed for up to three pill-taking cycles during 1996 for a total of 759 person-days. Consistency of pill taking was measured with electronic data obtained from a new blister package made by Anderson Clinical Technologies (Elmhurst, IL). Data from these devices were reviewed and interpreted by the study participants during in-depth private interviews. The users' reasons for missing pills included disruptions in their daily routines, their husband's absence, spotting, and trouble implementing the family planning program's instructions to take one pill per day for 22 days and start the next cycle on the fifth day of menses. One user gave these reasons for two cycles but denied missing numerous pills in her third cycle. Data from a series of four questionnaires showed that most demographic, psychosocial, and service system characteristics were not related to missed pills. However, results suggested that the daily routines of rural living may make consistent use more likely and that instructions for taking the pill may be associated with prolonged pill-free intervals and skipping pills during episodes of spotting. Three of the 10 women were at increased risk of pregnancy during the study period because of their pill-taking pattern. We concluded that the combination of qualitative with quantitative data

  5. The Pill vs. the Sword: Additional Considerations: Comment on "The Pill Is Mightier Than the Sword"

    OpenAIRE

    Lottes, Ilsa L.

    2015-01-01

    In this paper, I present additional information for policy-makers and researchers to consider in response to the view proposed by Potts et al that “the pill is mightier than the sword.” I identify states with both high rates of terrorism and a youth bulge and discuss correlates of both these societal characteristics. The research examined supports the view that factors other than access to family planning are more important in facilitating terrorism.

  6. The Pill vs. the Sword: Additional Considerations Comment on "The Pill Is Mightier Than the Sword".

    Science.gov (United States)

    Lottes, Ilsa L

    2015-08-21

    In this paper, I present additional information for policy-makers and researchers to consider in response to the view proposed by Potts et al that "the pill is mightier than the sword." I identify states with both high rates of terrorism and a youth bulge and discuss correlates of both these societal characteristics. The research examined supports the view that factors other than access to family planning are more important in facilitating terrorism. © 2015 by Kerman University of Medical Sciences.

  7. Pharmacokinetic profile of nomegestrol acetate and 17β-estradiol after multiple and single dosing in healthy women.

    Science.gov (United States)

    Gerrits, Mireille G F; Schnabel, Peter G; Post, Teun M; Peeters, Pierre A M

    2013-02-01

    The pharmacokinetics of the monophasic oral contraceptive nomegestrol acetate (NOMAC) plus 17β-estradiol (E(2)) were investigated after a single dose and multiple dosing. NOMAC/E2 (2.5 mg/1.5 mg) was administered daily to healthy women (18-50 years, n=23) for 24 days; blood samples for pharmacokinetic analysis were obtained on Day 24 and again, after a 10-day pill-free interval, on Day 35 after a single dose. NOMAC reached steady state after 5 days with mean ±standard deviation (SD) trough NOMAC concentration (C(av)) of 4.4±1.4 ng/mL. On Day 24, mean±SD peak NOMAC concentration (Cmax, 12.3±3.5 ng/mL) was reached in mean 1.5 h (t(max)); the mean±SD elimination half-life (t(½)) was 45.9±15.3 h. After a single dose, NOMAC mean±SD C(max) was 7.2±2.0 ng/mL and mean±SD t(½) was 41.9±16.2 h. On Day 24, E2 mean±SD C(av) was 50.3±25.7 pg/mL; mean±SD Cmax was 86.0±51.3 pg/mL. After a single dose, mean±SD E2 Cmax was 253±179 pg/mL. These data demonstrate that NOMAC/E2 has a pharmacokinetic profile consistent with once-daily dosing. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Oxycodone Ingestion Patterns in Acute Fracture Pain With Digital Pills.

    Science.gov (United States)

    Chai, Peter R; Carreiro, Stephanie; Innes, Brendan J; Chapman, Brittany; Schreiber, Kristin L; Edwards, Robert R; Carrico, Adam W; Boyer, Edward W

    2017-12-01

    Opioid analgesics are commonly prescribed on an as-needed (PRN) basis for acute painful conditions. Uncertainty of how patients actually take PRN opioids, coupled with a desire to completely cover pain, leads to variable and overly generous opioid prescribing practices, resulting in a surplus of opioids. This opioid surplus becomes a source for diversion and nonmedical opioid use. Understanding patterns of actual opioid ingestion after acute painful conditions can help clinicians counsel patients on safe opioid use, and allow timely recognition and intervention when escalating opioid self-dosing occurs, to prevent tolerance and addiction. We used a novel oxycodone digital pill system (ingestible biosensor within a standard gelatin capsule combined with 5-mg oxycodone) that when ingested, is activated by the chloride ion gradient in the stomach thereby emitting a radiofrequency signal captured by a wearable reader. The reader relays ingestion data to a cloud-based server that displays ingestion events to the study team. We deployed the oxycodone digital pill among opioid-naive individuals discharged from the emergency department with acute fracture pain. Participants were trained on digital pill operation and discharged with twenty-one 5-mg oxycodone digital pills. They were instructed to take digital pills PRN for pain on discharge. We conducted a brief interview 7 days after study enrollment, at which point participants returned the digital pill system. We identified oxycodone ingestion events in real time by data from the digital pill system and performed pill counts at the return visit to validate digital pill reporting of medication ingestion. In this study, 26 individuals were approached; 16 enrolled with 15 completing the study. Participants ingested a median of 6 (3-9.5) oxycodone digital pills over the course of 7 days, with 82% of the oxycodone dose ingested in the first 3 days. In individuals who required operative repair, 86% (N = 6) continued to ingest

  9. Effects of pill burden on discontinuation of the initial HAART regimen in minority female patients prescribed 1 pill/day versus any other pill burden.

    Science.gov (United States)

    Hill, Seth; Kavookjian, Jan; Qian, Jingjing; Chung, Allison; Vandewaa, John

    2014-01-01

    Highly active antiretroviral therapy (HAART) is a mainstay of treatment for patients with Human Immunodeficiency Virus (HIV). Since second line HAART therapies can be costlier and less effective, it is essential to understand the duration of initial HAART therapies. The overall aim of this study was to estimate the effects of daily pill burden on the time to discontinuation of the initial HAART regimen. Patients were initially identified through the clinic's CAREWARE database. A chart review was conducted for data collection, where only adult, female, HIV-positive patients initiating therapy at the study clinic between 1 January 2001 and 31 December 2011 were included. All study subjects were followed up from the initiation of HAART to treatment discontinuation. A Kaplan-Meier curve was generated to describe time to discontinuation by regimens, and a Cox proportional hazards model was developed to assess the impact of different regimen and patient demographic characteristics on the hazard of discontinuation of the initial regimen. A total of 498 charts were initially reviewed. After assessment of these patients for inclusion criteria, a cohort of 115 adult female patients who initiated HAART at the study clinic was included. Patients treated with 1 pill/day regimen had a significantly longer time to discontinuation than regimens of >1 pills/day (mean duration of initial therapy was 1062.56 days vs. 631.70 days, respectively, p = 0.003). Compared to 1 pill/day regimens, >1 pills/day regimens were associated with a higher hazard of discontinuation (hazard ratio (HR) =3.44 with 95% confidence interval (CI) = 1.25, 9.48). A higher viral load and patients without insurance were also found to be significantly associated with increased hazards of discontinuation. Overall, female HIV patients initiating therapy with the 1 pill/day HAART regimen were less likely to discontinue their treatment compared to patients initiating with >1 pills/day HAART regimen.

  10. The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early treatment-experienced subjects.

    Science.gov (United States)

    Ruane, P J; Brinson, C; Ramgopal, M; Ryan, R; Coate, B; Cho, M; Kakuda, T N; Anderson, D

    2015-05-01

    Following antiretroviral therapy failure, patients are often treated with a three-drug regimen that includes two nucleoside/tide reverse transcriptase inhibitors [N(t)RTIs]. An alternative two-drug nucleoside-sparing regimen may decrease the pill burden and drug toxicities associated with the use of N(t)RTIs. The Intelence aNd pRezista Once A Day Study (INROADS; NCT01199939) evaluated the nucleoside-sparing regimen of etravirine 400 mg with darunavir/ritonavir 800/100 mg once-daily in HIV-1-infected treatment-experienced subjects or treatment-naïve subjects with transmitted resistance. In this exploratory phase 2b, single-arm, open-label, multicentre, 48-week study, the primary endpoint was the proportion of subjects who achieved HIV-1 RNA treatment-experienced subjects or treatment-naïve subjects with transmitted resistance was virologically efficacious and well tolerated. © 2014 British HIV Association.

  11. Pharmacists' knowledge and perceptions of emergency contraceptive pills in Soweto and the Johannesburg Central Business District, South Africa.

    Science.gov (United States)

    Blanchard, Kelly; Harrison, Teresa; Sello, Mosala

    2005-12-01

    In South Africa, emergency contraceptive pills are available directly from pharmacies without a prescription, yet few studies have assessed pharmacists' knowledge of and attitudes toward the medication. In-person interviews were conducted with 34 pharmacists practicing in Soweto and the Johannesburg Central Business District, from February through April 2003. The pharmacists provided data on their knowledge of emergency contraceptive pills and their attitudes toward providing the medication to women in specific situations. Nearly all pharmacists sold at least one of the two types of dedicated emergency contraceptive pills available in South Africa. Although most had accurate knowledge about the method's dosing schedule, side effects and mechanism(s) of action, more than half erroneously believed that repeated use posed health risks. A large majority of pharmacists believed the pills should be available to rape victims, to single or married women and to women who had never given birth, but almost half did not think the pills should be given to women younger than 18, and a fourth said they would not give them to women with a late menstrual period. About one-third to half of pharmacists supported advance provision of the medication under certain circumstances. Most were willing to display promotional materials on emergency contraceptives in their pharmacies. Interventions aimed at educating pharmacists about the benefits of emergency contraceptive pills, especially for adolescents, are needed. Government and medical authorities should take advantage of pharmacists' willingness to display educational materials as a way to increase women's knowledge and use of the medication in South Africa.

  12. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).

    Science.gov (United States)

    Halperin, Jonathan L; Hankey, Graeme J; Wojdyla, Daniel M; Piccini, Jonathan P; Lokhnygina, Yuliya; Patel, Manesh R; Breithardt, Günter; Singer, Daniel E; Becker, Richard C; Hacke, Werner; Paolini, John F; Nessel, Christopher C; Mahaffey, Kenneth W; Califf, Robert M; Fox, Keith A A

    2014-07-08

    Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment. The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). This prespecified secondary analysis compares outcomes in older and younger patients. There were 6229 patients (44%) aged ≥75 years with atrial fibrillation and ≥2 stroke risk factors randomized to warfarin (target international normalized ratio=2.0-3.0) or rivaroxaban (20 mg daily; 15 mg if creatinine clearance <50 mL/min), double blind. The primary end point was stroke and systemic embolism by intention to treat. Over 10 866 patient-years, older participants had more primary events (2.57% versus 2.05%/100 patient-years; P=0.0068) and major bleeding (4.63% versus 2.74%/100 patient-years; P<0.0001). Stroke/systemic embolism rates were consistent among older (2.29% rivaroxaban versus 2.85% warfarin per 100 patient-years; hazard ratio=0.80; 95% confidence interval, 0.63-1.02) and younger patients (2.00% versus 2.10%/100 patient-years; hazard ratio=0.95; 95% confidence interval, 0.76-1.19; interaction P=0.313), as were major bleeding rates (≥75 years: 4.86% rivaroxaban versus 4.40% warfarin per 100 patient-years; hazard ratio=1.11; 95% confidence interval, 0.92-1.34; <75 years: 2.69% versus 2.79%/100 patient-years; hazard ratio=0.96; 95% confidence interval, 0.78-1.19; interaction P=0.336). Hemorrhagic stroke rates were similar in both age groups; there was no interaction between age and rivaroxaban response. Elderly patients had higher stroke and major bleeding rates than younger patients, but the efficacy and safety of rivaroxaban relative to warfarin did not differ with age, supporting rivaroxaban as an alternative for the elderly. © 2014 American Heart Association, Inc.

  13. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).

    Science.gov (United States)

    Washam, Jeffrey B; Stevens, Susanna R; Lokhnygina, Yuliya; Halperin, Jonathan L; Breithardt, Günter; Singer, Daniel E; Mahaffey, Kenneth W; Hankey, Graeme J; Berkowitz, Scott D; Nessel, Christopher C; Fox, Keith A A; Califf, Robert M; Piccini, Jonathan P; Patel, Manesh R

    2015-06-13

    Digoxin is a widely used drug for ventricular rate control in patients with atrial fibrillation (AF), despite a scarcity of randomised trial data. We studied the use and outcomes of digoxin in patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). For this retrospective analysis, we included and classified patients from ROCKET AF on the basis of digoxin use at baseline and during the study. Patients in ROCKET AF were recruited from 45 countries and had AF and risk factors putting them at moderate-to-high risk of stroke, with or without heart failure. We used Cox proportional hazards regression models adjusted for baseline characteristics and drugs to investigate the association of digoxin with all-cause mortality, vascular death, and sudden death. ROCKET AF was registered with ClinicalTrials.gov, number NCT00403767. In 14,171 randomly assigned patients, digoxin was used at baseline in 5239 (37%). Patients given digoxin were more likely to be female (42% vs 38%) and have a history of heart failure (73% vs 56%), diabetes (43% vs 38%), and persistent AF (88% vs 77%; p<0·0001 for each comparison). After adjustment, digoxin was associated with increased all-cause mortality (5·41 vs 4·30 events per 100 patients-years; hazard ratio 1·17; 95% CI 1·04-1·32; p=0·0093), vascular death (3·55 vs 2·69 per 100 patient-years; 1·19; 1·03-1·39, p=0·0201), and sudden death (1·68 vs 1·12 events per 100 patient-years; 1·36; 1·08-1·70, p=0·0076). Digoxin treatment was associated with a significant increase in all-cause mortality, vascular death, and sudden death in patients with AF. This association was independent of other measured prognostic factors, and although residual confounding could account for these results, these data show the possibility of digoxin having these effects. A randomised trial of digoxin in treatment of AF patients

  14. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF).

    Science.gov (United States)

    Sherwood, Matthew W; Douketis, James D; Patel, Manesh R; Piccini, Jonathan P; Hellkamp, Anne S; Lokhnygina, Yuliya; Spyropoulos, Alex C; Hankey, Graeme J; Singer, Daniel E; Nessel, Christopher C; Mahaffey, Kenneth W; Fox, Keith A A; Califf, Robert M; Becker, Richard C

    2014-05-06

    During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI. In the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-central nervous system systemic embolism, death, myocardial infarction, and bleeding, were reported in participants who experienced TI (3-30 days) for any reason. The at-risk period for outcomes associated with TI was from TI start to 30 days after resumption of study drug. In 14 236 participants who received at least 1 dose of study drug, 4692 (33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics. Only 6% (n=483) of TI incidences involved bridging therapy. Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% versus 0.41% per 30 days; hazard ratio [confidence interval]=0.74 [0.36-1.50]; P=0.40). Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants (0.99% versus 0.79% per 30 days; hazard ratio [confidence interval]=1.26 [0.80-2.00]; P=0.32). TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin. Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation

  15. Veevillad - hollandlaste väljakutse ja paratamatus / Pille Nagel

    Index Scriptorium Estoniae

    Nagel, Pille

    2005-01-01

    Arhitekt Pille Nagel veele ehitatud elumajadest Hollandis. Paatmajadest, Veersche Poorti elurajoonist (1999-2004) Middelburgis, "Gewild Wonen" elurajoonist (1999-2001) Eilandenbuurti linnajaos Almeres, kanaliäärsetest linnavilladest Sheepstimmermanstraatil Amsterdamis jm. 9 värv. ill

  16. Impact of Decontamination Therapy on Ultrasound Visualization of Ingested Pills

    Directory of Open Access Journals (Sweden)

    Jason Bothwell

    2014-03-01

    Full Text Available Introduction: Acute toxic ingestion is a common cause of morbidity and mortality. Emergency physicians (EP caring for overdose (OD patients are often required to make critical decisions with incomplete information. Point of care ultrasound (POCUS may have a role in assisting EPs manage OD patients. We evaluated the impact of different liquid adjuncts used for gastric decontamination on examiners’ ability to identify the presence of tablets using POCUS, and assessed examiners’ ability to quantify the numbers of tablets in a simulated massive OD. Methods: This prospective, blinded, pilot study was performed at an academic emergency department. Study participants were volunteer resident and staff EPs trained in POCUS. Five non-transparent, sealed bags were prepared with the following contents: 1 liter (L of water, 1 L of water with 50 regular aspirin (ASA tablets, 1 L of water with 50 enteric-coated aspirin tablets (ECA, 1 L of polyethylene glycol (PEG with 50 ECA, and 1 L of activated charcoal (AC with 50 ECA. After performing POCUS on each of the bags using a 10-5 MHz linear array transducer, participants completed a standardized questionnaire composed of the following questions: (1 Were pills present? YES/NO; (2 If tablets were identified, estimate the number (1-10, 11-25, >25. We used a single test on proportions using the binomial distribution to determine if the number of EPs who identified tablets differed from 50% chance. For those tablets identified in the different solutions, another test on proportions was used to determine whether the type of solution made a difference. Since 3 options were available, we used a probability of 33.3%. Results: Thirty-seven EPs completed the study. All (37/37 EP’s correctly identified the absence of tablets in the bag containing only water, and the presence of ECA in the bags containing water and PEG. For Part 2 of the study, most participants - 25/37 (67.5% using water, 23/37 (62.1% using PEG, and

  17. [Effect of heijiang pill on radiation skin ulcer in rats].

    Science.gov (United States)

    Fu, Qi; Yang, Yang; Xu, Yong-Mei

    2008-05-01

    To investigate the relationship between single dosage of 60Co radiation and the degree of radiation-induced skin ulcers, and to evaluate the curative effect of Heijiang Pill (HJP) on skin ulcer induced by various dosages of radiation in rats. Sixty-six Wistar female rats were randomly divided into three groups, the blank control group (n = 6) and the two radiation groups, each 30 rats, with their right hind leg exposed respectively to 60 Gy and 40 Gy of 60 Co radiation. The time of emergence and degree of skin ulcer were recorded. Then rats in the two radiation groups were subdivided into the HJP group, the Ethacridine group and the model group, 10 in each group, they received corresponding treatment after ulceration, and the incidence, pathology, cure rate and cure time of skin ulcer were observed in the 90 days of observation. The incidence of skin ulcer was higher and occurred earlier in rats radiated with 60 Gy than that with 40 Gy (P ulcer healing rate in rats treated with HJP was higher than that treated with Ethacridine (P cure time in the HJP group was shorter (P ulcers. HJP can effectively cure radiation skin ulcer, and the effect is especially significant on the ulcer induced by low dose radiation.

  18. Histomorphological and Immunophenotypic Features of Pill-Induced Esophagitis.

    Directory of Open Access Journals (Sweden)

    Ji Won Kim

    Full Text Available The aim of this study was to investigate histomorphological and immunophenotypic features in pill-induced esophagitis. We comparatively evaluated the histomorphological, immunophenotypic features of pill-induced esophagitis vs. reflux esophagitis, as well as clinical information and endoscopic findings. Fifty-two tissue pieces from 22 cases of pill-induced esophagitis, 46 pieces from 20 reflux esophagitis, and 16 pieces from 14 control samples were subjected to immunohistochemistry for inflammatory infiltrates (CD3 for T lymphocyte, CD20 for B lymphocyte, CD56 for NK cell, CD68 for macrophage, CD117 for mast cell and eosinophil chemotaxis-associated proteins (Erk, leptin, leptin receptor, pSTAT3, phospho-mTOR. As a result, Histomorphology showed that a diffuse pattern of dilated intercellular spaces was more frequently observed in pill-induced esophagitis, while reactive atypia and subepithelial papillary elongation were more often found in reflux esophagitis (P < 0.05, respectively. Interestingly, intraepithelial eosinophilic microabscess, intraepithelial pustule and diffuse pattern of dilated intercellular spaces were observed in 14% (3 cases, 9% (2 cases and 32% (7 cases of pill-induced esophagitis, respectively, but in no cases of reflux esophagitis. Regarding intraepithelial inflammatory infiltrates in pill-induced esophagitis, T lymphocytes were the most common cells, followed by eosinophil; 11 and 7 in one x400 power field, respectively. Intraepithelial pSTAT3-positive pattern was more frequently observed in pill-induced esophagitis than in reflux esophagitis, at 45% (10 cases versus 10% (2 cases, respectively (P < 0.05. Considering the distal esophageal lesion only, intraepithelial pustule, diffuse dilated intercellular spaces and stromal macrophages were more frequently found in distal pill-induced esophagitis, whereas reactive atypia and intraepithelial mast cells in reflux esophagitis (P < 0.05, respectively. In conclusion, diffuse

  19. [Assessing drug targeting of Yougui Pill, Zuogui Pill, and their disassembled prescriptions using infrared thermography].

    Science.gov (United States)

    Zheng, Xia; Deng, Yan-Li; Li, Qi-Jia; Lu, Hua

    2014-04-01

    To dynamically assess drug targeting of Yougui Pill (YP) and Zuogui Pill (ZP) using infrared thermography. In this self-control experiment, five healthy volunteers were recruited. By using infrared thermography 10 to 11 thermal images of different body locations were taken from each participant after they took warm water, YP, ZP, and their dissembled prescriptions at 30, 70, 100, 130, and 160 min, respectively. The heat values in the lower quadrant abdomen, uterus, Du channel, and Shenque (CV8) were statistically analyzed after scanning for 125 times. Administration of YP and its disassembled prescriptions enhanced the heat value of the locations of the Du channel and Shenque (CV8), but did no enhance the heat value of the lower quadrant abdomen at 30 min. Administration of ZP and its disassembled prescriptions reduced the heat value in the locations of the lower quadrant abdomen, uterus, Du channel, and Shenque (CV8) at each time point. The drug targeting of ZP and YP focused on the locations of the Du channel and Shenque (CV8), not on the locations of the lower quadrant abdomen or uterus.

  20. Imported fenproporex-based diet pills from Brazil: a report of two cases.

    Science.gov (United States)

    Cohen, Pieter A

    2009-03-01

    Banned amphetamine-based anorectics are illicitly imported into the United States (US), but little is known regarding the harm these diet pills pose to US residents. A 26-year-old woman using imported diet pills presented with a two-year history of intermittent chest pains, palpitations, headaches and insomnia. Urine toxicology screen detected amphetamines and benzodiazepines. Fenproporex and chlordiazepoxide were detected in her pills. Her symptoms resolved after she stopped using diet pills. A 38-year-old man using imported diet pills presented after his occupational urine screen was significantly positive for amphetamine. Fenproporex and fluoxetine were detected in his pills. These cases illustrate the potential harm from imported prescription diet pills that combine fenproporex with benzodiazepines, antidepressants, diuretics, laxatives and other substances. Increasing physicians' awareness of imported diet pill use may improve care of patients suffering from the pills' many adverse effects.

  1. THE BEHAVIOUR OF FABRICS USED FOR ANTIMIS PRODUCTION TO PILLING

    Directory of Open Access Journals (Sweden)

    CHIRILĂ Mihai Maxim

    2016-05-01

    Full Text Available The present study about the behaviour of plain textiles used for the production of antimis (Christian-orthodox liturgical item used in the liturgy to pilling explores the functional classification of different types of antimis as a textile product made out the following different types of fabrics: natural silk, flax, viscose, polyamide 6.6. Pilling is a phenomenon which consists of the formation of small balls made out of fibre congeries on the textile’s surface due to attrition and fatigue. For textiles used as liturgical items, the process of pilling formation includes the following stages: the emergence of the pilling surfaces (the formation of fuzzy, fibre tangle (appearance of small balls, and the detachment of small balls from the fabric’s surface. The analysis method of pilling for liturgical items made out the four types of fabrics mentioned above consists of stereoscopic microscopy techniques and electronic microscopy methods (SEM. The images of textiles samples (yarns and fabrics will be captured using a video microscope. Quantitative tests have been done to determine the metric number and the tex title of the above-mentioned fabrics. The increased resistance of silk to pilling compared to nylon, flax, and viscose can be attributed to the chemical properties of fibres and structural characteristics of silk fabric. The structural compactness of the same fiber mixture of natural silk fabric with bonded fabric will have a higher resistance coefficient to pilling compared to the other mentioned fabrics. Through this, the value of use and durability of the antimis will increase.

  2. Monitoring Location and Angular Orientation of a Pill

    Science.gov (United States)

    Schipper, John F.

    2012-01-01

    A mobile pill transmitter system moves through, or adjacent to, one or more organs in an animal or human body, while transmitting signals from its present location and/or present angular orientation. The system also provides signals from which the present roll angle of the pill, about a selected axis, can be determined. When the location coordinates angular orientation and the roll angle of the pill are within selected ranges, an aperture on the pill container releases a selected chemical into, or onto, the body. Optionally, the pill, as it moves, provides a sequence of visually perceptible images. The times for image formation may correspond to times at which the pill transmitter system location or image satisfies one of at least four criteria. This invention provides and supplies an algorithm for exact determination of location coordinates and angular orientation coordinates for a mobile pill transmitter (PT), or other similar device that is introduced into, and moves within, a GI tract of a human or animal body. A set of as many as eight nonlinear equations has been developed and applied, relating propagation of a wireless signal between either two, three, or more transmitting antennas located on the PT, to four or more non-coplanar receiving antennas located on a signal receiver appliance worn by the user. The equations are solved exactly, without approximations or iterations, and are applied in several environments: (1) association of a visual image, transmitted by the PT at each of a second sequence of times, with a PT location and PT angular orientation at that time; (2) determination of a position within the body at which a drug or chemical substance or other treatment is to be delivered to a selected portion of the body; (3) monitoring, after delivery, of the effect(s) of administration of the treatment; and (4) determination of one or more positions within the body where provision and examination of a finer-scale image is warranted.

  3. EPR study on non- and gamma-irradiated herbal pills

    Science.gov (United States)

    Aleksieva, K.; Lagunov, O.; Dimov, K.; Yordanov, N. D.

    2011-06-01

    The results of EPR studies on herbal pills of marigold, hawthorn, yarrow, common balm, tutsan, nettle and thyme before and after gamma-irradiation are reported. Before irradiation all samples exhibit one weak singlet EPR line with a g-factor of 2.0048±0.0005. After irradiation herbal pills could be separated in two groups according to their EPR spectra. Radiation-induced free radicals in pills of marigold, yarrow, nettle, tutsan and thyme could be attributed mainly to saccharide excipients. Tablets of hawthorn and common balm show "cellulose-like" EPR spectrum, superimposed on partly resolved carbohydrate spectrum, due to the active part (herb) and inulin, which is present in the pills as an excipient. Fading study of the radiation-induced EPR signals confirms that sugar radicals are more stable than cellulose species. The reported results show that the presence of characteristic EPR spectra of herbal pills due to excipients or active part can be used as unambiguous proof of radiation processing within 35 or more days after irradiation.

  4. EPR study on non- and gamma-irradiated herbal pills

    Energy Technology Data Exchange (ETDEWEB)

    Aleksieva, K., E-mail: katerina_bas@abv.b [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria); Lagunov, O. [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria); Dimov, K. [Institute of Cryobiology and Food Technologies, 1162 Sofia (Bulgaria); Yordanov, N.D. [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria)

    2011-06-15

    The results of EPR studies on herbal pills of marigold, hawthorn, yarrow, common balm, tutsan, nettle and thyme before and after gamma-irradiation are reported. Before irradiation all samples exhibit one weak singlet EPR line with a g-factor of 2.0048{+-}0.0005. After irradiation herbal pills could be separated in two groups according to their EPR spectra. Radiation-induced free radicals in pills of marigold, yarrow, nettle, tutsan and thyme could be attributed mainly to saccharide excipients. Tablets of hawthorn and common balm show 'cellulose-like' EPR spectrum, superimposed on partly resolved carbohydrate spectrum, due to the active part (herb) and inulin, which is present in the pills as an excipient. Fading study of the radiation-induced EPR signals confirms that sugar radicals are more stable than cellulose species. The reported results show that the presence of characteristic EPR spectra of herbal pills due to excipients or active part can be used as unambiguous proof of radiation processing within 35 or more days after irradiation.

  5. Improvement of the association between self-reported pill count and varenicline levels following exclusion of participants with misreported pill count: A commentary on Peng et al. (2017).

    Science.gov (United States)

    Peng, Annie R; Le Foll, Bernard; Morales, Mark; Lerman, Caryn; Schnoll, Robert; Tyndale, Rachel F

    2018-04-01

    We previously reported poor associations between salivary varenicline and pill counts, and a substantial overestimation of adherence by pill counts in "Measures and predictors of varenicline adherence in the treatment of nicotine dependence" (Peng et al., 2017). We have since conducted supplementary analyses characterizing, and then excluding, individuals with established inaccurate pill count recall. Based on published varenicline pharmacokinetics (including drug levels, and the long half-life) and our detection limits, conservatively we should be able to detect varenicline in anyone who took at least one pill during the 48h prior to saliva collection; thus, those reporting 1 or more pills in this time frame but who had undetectable salivary varenicline were deemed to have inaccurate pill count recall. Correlations between pill counts and salivary varenicline, and Receiver Operating Characteristics curve analyses were conducted following exclusion of participants with inaccurate pill count recall. Nearly 20% of our participants (N=67/376) had inaccurate self-reported pill counts. These participants were younger, non-white, lower income, and unmarried (evaluated using chi-square or Mann-Whitney U test). Following exclusion of these individuals, the correlations between salivary varenicline and pill count improved and the area under the curve (AUC) of pill counts for discriminating adherence improved modestly. When the 20% of individuals with inaccurate pill count recall were excluded, an improved association between self-reported pill count and salivary varenicline was observed, albeit still weak. A substantial overestimation of adherence by pill counts relative to salivary varenicline is still observed even after exclusion of almost 20% of the group having established inaccurate reporting suggesting that these individuals, with identifiable inaccuracies, were only part of the overestimation of adherence. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Efficacy of Suxiao Jiuxin Pill on Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Li Ren

    2018-01-01

    Full Text Available Suxiao jiuxin pill is considered an effective ancillary drug in patients with coronary heart disease. Although numerous small, single-center clinical trials have been conducted, the benefits and harms of suxiao jiuxin pill remain controversial. We performed a meta-analysis to clarify the efficacy of suxiao jiuxin pill on patients with coronary heart disease. Randomized controlled trials were identified by using the Cochrane Library, PubMed, Web of Science, Embase, Wanfang, Weipu, and China Knowledge Resource Integrated databases (until June 2016. Pooled relative risks (RR, weighted mean differences (WMD, and 95% confidence intervals (95% CIs were estimated using random-effects models. Forty-one trials involving 6276 patients were included in our analysis. Administration of suxiao jiuxin pill significantly improved electrocardiogram (ECG results when compared with other therapies (RR 1.32, 95% CI 1.26 to 1.38, and P<0.001. Subgroup analyses revealed that suxiao jiuxin pills improve ECG results more than salvia tablets (RR 1.54, 95% CI 1.41 to 1.67, and P<0.001, isosorbide dinitrate (RR 1.14, 95% CI 1.21 to 1.44, and P=0.001, nitroglycerin (RR 1.35, 95% CI 1.16 to 1.56, and P<0.001, and other drugs (RR 1.32, 95% CI 1.21 to 1.44, and P<0.001. Available evidence additionally suggests that suxiao jiuxin pills could significantly reduce total cholesterol (WMD −0.62 mmol/L, 95% CI −1.06 to –0.18 mmol/L, and P=0.005 and low-density lipoprotein (LDL levels (WMD −1.12 mmol/L, 95% CI −1.42 to −0.82 mmol/L, and P<0.001 and increase high-density lipoprotein (HDL levels (WMD 0.32 mmol/L, 95% CI 0.07 to 0.58 mmol/L, and P=0.014. However, no significant differences were observed in total triglyceride levels, plasma viscosity, hematocrit, and fibrinogen. No incidences of adverse reactions were observed after administration of suxiao jiuxin pill. Improvements in ECG results and lipid profiles were also observed after suxiao jiuxin

  7. Why Did My Doctor Prescribe Birth Control Pills for My Acne?

    Science.gov (United States)

    ... Search English Español Why Did My Doctor Prescribe Birth Control Pills for My Acne? KidsHealth / For Teens / Why Did My Doctor Prescribe Birth Control Pills for My Acne? Print My doctor prescribed ...

  8. Imported Fenproporex-based Diet Pills from Brazil: A Report of Two Cases

    OpenAIRE

    Cohen, Pieter A.

    2008-01-01

    Banned amphetamine-based anorectics are illicitly imported into the United States (US), but little is known regarding the harm these diet pills pose to US residents. A 26-year-old woman using imported diet pills presented with a two-year history of intermittent chest pains, palpitations, headaches and insomnia. Urine toxicology screen detected amphetamines and benzodiazepines. Fenproporex and chlordiazepoxide were detected in her pills. Her symptoms resolved after she stopped using diet pills...

  9. New objective system of pilling evaluation for various types of fabrics

    Czech Academy of Sciences Publication Activity Database

    Techniková, L.; Tunák, M.; Janáček, Jiří

    2017-01-01

    Roč. 108, č. 1 (2017), s. 123-131 ISSN 0040-5000 Institutional support: RVO:67985823 Keywords : objective pilling evaluation * 3D fabric surface reconstruction * image analysis * pill characteristics * pilling grade Subject RIV: JS - Reliability ; Quality Management, Testing OBOR OECD: Textiles Impact factor: 1.007, year: 2016

  10. Birth Control Pills and Nonprofessional Voice: Acoustic Analyses

    Science.gov (United States)

    Amir, Ofer; Biron-Shental, Tal; Shabtai, Esther

    2006-01-01

    Purpose: Two studies are presented here. Study 1 was aimed at evaluating whether the voice characteristics of women who use birth control pills that contain different progestins differ from the voice characteristics of a control group. Study 2 presents a meta-analysis that combined the results of Study 1 with those from 3 recent studies that…

  11. Contraception with combined oral contraceptive pills in Port ...

    African Journals Online (AJOL)

    Mass media was the commonest source of information, and one accidental pregnancy occurred (Pearl index 0.03 per 100 woman years). Conclusion: This study shows that combined oral contraceptives pills appear to be acceptable, safe and effective in Port Harcourt. This compares to world wide experience. Concerted ...

  12. Are we overestimating the stroke risk related to contraceptive pills?

    Science.gov (United States)

    Gompel, Anne; Plu-Bureau, Genevieve

    2014-02-01

    Hormonal contraceptives are used by million of women worldwide. Ischemic stroke is one of the major harmful effects of hormonal contraceptives, but remains a very uncommon disease before menopause. The increased risk of stroke under third and fourth-generation contraceptive pills and nonoral contraceptives has been recently highlighted. Given the benefits associated with combined hormonal contraceptives (COCs), it is important to properly evaluate their risks in order to provide a better benefit/risk balance to young women. Scarce studies addressing the rates of stroke in young women suggest that the fraction attributable to the contraceptive pill remains low. In contrast, there is abundant literature on the relative risks of stroke under COCs. The risk of arterial disease seems to be similar among users of second and third-generation pills, drospirenone-containing pills and nonoral hormonal contraceptives. Progestin-only contraceptives do not appear to be associated with an increased risk of stroke. New formulations of hormonal contraceptives are not safer than second-generation COCs. Even if the absolute numbers of strokes attributable to hormonal contraceptives is very low, stringent selection of patients should help to reduce the events still more, and progestin-only contraceptives/nonhormonal methods should be preferred in cases of associated risk factors.

  13. Knowledge of pharmacists on proper use of oral contraceptive pills ...

    African Journals Online (AJOL)

    Purpose: To assess the knowledge of community pharmacists and senior pharmacy students in United Arab Emirates (UAE) about the proper use of oral contraceptive pills (OCPs) and to investigate factors associated with their knowledge. Method: A cross-sectional study was conducted using a validated self-administered ...

  14. Johannes Hindi tütar Pille Pae : inimlik headus ei sõltu rezhiimist / Pille Pae ; interv. Anneli Ammas

    Index Scriptorium Estoniae

    Pae, Pille

    2006-01-01

    Desintegraatori juhi Johannes Hindi tütar Pille Pae vastab küsimustele, mis puudutavad tema isa armuandmispalve esitamist, isale toetusallkirjade kogumist ning Arnold Rüütli suhteid Johannes Hindiga. Lisa: Kes oli Johannes Hint ja mis Desintegraator?

  15. Discussing Smart Pills versus Endorsing Smart Pills: Reply to Swanson, Wigal, and Volkow (2011) and Elliott and Elliott (2011)

    Science.gov (United States)

    Farah, Martha J.; Smith, M. Elizabeth

    2011-01-01

    We find much of interest, and little to disagree with, in the commentaries on our article. We take issue only with the suggestion that our article was provocative and submit that the attempt to understand the use of stimulants as smart pills does not imply an endorsement of the practice.

  16. Emergency contraceptive pills as a backup for lactational amenorrhea method (LAM) of contraception: a randomized controlled trial.

    Science.gov (United States)

    Shaaban, Omar M; Hassen, Shaimaa G; Nour, Sanna A; Kames, Mervat A; Yones, Entsar M

    2013-03-01

    The use of breastfeeding as a method of birth spacing occasionally ends in "unplanned pregnancy." This is due to unexpected expiration of one or more of the lactation amenorrhea method (LAM) prerequisites. The current study tests a new concept that the in-advance provision of single packet of progestogen emergency contraception (EC) pills during the postpartum LAM counseling may decrease the incidence of unplanned pregnancy during breastfeeding. This was a registered two-armed randomized controlled trial (NCT 01111929). Women intending to breastfeed and to postpone pregnancy for 1 year or more were approached. They received adequate postpartum contraceptive counseling. Women intending to use LAM were randomly assigned to one of two groups. The LAM-only group received the proper LAM counseling and did not receive counseling about EC. The LAM-EC group received counseling for both LAM and EC with in-advance provision of one packet of EC pills. They were advised to use these pills if one of the prerequisites of LAM expires and sexual relation has occurred before the initiation of another regular contraceptive protection. All the participants were advised that they need to use another regular method upon expiration of any of the LAM prerequisites. Eligible women were 1158 parturients randomized into two equal groups. Forty-four percent of the women provided with EC used them. Significantly more women in the LAM-EC group initiated regular contraception within or shortly after the first 6 months postpartum when compared with those in the LAM-only group (30.5% vs. 7.3%, respectively; p=.0004). Pregnancy occurred in 5% of the LAM-only group as compared with 0.8% in the LAM-EC group (p=.005). Minimal side effects were reported after EC use. In-advance provision of EC pills can increase the rate of initiation of regular contraception once one or more of the prerequisites of LAM expire. Consequently, the use of EC pills as a temporary backup of LAM can decrease the incidence

  17. More research on the pill and alternative methods (of contraception).

    Science.gov (United States)

    1978-05-31

    More research on the pill and alternative methods of contraception was urged by Ralph Nader's Health Research Group (HRG), which also recommended that the Food and Drug Administration develop a new patient package insert for all forms of contraceptives, including nonprescription methods. The group also said the government and drug companies should share the cost of long-term follow-up studies of the effects on health of the pill and other birth control methods. The recommendations followed presentations at an HRG forum from NIH scientists and S. Ramcharan, principal investigator of the Walnut Creek (California) Contraceptive Study supported by the National Institute of Child Health and Human Development. Ramcharan studied 15,000 women over 10 years and found cervical cancer incidence of 173/100,000 person years for women who used the pill for more than 4 years, compared with a rate of 32/100,000 for women who never used the pill. Ramcharan declined to draw any cause-effect conclusions based on these results, stating they were "confounded" by possible differences in sexual activity between the 2 groups. She said a preliminary case comparison study to adjust for these differences "suggests sexual behavior may account for some, but not all," of the 5-fold increase in cervical cancer incidence among pill users. HRG director S. Wolfe said enough data exists to state a relationship between the pill and cervical cancer. "There's no other explanation for the increase," he said, adding that Ramcharan had controlled for the effects of age, education, marital status, number of Papanicolaou smears, religion, number of pregnancies, a history of genital infections, and smoking. Forum participants urged more research on contraceptive devices and drugs now in use, long-term effects of sterilization, value of condoms and spermicides in preventing VD, and development of a patient package insert for all forms of contraception stating the relative effectiveness and risks of each. The

  18. A 12-week placebo-controlled study of rupatadine 10 mg once daily compared with cetirizine 10 mg once daily, in the treatment of persistent allergic rhinitis.

    Science.gov (United States)

    Fantin, S; Maspero, J; Bisbal, C; Agache, I; Donado, E; Borja, J; Mola, O; Izquierdo, I

    2008-07-01

    With the current increasing incidence of allergies worldwide, new treatments showing efficacy and long term safety are needed for chronic conditions such as persistent allergic rhinitis (PER). New generation H1-antihistamines have demonstrated anti-allergic properties, which could possibly enhance their effectiveness in long-term periods of treatment. To investigate the efficacy of rupatadine, in controlling symptoms of PER over a 12-week period. A randomized, double blind, parallel-group, placebo-controlled study was carried out in patients aged older than 12 years with PER. Main inclusion criteria were: instantaneous total symptom score (i6TSS) >or=45, nasal obstruction score or=2 as moderate during the first visit. The primary efficacy endpoint was the 12-week average change from baseline of the patients' i6TSS. In all, 736 patients were selected. Of them, 543 (73.8%) were randomized in three different groups: placebo (n = 185), cetirizine (n = 175) and rupatadine (n = 183). Rupatadine (P = 0.008) but not cetirizine (P = 0.07) statistically reduced the baseline i6TSS vs placebo (47.8%, 44.7% and 38.8%, respectively), after 12 weeks. Onset of action was observed at the first 24 h for both treatments (rupatadine vs placebo, P = 0.013; cetirizine vs placebo, P = 0.015). Furthermore, instantaneous total nasal symptoms score (iTNSS) (including nasal blockage) mean change from baseline showed a significant reduction with rupatadine 10 mg in comparison with placebo, along all treatment duration of 12 weeks. Study treatments were well tolerated. Rupatadine significantly relieves symptoms of PER, providing a rapid onset of action and maintains its effects over a long period of 12-weeks.

  19. A Longitudinal Analysis of Daily Pill Burden and Likelihood of Optimal Adherence to Antiretroviral Therapy Among People Living With HIV Who Use Drugs.

    Science.gov (United States)

    Mohd Salleh, Nur Afiqah; Richardson, Lindsey; Kerr, Thomas; Shoveller, Jean; Montaner, Julio; Kamarulzaman, Adeeba; Milloy, M-J

    2018-03-07

    Among people living with HIV (PLWH), high levels of adherence to prescribed antiretroviral therapy (ART) is required to achieve optimal treatment outcomes. However, little is known about the effects of daily pill burden on adherence amongst PLWH who use drugs. We sought to investigate the association between daily pill burden and adherence to ART among members of this key population in Vancouver, Canada. We used data from the AIDS Care Cohort to Evaluate Exposure to Survival Services study, a long-running community-recruited cohort of PLWH who use illicit drugs linked to comprehensive HIV clinical records. The longitudinal relationship between daily pill burden and the odds of ≥95% adherence to ART among ART-exposed individuals was analyzed using multivariable generalized linear mixed-effects modeling, adjusting for sociodemographic, behavioural, and structural factors linked to adherence. Between December 2005 and May 2014, the study enrolled 770 ART-exposed participants, including 257 (34%) women, with a median age of 43 years. At baseline, 437 (56.7%) participants achieved ≥95% adherence in the previous 180 days. Among all interview periods, the median adherence was 100% (interquartile range 71%-100%). In a multivariable model, a greater number of pills per day was negatively associated with ≥95% adherence (adjusted odds ratio [AOR] 0.87 per pill, 95% confidence interval [CI] 0.84-0.91). Further analysis showed that once-a-day ART regimens were positively associated with optimal adherence (AOR 1.39, 95% CI 1.07-1.80). In conclusion, simpler dosing demands (ie, fewer pills and once-a-day single tablet regimens) promoted optimal adherence among PLWH who use drugs. Our findings highlight the need for simpler dosing to be encouraged explicitly for PWUD with multiple adherence barriers.

  20. Depression as a side effect of the contraceptive pill.

    Science.gov (United States)

    Kulkarni, Jayashri

    2007-07-01

    Millions of women worldwide use the combined oral contraceptive pill as an effective form of contraception. However, the focus on its side effects to date has mainly been on physical aspects, even though the most commonly stated reason for discontinuation is depression. There are surprisingly few large studies investigating depression related to oral contraceptive use. A pilot study was conducted showing that women using the combined oral contraceptive pill were significantly more depressed than a matched group who were not. More research is needed to better inform women and doctors about depression related to oral contraceptive use, and clinical guidelines are needed regarding the different types of oral contraceptives and their potential depressogenic properties.

  1. Inflammatory Bowel Disease, the Oral Contraceptive Pill and Pregnancy

    OpenAIRE

    Allan, Robert N

    1994-01-01

    This paper summarizes our current knowledge of the role of the oral contraceptive pill in the pathogenesis of inflammatory bowel disease (IBO), followed by a review of fertility in women and men. IBD and pregnancy, including the impact on the fetus and the mother with ulcerative colitis or Crohn’s disease, is considered. The safety of drug treatment during pregnancy, the outcome of surgical treatment during pregnancy and the problems that may be encountered during pregnancy in patients with a...

  2. Social constructions of the male contraception pill: When are we going to break the vicious circle?

    Science.gov (United States)

    Dismore, Lorelle; Van Wersch, Anna; Swainston, Katherine

    2016-05-01

    Social constructions of men towards the availability of a male hormonal contraceptive, the 'male pill', were explored. A qualitative approach applying semi-structured interviews and scenarios with 22 men (mean age 35 years) from the North East of England revealed two core constructs and six sub-constructs using a Thematic-Construct Analysis in line with the method of Toerien and Wilkinson and Clarke and Kitzinger. Verbal accounts were inductively used to balance the deductively created two core constructs 'Constructing the male pill norm: dominant system of sensemaking' and 'Living by the male pill norm' to represent a normative framework within a changing ideology of shared responsibility in contraceptive choice. Constructing the male pill norm was divided into two sub-constructs: 'Male pill: we are going to join the women and become responsible - too!' and 'Male pill: you look so girly - what are they going to think of me?' The 'Living by the male pill norm' was further divided into four sub-constructs 'Male pill - thank you for giving me promises not to have to become a dad as yet!'; 'Male pill: thank you for the idea of fun - sorry about my morals!'; 'Male pill: in stable relations - yes, I would have you now - sorry, I am too late!' and 'Male pill, we love you - but we are too anxious - we are not ready as yet!' From this male discourse, it is clear that discussions over the male pill follow the line of a vicious circle. In order to establish long-term side effects, Phase IV studies are necessary, and these cannot commence without the male hormonal contraception being a marketable product. So, unless this circle gets broken by some brave men, the male pill will remain a virtual rotating idea for a long time. © The Author(s) 2014.

  3. Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake

    DEFF Research Database (Denmark)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique

    2016-01-01

    OBJECTIVES: Traditional progestogen-only pills (POPs) have stringent daily timing and missed pill rules that might affect contraceptive reliability. A new-generation oestrogen-free pill has been developed, containing 4-mg drospirenone with a unique regimen of 24 active treatment days followed...... of ovulation was maintained after four scheduled 24-h delays in tablet intake. STUDY DESIGN: One hundred thirty healthy women with proven ovulatory cycles were randomized, and 127 were treated with the drospirenone-only pill during two cycles. In treatment Group A (n=62), 24-h delays in tablet intake were...... inhibition by the new-generation oestrogen-free pill, containing 4-mg drospirenone for 24 days followed by a 4-day treatment-free period, was maintained despite four 24-h delays in tablet intake, so the impact of delayed intake on contraceptive reliability will be low....

  4. The Pill vs. the Sword: Additional Considerations; Comment on “The Pill Is Mightier Than the Sword”

    Directory of Open Access Journals (Sweden)

    Ilsa L. Lottes

    2015-12-01

    Full Text Available In this paper, I present additional information for policy-makers and researchers to consider in response to the view proposed by Potts et al that “the pill is mightier than the sword.” I identify states with both high rates of terrorism and a youth bulge and discuss correlates of both these societal characteristics. The research examined supports the view that factors other than access to family planning are more important in facilitating terrorism.

  5. Low efficacy of an ultra-short term, once-daily dose triple therapy with omeprazole, azithromycin, and secnidazole for Helicobacter pylori eradication in peptic ulcer Baixa eficácia de um tratamento tríplice de curta duração, em dose única diária, para erradicação do Helicobacter pylori em pacientes ulcerosos com Omeprazol, Azitromicina e Secnidazol

    Directory of Open Access Journals (Sweden)

    Fernando Marcuz Silva

    2002-02-01

    Full Text Available PURPOSE: To determine the eradication rate of an ultra-short treatment schedule for Helicobacter pylori infection in a population with peptic ulcers, using omeprazole, secnidazole, and azithromycin in a once-daily dose for 3 days. METHODS: Thirty patients with peptic ulcer diagnosed by upper endoscopy and for Helicobacter pylori infection by rapid urease test and histologic examination received omeprazole 40 mg, secnidazole 1000 mg, and azithromycin 500 mg, administered once daily for 3 days. A follow-up exam was performed 12 weeks after the end of the treatment. Patients who were negative for Helicobacter pylori infection by rapid urease test and histologic examination were considered cured. RESULTS: Patients were predominantly female, and the mean age was 50 years. Duodenal peptic ulcer was found in 73% of the patients. Eradication was achieved in 9 of the 28 (32% patients as determined from the follow-up endoscopic exam. The eradication rate by intention to treat was 30%. Side effects were present in 3% of the patients, and compliance to treatment was total. CONCLUSIONS: In spite of the low rate of side effects and good compliance, the eradication index was low. A possible drawback of this therapy is that it reduces the efficacy of macrolide and nitroimidazole compounds in subsequent treatments.OBJETIVO: Testar a eficácia de um esquema ultra-curto de erradicação do H. pylori em uma população de ulcerosos, usando Omeprazol, Secnidazol e Azitromicina em dose única diária por três dias. PACIENTES E MÉTODOS: Trinta doentes portadores de úlcera péptica, documentada por exame endoscópico e com infecção pelo H. pylori confirmada pelo teste da urease e exame histológico, foram tratados com Omeprazol 40mg, Secnidazol 1000 mg e Azitromicina 500mg dados em dose única diária por três dias. Em controle endoscópico realizado 12 semanas após o término do tratamento, foram considerados curados da infecção os pacientes que apresentaram

  6. [Study on absorption ingredients of yuanhuzhitong pill by everted intestinal sac method].

    Science.gov (United States)

    Chen, Xiaomeng; Zhang, Yingchun; Lin, Shuo; Yang, Hongjun; Wu, Hongwei; Li, Shaojing; Li, Defeng; Xu, Haiyu

    2012-07-01

    To establish an everted intestinal sac method for determining absorption ingredients of yuanhuzhitong pill and study absorption characteristics of major chemical constituents of yuanhuzhitong pill. The everted intestinal sac model was adopted. Intestinal sac fluid samples at different time points after administration of three concentrations of Yuanhuzhitong pill were collected and determined by HPLC. The accumulative absorbed doses of active constituents were calculated, while the proportion between samples of yuanhuzhitong pill and absorption ingredients was compared. Eight ingredients of Yuanhuzhitong pill can be detected in intestinal sac, they are protopine, palmatine, coptisine, imperatorin, berberine, byakangelicin, alpha-allocryptopine and tetrahydropalmatine. The absorption rate constants (Ka) of eight constituents increased in jejunum and ileum with the increase in concentration of Yuanhuzhitong pill extracts (P absorption. As ingredients are selectively absorbed in intestinal sac, the everted intestinal sac method is selected to assess the intestinal absorption characteristics of ingredients of Yuanhuzhitong prescription.

  7. Knowledge and opinions of emergency contraceptive pills among female factory workers in Tijuana, Mexico.

    Science.gov (United States)

    García, Sandra G; Becker, Davida; de Castro, Marcela Martínez; Paz, Francisco; Olavarrieta, Claudia Díaz; Acevedo-García, Dolores

    2008-09-01

    Workers in Mexico's maquiladoras (assembly plants) are mainly young, single women, many of whom could benefit from emergency contraceptive pills (ECPs). Because ECPs are readily available in Mexico, women who know about the therapy can obtain it easily. Do maquiladora workers know about the method? Could worksite programs help increase awareness? To investigate these questions, we conducted a five-month intervention during which workers in three maquiladoras along the Mexico-United States border could attend educational talks on ECPs, receive pamphlets, and obtain kits containing EC supplies. Among the workers exposed to our intervention, knowledge of ECPs increased. Reported ECP use also increased. Although our intervention apparently increased workers' knowledge and use, the factory proved to be a difficult intervention setting. Problems we experienced included a factory closure and management/staff opposition to certain project elements. Future studies should continue to investigate work-site interventions and other strategies to reach workers.

  8. Influence of pill burden and drug cost on renal function after transplantation.

    Science.gov (United States)

    Hardinger, Karen L; Hutcherson, Timothy; Preston, David; Murillo, Daniel

    2012-05-01

    To determine the influence of pill burden and drug cost on outcomes after renal transplantation. Retrospective medical record review. Kidney and pancreas transplantation center. Sixty-eight adults who underwent kidney or kidney-pancreas transplantation during 2007. The median pretransplantation pill burden was 15 pills/day, which increased to 25 pills/day at 1 month after transplantation and returned to 16 pills/day by 1 year after transplantation. Pretransplantation pill burden was lower than the burden at 1, 3, 6, 12, and 24 months after transplantation (pafter transplantation ($2564/mo, p=0.04) but was similar thereafter. Higher pretransplantation pill burden was associated with increased serum creatinine concentration at 6 months after transplantation (r=0.288, p=0.017). Higher pill burdens at 1 month (r=0.364, p=0.002), 3 months (r=0.332, p=0.006), and 6 months (r=0.374, p=0.002) were associated with increased 3-month serum creatinine concentration. Higher drug costs were associated with increased serum creatinine concentrations throughout the study. Higher pretransplantation pill burden and higher drug cost may be associated with poor renal function after transplantation. Further study addressing factors associated with nonadherence is needed. © 2012 Pharmacotherapy Publications, Inc.

  9. THE IDENTIFICATION OF PILL USING FEATURE EXTRACTION IN IMAGE MINING

    Directory of Open Access Journals (Sweden)

    A. Hema

    2015-02-01

    Full Text Available With the help of image mining techniques, an automatic pill identification system was investigated in this study for matching the images of the pills based on its several features like imprint, color, size and shape. Image mining is an inter-disciplinary task requiring expertise from various fields such as computer vision, image retrieval, image matching and pattern recognition. Image mining is the method in which the unusual patterns are detected so that both hidden and useful data images can only be stored in large database. It involves two different approaches for image matching. This research presents a drug identification, registration, detection and matching, Text, color and shape extraction of the image with image mining concept to identify the legal and illegal pills with more accuracy. Initially, the preprocessing process is carried out using novel interpolation algorithm. The main aim of this interpolation algorithm is to reduce the artifacts, blurring and jagged edges introduced during up-sampling. Then the registration process is proposed with two modules they are, feature extraction and corner detection. In feature extraction the noisy high frequency edges are discarded and relevant high frequency edges are selected. The corner detection approach detects the high frequency pixels in the intersection points. Through the overall performance gets improved. There is a need of segregate the dataset into groups based on the query image’s size, shape, color, text, etc. That process of segregating required information is called as feature extraction. The feature extraction is done using Geometrical Gradient feature transformation. Finally, color and shape feature extraction were performed using color histogram and geometrical gradient vector. Simulation results shows that the proposed techniques provide accurate retrieval results both in terms of time and accuracy when compared to conventional approaches.

  10. [Serious adverse effect of combined oral contraceptive pills among teenagers].

    Science.gov (United States)

    Nylander, Malin Chatarina; Clausen, Helle V

    2014-06-23

    PubMed-search found studies investigating adverse effects of combined oral contraceptive pills (COC) among teenagers. Four studies found a small negative impact of COC on acquisition of bone mineral density. COC is associated with elevated risk of venous thrombotic events (VTE), especially during the first year of usage. VTE risk increases with EE dose and progestin of 3rd and 4th generation. There are several difficulties in studying COC use in teenagers: high dropout rates, ethical considerations and many different COC formulas.

  11. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts.

    Science.gov (United States)

    Piccini, Jonathan P; Stevens, Susanna R; Chang, YuChiao; Singer, Daniel E; Lokhnygina, Yuliya; Go, Alan S; Patel, Manesh R; Mahaffey, Kenneth W; Halperin, Jonathan L; Breithardt, Günter; Hankey, Graeme J; Hacke, Werner; Becker, Richard C; Nessel, Christopher C; Fox, Keith A A; Califf, Robert M

    2013-01-15

    We sought to define the factors associated with the occurrence of stroke and systemic embolism in a large, international atrial fibrillation (AF) trial. In ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation), 14 264 patients with nonvalvular AF and creatinine clearance ≥30 mL/min were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards modeling was used to identify factors at randomization independently associated with the occurrence of stroke or non-central nervous system embolism based on intention-to-treat analysis. A risk score was developed in ROCKET AF and validated in ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation), an independent AF patient cohort. Over a median follow-up of 1.94 years, 575 patients (4.0%) experienced primary end-point events. Reduced creatinine clearance was a strong, independent predictor of stroke and systemic embolism, second only to prior stroke or transient ischemic attack. Additional factors associated with stroke and systemic embolism included elevated diastolic blood pressure and heart rate, as well as vascular disease of the heart and limbs (C-index 0.635). A model that included creatinine clearance (R(2)CHADS(2)) improved net reclassification index by 6.2% compared with CHA(2)DS(2)VASc (C statistic=0.578) and by 8.2% compared with CHADS(2) (C statistic=0.575). The inclusion of creatinine clearance <60 mL/min and prior stroke or transient ischemic attack in a model with no other covariates led to a C statistic of 0.590.Validation of R(2)CHADS(2) in an external, separate population improved net reclassification index by 17.4% (95% confidence interval, 12.1%-22.5%) relative to CHADS(2). In patients with nonvalvular AF at moderate to high risk of stroke, impaired renal function is a potent predictor of stroke and systemic embolism. Stroke risk stratification in patients

  12. Effects of the Chinese herbal formula "Zuojin Pill" on the pharmacokinetics of dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype.

    Science.gov (United States)

    Qiu, Furong; Liu, Songcan; Miao, Ping; Zeng, Jin; Zhu, Leilei; Zhao, TongFang; Ye, Yujie; Jiang, Jian

    2016-06-01

    Zuojin Pill has been shown to inhibit the cytochrome P450 (CYP) 2D6 isoenzyme in vitro. In Chinese individuals, CYP 2D6*10 is the most common allele with reduced enzyme activity. In this study, we investigated the pharmacokinetic interaction between Zuojin Pill and the sensitive CYP2D6 probe dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype. A pharmacokinetics interaction study was carried out in three groups with CYP2D6*1/*1 (n = 6), CYP2D6*1/*10 (n = 6), and CYP2D6*10/*10 (n = 6) genotypes. Each participant received a single oral dose of dextromethorphan (15 mg) followed by Zuojin Pill (3 g twice daily) for 7 days, and received 3 g Zuojin Pill with 15 mg dextromethorphan in the last day. Blood samples (0-24 h) and urine samples (0-12 h) were collected at baseline and after the administration of Zuojin Pill, and the samples' concentration of dextromethorphan and its main metabolite dextrorphan was determined. Compared to baseline values, co-administration of Zuojin Pill (3 g twice daily) for 7 days increased the AUC0-24 of dextromethorphan [mean (90 % CI)] by 3.00-fold (2.49∼3.61) and 1.71-fold (1.42∼2.06), and decreased oral clearance(CL/F) by 0.27-fold (0.2-0.40) and 0.57-fold (0.48-0.67) in the participants with CYP2D6*1/*1 and CYP2D6*1/*10 genotypes, respectively. In contrast, no significant change was observed in these pharmacokinetic parameters of the participants with CYP2D6*10/*10 genotype. These data demonstrated that administration of Zuojin Pill inhibited moderately CYP2D6-mediated metabolism of dextromethorphan in healthy volunteers. The inhibitory influence of CYP2D6 was greater in CYP2D6*1/*1 and CYP2D6*1/*10 groups than CYP2D6 *10/*10 group.

  13. Johannes Hindi tütar Pille Pae : inimlik headus ei sõltu režiimist / Pille Pae ; interv. Anneli Ammas

    Index Scriptorium Estoniae

    Pae, Pille

    2006-01-01

    Desintegraatori juhi Johannes Hindi tütar Pille Pae vastab küsimustele, mis puudutavad tema isa armuandmispalve esitamist, isale toetusallkirjade kogumist, Arnold Rüütli suhteid Johannes Hindiga. Lisa: Kes oli Johannes Hint ja mis Desintegraator?

  14. Provision of emergency contraceptive pills to spermicide users in ghana.

    Science.gov (United States)

    Lovvorn, A; Nerquaye-Tetteh, J; Glover, E K; Amankwah-Poku, A; Hays, M; Raymond, E

    2000-04-01

    This study evaluated the effect of two approaches to provision of emergency contraceptive pills (ECPs) on ECP use and unprotected intercourse among women relying on spermicides for contraception. The study enrolled 211 women at 4 family planning clinics in Ghana. At two clinics, participants were advised to return to the clinic within 3 days after unprotected intercourse to obtain ECPs. At the other two clinics, participants were given ECPs to take home for use if unprotected intercourse occurred. All participants were asked to maintain daily diaries for 8 weeks to record information on sexual activity, spermicide use, and ECP use. Women at all clinics used ECPs after at least 78% of unprotected coital acts. ECPs were used more promptly by women who had the pills at home. At three of the clinics, at most 1.3% of the coital acts were unprotected; at the fourth, 6.7% were unprotected. Our data did not suggest that the availability of ECPs increased the frequency of unprotected intercourse.

  15. Cloxacillin: A New Cause of Pill-Induced Esophagitis

    Directory of Open Access Journals (Sweden)

    Petros Zezos

    2016-01-01

    Full Text Available A large variety of medications can cause pill-induced esophagitis. Herein we present a case of cloxacillin-induced esophagitis. A 66-year-old male presented with an acute onset of epigastric and retrosternal pain on the 5th day of a course of oral cloxacillin prescribed for erysipelas. Initial clinical and imaging assessment was negative and he was sent home. A few days later, he returned with persistent severe retrosternal pain; endoscopy at the same day revealed a normal upper esophagus, several small stellate erosions in the midesophagus, and a normal squamocolumnar junction with a small hiatus hernia. Treatment with esomeprazole 40 mg bid and MucaineR suspension resulted in complete resolution of his symptoms. Pill-induced esophagitis may be underreported by patients, when symptoms are mild and unrecognized and/or underdiagnosed by the clinicians as a cause of retrosternal pain, odynophagia, or dysphagia. Failure of early recognition may result in unnecessary diagnostic investigations and prolongation of the patient’s discomfort. This case signifies the importance of enhancing clinician awareness for drug-associated esophageal injury when assessing patients with retrosternal pain, as well as the value of prophylaxis against this unpleasant condition by universally recommending drinking enough water in an upright position during ingestion of any oral medication.

  16. A thyrotoxicosis outbreak due to dietary pills in Paris

    Directory of Open Access Journals (Sweden)

    Vincent Ioos

    2008-10-01

    Full Text Available Vincent Ioos1, Vincent Das1, Eric Maury1,2, Jean-Luc Baudel1, Jérôme Guéchot3, Bertrand Guidet1,2, Georges Offenstadt1,21Réanimation Médicale; 2Université Pierre et Marie Curie-Paris 6, INSERM, UMR-S 707; 3Unité d’Hormonologie, APHP, Hôpital Saint Antoine, F-75012, Paris, FranceAbstract: Three women were consecutively admitted to our medical intensive care unit for thyrotoxicosis after the ingestion of dietary pills accidentally containing high levels of thyroxin. These cases were observed during an outbreak in the Paris area. Despite similar blood levels of thyroid hormones, their clinical presentation and outcome were very different. One patient developed febrile confusion and died from malignant hyperthermia. The second one had progressive confusion requiring mechanical plasma exchange therapy and had a favorable outcome. The third one had very moderate symptoms. These exceptional observations raise several issues concerning diagnosis, physiopathology and treatment of thyrotoxicosis factitia.Keywords: thyrotoxicosis, dietary pills, thyroxin

  17. Kino Kosmos Imax = Kosmos Imax cinema / Pille Lausmäe ; kommenteerinud Karen Jagodin

    Index Scriptorium Estoniae

    Lausmäe, Pille, 1958-

    2015-01-01

    Kino Kosmos Imax Tallinnas Pärnu mnt 45. 1964. aastal valminud hoone arhitekt Ilmar Laasi. Renoveeritud interjööri autorid Pille Lausmäe, Kerli Lepp (Pille Lausmäe Sisearhitektuuri büroo). Projekti autorid Urmas Lõoke, Riina Poopuu (Urmas Lõokese Arhitektibüroo)

  18. Study on anti-atherosclerotic effect of suxiao jiuxin pill and its ...

    African Journals Online (AJOL)

    Background: Suxiao Jiuxin Pill is composed of Ligusticum wallichii, Borneolum Syntheticum and other drugs; it has qi promoting and blood circulation activating, meridian dredging and pain relieving efficacies. The objective of this paper is to study the effect of Suxiao Jiuxin Pill (quick-acting heart reliever), in atherosclerosis ...

  19. Validation of self-report and hospital pill count using unannounced ...

    African Journals Online (AJOL)

    Adherence to anti-retroviral therapy (ART) is very crucial for successful treatment outcomes. This study aimed to validate patient-self report (PSR) and hospital based pill count (HoPC) as adherence determination methods by using unannounced home visit pill count (HPC). The study was carried out at Muhimbili National ...

  20. Pilling evaluation of patterned fabrics based on a gradient field method

    Czech Academy of Sciences Publication Activity Database

    Techniková, L.; Tunák, M.; Janáček, Jiří

    2016-01-01

    Roč. 41, č. 1 (2016), s. 97-101 ISSN 0971-0426 Institutional support: RVO:67985823 Keywords : 3D surface reconstruction * fabric pilling * gradient field method * patterned fabric * pills detection Subject RIV: JS - Reliability ; Quality Management, Testing Impact factor: 0.430, year: 2016

  1. Sisearhitekt Pille Lausmäe - Tallinna töö- ja toidukultuuri looja / Karen Jagodin

    Index Scriptorium Estoniae

    Jagodin, Karen, 1982-

    2006-01-01

    Omanimelise arhitektuuribüroo omanik sisearhitekt Pille Lausmäe oma elust ja tööst, isast sisearhitekt Väino Tammest. Eesti Kunstiakadeemias õpib sisearhitektuuri ka Pille poeg Ville Lausmäe ja töötab ema büroos. Pillet iseloomustavad Priit Põldme, Riina Sildots, Rein Tallermo, Mari Kaljuste

  2. Study on prevention effect of Zishen Yutai pill combined with progesterone for threatened abortion in rats.

    Science.gov (United States)

    Zhang, Yi; Yan, Wei; Ge, Pu-Feng; Li, Yan; Ye, Qian

    2016-06-01

    To observe preventive and therapeutic effects and the mechanism of actions on Zishen Yutai pill combined with progesterone on threatened abortion in rats. After pregnancy, 50 SPF female SD rats were selected and divided into control group, model group, progesterone group, Zishen Yutai pill group, and progesterone plus Zishen Yutai pill group (combination group), with 10 rats in each group. The rats of control group and abortion model group were lavaged with 2 mL/kg normal saline on pregnancy day 1 for continuous 10 days. Rats in Zishen Yutai pill group were given 1.575 g/kg/d of Zishen Yutai pill for intragastric administration for continuous 10 days. Rats in progesterone group were given intramuscular injection treatment of 0.1 mL/d progestin, continuous for 10 days. Rats in combination group were given injection therapy of aqueous solution of Zishen Yutai pill for continuous 10 days, and other treatments were the same as previous two groups. Abortion model were established then and live births, numbers of abortion and average rate of abortion were compared between the five groups. Peripheral blood was collected to detect the estradiol (E2) and progestational hormone (P), and obtain ratio of Th1/Th2 cytokines (IL-2, INF-γ, IL-4, IL-10). Significant more live births of rats were found in the control group compared with other four groups (P pill group and joint group (P pill group. The serum E2 level of P of rats in the control group, progesterone group, Zishen Yutai pill group and joint group were significant higher than that of abortion model group (P pill group and joint group were not significant different (P > 0.05) but these levels in the control group and Zishen Yutai pill group were significant lower than that of progesterone group and joint group (P pill group and joint group were balanced deviating to Th2, and joint group' deviation was better than progesterone group and Zishen Yutai pill group (P pill combined with progesterone has a

  3. Access to the Birth Control Pill and the Career Plans of Young Men and Women

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    The paper explores the effect of unrestricted access to the birth control pill on young people’s career plans, using annual surveys of college freshmen from 1968 to 1980. In particular it addresses the question of who was affected by the introduction of the birth control pill by looking at career...... access to the pill is found to be on non-white students, both among men and women. The paper uses Census Data to compare the changes in career plans to actual changes in labor market outcomes. When looking at the actual career outcomes, early access to the pill affects both men and women - shifting...... their careers towards traditionally male dominated occupations associated with higher wages. Early access to the pill is also associated with significantly higher actual income for men....

  4. Access to the Birth Control Pill and the Career Plans of Young Men and Women

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    plans of both men and women, and by separating the effect by level of academic ability, race and family income. The results show that unrestricted access to the pill caused high ability women to move towards occupations with higher wages, higher occupational prestige scores and higher male ratios......The paper explores the effect of unrestricted access to the birth control pill on young people’s career plans, using annual surveys of college freshmen from 1968 to 1980. In particular it addresses the question of who was affected by the introduction of the birth control pill by looking at career...... access to the pill is found to be on non-white students, both among men and women. The paper uses Census Data to compare the changes in career plans to actual changes in labor market outcomes. When looking at the actual career outcomes, early access to the pill affects both men and women - shifting...

  5. The comparative study of side effect of the two kinds of LD combined oral contraceptive pills containing Norgestimate and Levonorgestrel

    OpenAIRE

    Ghazizade Sh; Nowruzi A

    1998-01-01

    In order to compare the new generation of oral contraceptive pills containing Norgestimate (NGM) with currently available pills containing levonorgestrel (LNG) a clinical trial was conducted. 413 women (age 18-35 years) with no contrainindication to pill use entered the study and randomly received one type of pills. Premenstrual syndrome and depression were significantly decreased in NGM group (P=0.00016, P=0.005), on the other hand, breast tenderness, mood changes and hair loss were signific...

  6. Using Six Sigma to improve once daily gentamicin dosing and therapeutic drug monitoring performance.

    LENUS (Irish Health Repository)

    Egan, Sean

    2012-08-07

    BACKGROUND: Safe, effective therapy with the antimicrobial gentamicin requires good practice in dose selection and monitoring of serum levels. Suboptimal therapy occurs with breakdown in the process of drug dosing, serum blood sampling, laboratory processing and level interpretation. Unintentional underdosing may result. This improvement effort aimed to optimise this process in an academic teaching hospital using Six Sigma process improvement methodology. METHODS: A multidisciplinary project team was formed. Process measures considered critical to quality were defined, and baseline practice was examined through process mapping and audit. Root cause analysis informed improvement measures. These included a new dosing and monitoring schedule, and standardised assay sampling and drug administration timing which maximised local capabilities. Three iterations of the improvement cycle were conducted over a 24-month period. RESULTS: The attainment of serum level sampling in the required time window improved by 85% (p≤0.0001). A 66% improvement in accuracy of dosing was observed (p≤0.0001). Unnecessary dose omission while awaiting level results and inadvertent disruption to therapy due to dosing and monitoring process breakdown were eliminated. Average daily dose administered increased from 3.39 mg\\/kg to 4.78 mg\\/kg\\/day. CONCLUSIONS: Using Six Sigma methodology enhanced gentamicin usage process performance. Local process related factors may adversely affect adherence to practice guidelines for gentamicin, a drug which is complex to use. It is vital to adapt dosing guidance and monitoring requirements so that they are capable of being implemented in the clinical environment as a matter of routine. Improvement may be achieved through a structured localised approach with multidisciplinary stakeholder involvement.

  7. Tadalafil once daily and intralesional verapamil injection: A new therapeutic direction in Peyronie′s disease

    Directory of Open Access Journals (Sweden)

    Lucio Dell′Atti

    2015-01-01

    Full Text Available Introduction: The aim of this study was to evaluate the combination of intralesional verapamil injection (IVI therapy with and tadalafil in men affected by Peyronie′s disease (PD. Materials and Methods: In this study, 59 patients diagnosed with PD, were divided into three groups. Group A (GA counted 23 patients treated with IVI; Group B (GB treated 19 patients with tadalafil 5 mg once a day, and Group C (GC treated 17 patients with IVI and tadalafil for 3 months. There were assessed at baseline and follow-up: Erectile function, presence and severity of painful erections, penile plaque size and penile curvature degree. Results: After 3 months pain resolved completely in 57% cases of GA, 61% of GB and 76% of GC; the final mean curvature degree further decreased in all groups without statistically significant differences; mean plaque size remained stable in GA: 1.57 versus 1.59 at baseline (P = 0.364 and GB: 1.51 versus 1.52 at baseline (P = 0,265, while a further decrease was evident in GC: 1.46 versus 1.58 at baseline (P = 0.03. Mean International Index of Erectile Function-5 score further improved significantly in the group treated with verapamil plus tadalafil: 23.1 versus 14.4 of GA and 18.2 of GB ( P ≤ 0.01. Conclusions: The association of IVI and tadalafil showed better pain control while reducing penile curvature and erectile function, improving the quality of life.

  8. New developments in the treatment of rosacea – role of once-daily ivermectin cream

    Directory of Open Access Journals (Sweden)

    Cardwell LA

    2016-03-01

    Full Text Available Leah A Cardwell,1 Hossein Alinia,1 Sara Moradi Tuchayi,1 Steven R Feldman,1–31Department of Dermatology, Center for Dermatology Research, 2Department of Pathology, 3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA Abstract: Rosacea is a chronic dermatological disorder with a variety of clinical manifestations localized largely to the central face. The unclear etiology of rosacea fosters therapeutic difficulty; however, subtle clinical improvement with pharmacologic treatments of various drug categories suggests a multifactorial etiology of the disease. Factors that may contribute to disease pathogenesis include immune abnormality, vascular abnormality, neurogenic dysregulation, presence of cutaneous microorganisms, UV damage, and skin barrier dysfunction. The role of ivermectin in the treatment of rosacea may be as an anti-inflammatory and anti-parasitic agent targeting Demodex mites. In comparing topical ivermectin and metronidazole, ivermectin was more effective; this treatment modality boasted more improved quality of life, reduced lesion counts, and more favorable participant and physician assessment of disease severity. Patients who received ivermectin 1% cream had an acceptable safety profile. Ivermectin is efficacious in decreasing inflammatory lesion counts and erythema. Keywords: papulopustular rosacea, topical ivermectin, metronidazole, azelaic acid, topical

  9. Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Petersen, Andreas Brønden; Christensen, Mikkel

    2013-01-01

    The glucagon-like peptide (GLP)-1 receptor agonist lixisenatide (Lyxumia(®)) was approved for marketing by the European Medicines Agency in February 2013 and has been evaluated in a clinical study program called GetGoal. Lixisenatide activates the GLP-1 receptor and thereby exercises the range of...... of lixisenatide seems to be in combination with basal insulin. A large multicenter study will determine the future potential of lixisenatide in preventing cardiovascular events and mortality, in patients with type 2 diabetes and recent acute coronary syndrome....

  10. Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2012-01-01

    Long-acting bronchodilators are central in the pharmacological management of patients with chronic obstructive pulmonary disease (COPD). The aim of this systematic review is to provide an overview of the studies evaluating the safety and clinical efficacy of inhaled glycopyrronium bromide, a novel...

  11. Development and in-vitro Evaluation of Once Daily Tablet Dosage ...

    African Journals Online (AJOL)

    Faisalabad, 5Punjab Forensic Science Agency, Toxicology Unit, Lahore, Pakistan, 6Faculty of Pharmacy University of. Sargodha, Sargodha, Pakistan, 7Faculty of Pharmacy University of Central Punjab, Lahore, Pakistan. *For correspondence: Email: m.zaman2157@gmail.com; Tel: +92-3006095928. Received: 2 October ...

  12. Pills on the World Wide Web: reducing barriers through technology.

    Science.gov (United States)

    Gawron, Lori M; Turok, David K

    2015-10-01

    Oral contraceptive pills are safe, effective, and available without a prescription in most countries. Despite support from the American Congress of Obstetricians and Gynecologists to provide oral contraceptives as an over-the-counter medication, US women are still required to have a prescription to obtain them. Use of online applications and the Internet has made most things easier to obtain in our society and this includes contraceptive methods. Several online ventures are now underway to enable US women to obtain oral contraceptives without visiting a medical provider's office. Women's health care professionals should encourage these novel approaches, as they will improve contraceptive access. As US women experiment with innovative health care models, providers will need to lead, follow, or be left behind. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Telemetry pill versus rectal and esophageal temperature during extreme rates of exercise-induced core temperature change

    International Nuclear Information System (INIS)

    Teunissen, L P J; Daanen, H A M; De Haan, A; De Koning, J J

    2012-01-01

    Core temperature measurement with an ingestible telemetry pill has been scarcely investigated during extreme rates of temperature change, induced by short high-intensity exercise in the heat. Therefore, nine participants performed a protocol of rest, (sub)maximal cycling and recovery at 30 °C. The pill temperature (T pill ) was compared with the rectal temperature (T re ) and esophageal temperature (T es ). T pill corresponded well to T re during the entire trial, but deviated considerably from T es during the exercise and recovery periods. During maximal exercise, the average ΔT pill −T re and ΔT pill −T es were 0.13 ± 0.26 and −0.57 ± 0.53 °C, respectively. The response time from the start of exercise, the rate of change during exercise and the peak temperature were similar for T pill and T re. T es responded 5 min earlier, increased more than twice as fast and its peak value was 0.42 ± 0.46 °C higher than T pill . In conclusion, also during considerable temperature changes at a very high rate, T pill is still a representative of T re . The extent of the deviation in the pattern and peak values between T pill and T es (up to >1 °C) strengthens the assumption that T pill is unsuited to evaluate central blood temperature when body temperatures change rapidly. (paper)

  14. Emergency contraceptive pills: what you need to know. Brochure for programs providing combined ECPs.

    Science.gov (United States)

    1998-01-01

    This informational brochure was prepared for potential users of emergency contraceptive pills. In question-and-answer format, it presents facts on the mechanism of action, effectiveness, safety, and side effects of emergency contraception. It then outlines the regimen for method use. The brochure notes that emergency contraceptive pills cannot offer protection against HIV and other sexually transmitted diseases. Finally, two other emergency contraceptive regimens--the copper T IUD and progestin-only pills--are discussed. The brochure may be reproduced by family planning and other health programs.

  15. Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake.

    Science.gov (United States)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique; Colli, Enrico; Skouby, Sven

    2016-04-01

    Traditional progestogen-only pills (POPs) have stringent daily timing and missed pill rules that might affect contraceptive reliability. A new-generation oestrogen-free pill has been developed, containing 4-mg drospirenone with a unique regimen of 24 active treatment days followed by four placebo tablets. A previous study showed that this new drospirenone-only pill effectively inhibited ovulation. Clinical efficacy, however, can be affected by compliance, and delayed or forgotten pill intake often occurs in daily life. The aim of this study was to investigate if inhibition of ovulation was maintained after four scheduled 24-h delays in tablet intake. One hundred thirty healthy women with proven ovulatory cycles were randomized, and 127 were treated with the drospirenone-only pill during two cycles. In treatment Group A (n=62), 24-h delays in tablet intake were scheduled on days 3, 6, 11 and 22 during Cycle 2 and, in treatment Group B (n=65) during Cycle 1, respectively. Ovulation was defined as disappearance or persistence of a large follicle and progesterone levels higher than 5 ng/mL for at least 5 consecutive days. The overall ovulation rate was 0.8%; only one subject in Group A fulfilled the ovulation criteria in Cycle 2. Follicular diameters in the regular-intake and the delayed-intake cycles were similar. Despite the 4-day hormone-free period and multiple intentional 24-h delays in tablet intake, ovulation inhibition was maintained. This property distinguishes this new-generation oestrogen-free pill from traditional POPs by allowing the same "safety window" or flexibility in intake as combined oral contraceptives without compromising contraceptive reliability. Delayed or forgotten pill intake is very common. Ovulation inhibition by the new-generation oestrogen-free pill, containing 4-mg drospirenone for 24 days followed by a 4-day treatment-free period, was maintained despite four 24-h delays in tablet intake, so the impact of delayed intake on contraceptive

  16. Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection

    OpenAIRE

    Spada, Cristiano; De Vincentis, Fabio; Cesaro, Paola; Hassan, Cesare; Riccioni, Maria Elena; Minelli Grazioli, Leonardo; Bolivar, Santiago; Zurita, Andrade; Costamagna, Guido

    2012-01-01

    PillCam COLON capsule endoscopy (CCE) (Given Imaging Ltd, Yoqneam, Israel) is one of the most recent diagnostic, endoscopic technologies designed to explore the colon. CCE is a noninvasive, patient-friendly technique that is able to explore the colon without requiring sedation and air insufflation. The first generation of CCE was released onto the market in 2006 and although it generated great enthusiasm, it showed suboptimal accuracy. Recently, a second-generation system (PillCam COLON 2) (C...

  17. Evaluating the practice of Iranian community pharmacists regarding oral contraceptive pills using simulated patients

    OpenAIRE

    Foroutan, Nazanin; Dabaghzadeh, Fatemeh

    2016-01-01

    Background: As oral contraceptive pills are available over the counter in pharmacies, pharmacists are professionally responsible for checking and informing patients about every aspect of taking these drugs. Simulated patient method is a new and robust way to evaluate professional performance of pharmacists. Objective: The aim of the present study was to evaluate the pharmacy practice of Iranian pharmacists regarding over-the-counter use of oral contraceptive pills using simulated patient m...

  18. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Science.gov (United States)

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  19. Impact of oral contraceptive pill use on premenstrual mood: predictors of improvement and deterioration.

    Science.gov (United States)

    Joffe, Hadine; Cohen, Lee S; Harlow, Bernard L

    2003-12-01

    The purpose of this study was to estimate risk factors for the deterioration and improvement of premenstrual mood disturbance with oral contraceptive pill use. Predictors of the deleterious and beneficial effects of oral contraceptive pill use on premenstrual mood were analyzed with the use of logistic regression in a nested case-control study within a community-based cohort of 976 premenopausal women in Massachusetts. Of 658 women who were using oral contraceptive pills, 16.3% of the women reported oral contraceptive pill-related premenstrual mood deterioration, and 12.3% of the women reported premenstrual mood improvement. In adjusted models, previous depression was the only significant predictor of mood deterioration (odds ratio, 2.0; 95% CI, 1.1-3.8); early-onset premenstrual mood disturbance and dysmenorrhea were significant predictors of oral contraceptive pill-related mood improvement (odds ratio, 3.1 [95% CI, 1.9-5.2] and odds ratio, 2.3 [95% CI, 1.4-3.9], respectively). Oral contraceptive pills do not influence premenstrual mood in most women. Premenstrual mood is most likely to deteriorate in women with a history of depression and to improve in women with early-onset premenstrual mood disturbance or dysmenorrhea.

  20. [Impact of media alerts on contraceptive pills medication].

    Science.gov (United States)

    Pozzi-Gaudin, S; Deffieux, X; Davitian, C; Guerre, N; Faucher, P; Bacle, F; Teboul, M; Larmignat, P; Hatchuel, M; Benachi, A

    2015-09-01

    The end of 2012 was marked by some media alerts regarding combined hormonal contraceptives (CHC) and lawsuit against pharmaceutical companies selling these birth control pills. In this study, we analyzed whether these information had an impact on the number of abortion. Prospective study determining the number of women asking for abortion and who spontaneously declare that the contraception defect was due to an abandon of their oral contraception as they were scared of some information they received from media about the medication. Eleven centers out of 16 did participate to the study, allowing the study of 2300 abortion during this time frame. Ninety-eight of these pregnancies (4.2%) were due to an interruption of the contraceptive treatment as a consequence of media alerts. Average age was 26 years old. Within these pregnancies, 4 (6%) started in December 2012, 3 months after the beginning of the alerts, 11 (16%) in January, 24 (36%) in February and 18 (27%) in March 2013 (4-6 months later). In 7 cases (10%) CHC stopped by fear of information reported by media were of 2nd generation, in 17 cases (25%) of 3rd generation, in 32 cases (48%) of 4th generation and microprogestative in 2 cases (3%). Women who declared that they stopped their birth control medication by fear of information reported in media, represented 4% of the number of abortions performed between 2013 February 18th and 2013 April 30th. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  1. Desogestrel mini pill: is this safe in lactating mother?

    Science.gov (United States)

    Dutta, Dilip Kumar; Dutta, Indranil

    2013-08-01

    To find out the safety, effectiveness and tolerability of using desogestrel (75 microg/day), a progesterone only pill on lactating mother, a prospective clinical study was undertaken among 200 lactating women during the period from 1st January 2010 to 13th June 2011 at Gice Clinic, Kalyani, Nadia, West Bengal. The same number of cases were taken as placebo for comparison. Desogestrel was started after six weeks of delivery for six months. Patients were reviewed at 8th, 12th, 16th, 24th weeks and one year. The very interesting results were found from the follow-up study that desogestrel (75 microg/day) did not alter the amount and composition of breast milk, pregnancy was not reported as compared to placebo. The drug had good tolerability, less side-effects and did not affect the growth and development of breastfed babies. Due to the safety, good efficacy, tolerability and less side-effects it is concluded that desogestrel (75 microg/day) was well accepted in majority of women (97.5%) and provided good contraceptive efficacy during the lactating period. This treatment does not have any effect on the growth and development of breastfed baby.

  2. Young adult couples' decision making regarding emergency contraceptive pills.

    Science.gov (United States)

    Beaulieu, Richard; Kools, Susan M; Kennedy, Holly Powell; Humphreys, Janice

    2011-03-01

    Unintended pregnancy is a significant public health problem among young people worldwide. The purpose of this study was to explore and better understand the reasons for the apparent underuse of emergency contraceptive pills (ECP) in young people in coupled relationships. THEORETICAL RATIONAL: In postmodern explications of grounded theory, social construction of realities and the influence of subjectivities on the meanings of experiences lead to the development of partial truths that may change with time, context, and situation. Grounded theory methods guided semi-structured face-to-face interviews and data analysis. Twenty-two couples aged 18 to 25 years old were recruited through public notices. Four salient and interrelated conditions were constructed to help explain the complexities involved in young couples decision making regarding ECP use: (a) the shifting locus of responsibility for contraceptive decision making: in a perfect world versus biological reality; (b) relationship power: control-vulnerability continuum; (c) a woman's autonomy over her own body; and (d) conflicting views on ECP. Healthcare professionals whose practice includes young people need to be aware of possible couple dynamics when discussing contraception. Clients in supportive relationships should be encouraged to engage in open communication with their partners about their contraception needs, including possible ECP use. The results of this study contribute to the body of knowledge with regard to decision making related to ECP use in young adults. © 2011 Sigma Theta Tau International.

  3. Early History of Oral Contraceptive Pill in Finland: The Diffusion of the New Contraceptive and Fertility Patterns

    Directory of Open Access Journals (Sweden)

    Aura Pasila

    2011-01-01

    Full Text Available The 1960s is often characterized as a decade of outstanding social and demographic changes in Western societies. The introduction of the contraceptive pill is assumed to have contributed to these changes. Yet the social as well as the demographic significance of the pill is ambiguous. This article has two aims: 1 to describe the early history of the pill in Finland in the 1960s and in the early 1970s and 2 to explore relationships between fertility and the pill. Surveys, pharmaceutical market data, and estimations are used to depict the diffusion of the pill. Based on calculated user percentages, the pill was adopted neither instantly nor extremely widely in Finland during the period under study. The results show that the diffusion coincided with fertility decline and other changes in fertility patterns. However, a causal connection of any kind cannot be established due to a lack of sufficient data.

  4. Impact of a warning CPOE system on the inappropriate pill splitting of prescribed medications in outpatients.

    Directory of Open Access Journals (Sweden)

    Chia-Chen Hsu

    Full Text Available Prescribing inappropriate pill splitting is not rare in clinical practice. To reduce inappropriate pill splitting, we developed an automatic warning system linked to a computerized physician order entry (CPOE system for special oral formulation drugs in outpatient settings. We examined the impact of the warning system on inappropriate prescribing of pill splitting and assess prescribers' responses to the warnings.Drugs with extended-release or enteric-coated formulations that were not originally intended to be split were recognized as "special oral formulations". A hard-stop system which could examine non-integer doses of drugs with special oral formulations, provide warnings to interrupt inappropriate prescriptions was integrated in CPOE in a medical center since June 2010. We designed an intervention study to compare the inappropriate splitting before and after the implementation of the warning system (baseline period 2010 January to May vs. intervention period 2010 June to 2011 August. During the intervention period, prescription changes in response to a warning were logged and analyzed.A total of 470,611 prescribed drug items with 34 different drugs with special oral formulations were prescribed in the study period. During the 15-month intervention period, 909 warnings for 26 different drugs were triggered among 354,523 prescribed drug items with special oral formulations. The warning rate of inappropriate splitting in the late intervention period was lower than those in baseline period (0.16% vs. 0.61%, incidence rate ratio 0.27, 95% CI 0.23-0.31, P<0.001. In respond to warnings, physicians had to make adjustments, of which the majority was changing to an unsplit pill (72.9%.The interruptive warning system could avoid the prescriptions with inappropriate pill splitting. Accordingly, physicians changed their behavior of prescribing special oral formulations regarding inappropriate pill splitting. We suggest the establishment of such system

  5. Effect of a "pill mill" law on opioid prescribing and utilization: The case of Texas.

    Science.gov (United States)

    Lyapustina, Tatyana; Rutkow, Lainie; Chang, Hsien-Yen; Daubresse, Matthew; Ramji, Alim F; Faul, Mark; Stuart, Elizabeth A; Alexander, G Caleb

    2016-02-01

    States have attempted to reduce prescription opioid abuse through strengthening the regulation of pain management clinics; however, the effect of such measures remains unclear. We quantified the impact of Texas's September 2010 "pill mill" law on opioid prescribing and utilization. We used the IMS Health LRx LifeLink database to examine anonymized, patient-level pharmacy claims for a closed cohort of individuals filling prescription opioids in Texas between September 2009 and August 2011. Our primary outcomes were derived at a monthly level and included: (1) average morphine equivalent dose (MED) per transaction; (2) aggregate opioid volume; (3) number of opioid prescriptions; and (4) quantity of opioid pills dispensed. We compared observed values with the counterfactual, which we estimated from pre-intervention levels and trends. Texas's pill mill law was associated with declines in average MED per transaction (-0.57 mg/month, 95% confidence interval [CI] -1.09, -0.057), monthly opioid volume (-9.99 kg/month, CI -12.86, -7.11), monthly number of opioid prescriptions (-12,200 prescriptions/month, CI -15,300, -9,150) and monthly quantity of opioid pills dispensed (-714,000 pills/month, CI -877,000, -550,000). These reductions reflected decreases of 8.1-24.3% across the outcomes at one year compared with the counterfactual, and they were concentrated among prescribers and patients with the highest opioid prescribing and utilization at baseline. Following the implementation of Texas's 2010 pill mill law, there were clinically significant reductions in opioid dose, volume, prescriptions and pills dispensed within the state, which were limited to individuals with higher levels of baseline opioid prescribing and utilization. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. Therapeutic effects of Qishen Yiqi Dropping Pill on myocardial injury induced by chronic hypoxia in rats.

    Science.gov (United States)

    Yu, Fu-Chao; Xu, Yan-Juan; Tong, Jia-Yi; Lu, Zhou-Zhou; Zhang, Xiao-Hui

    2015-10-01

    The present study was designed to determine the effects of a traditional Chinese medicine, called Qishen Yiqi Dropping Pill on chronic hypoxia-induced myocardial injury. To establish a rat chronic hypoxia model to be used in the evaluation of the therapeutic effects of the Qishen Yiqi Dropping Pill, Sprague-Dawley (SD) rats were randomly divided into three groups: the control, model, and treatment groups (n = 10 per group). The animals were housed in a plexiglass container. The control animals were under normal oxygen concentration and the model and treatment groups were exposed to air and nitrogen for 5 weeks. The rats in the treatment group were orally administered the Qishen Yiqi Dropping pill (35 mg·kg(-1)·d(-1)) for 5 weeks. After the treatment, the cardiac function and morphology were analyzed, and the expression levels of hypoxia-inducible factor 1α (HIF-1α) were determined using Western blotting. Our results indicated that the cardiac function was impaired, cell apoptosis was enhanced, and HIF-1α expression was up-regulated in the model group, compared to the control group. These changes were ameliorated by the treatment with the Qishen Yiqi Dropping Pill. In conclusion, Qishen Yiqi Dropping pill can ameliorate myocardial injury induced by chronic hypoxia, improve cardiac function, and decrease myocardial cell apoptosis, which may provide a basis for its clinical use for the treatment of chronic cardiovascular diseases. Copyright © 2015 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

  7. Feminism, biomedicine and the 'reproductive destiny' of women in clinical texts on the birth control pill.

    Science.gov (United States)

    Carson, Andrea

    2017-10-18

    The birth control pill is one of the most popular forms of contraception in North America and has been a key player in women's rights activism for over 50 years. In this paper, I conduct a feminist deconstructive analysis of 12 biomedical texts on the birth control pill, published between 1965 and 2016. This study is situated amongst the feminist scholarship that challenges the representation of women's bodies in biomedicine. Findings suggest that clinical texts on the birth control pill continue to universalise women's lives and experiences, and essentialise them based on their reproductive capacities. One way the texts accomplish this is by making women absent or passive in the literature thereby losing concern for the diversity of their lives, interpretations and identities as more than reproductive beings. The consequence of such representations is that biomedical texts disseminate limited forms of knowledge, in particular concerning definitions of 'natural' and 'normal' behaviour, with important consequences for the embodied experiences of women.

  8. Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Thompson N

    2011-09-01

    Full Text Available Nia Thompson1, Niaman Nazir1, Lisa Sanderson Cox1,2, Babalola Faseru1,2, Kathy Goggin3, Jasjit S Ahluwalia4, Nicole L Nollen1,21University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS, USA; 2University of Kansas Cancer Center, Kansas City, KS, USA; 3University of Missouri-Kansas City, Department of Psychology, Kansas City, MO, USA; 4University of Minnesota Medical School, Department of Medicine and Center for Health Equity, Minneapolis, MN, USABackground: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.Research design: Secondary data analysis of a randomized pilot study.Participants: 46 moderate-to-heavy (>10 cigarettes per day African-American smokers.Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.Results: Participants were a mean age of 48 years (SD = 13, predominately female (59%, low income (60% < $1800 monthly family income, and smoked an average of 17 (SD = 7 cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001. Participants with discordant counts (n = 7 had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005, but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004 than participants with matching phone and in

  9. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel).

    Science.gov (United States)

    Lakha, F; Ho, P C; Van der Spuy, Z M; Dada, K; Elton, R; Glasier, A F; Critchley, H O D; Williams, A R W; Baird, D T

    2007-09-01

    The acceptability and continuation rate of oral contraceptive steroids are limited by unpredictable bleeding and the fear of long-term risks such as breast cancer. By inhibiting ovulation and by altering the receptivity of the endometrium, antagonists of progesterone, such as mifepristone, could be developed as estrogen-free novel contraceptives. Multicentre, double-blind, randomized controlled trial comparing frequency of amenorrhoea (primary outcome), bleeding patterns, side effects and efficacy in women taking daily 5 mg mifepristone (n = 73) or 0.03 mg levonorgestrel (progestogen-only pill; POP, n = 23) for 24 weeks. More women were amenorrhoeic while taking mifepristone than POP (49 versus 0% P 5 days per month (4 versus 39% P contraception. Two pregnancies occurred in women taking mifepristone who were also using condoms for dual protection. Daily mifepristone (5 mg) is an effective oral contraceptive pill which has a better pattern of menstrual bleeding than an existing POP (levonorgestrel).

  10. Evaluation of a telemetric gastrointestinal pill for continuous monitoring of gastrointestinal temperature in horses at rest and during exercise

    NARCIS (Netherlands)

    Verdegaal, Elisabeth Lidwien J.M.M.; Delesalle, Catherine; Caraguel, Charles G.B.; Folwell, Louise E.; McWhorter, Todd J.; Howarth, Gordon S.; Franklin, Samantha H.

    2017-01-01

    OBJECTIVE To evaluate use of a telemetric gastrointestinal (GI) pill to continuously monitor GI temperature in horses at rest and during exercise and to compare time profiles of GI temperature and rectal temperature. ANIMALS 8 Standardbred horses. PROCEDURES Accuracy and precision of the GI pill and

  11. Kino Kosmos Imax restaureerimine = Restoration of the Kino Kosmos as an Imax cinema / Pille Lausmäe

    Index Scriptorium Estoniae

    Lausmäe, Pille, 1958-

    2015-01-01

    Kino Kosmos Imax Tallinnas Pärnu mnt 45, hoone valminud 1964, restaureeritud 2014. Hoone arhitekt Ilmar Laasi, restaureerimisprojekt Urmas Lõokese Arhitektibüroo, sisearhitektid Kerli Lepp, Pille Lausmäe (Pille Lausmäe Sisearhitektuuribüroo). 2014. aasta Kultuurkapitali Arhitektuuripreemia kandidaat

  12. New low-dose, extended-cycle pills with levonorgestrel and ethinyl estradiol: an evolutionary step in birth control.

    Science.gov (United States)

    Nelson, Anita

    2010-08-09

    To review milestones in development of oral contraceptive pills since their introduction in the US 50 years ago in order to better understand how a new formulation with low-dose estrogen in an extended-cycle pattern fits into the evolution of birth control pills. This is a review of trends in the development of various birth controls pills and includes data from phase III clinical trials for this new formulation. The first birth control pill was a very high-dose monophasic formulation with the prodrug estrogen mestranol and a first-generation progestin. Over the decades, the doses of hormones have been markedly reduced, and a new estrogen and several different progestins were developed and used in different dosing patterns. The final element to undergo change was the 7-day pill-free interval. Many of these same changes have been made in the development of extended-cycle pill formulation. The newest extended-cycle oral contraceptive formulation with 84 active pills, each containing 20 μg ethinyl estradiol and 100 μg levonorgestrel, represents an important evolution in birth control that incorporates lower doses of estrogen (to reduce side effects and possibly reduce risk of thrombosis), fewer scheduled bleeding episodes (to meet women's desires for fewer and shorter menses) and the use of low-dose estrogen in place of placebo pills (to reduce the number of days of unscheduled spotting and bleeding). Hopefully, this unique formation will motivate women to be more successful contraceptors.

  13. A Little Bit of Sugar Helps the Pill Go Down: Resilience, Peace, and Family Planning: Comment on "The Pill Is Mightier Than the Sword"

    OpenAIRE

    De Souza, Roger-Mark

    2015-01-01

    The article by Potts et al, “The Pill is Mightier than the Sword,” points out that family planning has an important role to play in building peace by increasing women’s empowerment and their agency, ultimately helping peacebuilding efforts. Evidence has demonstrated that family planning programs are cost effective, produce quick results, help women and couples meet their desired fertility levels, and produce a multitude of benefits around economic productivity, community engagement, conservat...

  14. Use of the Oral Contraceptive Pill by Austrian Adolescents with Emphasis on the Age of Onset, Side Effects, Compliance and Lifestyle

    OpenAIRE

    Brunnhuber, S.; Kirchengast, S.

    2002-01-01

    The present study investigated the use of the oral contraceptive pill in 880 Austrian high school girls. All participants filled in a questionnaire on lifestyle and menarche. Furthermore, subjects on the pill were asked about their preparation, age at first use, reasons why they take it, side effects and oral contraceptive compliance. All 139 subjects on the pill used low dose monophasic preparations. The girls started the pill at a mean age of 16.0 0.9 years for contraceptive ...

  15. Providing innovative solutions in a single pill: Servier's portfolio in hypertension.

    Science.gov (United States)

    Mourad, Jean-Jacques; Guillerm, Jean-Christophe

    2016-09-01

    Jean-Jacques Mourad & Jean-Christophe Guillerm speak to Henry Ireland, Drug Evaluation Editor: Jean-Jacques Mourad talks about his vision of the current landscape and unmet medical needs in the field of hypertension. Jean-Christophe Guillerm describes the family of antihypertensive treatments from Servier, which were designed to address the current challenges in the management of hypertension by providing an adapted solution to doctors and to the specific needs of each patient. Jean-Jacques Mourad currently works as Professor of Medicine and is the Head of the Hypertension Unit at the Hôpital Avicenne in Bobigny, France. He completed his academic degrees at the Pierre and Marie Curie University, Paris VI in the field of internal and vascular medicine in 1996, and in the area of cardiovascular medicine and pharmacology in 2001. He is the past president of the French League Against Hypertension (since 2012), and the former General Secretary of the French Microcirculation Society. He is the actual Scientific Secretary of the French Society of Hypertension. He is also a member of the administrative council of the Collège Français de Pathologie Vasculaire. His research focuses on the epidemiology of hypertension, arterial structure and function, determinants of adherence to chronic treatment and the effects of antihypertensive agents. He was involved in several studies and surveys. He is a co-author of more than 130 publications and of 900 communications presented at national and international meetings. Jean-Christophe Guillerm, joined the pharmaceutical industry 17 years ago. He is currently the Head of the Cardiovascular Division for Servier, in charge of both cardiology and hypertension's medical strategy at a global level. Prior to this, he was in charge of the diabetes and internal medicine franchise at a global level. He also has experience in French commercial operations.

  16. Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study

    Science.gov (United States)

    Carreiro, Stephanie; Innes, Brendan J; Rosen, Rochelle K; O'Cleirigh, Conall; Mayer, Kenneth H; Boyer, Edward W

    2017-01-01

    Background Nonadherence to prescribed regimens for opioid analgesic agents contributes to increasing opioid abuse and overdose death. Opioids are frequently prescribed on an as-needed basis, placing the responsibility to determine opioid dose and frequency with the patient. There is wide variability in physician prescribing patterns because of the lack of data describing how patients actually use as-needed opioid analgesics. Digital pill systems have a radiofrequency emitter that directly measures medication ingestion events, and they provide an opportunity to discover the dose, timing, and duration of opioid therapy. Objective The purpose of this study was to determine the feasibility of a novel digital pill system to measure as-needed opioid ingestion patterns in patients discharged from the emergency department (ED) after an acute bony fracture. Methods We used a digital pill with individuals who presented to a teaching hospital ED with an acute extremity fracture. The digital pill consisted of a digital radiofrequency emitter within a standard gelatin capsule that encapsulated an oxycodone tablet. When ingested, the gastric chloride ion gradient activated the digital pill, transmitting a radiofrequency signal that was received by a hip-worn receiver, which then transmitted the ingestion data to a cloud-based server. After a brief, hands-on training session in the ED, study participants were discharged home and used the digital pill system to ingest oxycodone prescribed as needed for pain for one week. We conducted pill counts to verify digital pill data and open-ended interviews with participants at their follow-up appointment with orthopedics or at one week after enrollment in the study to determine the knowledge, attitudes, beliefs, and practices regarding digital pills. We analyzed open-ended interviews using applied thematic analysis. Results We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants

  17. The Role of Liuwei Dihuang Pills and Ginkgo Leaf Tablets in Treating Diabetic Complications

    Directory of Open Access Journals (Sweden)

    Yue Zhao

    2016-01-01

    Full Text Available Objective. To observe the clinical prophylactic and therapeutic efficacy of Liuwei Dihuang Pills and Ginkgo Leaf Tablets for type 2 diabetic vascular complications. Methods. It was a randomized, double-blind and placebo-controlled clinical trial. 140 outpatients with type 2 diabetes were recruited and randomly divided into the treatment group and control group. The two groups were given basic therapy (management of blood sugar, blood pressure, etc.. Additionally, the treatment group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets, while the control group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets placebos. All subjects were followed up for consecutive 36 months and observed monthly. The clinical data as urinary microalbumin to urinary creatinine ratio (Umalb/cr, carotid intima-media thickness (IMT, diabetic nephropathy (DN and diabetic retinopathy (DR prevalence, cardiovascular and cerebrovascular events, blood glucose, and blood pressure were collected and analyzed statistically. Results. After 36-month treatment, the Umalb/cr level and DN and DR prevalence in treatment group were all significantly lower than control group (P0.05. Conclusions. Liuwei Dihuang Pills and Ginkgo Leaf Tablets are beneficial to diabetic microvascular complications, while the efficacy to diabetic macrovascular complications needs more observations.

  18. Improving combined contraceptive pill/oral contraceptives prescribing in general practice.

    Science.gov (United States)

    Russell, Sophie; Wiles, Helen

    2017-01-01

    Eighty per cent of contraceptive care occurs in the general practice setting. UK Medical Eligibility Criteria provides clear guidelines for the safe provision of appropriate contraception. The Faculty of Sexual and Reproductive Health and the National Institute for Health and Care Excellence offer further recommendations for initiation and continuation of the combined contraceptive pill/oral contraceptives. Using the Egton Medical Information Systems database of an inner city, average size general practice we performed a retrospective analysis of combined contraceptive pill/oral contraceptives consultations to identify areas of substandard prescribing. Through three subsequent improvement cycles we demonstrated that the safety of combined contraceptive pill/oral contraceptives prescribing could be enhanced by consistent application of UK Medical Eligibility Criteria. By encouraging general practitioners to promote safe sex and use local long-acting reversible contraception options we were able to enhance the quality of consultations as dictated by national guidelines. Regular education and use of an amended EMIS template (to include UK Medical Eligibility Criteria) enabled us to improve both the safety and quality of community-combined contraceptive pill/oral contraceptives prescribing in a sustainable fashion.

  19. [Optimize dropping process of Ginkgo biloba dropping pills by using design space approach].

    Science.gov (United States)

    Shen, Ji-Chen; Wang, Qing-Qing; Chen, An; Pan, Fang-Lai; Gong, Xing-Chu; Qu, Hai-Bin

    2017-07-01

    In this paper, a design space approach was applied to optimize the dropping process of Ginkgo biloba dropping pills. Firstly, potential critical process parameters and potential process critical quality attributes were determined through literature research and pre-experiments. Secondly, experiments were carried out according to Box-Behnken design. Then the critical process parameters and critical quality attributes were determined based on the experimental results. Thirdly, second-order polynomial models were used to describe the quantitative relationships between critical process parameters and critical quality attributes. Finally, a probability-based design space was calculated and verified. The verification results showed that efficient production of Ginkgo biloba dropping pills can be guaranteed by operating within the design space parameters. The recommended operation ranges for the critical dropping process parameters of Ginkgo biloba dropping pills were as follows: dropping distance of 5.5-6.7 cm, and dropping speed of 59-60 drops per minute, providing a reference for industrial production of Ginkgo biloba dropping pills. Copyright© by the Chinese Pharmaceutical Association.

  20. Diet Pills, Powders, and Liquids: Predictors of Use by Healthy Weight Females

    Science.gov (United States)

    Thorlton, Janet; Park, Chang; Hughes, Tonda

    2014-01-01

    About 35% of healthy weight adolescent females describe themselves as overweight, and 66% report planning to lose weight. Body weight dissatisfaction is associated with unhealthy weight loss practices including diet pill/powder/liquid (PPL) use. Few studies have examined diet PPL use in healthy weight adolescent females; therefore, Youth Risk…

  1. Can We Pop a Pill to Cure Obesity? Genetic Studies of a Complex ...

    Indian Academy of Sciences (India)

    Home; Journals; Resonance – Journal of Science Education; Volume 1; Issue 12. Can We Pop a Pill to Cure Obesity? Genetic Studies of a Complex Trait. Sujatha Byravan. Research News Volume 1 Issue 12 December 1996 pp 69-72. Fulltext. Click here to view fulltext PDF. Permanent link:

  2. Biochemical composition of two giant pill-millipedes of the Western Ghats of India

    Directory of Open Access Journals (Sweden)

    Ambarish Cheviri N.

    2015-12-01

    Full Text Available Many invertebrates have an unexpected nutraceutical potential and are of nutritional or ethnomedicinal significance to many tribals throughout the world. The giant pill-millipedes of the genus Arthrosphaera are traditionally used as natural medicines by tribals in the Western Ghats of India. In this study, two species of pill-millipedes (Arthrosphaera fumosa and A. magna were subjected to proximate and biochemical analysis to ascertain their nutritional potential. Bodies of A. fumosa and A. magna (after removal of their intestines had a low protein content (8-15% and high quantity of carbohydrates (40-41%. They were rich in many essential elements, especially in calcium. The essential amino acids of pillmillipedes were in high quantities. The level of glycine was the highest, followed by lysine and serine. The fatty acid methyl esters (FAMEs of males and females consist of high quantities of unsaturated fatty acids. The mono-unsaturated fatty acids were more abundant than poly-unsaturated fatty acids. Palmitic and oleic acids were dominant saturated and unsaturated fatty acids, respectively. The study has revealed for the first time that pill-millipedes of the Western Ghats of India constitute a good source of essential minerals, essential fatty acids, and essential amino acids. Being valuable contributors of organic manure by processing recalcitrant plant lignocellulosic wastes, pill-millipedes become part and parcel of organic farming as well as future nutraceutical sources.

  3. How to illustrate science - a lesson from the 1970s / Pille-Triin Männik

    Index Scriptorium Estoniae

    Männik, Pille-Triin

    2006-01-01

    Tallinna IV rakenduskunsti triennaali Pille-Riin Männiku ja Anneli Porri kureeritud satelliitnäitusest "Teadus ja tänapäev" A-galeriis, Draakoni galeriis ja Hobusepea galeriis. Suure osa näitusest moodustavad Tõnis Vindi illustratsioonid 1979. a. ilmunud Juhan Kivi raamatule "Teadus ja tänapäev". Fotod Ene Kull

  4. Rein Pill võitis Venemaal kõrgetasemelise võistluse / Maarja Värv

    Index Scriptorium Estoniae

    Värv, Maarja

    2008-01-01

    Ratsutaja Rein Pill tegi Venemaal Tsherjahovskis CS14* taseme rahvusvahelistel ratsutamise takistussõiduvõistlustel ajalugu, võites hobusel A Big Boy võistluste Grand Prix' 160 cm kõrgusel parkuuril ja täites seega Euroopa meistrivõistluste kvalifikatsiooninormi

  5. Oral contraceptive pills induced hemichorea in an adolescent female with polycystic ovarian disease

    OpenAIRE

    Sharmila, Vijayan; Babu, Thirunavukkarasu Arun

    2015-01-01

    Chorea is a neurological adverse effect of oral contraceptive pills (OCPs). The onset of chorea following OCPs usage varies widely from few weeks to several years. We report a rare case of chorea which developed within a week of starting OCPs in an adolescent girl with polycystic ovarian disease.

  6. Oral contraceptive pills induced hemichorea in an adolescent female with polycystic ovarian disease.

    Science.gov (United States)

    Sharmila, Vijayan; Babu, Thirunavukkarasu Arun

    2015-01-01

    Chorea is a neurological adverse effect of oral contraceptive pills (OCPs). The onset of chorea following OCPs usage varies widely from few weeks to several years. We report a rare case of chorea which developed within a week of starting OCPs in an adolescent girl with polycystic ovarian disease.

  7. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial.

    Science.gov (United States)

    Espey, Eve; Ogburn, Tony; Leeman, Lawrence; Singh, Rameet; Ostrom, Katie; Schrader, Ronald

    2012-01-01

    To estimate the effect of progestin-only compared with combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation, and patient satisfaction with breastfeeding and contraceptive method. Postpartum breastfeeding women who desired oral contraceptives were randomly assigned to progestin-only and combined hormonal contraceptive pills. At 2 and 8 weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length, and head circumference were assessed at 8 weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation, and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using χ tests, Fisher exact test, or two-sample t tests as appropriate. Breastfeeding continuation rates at 8 weeks (progestin-only 63.5%; combined hormonal 64.1%), contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Choice of combined hormonal or progestin-only contraceptive pills administered 2 weeks postpartum did not adversely affect breastfeeding continuation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01465022.

  8. Pills that swallow policy: clinical ethnography of a Community Mental Health Program in northern India.

    Science.gov (United States)

    Jain, Sumeet; Jadhav, Sushrut

    2009-03-01

    India's National Mental Health Program (NMHP) was initiated in 1982 with the objective of promoting community participation and accessible mental health services. A key component involves central government calculation and funding for psychotropic medication. Based on clinical ethnography of a community psychiatry program in north India, this article traces the biosocial journey of psychotropic pills from the centre to the periphery. As the pill journeys from the Ministry of Health to the clinic, its symbolic meaning transforms from an emphasis on accessibility and participation to the administration of a discrete ;treatment.' Instead of embodying participation and access, the pill achieves the opposite: silencing community voices, re-enforcing existing barriers to care, and relying on pharmacological solutions for psychosocial problems. The symbolic inscription of NMHP policies on the pill fail because they are undercut by more powerful meanings generated from local cultural contexts. An understanding of this process is critical for the development of training and policy that can more effectively address local mental health concerns in rural India.

  9. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen.

    Science.gov (United States)

    Dinger, Jürgen; Minh, Thai Do; Buttmann, Nina; Bardenheuer, Kristina

    2011-01-01

    To estimate real-life effectiveness of oral contraceptive pills by progestogen, length of pill-free interval, and body mass index while focusing on the effect of progestogens with a long half-life and on 24-day oral contraceptive pills regimens. Outcome data from 52,218 U.S. participants in the International Active Surveillance of Women Taking Oral Contraceptives—a large, prospective, controlled, noninterventional, long-term cohort study with active surveillance of the study participants—were used to analyze contraceptive failure in association with oral contraceptive pills use. Low loss to follow-up is ensured by a comprehensive follow-up procedure. Contraceptive failure rates are described by Pearl Index and life-table analysis. Inferential statistics for contraceptive failure are based on Cox regression models. Analyses are based on 1,634 unintended pregnancies during 73,269 woman-years of oral contraceptive pills exposure. Life-table estimates of contraceptive failure for a 24-day regimen of drospirenone and ethinyl estradiol and 21-day regimens of other progestogens were 2.1% and 3.5% after the first study year, and 4.7% and 6.7% after the third year. The adjusted hazard ratio was 0.7 (95% confidence interval 0.6–0.8). Direct comparisons of the 24-day and 21-day regimens of drospirenone and norethisterone, respectively, showed also lower contraceptive failure rates for 24-day regimens. Contraceptive failure rates adjusted for age, parity and educational level showed a slight increase with higher body mass index. The 24-day oral contraceptive regimens containing a progestogen with a long half-life show higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens. Obesity seems to be associated with a slight reduction of contraceptive effectiveness. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00335257. II

  10. Successful treatment of pill-swallowing difficulties with head posture practice.

    Science.gov (United States)

    Kaplan, Bonnie J; Steiger, Roberta A; Pope, Jamie; Marsh, Ashley; Sharp, Maegan; Crawford, Susan G

    2010-05-01

    Clinics often encounter neurologically intact patients who are unable to swallow pills. All of the interventions published previously have used traditional behavioural techniques, which are time consuming and often not helpful. To determine whether children who had never been able to swallow a whole pill could become successful as a result of an intervention based on head posture. A novel intervention was developed based on published research showing that changing head position alters swallowing dynamics. The method was developed in two studies of 240 adults and children, pilot tested in a study of 108 university students with very mild pill-swallowing discomfort, and then evaluated in a study of 41 children who had never successfully swallowed a pill in spite of much instruction and coaxing. Children were recruited from a tertiary paediatric hospital: 34 were clinic patients, four were their siblings or friends, and three were children of hospital staff. The primary intervention involved teaching five head positions (centre, up, down, left and right) followed by a two-week period of daily practice. EIGHT CHILDREN (ALL CLINIC REFERRALS) WITHDREW WITHOUT PRACTICING: four were too ill to practice (primarily due to sedation or nausea) and four simply refused to do the homework practice. All 33 of the children who were able and willing to practice daily were successful. Practice with head posture variations was successful in treating pill-swallowing difficulties in all 33 children who practiced for 14 days. A training video can be viewed at www.ucalgary.ca/research4kids/pillswallowing.

  11. Evaluating the practice of Iranian community pharmacists regarding oral contraceptive pills using simulated patients.

    Directory of Open Access Journals (Sweden)

    Foroutan N

    2016-12-01

    Full Text Available Background: As oral contraceptive pills are available over the counter in pharmacies, pharmacists are professionally responsible for checking and informing patients about every aspect of taking these drugs. Simulated patient method is a new and robust way to evaluate professional performance of pharmacists. Objective: The aim of the present study was to evaluate the pharmacy practice of Iranian pharmacists regarding over-the-counter use of oral contraceptive pills using simulated patient method. Methods: Simulated patients visited pharmacy with a prescription containing ciprofloxacin and asked for oral contraceptive pills. The pharmacist was expected to ask important questions for using these drugs and to inform the patient about them properly. Moreover, the Pharmacists should advise patients in regard to the possible interaction. Results: Ninety four pharmacists participated in this study. In 24 (25.3% visits, the liable pharmacist was not present at the time of purchase. Furthermore, In 13 (18.57 % visits by the simulated patients, the liable pharmacists did not pay any attention to the simulated patients even when they asked for consultation. Twenty nine (41.43% pharmacists did not ask any question during dispensing. Nausea was the most frequent described side effect by pharmacists (27 (38.57%. Yet important adverse effects of oral contraceptive pills were not mentioned by the pharmacists except for few ones. Only twelve (17.14% pharmacists mentioned the possible interaction. There was a significant relation between the pharmacists’ gender and detection of possible interaction (p value= 0.048. Conclusion: The quality of the pharmacists’ consultations regarding the over the counter use of oral contraceptive pills was not satisfactory and required improvement.

  12. New low-dose, extended-cycle pills with levonorgestrel and ethinyl estradiol: an evolutionary step in birth control

    Directory of Open Access Journals (Sweden)

    Anita Nelson

    2010-05-01

    Full Text Available Anita NelsonHarbor-UCLA Hospital, Los Angeles Biomedical Research Institute, Los Angeles, CA, USAAim: To review milestones in development of oral contraceptive pills since their introduction in the US 50 years ago in order to better understand how a new formulation with low-dose estrogen in an extended-cycle pattern fits into the evolution of birth control pills.Methods: This is a review of trends in the development of various birth controls pills and includes data from phase III clinical trials for this new formulation.Results: The first birth control pill was a very high-dose monophasic formulation with the prodrug estrogen mestranol and a first-generation progestin. Over the decades, the doses of hormones have been markedly reduced, and a new estrogen and several different progestins were developed and used in different dosing patterns. The final element to undergo change was the 7-day pill-free interval. Many of these same changes have been made in the development of extended-cycle pill formulation.Conclusion: The newest extended-cycle oral contraceptive formulation with 84 active pills, each containing 20 μg ethinyl estradiol and 100 μg levonorgestrel, represents an important evolution in birth control that incorporates lower doses of estrogen (to reduce side effects and possibly reduce risk of thrombosis, fewer scheduled bleeding episodes (to meet women’s desires for fewer and shorter menses and the use of low-dose estrogen in place of placebo pills (to reduce the number of days of unscheduled spotting and bleeding. Hopefully, this unique formation will motivate women to be more successful contraceptors.Keywords: extended-cycle oral contraceptives, low-dose extended-cycle pills, Lo Seasonique

  13. Behavioral evidence for internal factors affecting duration of conglobation in pill bugs (Armadillidium vulgare, Isopoda, Crustacea). Short communication.

    Science.gov (United States)

    Matsuno, Hiroe; Moriyama, T

    2012-01-01

    Pill bugs individually walked an experimental pathway, then were induced to conglobate with a puff of air. After recovering, they were stimulated again. Sixty of 80 pill bugs conglobated both times, first moving either antennae (A) or legs (L) during recovery. Both AA and LL groups showed a significant positive correlation between first (t1) and second (t2) conglobation times. In the AL group, pathway locomotion time (t0) was significantly positively correlated to both t1 and t2. We conclude that pill bugs determine conglobation time based partly on their previous states.

  14. Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study

    Science.gov (United States)

    Briggs, Paula; Serrani, Marco; Vogtländer, Kai; Parke, Susanne

    2016-01-01

    Background Oral contraceptives are still associated with high discontinuation rates, despite their efficacy. There is a wide choice of oral contraceptives available, and the aim of this study was to assess continuation rates, bleeding profile acceptability, and the satisfaction of women in the first year of using a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) versus a progestogen-only pill (POP) in a real-life setting after discontinuing an ethinylestradiol-containing pill. Methods and results In this prospective, noninterventional, observational study, 3,152 patients were included for the efficacy analyses (n=2,558 women in the E2V/DNG group and n=592 in the POP group (two patients fulfilled the criteria of the efficacy population, but the used product was not known). Women had been taking an ethinylestradiol-containing pill ≥3 months before deciding to switch to the E2V/DNG pill or a POP. Overall, 19.8% (n=506) of E2V/DNG users and 25.8% (n=153) of POP users discontinued their prescribed pill. The median time to discontinuation was 157.0 days and 127.5 days, respectively. Time to discontinuation due to bleeding (P<0.0001) or other reasons (P=0.022) was significantly longer in the E2V/DNG group versus the POP group. The E2V/DNG pill was also associated with shorter (48.7% vs 44.1%), lighter (54% vs 46.1%), and less painful bleeding (91.1% vs 73.7%) and greater user satisfaction (80.7% vs 64.6%) than POP use, within 3–5 months after switch. Conclusion The E2V/DNG pill was associated with higher rates of continuation, bleeding profile acceptability, and user satisfaction than POP use and may be an alternative option for women who are dissatisfied with their current pill. PMID:27695365

  15. A first phylogenetic analysis of the pill millipedes of the order Glomerida, with a special assessment of mandible characters (Myriapoda, Diplopoda, Pentazonia).

    Science.gov (United States)

    Oeyen, Jan Philip; Wesener, Thomas

    2018-03-01

    The pill millipedes of the order Glomerida are a moderately diverse group with a classical Holarctic distribution pattern. Their classification is based on a typological system utilizing mainly a single character complex, the male telopods. In order to infer the apomorphies of the Glomerida, to elucidate its position in the Pentazonia, and to test the monophyly of its families and subfamilies, we conduct the first phylogenetic analysis of the order. To provide additional characters, we comparatively analyze the mandible using scanning electron microscopy. The final character matrix consists of 69 characters (11 mandible characters) and incorporates 22 species from 20 of the 34 pill millipede genera, representing all families and subfamilies, except the monotypic Mauriesiinae. Two species from each of the two other Pentazonian orders Sphaerotheriida and Glomeridesmida, as well as two Spirobolida, are included as outgroup taxa. The Glomerida are recovered as monophyletic and are supported by five apomorphies. Within the Pentazonia, the Glomeridesmida are recovered as the sister group to the classical Oniscomorpha (Sphaerotheriida + Glomerida) with weak support. The analysis provides little resolution within the Glomerida, resulting in numerous polytomies. Further morphological characters and/or the addition of molecular analyses are needed to produce a robust phylogenetic classification of the Glomerida. Copyright © 2018 Elsevier Ltd. All rights reserved.

  16. Fatigue and Use of Go/Nogo Pills in F-16 Pilots Subjected to Extraordinarily Long Combat Sorties

    National Research Council Canada - National Science Library

    Schultz, Darlene

    2004-01-01

    We lack knowledge of real world pilot fatigue and use of GO/NOGO pills. To analyze this, a forward-deployed flight surgeon studied fighter pilots subjected to combat sorties often longer than 8 hours in duration. Methods...

  17. Muusajüngrid pühitsesid Kreutzwaldi 200. sünnipäeva / Toomas Pill

    Index Scriptorium Estoniae

    Pill, Toomas

    2004-01-01

    13. dets. 2003 Sydneys toimunud tähtpäevaüritusel esines Toomas Pill referaadiga "Kalevipoja" retseptsioonist, loeti ette katkendeid Kreutzwaldi ja Koidula kirjavahetusest ning deklameeriti Heidi Aedma poolt valitud katkendeid "Kalevipojast"

  18. The comparative study of side effect of the two kinds of LD combined oral contraceptive pills containing Norgestimate and Levonorgestrel

    Directory of Open Access Journals (Sweden)

    Ghazizade Sh

    1998-05-01

    Full Text Available In order to compare the new generation of oral contraceptive pills containing Norgestimate (NGM with currently available pills containing levonorgestrel (LNG a clinical trial was conducted. 413 women (age 18-35 years with no contrainindication to pill use entered the study and randomly received one type of pills. Premenstrual syndrome and depression were significantly decreased in NGM group (P=0.00016, P=0.005, on the other hand, breast tenderness, mood changes and hair loss were significantly increased in LNG group (P=0.001, P=0.042, P=0.011. Comparing two groups with each other, following variables were significantly lower in NGM group: headache (P<0.05, vertigo (P<0.05, cloasma (P<0.05, acne (P<0.04, depression (P<0.05, appetite change (P<0.03. Overall patient satisfaction was similar in two groups.

  19. Swallowable smart pills for local drug delivery: present status and future perspectives.

    Science.gov (United States)

    Goffredo, Rosa; Accoto, Dino; Guglielmelli, Eugenio

    2015-01-01

    Smart pills were originally developed for diagnosis; however, they are increasingly being applied to therapy - more specifically drug delivery. In addition to smart drug delivery systems, current research is also looking into localization systems for reaching the target areas, novel locomotion mechanisms and positioning systems. Focusing on the major application fields of such devices, this article reviews smart pills developed for local drug delivery. The review begins with the analysis of the medical needs and socio-economic benefits associated with the use of such devices and moves onto the discussion of the main implemented technological solutions with special attention given to locomotion systems, drug delivery systems and power supply. Finally, desired technical features of a fully autonomous robotic capsule for local drug delivery are defined and future research trends are highlighted.

  20. The Pill and Men’s Disappearance from the Teaching Sector

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    and 1980, the ratio of male college freshmen planning to become a teacher fell from 12.4% to 2.4% and the share of males among those who aspired to teach dropped from 30.6% to 19.7%. Using nationally representative data on the career plans of college freshmen I find that unrestricted access to the birth...... control pill bears a negative relation to the likelihood that men plan to teach, while changes in the strength of teacher unions and relative wages of teachers have limited effect on their career plans. Men’s aspirations shift away from teaching towards occupations that are associated with higher average......In this paper I look at the relationship between increased access to reliable fertility controls and men’s disappearance from teaching. As the pill has been found to have a substantial effect on women’s family responsibilities, career investments and labor market outcomes, men’s bargaining position...

  1. The Pill and Men’s Disappearance from the Teaching Sector

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    control pill bears a negative relation to the likelihood that men plan to teach, while changes in the strength of teacher unions and relative wages of teachers have limited effect on their career plans. Men’s aspirations shift away from teaching towards occupations that are associated with higher average......In this paper I look at the relationship between increased access to reliable fertility controls and men’s disappearance from teaching. As the pill has been found to have a substantial effect on women’s family responsibilities, career investments and labor market outcomes, men’s bargaining position...... in the marriage market is likely to have changed considerably. Teaching stands out among the career choices of male college freshmen in terms of average income and prestige. The effect of the shift in bargaining power on men’s career choices is hence likely to be prominent in the teaching sector. Between 1968...

  2. 'Stratified Contraception': Emergency Contraceptive Pills and Women's Differential Experiences in Contemporary India.

    Science.gov (United States)

    Sheoran, Nayantara

    2015-01-01

    Available without prescriptions in India since 2005, emergency contraceptive pills (ECPs) and their advertisements have provided women with increased contraceptive options and a vocabulary to talk about their reproductive lives. I draw on long-term fieldwork with women in urban India about ECPs, demonstrating a new form of 'stratified contraception' enabled by these pills and their advertisements. I posit that there are within India spaces that replicate the luxuries and privileges of the global North. These material conditions, I suggest, are replicated when it comes to contraception as there are hubs of women consumers of contraception and contraceptive advertising that participate in an 'imagined cosmopolitanism' within the global South in close proximity to 'contraceptive ghettos.' Moving beyond simplistic binaries, I outline three major stratifications along which women experience this medical technology and outline the implications for women and their contraceptive choices when notions of northern privilege exist in the 'South.'

  3. A Little Bit of Sugar Helps the Pill Go Down: Resilience, Peace, and Family Planning: Comment on "The Pill Is Mightier Than the Sword".

    Science.gov (United States)

    De Souza, Roger-Mark

    2015-10-04

    The article by Potts et al, "The Pill is Mightier than the Sword," points out that family planning has an important role to play in building peace by increasing women's empowerment and their agency, ultimately helping peacebuilding efforts. Evidence has demonstrated that family planning programs are cost effective, produce quick results, help women and couples meet their desired fertility levels, and produce a multitude of benefits around economic productivity, community engagement, conservation, resilience, and peacebuilding. In order for policy audiences from a variety of sectors, including conflict and peacebuilding, to appreciate these benefits, it is important to find common ground and articulate co-benefits that will help them appreciate and value the role of family planning, as it were, give them sugar to help the pill go down. This commentary examines how resilience, peacebuilding and family planning efforts need to focus on co-benefits in order to build on the successful interventions and opportunities that Potts et al highlight. © 2016 by Kerman University of Medical Sciences.

  4. A Little Bit of Sugar Helps the Pill Go Down: Resilience, Peace, and Family Planning; Comment on “The Pill Is Mightier Than the Sword”

    Directory of Open Access Journals (Sweden)

    Roger-Mark De Souza

    2016-02-01

    Full Text Available The article by Potts et al, “The Pill is Mightier than the Sword,” points out that family planning has an important role to play in building peace by increasing women’s empowerment and their agency, ultimately helping peacebuilding efforts. Evidence has demonstrated that family planning programs are cost effective, produce quick results, help women and couples meet their desired fertility levels, and produce a multitude of benefits around economic productivity, community engagement, conservation, resilience, and peacebuilding. In order for policy audiences from a variety of sectors, including conflict and peacebuilding, to appreciate these benefits, it is important to find common ground and articulate co-benefits that will help them appreciate and value the role of family planning, as it were, give them sugar to help the pill go down. This commentary examines how resilience, peacebuilding and family planning efforts need to focus on co-benefits in order to build on the successful interventions and opportunities that Potts et al highlight.

  5. Neurological function following cerebral ischemia/reperfusion is improved by the Ruyi Zhenbao pill in a rats

    OpenAIRE

    WANG, TIAN; DUAN, SIJIN; WANG, HAIPING; SUN, SHAN; HAN, BING; FU, FENGHUA

    2016-01-01

    The present study aimed to investigate the effect and underlying mechanisms of the Ruyi Zhenbao pill on neurological function following cerebral ischemia/reperfusion in rats. Male Sprague-Dawley rats underwent middle cerebral artery occlusion following reperfusion. The rats received intragastrically either sodium carboxymethyl cellulose (control and model groups) or Ruyi Zhenbao pill at doses of 0.2, 0.4 or 0.8 g/kg. Neurological function was assessed by cylinder, adhesive and beam-walking te...

  6. Women's knowledge of taking oral contraceptive pills correctly and of emergency contraception: effect of providing information leaflets in general practice.

    OpenAIRE

    Smith, L F; Whitfield, M J

    1995-01-01

    BACKGROUND. About one third of all pregnancies are unplanned and 20% of all pregnancies end in abortion. More than 170,000 legal abortions are performed in the United Kingdom annually. Nearly all general practitioners provide contraceptive advice; the most commonly used form of reversible contraception is the oral contraceptive pill. AIM. The aim of this study was to determine factors associated with women's knowledge of taking the contraceptive pill correctly and of emergency contraception, ...

  7. Comparison of a 24-day and a 21-day pill regimen for the novel combined oral contraceptive, nomegestrol acetate and 17β-estradiol (NOMAC/E2): a double-blind, randomized study.

    Science.gov (United States)

    Christin-Maitre, S; Serfaty, D; Chabbert-Buffet, N; Ochsenbein, E; Chassard, D; Thomas, J-L

    2011-06-01

    BACKGROUND Nomegestrol acetate/17β-estradiol (NOMAC/E(2)) is a new monophasic oral contraceptive combining NOMAC (2.5 mg), a highly selective progesterone-derived progestogen, with E(2) (1.5 mg), which is structurally identical to endogenous estrogen. The objective of this study was to compare the effects on ovarian activity of two different NOMAC/E(2) regimens. METHODS This was a double-blind, randomized study. Healthy, premenopausal women (aged 18-38 years, previous menstrual cycle length 28 ± 7 days) were randomized by computer-generated code to once-daily NOMAC/E(2) for three consecutive 28-day cycles: either 24 days with a 4-day placebo interval (n = 40) or 21 days with a 7-day placebo interval (n = 37) per cycle. Follicular growth (primary outcome measure), plasma hormone profiles and bleeding patterns were assessed. RESULTS There was no evidence of ovulation during treatment with either NOMAC/E(2) regimen. The largest follicle diameter was significantly smaller in the 24-day group than in the 21-day group [mean (SD) mm in cycle 2: 9.0 (3.0) versus 11.3 (5.3) (P = 0.02); in cycle 3: 9.2 (3.0) versus 11.5 (6.0) (P = 0.04)]. Mean FSH plasma levels were significantly lower in the 24-day versus the 21-day group on Day 24 of cycles 1 and 2. Withdrawal bleeding duration was significantly shorter in the 24-day than in the 21-day group [mean (SD) days after cycle 1: 3.5 (1.3) versus 5.0 (2.6) (P = 0.002); after cycle 2: 3.9 (1.6) versus 4.8 (1.7) (P = 0.03)]. CONCLUSIONS The 24-day NOMAC/E(2) regimen was associated with greater inhibition of follicular growth and shorter duration of withdrawal bleeding than the 21-day regimen, suggesting the shorter pill-free interval results in a greater margin of contraceptive efficacy and tolerability, and fewer withdrawal symptoms.

  8. Effect of Florida's Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use.

    Science.gov (United States)

    Rutkow, Lainie; Chang, Hsien-Yen; Daubresse, Matthew; Webster, Daniel W; Stuart, Elizabeth A; Alexander, G Caleb

    2015-10-01

    Prescription Drug Monitoring Program (PDMP) and pill mill laws are among the principal means states use to reduce prescription drug abuse and diversion, yet little high-quality evidence exists regarding their effect. To quantify the effect of Florida's PDMP and pill mill laws on overall and high-risk opioid prescribing and use. We applied comparative interrupted time-series analyses to IMS Health LifeLink LRx data to characterize the effect of PDMP and pill mill law implementation on a closed cohort of prescribers, retail pharmacies, and patients from July 2010 through September 2012 in Florida (intervention state) compared with Georgia (control state). We conducted sensitivity analyses, including varying length of observation and modifying requirements for continuous observation of individuals throughout the study period. Total opioid volume, mean morphine milligram equivalent (MME) per transaction, mean days' supply per transaction, and total number of opioid prescriptions dispensed. Analyses were conducted per prescriber and per patient, in aggregate and after stratifying by volume of baseline opioid prescribing for prescribers and use for patients. From July 2010 through September 2012, a cohort of 2.6 million patients, 431,890 prescribers, and 2829 pharmacies was associated with approximately 480 million prescriptions in Florida and Georgia, 7.7% of which were for opioids. Total monthly opioid volume, MME per transaction, days' supply, and prescriptions dispensed were higher in Florida than Georgia before implementation. Florida's laws were associated with statistically significant declines in opioid volume (2.5 kg/mo, Pprescriptions, 2.5% decrease in opioid volume, and 5.6% decrease in MME per transaction. Reductions were limited to prescribers and patients with the highest baseline opioid prescribing and use. Sensitivity analyses, varying time windows, and enrollment criteria supported the main results. Florida's PDMP and pill mill laws were associated with

  9. Distribution of the pill clam Pisidium langleyanum melvill & Ponsonby, 1891 (Bivalvia: Sphaeriidae) in South Africa

    OpenAIRE

    Wolmarans, Cornelius T; De Kock, Kenne N

    2008-01-01

    This article focuses on the geographical distribution and habitats of the pill clam, Pisidium langleyanum as reflected by 632 samples on record in the database of the National Freshwater Snail Collection (NFSC). The 177 different loci (1/16 -degree squares) from which these samples were collected display a relatively continuous distribution in southern Gauteng, northeastern Free State, the central area of Mpumulanga and the western part of Lesotho. However, it is discontinuously spre...

  10. Decision-Making and Turn Alternation in Pill Bugs (Armadillidium Vulgare)

    OpenAIRE

    Moriyama, Tohru

    1999-01-01

    Twelve pill bugs (Armadillidium vulgare, Isopoda, Cmstacean) were examined in 200 successive T-mazes. When obstacles are present, A. vulgare tend to move by means of turn alternation, which is generally considered an innate adaptive behavior. With a decrease in air moisture, the bugs have a tendency to increase their turn alternation rate. However, in such long successive T-mazes as in this study, continued turn alternation should actually accelerate the bugs' desiccation. This fact implies t...

  11. Hyperglycemia in poor controlled diabetes from crude tamarind herbal pill: a case study.

    Science.gov (United States)

    Wiwanitkit, Viroj

    2011-01-01

    Hyperglycemia is an important finding in the diabetic patient with poor glycemic control. There are several possible causes of hyperglycemic. Here, the author presents an interesting case study on a female diabetic patient presenting with hyperglycemic due to intake of crude tamarind herbal pill. General practitioner should realize that the use of alternative medicine can be a cause of unexplained hyperglycemic episode in diabetic patient.

  12. Knowledge about missed contraceptive pills among married women at King Abdulaziz University Hospital

    Directory of Open Access Journals (Sweden)

    Iftikhar R

    2015-03-01

    Full Text Available Rahila Iftikhar, Bahaa Abdulrahman Aba Al Khail Family and Community Medicine Department, King Abdulaziz University Hospital, Jeddah, Saudi Arabia Background: Oral contraceptive pills (OCPs are one of the most reliable methods of contraception. However, lack of knowledge about oral contraceptive use and inconsistent pill-taking might result in decreased efficacy. The study reported here aimed to explore women’s knowledge about oral contraceptive use and assess the factors associated with knowledge about OCPs among users.Methods: This cross-sectional survey was conducted at King Abdulaziz University Hospital, Jeddah, Saudi Arabia between April and June 2014. We included married, non-pregnant women >18 years old who had used a combined 21-day OCP for at least 3 months prior to recruitment. A questionnaire was used to collect the participants’ demographic information. It also assessed their knowledge about OCPs. Data were entered into and analyzed using SPSS software.Results: A total of 357 women were recruited. Of these, 57.7% reported they knew what to do after missing one or two pills, but only 18.3% knew exactly what to do after missing more than two pills consecutively. Postgraduate women had a significantly higher knowledge score than illiterate women (P=0.002 and those who had completed at least primary education (P=0.001. Conversely, there was no difference in knowledge scores between Saudi and expatriate women (P=0.2. Monthly incomes (P=0.2 and mode of OCP selection (P=0.2 were also not significantly associated with knowledge scores.Conclusion: Women had poor knowledge about OCP use. Appropriate measures should be taken to educate women about proper oral contraceptive use. Keywords: oral contraception, oral contraceptive, Saudi Arabia, OCP

  13. Pill testing or drug checking in Australia: Acceptability of service design features.

    Science.gov (United States)

    Barratt, Monica J; Bruno, Raimondo; Ezard, Nadine; Ritter, Alison

    2018-02-01

    This study aimed to determine design features of a drug-checking service that would be feasible, attractive and likely to be used by Australian festival and nightlife attendees. Web survey of 851 Australians reporting use of psychostimulants and/or hallucinogens and attendance at licensed venues past midnight and/or festivals in the past year (70% male; median age 23 years). A drug-checking service located at festivals or clubs would be used by 94%; a fixed-site service external to such events by 85%. Most (80%) were willing to wait an hour for their result. Almost all (94%) would not use a service if there was a possibility of arrest, and a majority (64%) would not use a service that did not provide individual feedback of results. Drug-checking results were only slightly more attractive if they provided comprehensive quantitative results compared with qualitative results of key ingredients. Most (93%) were willing to pay up to $5, and 68% up to $10, per test. One-third (33%) reported willingness to donate a whole dose for testing: they were more likely to be male, younger, less experienced, use drugs more frequently and attend venues/festivals less frequently. In this sample, festival- or club-based drug-checking services with low wait times and low cost appear broadly attractive under conditions of legal amnesty and individualised feedback. Quantitative analysis of ecstasy pills requiring surrender of a whole pill may appeal to a minority in Australia where pills are more expensive than elsewhere. [Barratt MJ, Bruno R, Ezard N, Ritter A. Pill testing or drug checking in Australia: Acceptability of service design features. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  14. Biocompatibility of a lab-on-a-pill sensor in artificial gastrointestinal environments

    OpenAIRE

    Johannessen, E.A.; Wang, L.; Wyse, C.; Cumming, D.R.S.; Cooper, J.M.

    2006-01-01

    n this paper, we present a radiotelemetry sensor, designed as a lab-in-a-pill, which incorporates a two-channel microfabricated sensor platform for real-time measurements of temperature and pH. These two parameters have potential application for use in remote biological sensing (for example they may be used as markers that reflect the physiological environment or as indicators for disease, within the gastrointestinal tract). We have investigated the effects of biofouling on these sensors, by ...

  15. Putting abortion pills into women's hands: realizing the full potential of medical abortion.

    Science.gov (United States)

    Jelinska, Kinga; Yanow, Susan

    2018-02-01

    The promise of medical abortion to both reduce maternal mortality and morbidity from unsafe abortion and to expand the reproductive rights of women can only be realized if information and reliable medicines are available to all women, regardless of their location or the restrictions of their legal system. Activist strategies to actualize the full potential of abortion pills are highlighted. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting.

    Science.gov (United States)

    Lam, Annie Y; Nguyen, Juliet K; Parks, Jason J; Morisky, Donald E; Berry, Donna L; Wolpin, Seth E

    To test the effect of "Talking Pill Bottles" on medication self-efficacy, knowledge, adherence, and blood pressure readings among hypertensive patients with low health literacy and to assess patients' acceptance of this innovation. Longitudinal nonblinded randomized trial with standard treatment and intervention arms. Two community pharmacies serving an ethnically diverse population in the Pacific Northwest. Participants were consented patients with antihypertension prescriptions who screened positive for low health literacy based on the Test of Functional Health Literacy Short Form. Participants in the intervention arm received antihypertensive medications and recordings of pharmacists' counseling in Talking Pill Bottles at baseline. Control arm participants received antihypertensive medications and usual care instructions. Comparison and score changes between baseline and day 90 for medication knowledge test, Self-Efficacy for Appropriate Medication Use Scale (SEAMS), Morisky Medication Adherence Scale (MMAS-8), blood pressure, and responses to semistructured exit interviews and Technology Acceptance Model surveys. Of 871 patients screened for health literacy, 134 eligible participants were enrolled in the trial. The sample was elderly, ethnically diverse, of low income, and experienced regarding hypertension and medication history. In both arms, we found high baseline scores in medication knowledge test, SEAMS, and MMAS-8 and minimal changes in these measures over the 90-day study period. Blood pressure decreased significantly in the intervention arm. Acceptability scores for the Talking Pill Bottle technology were high. Our results suggest that providing audio-assisted medication instructions in Talking Pill Bottles positively affected blood pressure control and was well accepted by patients with low health literacy. Further research involving newly diagnosed patients is needed to mitigate possible ceiling effects that we observed in an experienced population

  17. Providers′ knowledge, attitude and dispensing practices of E-Pills in government dispensaries of south district in Delhi, India

    Directory of Open Access Journals (Sweden)

    Kishore Vertika

    2010-01-01

    Full Text Available Background: South Delhi is one of the well developed districts in the capital with best public health care facilities. Knowledge, attitude and dispensing practices of emergency contraceptive pills (E-pills were assessed among health care providers of government dispensaries in South Delhi. Study Design: A descriptive epidemiological study. Materials and Methods: Both medical and paramedical (n = 428 providers in 63 government health care facilities were interviewed between August to December 2007 using a semi-structured interview schedule. Results: Among the different categories of the providers, medical officers were observed to be most knowledgeable about E-pills and the pharmacists were the least. The correct prescribed dose of E-pill was known only to 32% of the providers while 49% knew about its right time of intake. Misconceptions and apprehensions for promoting its use were very much prevalent even among medical officers as majority felt that open access to E-pills would increase promiscuity. The dispensing practice of providers was found positively ( P < 0.05 correlated with their knowledge. Training resulted a significant ( P < 0.05 improvement in knowledge, attitude and dispensing practice of the providers. Knowledge and training combined together contributed 35% to the dispensing practice (R 2 = 0.35. Conclusion: Besides knowledge, behavior change communication strategies should form a part of the training curricula of health care providers that would help to improve the dispensing practice of E-pills.

  18. Oral contraceptive pills decrease pulmonary airway resistance in healthy north Indian women.

    Science.gov (United States)

    Kumar, Pradeep; Singh, Shraddha; Singh, Uma; Verma, Pratima

    2011-02-01

    Oral contraceptive pills (OCPs) are hormonal pills used by females to prevent conception; they are a combination of estrogen and progestin. There is, however, compelling evidence that throughout the reproductive life of a woman, her airways are subject to the influence of the cyclical variations in sex hormones which occur in relation to circadian rhythms. The present study has been designed to investigate the effects of OCPs on airway resistance in terms of spirometric parameters in OCP users and nonusers. A total of 100 women (age: 20-40 years) ware selected for the present study. The subjects were provided with a one-month supply of OCPs. The constituents per tablet of MALA-N used were levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg. Peak expiratory flow rate (PEFR), forced expiratory flow in expiring 25-75% air (FEF 25-75), forced expiratory volume percentage in one second (FEV1% or FEV1/FVC), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) were recorded. In our study, the FEF 25-75and PEFR increased significantly in OCP users, showing that these hormone pills decrease the resistance offered by small bronchioles.

  19. New regimens with combined oral contraceptive pills--moving away from traditional 21/7 cycles.

    Science.gov (United States)

    Read, Christine M

    2010-12-01

    The practice of extending combined oral contraceptive use (COC) and eliminating or reducing the hormone free interval has been in use for many years. More recently a range of products with new dosing options has been developed and marketed. Women and physicians in developed countries are comfortable with and many prefer the use of extended COC regimens which provide an option to eliminate or reduce the frequency of regular withdrawal bleeding. The extension of active pill taking and the reduction or elimination of the hormone-free interval have been shown to be beneficial for women who experience menstrual cycle-related problems such as heavy bleeding or dysmenorrhoea. The hormone-free interval of less than seven days has additional benefits in managing hormone withdrawal symptoms and efficacy may be improved in situations where pills are inadvertently missed or in women who are perceived as 'poor' pill takers. This paper provides a descriptive review highlighting the development of new dosing options that alter the traditional 21/7 COC regimen. The rationale for and the acceptability of COCs developed with alternative dosing regimens is examined.

  20. Fifty years of "the pill": risk reduction and discovery of benefits beyond contraception, reflections, and forecast.

    Science.gov (United States)

    Chadwick, Kristina D; Burkman, Ronald T; Tornesi, Belen M; Mahadevan, Brinda

    2012-01-01

    Widely regarded as a revolutionary drug in its early years, "the pill" may be considered the first designer or lifestyle drug. Approximately 85% of women in the United States will use an oral contraceptive (OC) for an average of 5 years. Since the introduction of OCs in the 1960s, both health benefits and safety concerns have been attributed to their use. Widespread use of OC formulations by women throughout their reproductive life cycle gave rise to concerns about the effects of OCs on risk factors for cardiovascular disorders and cancer. In most instances, the noncontraceptive benefits of OCs outweigh the potential risks. As with many first in class drugs, lessons can be learned from its development and use. Indeed, "the pill" played a significant role in reshaping the regulatory process for new drugs during the second half of the 20th century. The birth control pill celebrates its 50th birthday this year, as women and men celebrate five decades of this revolutionary method of family planning. Recent scientific and technological advances in genomics, proteomics, new materials, and new drug delivery systems, along with a new understanding of reproductive biology, offer the promise of new, safe, and effective forms of contraception. In addition to the history of OC therapeutic advances and unintended side effects, the noncontraceptive health benefits that women experience beyond pregnancy prevention are discussed. This article summarizes a symposium presented at the 50th Anniversary of the Society of Toxicology National Meeting, held from 6 to 10 March 2011 in Washington, DC.

  1. Effect of compound radix sophorae flavescentis injection combined with Xiaoyao pill on breast cancer

    Directory of Open Access Journals (Sweden)

    Xiao-Li Li

    2016-12-01

    Full Text Available Objective: To investigate the influence of compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy on tumor markers, cytokines and lymphocyte subpopulations of breast cancer patients, thus provide relevant assistance on clinical therapy for breast cancer patients. Methods: A total of 170 breast cancer patients treated in our hospital were selected and divided to be the observe group and control group at random, 85 cases for each group. For patients in control group, AC chemotherapeutic project was utilized, and for patients in observe group, compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy were provided on the basis of AC chemotherapy. Tumor markers, cytokines and lymphocyte subpopulations of breast cancer patients in each group were detected before and after therapy. Results: Comparison of tumor markers, cytokines and lymphocyte subpopulations levels between the two groups of breast cancer patients before therapy showed no statistical significant difference (P>0.05. Compared with prior therapy, the tumor markers (CA153, CEA and CYRA21-1, CD8+ and cytokines (IL-4, IL-6 and IL-10 on both the two groups of breast cancer patients were dramatically decreased, while lymphocyte subpopulations (CD3+ , CD4+ , CD4+ /CD8+ , IFN-γ and IL-2 were significantly increased (P<0.05. Conclusions: Compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy can significantly improve the tumor markers, cytokines and lymphocyte subpopulations of the breast cancer patients. It is of vital clinical significance for treatment on breast cancer patients.

  2. Can pill placebo augment cognitive-behavior therapy for panic disorder?

    Directory of Open Access Journals (Sweden)

    Churchill Rachel

    2007-12-01

    Full Text Available Abstract Background In a number of drug and psychotherapy comparative trials, psychotherapy-placebo combination has been assumed to represent psychotherapy. Whether psychotherapy plus pill placebo is the same as psychotherapy alone is an empirical question which however has to date never been examined systematically. Methods We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs that directly compared cognitive-behavior therapy (CBT alone against CBT plus pill placebo in the treatment of panic disorder. Results Extensive literature search was able to identify three relevant RCTs. At the end of the acute phase treatment, patients who received CBT plus placebo had 26% (95%CI: 2 to 55% increased chances of responding than those who received CBT alone. At follow-up the difference was no longer statistically significant (22%, 95%CI: -10% to 64%. Conclusion The act of taking a pill placebo may enhance the placebo effect already contained in the effective psychotherapeutic intervention during the acute phase treatment. Theoretically this is an argument against the recently claimed null hypothesis of placebo effect in general and clinically it may point to some further room for enhancing the psychotherapeutic approach for panic disorder.

  3. Inhibition of NADPH Oxidase Mediates Protective Effect of Cardiotonic Pills against Rat Heart Ischemia/Reperfusion Injury.

    Science.gov (United States)

    Yang, Xiao-Yuan; Zhao, Na; Liu, Yu-Ying; Hu, Bai-He; Sun, Kai; Chang, Xin; Wei, Xiao-Hong; Fan, Jing-Yu; Han, Jing-Yan

    2013-01-01

    Cardiotonic pill (CP) is a compound Chinese medicine currently used in China for treatment of ischemic angina pectoris. Our previous results indicated that a single dosing of CP pretreatment at 0.8 g/kg attenuates ischemia/reperfusion- (I/R-) induced myocardial injury and cardiac microcirculatory disturbance. The present study aimed to investigate the effect of CP at low dosage in a multiple dosing manner and to uncover the mechanism of antioxidative activity of CP. Male Sprague-Dawley rats were subjected to left anterior descending artery occlusion for 30 min followed by 60 min reperfusion. CP was administrated daily by gavage for six days at 0.1, 0.4, and 0.8 g/kg/day before I/R. Results showed that multiple dosing of CP at three doses significantly reduced I/R-induced myocardial injury, microcirculatory disturbance, and oxidative stress. CP dramatically inhibited I/R-induced nicotinamide adenosine dinucleotide phosphate (NADPH) oxidase subunit gp91(phox) expression and p67(phox) and p47(phox) translocation from cytosol to cell membrane. Translocation of cytosolic subunits to membrane is required for the activation of NADPH oxidase. These data suggested that multiple dosing of CP at doses ranging from 0.1 to 0.8 g/kg/day reduced I/R-induced rat myocardial injury and microcirculatory disturbance, which was mediated by inhibition of NADPH oxidase activation.

  4. Inhibition of NADPH Oxidase Mediates Protective Effect of Cardiotonic Pills against Rat Heart Ischemia/Reperfusion Injury

    Directory of Open Access Journals (Sweden)

    Xiao-Yuan Yang

    2013-01-01

    Full Text Available Cardiotonic pill (CP is a compound Chinese medicine currently used in China for treatment of ischemic angina pectoris. Our previous results indicated that a single dosing of CP pretreatment at 0.8 g/kg attenuates ischemia/reperfusion- (I/R- induced myocardial injury and cardiac microcirculatory disturbance. The present study aimed to investigate the effect of CP at low dosage in a multiple dosing manner and to uncover the mechanism of antioxidative activity of CP. Male Sprague-Dawley rats were subjected to left anterior descending artery occlusion for 30 min followed by 60 min reperfusion. CP was administrated daily by gavage for six days at 0.1, 0.4, and 0.8 g/kg/day before I/R. Results showed that multiple dosing of CP at three doses significantly reduced I/R-induced myocardial injury, microcirculatory disturbance, and oxidative stress. CP dramatically inhibited I/R-induced nicotinamide adenosine dinucleotide phosphate (NADPH oxidase subunit gp91phox expression and p67phox and p47phox translocation from cytosol to cell membrane. Translocation of cytosolic subunits to membrane is required for the activation of NADPH oxidase. These data suggested that multiple dosing of CP at doses ranging from 0.1 to 0.8 g/kg/day reduced I/R-induced rat myocardial injury and microcirculatory disturbance, which was mediated by inhibition of NADPH oxidase activation.

  5. Optimal HIV Postexposure Prophylaxis Regimen Completion With Single Tablet Daily Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine Compared With More Frequent Dosing Regimens.

    Science.gov (United States)

    Mayer, Kenneth H; Jones, Daniel; Oldenburg, Catherine; Jain, Sachin; Gelman, Marcy; Zaslow, Shayne; Grasso, Chris; Mimiaga, Matthew J

    2017-08-15

    The study evaluated elvitegravir/cobicistat/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) ("Quad pill") for postexposure prophylaxis (PEP). HIV-exposed individuals may benefit from PEP, but completion rates have been suboptimal because of regimen complexity and side effects. Newer antiretroviral combinations coformulated as single daily pills may optimize PEP adherence. One hundred HIV-uninfected individuals who presented to a Boston community health center after an acute HIV sexual exposure were enrolled and initiated PEP with the daily, single-pill combination Quad pill for a 28-day course. Side effects and medication completion rates from study participants were compared with historical controls who had used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using χ tests for independence. Of the 100 participants who initiated the Quad pill for PEP after a high-risk sexual exposure, 71% completed the 28-day Quad pill regimen, which was significantly greater than historical controls who used TDF/FTC and raltegravir (57%, P pill users were as follows: abdominal discomfort or pain, gas or bloating (42%), diarrhea (38%), fatigue (28%), nausea or vomiting (28%), headache (14%), or dizziness or lightheadedness (6%). Most symptoms were mild, limited, and did not result in medication discontinuation. No participants became HIV infected. Fixed-dose combination of elvitegravir/cobicistat/TDF/FTC was safe and well tolerated for PEP, with higher regimen completion rates than more frequently dosed PEP regimens.

  6. Pharmaceutical Pill Counting and Inspection Using a Capacitive Sensor

    Directory of Open Access Journals (Sweden)

    Ganesan LETCHUMANAN

    2008-01-01

    Full Text Available A capacitive sensor for high-speed counting and inspection of pharmaceutical products is proposed and evaluated. The sensor is based on a patented Electrostatic Field Sensor (EFS device, previously developed by Sparc Systems Limited. However, the sensor head proposed in this work has a significantly different geometry and has been designed with a rectangular inspection aperture of 160mm × 21mm, which best meets applications where a larger count throughput is required with a single sensor. Finite element modelling has been used to simulate the electrostatic fields generated within the sensor, and as a design tool for optimising the sensor head configuration. The actual and simulated performance of the sensor is compared and analysed in terms of the sensor performance at discriminating between damaged products or detection of miscount errors.

  7. Pulmonary Disposition of Tedizolid following Administration of Once-Daily Oral 200-Milligram Tedizolid Phosphate in Healthy Adult Volunteers

    Science.gov (United States)

    Housman, Seth T.; Pope, J. Samuel; Russomanno, John; Salerno, Edward; Shore, Eric; Kuti, Joseph L.

    2012-01-01

    This study assessed the pulmonary disposition of tedizolid, an oxazolidinone, in adult volunteers receiving 200 mg of the prodrug tedizolid phosphate orally every 24 h for 3 days to steady state. Plasma samples were collected over the dosing interval, and participants were randomized to undergo bronchoalveolar lavage (BAL) at 2, 6, 12, or 24 h after the last dose. Drug concentrations in plasma, BAL fluid, and alveolar macrophages (AM) were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the urea correction method was used to calculate epithelial lining fluid (ELF) concentrations. Pharmacokinetic parameters were estimated by noncompartmental methods followed by compartmental population pharmacokinetics. Penetration was calculated as the area under the concentration-time curve during the dosing interval (AUC0–24) for ELF and AM relative to the free AUC0–24 (fAUC0–24) in plasma. The half-life and volume of distribution in plasma were 9.23 ± 2.04 h and 108.25 ± 20.53 liters (means ± standard deviations), respectively. Total AUC0–24 in plasma was 25.13 ± 5.78 μg · h/ml. Protein binding was 89.44% ± 1.58%, resulting in a mean fAUC0–24 of 2.65 ± 0.72 μg · h/ml in plasma. Mean concentrations (μg/ml) at 2, 6, 12, and 24 h were 9.05 ± 3.83, 4.45 ± 2.18, 5.62 ± 1.99, and 1.33 ± 0.59 in ELF and 3.67 ± 1.02, 4.38 ± 2.18, 1.42 ± 0.63, and 1.04 ± 0.52 in AM. ELF and AM penetration ratios were 41.2 and 20.0. The mean ELF penetration ratio after population analyses was 39.7. This study demonstrates that tedizolid penetrates into ELF and AM to levels approximately 40-fold and 20-fold, respectively, higher than free-drug exposures in plasma. PMID:22330925

  8. Tadalafil once daily: Narrative review of a treatment option for female sexual dysfunctions (FSD in midlife and older women

    Directory of Open Access Journals (Sweden)

    Chiara Borghi

    2017-03-01

    Full Text Available Female Sexual Disorders (FSD include a complex, multidimensional, individual experience that can change as an individual age, suggesting that these problems are caused by multiple factors including psychosocial factors, personal relationships, pathologic changes caused by diseases, and pharmacologic influences. Menopause is an important time for middle aged women and postmenopausal physiological changes could have a significant role in the development of FSD. Few is still known about their correct definition and treatment. Their incidence, prevalence and risk factors are difficult to define because of a high level of overlap in the experience of problems with desire, arousal, and orgasm. Little evidences are known about the best therapeutic approach, and both non-pharmacological and pharmacological treatment options have been described. Among these, phosphodiesterase type 5 inhibitors could be an effective option for many subtypes of female sexual disorders, with an improvement in different aspects of sexual function, such as desire, arousal, orgasm and sexual satisfaction. In this paper authors reviewed what is already known about the use of these vasoactive agents, particularly tadalafil, as a treatment option for female sexual disturbances.

  9. The economics of 4 grams once daily mesalazine dosing compared with 4 grams twice daily in active ulcerative colitis

    NARCIS (Netherlands)

    Connolly, M.; Kuyvenhoven, J.; Postma, M.; Nielsen, S.

    2013-01-01

    Background: Dosing frequency is an important treatment consideration that has been shown to influence adherence and outcomes when treating ulcerative colitis (UC). In this analysis we evaluate the economic consequences of outcome differences observed in the study comparing mesalazine 4g per day once

  10. Efficacy and safety of once daily triamcinolone acetonide aqueous nasal spray in adults with non-allergic and allergic rhinitis.

    Science.gov (United States)

    Baccioglu Kavut, A; Kalpaklıoğlu, F

    2013-01-01

    The efficacy of corticosteroid has not been thoroughly studied in the treatment of non-allergic rhinitis. This study was designed to compare the efficacy of nasal corticosteroid in patients with allergic rhinitis (AR), and non-allergic rhinitis (NAR). The efficacy of triamcinolone acetonide nasal spray (TANS) on total nasal symptom scores (TNSS), and nasal peak inspiratory flow rate (nPIFR) was studied in a six-week parallel-group trial of NAR (n: 25), and AR (n: 16) patients. Health-related quality of life (HRQoL) and Epworth Sleepiness Scale (ESS) were also analysed. The TNSSs, and symptom scores of conjunctivitis, snoring, and postnasal drainage were significantly improved in both groups, after two and six weeks of treatment. In contrast to AR, patients with NAR had statistically significant improvement in nasal obstruction, and postnasal drainage beginning from two weeks of the treatment. nPIFR slightly increased in both groups. Scores of generic (SF-36), rhinitis specific (MiniRQLQ) and ESS questionnaires generally improved better in AR than NAR. TANS was well-tolerated in AR and NAR groups with minor adverse events including headache, nasal burning, and bitter mouth taste. Our study disproved the idea of ineffectiveness of corticosteroid treatment in NAR, and showed that triamcinolone acetate may be an alternative drug in the treatment of NAR. Copyright © 2012 SEICAP. Published by Elsevier Espana. All rights reserved.

  11. Once-daily glycopyrronium bromide (Seebri Breezhaler(®)) for the treatment of chronic obstructive pulmonary disease (COPD)

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2015-01-01

    glycopyrronium bromide (Seebri Breezhaler®) is a well-tolerated long-acting anti-muscarinic agent (LAMA) with a fast onset of action. In patients with moderate to severe COPD, glycopyrronium bromide has clinically important effects on level of FEV1, use of relief medication, day-time dyspnea scores, and probably...

  12. Long-Term Tolerability and Effectiveness of Once-Daily Mixed Amphetamine Salts (Adderall XR) in Children with ADHD

    Science.gov (United States)

    McGough, James J.; Biederman, Joseph; Wigal, Sharon B.; Lopez, Frank A.; McCracken, James T.; Spencer, Thomas; Zhang, Yuxin; Tulloch, Simon J.

    2005-01-01

    Objective: To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR[R]) in children with attention-deficit/hyperactivity disorder (ADHD). Method: This was a 24-month, multicenter, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12…

  13. Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy.

    NARCIS (Netherlands)

    Ananworanich, J.; Gorowara, M.; Avihingsanon, A.; Kerr, S.J.; Heesch, N. van; Khongpetch, C.; Uanithirat, A.; Hill, A.; Ruxrungtham, K.; Burger, D.M.

    2012-01-01

    Because studies showed similar viral suppression with lower raltegravir doses and because Asians usually have high antiretroviral concentrations, we explored low-dose raltegravir therapy in Thais. Nineteen adults on raltegravir at 400 mg twice daily (BID) with HIV RNA loads of <50 copies/ml were

  14. Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses

    Science.gov (United States)

    Nagy, Christa F; Kumar, Dinesh; Perdomo, Carlos A; Wason, Suman; Cullen, Edward I; Pratt, Raymond D

    2004-01-01

    Aim This study evaluated the safety and pharmacokinetics (PK) of donepezil HCl and sertraline HCl when administered separately and in combination. Methods This was a randomized, open-label, three-period crossover study. In consecutive dosing periods separated by washout periods of ≥3 weeks, healthy volunteers received either oral donepezil HCI 5 mg once daily for 15 days, oral sertraline HCl 50 mg once daily for 5 days followed by 10 days of once-daily sertraline HCl 100 mg, or the simultaneous administration of oral donepezil HCl and sertraline HCl. Plasma donepezil and sertraline concentrations were determined by high performance liquid chromatography/mass spectrometry. Safety was evaluated by physical and laboratory evaluations and the monitoring of adverse events (AEs). Results A total of 19 volunteers (16 male and three female) were enrolled. Three male subjects withdrew from the study prematurely due to AEs (one case of nausea/stomach cramps and one case of eosinophilia during combination treatment, and one upper respiratory tract infection during treatment with sertraline HCl alone). In subjects who completed all three treatment periods (n = 16), the concurrent administration of donepezil HCl and sertraline HCl did not alter the steady-state (day 15) PK parameters of donepezil HCl. A small (<12%) but statistically significant (P = 0.02) increase in donepezil Cmax was seen after single doses of sertraline HCl and donepezil HCl on day 1 but this was not thought to be clinically meaningful. No significant differences in the tmax or AUC0–24 h of donepezil were observed between the donepezil HCl only or donepezil HCl plus sertraline HCl groups on day 1. No significant changes in sertraline PK parameters were observed either on day 1 (single dose) or on day 15 (steady state) when sertraline HCl was co-administered with donepezil HCl. Generally, the concurrent administration of donepezil HCl and sertraline HCl was well tolerated, with no serious AEs reported

  15. Wireless capsule motility: comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit.

    Science.gov (United States)

    Maqbool, Sabba; Parkman, Henry P; Friedenberg, Frank K

    2009-10-01

    Assessment of whole gut transit, by radio-opaque markers or scintigraphy, is used to evaluate patients with constipation for slow gastrointestinal transit. Wireless capsule motility, using the SmartPill GI monitoring system, samples and transmits intraluminal pH, pressure, and temperature data from a capsule at regular intervals as it traverses through the gastrointestinal tract; from these, gastric emptying and whole gastrointestinal tract transit can be assessed. The objective of this study was to compare the SmartPill with whole gut transit scintigraphy to determine whether the SmartPill system could serve as a test for measurement of whole gut motility and transit. Ten healthy, asymptomatic subjects underwent simultaneous whole gut scintigraphy and SmartPill assessment of whole gut transit. All subjects completed the study per protocol and experienced natural passage of the pill. Capsule residence time in the stomach correlated very strongly with percent gastric retention of the Tc-99 radiolabel at 120 min (r = 0.95) and at 240 min (r = 0.73). Small bowel contraction-min(-1) measured by the SmartPill correlated with small bowel transit % (r = 0.69; P = 0.05) and with isotopic colonic geometric center at 24 h after ingestion (r = 0.70, P = 0.024). Capsule transit time correlated with scintigraphic assessment of whole gut transit. SmartPill capsule assessment of gastric emptying and whole gut transit compares favorably with that of scintigraphy. Wireless capsule motility shows promise as a useful diagnostic test to evaluate patients for GI transit disorders and to study the effect of prokinetic agents on GI transit.

  16. Harm reduction or women's rights? Debating access to emergency contraceptive pills in Canada and the United States.

    Science.gov (United States)

    Wynn, L L; Erdman, Joanna N; Foster, Angel M; Trussell, James

    2007-12-01

    This article compares the ethical pivot points in debates over nonprescription access to emergency contraceptive pills in Canada and the United States. These include women's right to be informed about the contraceptive method and its mechanism of action, pharmacists' conscientious objection concerning the dispensing of emergency contraceptive pills, and rights and equality of access to the method, especially for poor women and minorities. In both countries, arguments in support of expanding access to the pills were shaped by two competing orientations toward health and sexuality. The first, "harm reduction," promotes emergency contraception as attenuating the public health risks entailed in sex. The second orientation regards access to pills as a question of women's right to engage in nonprocreative sex and to choose from among all reproductive health-care options. The authors contend that arguments for expanding access to emergency contraceptive pills that frame issues in terms of health and science are insufficient bases for drug regulation; ultimately, women's health is also a matter of women's rights.

  17. Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association.

    Directory of Open Access Journals (Sweden)

    Jian Kong

    Full Text Available Placebo treatments and healing rituals have been used to treat pain throughout history. The present within-subject crossover study examines the variability in individual responses to placebo treatment with verbal suggestion and visual cue conditioning by investigating whether responses to different types of placebo treatment, as well as conditioning responses, correlate with one another. Secondarily, this study also examines whether responses to sham acupuncture correlate with responses to genuine acupuncture. Healthy subjects were recruited to participate in two sequential experiments. Experiment one is a five-session crossover study. In each session, subjects received one of four treatments: placebo pills (described as Tylenol, sham acupuncture, genuine acupuncture, or no treatment rest control condition. Before and after each treatment, paired with a verbal suggestion of positive effect, each subject's pain threshold, pain tolerance, and pain ratings to calibrated heat pain were measured. At least 14 days after completing experiment one, all subjects were invited to participate in experiment two, during which their analgesic responses to conditioned visual cues were tested. Forty-eight healthy subjects completed experiment one, and 45 completed experiment two. The results showed significantly different effects of genuine acupuncture, placebo pill and rest control on pain threshold. There was no significant association between placebo pills, sham acupuncture and cue conditioning effects, indicating that individuals may respond to unique healing rituals in different ways. This outcome suggests that placebo response may be a complex behavioral phenomenon that has properties that comprise a state, rather than a trait characteristic. This could explain the difficulty of detecting a signature for "placebo responders." However, a significant association was found between the genuine and sham acupuncture treatments, implying that the non

  18. Space dosimetry measurement results using the Pille instrument during the EUROMIR/NASAMIR space flights

    International Nuclear Information System (INIS)

    Hejja, I.; Apathy, J.; Deme, S.

    1997-01-01

    The Pille dosimeter developed in Hungary for space applications is described briefly, and its two versions are presented for the two space flights. The results of the EUROMIR mission in 1995-1996 are discussed for positional dosimetric applications. The characteristic dose rates at various space stations in the Salyut range are displayed. The NASAMIR4 mission between January 1997 and September 1998 are also discussed from the dosimetric point of view. The results of the measurements are presented and a preliminary analysis is reported. (R.P.)

  19. How do levonorgestrel-only emergency contraceptive pills prevent pregnancy? Some considerations.

    Science.gov (United States)

    Mozzanega, Bruno; Cosmi, Erich

    2011-06-01

    Controversial opinions exist about the possible mechanisms throughout emergency contraception prevents pregnancy. Recently, the International Federation of Gynaecology and Obstetrics and the International Consortium for Emergency Contraception released a Joint Statement declaring that 'inhibition or delay of ovulation should be their primary and possibly only mechanism of action'. They still added that 'Review of the evidence suggests that LNG-ECPs cannot prevent implantation'. Concerning levonorgestrel-only emergency contraceptive pills effects on ovulation, the Statement based on seven reference papers which considered a total of only 142 patients, divided into still different subgroups. Basing on their same references we got quite different conclusions.

  20. Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC Drugs: Time to Take a Bitter Pill

    Directory of Open Access Journals (Sweden)

    Geetha Mani

    2016-10-01

    Full Text Available Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC drugs are an emerging public health concern in India. With one of the huge pharmaceutical sectors in the world, India has a varied prevalence of SSSFC drugs ranging from 0.04% to 34% according to various studies. Apart from severe health consequences, SSSFC drugs also weaken community's trust in the health care system. India is tackling the epidemic of SSSFC drugs through various existing and new regulatory measures. Considering the calamitous consequences of this silent epidemic, it is time to prescribe a bitter pill.

  1. The Pill Really Can Be Mightier Than the Sword: A Response to Recent Commentaries.

    Science.gov (United States)

    Potts, Malcolm; Graves, Alisha

    2016-01-06

    We appreciate the four commentaries that add new material and fresh perspectives to our article "The pill is mightier than the sword." In emphasizing the role of voluntary family planning and girls' education as achievable strategies with a potential to make the world a more peaceable place, we did not mean to oversimplify or disregard the intrinsic complexity of human conflict. On the whole, the commentators support and add to our thesis, although we question Pillai and Ya-Chien Wang's suggestion that we may have overstated the unique human predisposition to kill our own species. We present additional data on male team aggression. © 2016 by Kerman University of Medical Sciences.

  2. The Pill Really Can Be Mightier Than the Sword: A Response to Recent Commentaries

    OpenAIRE

    Malcolm Potts; Alisha Graves

    2016-01-01

    We appreciate the four commentaries that add new material and fresh perspectives to our article "The pill is mightier than the sword." In emphasizing the role of voluntary family planning and girls’ education as achievable strategies with a potential to make the world a more peaceable place, we did not mean to oversimplify or disregard the intrinsic complexity of human conflict. On the whole, the commentators support and add to our thesis, although we question Pillai and Ya-Chien Wang’s sugge...

  3. The Pill Really Can Be Mightier Than the Sword: A Response to Recent Commentaries

    Directory of Open Access Journals (Sweden)

    Malcolm Potts

    2016-03-01

    Full Text Available We appreciate the four commentaries that add new material and fresh perspectives to our article “The pill is mightier than the sword.” In emphasizing the role of voluntary family planning and girls’ education as achievable strategies with a potential to make the world a more peaceable place, we did not mean to oversimplify or disregard the intrinsic complexity of human conflict. On the whole, the commentators support and add to our thesis, although we question Pillai and Ya-Chien Wang’s suggestion that we may have overstated the unique human predisposition to kill our own species. We present additional data on male team aggression.

  4. [Zoely, a combined oral contraceptive, monophasic pill containing estradiol and nomegestrol acetate].

    Science.gov (United States)

    Pintiaux, A; Gaspard, U; Nisolle, M

    2012-03-01

    A new combined oral contraceptive called Zoely has just been marketed in Belgium. It contains nomegestrol acetate, a progestin known for its high contraceptive reliability based on its antigonadotropic power and long half-life. This progestin is associated with estradiol and Zoely is devoid of ethinyl estradiol, which is the usual component of the majority of combined oral contraceptives and is primarily responsible for thrombotic side effects of the pill. The compositon and type of regimen of this new oral contraceptive contribute to its efficacy and excellent clinical tolerance.

  5. Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study

    Directory of Open Access Journals (Sweden)

    Briggs P

    2016-09-01

    Full Text Available Paula Briggs,1 Marco Serrani,2 Kai Vogtländer,3 Susanne Parke4 1Sexual and Reproductive Health, Southport and Ormskirk Hospital NHS Trust, Merseyside, UK; 2Global Medical Affairs Women’s HealthCare, Bayer Pharma AG, Berlin, 3Global Integrated Analysis & Life Cycle Management Statistics, Bayer Pharma AG, Wuppertal, 4Global Clinical Development Women’s HealthCare, Bayer Pharma AG, Berlin, Germany Background: Oral contraceptives are still associated with high discontinuation rates, despite their efficacy. There is a wide choice of oral contraceptives available, and the aim of this study was to assess continuation rates, bleeding profile acceptability, and the satisfaction of women in the first year of using a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG versus a progestogen-only pill (POP in a real-life setting after discontinuing an ethinylestradiol-containing pill.Methods and results: In this prospective, noninterventional, observational study, 3,152 patients were included for the efficacy analyses (n=2,558 women in the E2V/DNG group and n=592 in the POP group (two patients fulfilled the criteria of the efficacy population, but the used product was not known. Women had been taking an ethinylestradiol-containing pill ≥3 months before deciding to switch to the E2V/DNG pill or a POP. Overall, 19.8% (n=506 of E2V/DNG users and 25.8% (n=153 of POP users discontinued their prescribed pill. The median time to discontinuation was 157.0 days and 127.5 days, respectively. Time to discontinuation due to bleeding (P<0.0001 or other reasons (P=0.022 was significantly longer in the E2V/DNG group versus the POP group. The E2V/DNG pill was also associated with shorter (48.7% vs 44.1%, lighter (54% vs 46.1%, and less painful bleeding (91.1% vs 73.7% and greater user satisfaction (80.7% vs 64.6% than POP use, within 3–5 months after switch.Conclusion: The E2V/DNG pill was associated with higher rates of continuation

  6. Methamphetamine Pills

    Science.gov (United States)

    ... use include paranoia, hallucinations, repetitive behavior patterns, and delusions of parasites or insects under the skin. People ... Agency (DEA) Related Drugs Methamphetamine (Meth) Prescription Stimulants Cocaine / Crack Caffeine Next Steps Preventing Teen Drug Use: ...

  7. The Role of Oral Contraceptive Pills on Increased Risk of Breast Cancer in Iranian Populations: A Meta-analysis.

    Science.gov (United States)

    Soroush, Ali; Farshchian, Negin; Komasi, Saeid; Izadi, Neda; Amirifard, Nasrin; Shahmohammadi, Afshar

    2016-12-01

    Cancer is one of the main public health issues in the world. Breast cancer is one of the most common types of cancer among women. It is also the second cause of mortality in women. The association between the use of oral contraceptive pills and breast cancer is controversial and a main issue in public health. Some findings have shown that taking these pills does not have a significant effect in increasing the risk of breast cancer, while others have confirmed the carcinogenic effect of these products. These contradictory findings necessitated this meta-analysis, through of all correlated studies in Iran. All published studies were considered from June 2000 until June 2015, using reliable Latin databases like PubMed, Google Scholar, Google search, Scopus, and Science Direct, and Persian database like SID, Irandoc, IranMedex, and Magiran. Finally, 26 papers were selected: 24 studies were case control while two were population based studies. A total of 26 papers with 46,260 participants were assessed since 2001. Overall estimate of OR for the effect of oral contraceptive pills on breast cancer is 1.521 (CI = 1.25-1.85), which shows that the intervention group had more chance (52%) compared to the control group ( P = 0.001). Using these pills increased the risk of breast cancer up to 1.52 times. Because of directly increasing levels of estrogen and the role of estrogen in gaining weight indirectly, oral contraceptive pills can stimulate the occurrence of breast cancer. More studies should be conducted for controlling the period of pill use.

  8. Evaluation of pharmacists' services for dispensing emergency contraceptive pills in Delhi, India: A mystery shopper study

    Directory of Open Access Journals (Sweden)

    Pikee Saxena

    2016-01-01

    Full Text Available Background: Although emergency contraceptive pills are available over the counter, the quality of consultation, including key areas of contraceptive counseling and prevention of sexually transmitted infections (STI, has not been well documented. Objective: To evaluate actual pharmacist services while dispensing emergency contraception through a mystery shopper technique. Material and Methods: This cross-sectional study was conducted in 81 pharmacies situated in Delhi by 4 trained mystery shoppers posed as customers over a period of 6 months. Results: None of the pharmacists asked about the time lapsed since last unprotected sexual intercourse or last menstrual period before deciding the eligibility of the customer. The majority were unclear about side effects associated with emergency contraception (78.57% or with anticipated changes in menstrual flow (78.57%; 85.71% did not know whether subsequent unprotected intercourse would be protected. Only 15.71% counseled shoppers regarding risk of STI on asking leading questions and 88.5% did not provide any contraceptive advice. Conclusion: There is a huge gap in the technical knowledge and mindset of the pharmacists when it comes to checking for the eligibility of the client and providing advice regarding use of regular contraception and barrier for protection from STI, which needs to be addressed in order to realize the full benefit of making emergency contraceptive pills available over the counter.

  9. Effect of contraceptive pill on the selenium and zinc status of healthy subjects.

    Science.gov (United States)

    Fallah, Soudabeh; Sani, Fatemeh Valinejad; Firoozrai, Mohsen

    2009-07-01

    The study was conducted to ascertain the influence of oral contraceptive pill (OCP) uptake on serum zinc and selenium in contraceptive pill users. The concentration of zinc and selenium was determined by atomic absorption spectrophotometer in 50 healthy women with normal menstrual cycles as a control group and 50 women taking low-dose OCP. The control reference values were 81.61+/-9.44 and 70.35+/-25.57 mcg/dL, which were obtained for zinc and selenium, respectively. Use of OCP resulted in a significant decrease in serum zinc levels (pselenium levels but not significantly (p=.08, t=0.935). The duration of use beyond 3 months had no effect on the magnitude of the decrease in serum zinc levels. These findings may be important because selenium is currently believed to offer protective benefits against carcinogenesis. It has been thought that the decrease in serum zinc could be reflected in a reduction of tissue zinc status due to changes in zinc absorption, excretion or tissue turnover. If these changes occur, the dietary zinc requirement would be greater in women using OCP.

  10. Quality evaluation of Huaijiao pill by chromatographic fingerprint and simultaneous determination of its major bioactive components

    Directory of Open Access Journals (Sweden)

    Shuangqin Wang

    2016-08-01

    Full Text Available For quality control purpose, an approach of combining chromatographic fingerprint of Huaijiao pill (HP and simultaneous determination of its major bioactive components was developed using high performance liquid chromatography coupled with diode array detector (HPLC--DAD. For fingerprint analysis, 16 peaks were selected as the characteristic peaks to evaluate the similarities of different samples collected from different batches of three manufacturers. The similarities of 17 Huaijiao pill samples were beyond 0.966, indicating that samples from different batches and manufacturers were, to some extent, consistent. Additionally, simultaneous quantification of seven bioactive markers, namely sophoricoside, baicalin, naringin, genistein, rutin, quercetin and 5-O-methylvisammioside, in HP was performed to interpret the quality consistency. The validation of the proposed approach was acceptable, with the accuracy of 90.2%–106.9% in recovery test. The intra-day and inter-day precisions of the method were evaluated and the RSD values were less than 2.81%. The results from the quantitative data showed that the contents of six marker compounds (except for 5-O-methylvisammioside were quite consistent between batches produced by one manufacturer and significantly distinctive among different manufacturers. The proposed approach was expected to be developed as a powerful tool for the quality control of HP.

  11. Evaluation of Pharmacists' Services for Dispensing Emergency Contraceptive Pills in Delhi, India: A Mystery Shopper Study.

    Science.gov (United States)

    Saxena, Pikee; Mishra, Archana; Nigam, Aruna

    2016-01-01

    Although emergency contraceptive pills are available over the counter, the quality of consultation, including key areas of contraceptive counseling and prevention of sexually transmitted infections (STI), has not been well documented. To evaluate actual pharmacist services while dispensing emergency contraception through a mystery shopper technique. This cross-sectional study was conducted in 81 pharmacies situated in Delhi by 4 trained mystery shoppers posed as customers over a period of 6 months. None of the pharmacists asked about the time lapsed since last unprotected sexual intercourse or last menstrual period before deciding the eligibility of the customer. The majority were unclear about side effects associated with emergency contraception (78.57%) or with anticipated changes in menstrual flow (78.57%); 85.71% did not know whether subsequent unprotected intercourse would be protected. Only 15.71% counseled shoppers regarding risk of STI on asking leading questions and 88.5% did not provide any contraceptive advice. There is a huge gap in the technical knowledge and mindset of the pharmacists when it comes to checking for the eligibility of the client and providing advice regarding use of regular contraception and barrier for protection from STI, which needs to be addressed in order to realize the full benefit of making emergency contraceptive pills available over the counter.

  12. When can a woman resume or initiate contraception after taking emergency contraceptive pills? A systematic review.

    Science.gov (United States)

    Salcedo, Jennifer; Rodriguez, Maria I; Curtis, Kathryn M; Kapp, Nathalie

    2013-05-01

    Hormonal emergency contraception can postpone ovulation, making a woman vulnerable to pregnancy later in the same cycle. However, concern exists as to whether concurrently administered emergency contraception pills (ECP) and other hormonal methods of contraception may affect the effectiveness of both medications. A systematic review of the literature using PubMed and the Cochrane databases was performed to identify articles concerning the resumption or initiation of regular contraception within the same cycle as ECP use. We searched for articles in any language, published between 1980 and April 2012 and included all methods of emergency contraception pills available in the USA. The search strategy identified 184 articles in the PubMed and Cochrane databases, of which none met inclusion criteria. The drug manufacturer advises continuation or initiation of routine contraception as soon as possible after use of ulipristal acetate, with concomitant use of a reliable barrier method until next menses. However, a theoretical concern exists that given ulipristal acetate's function as a selective progesterone receptor modulator, coadministration of a progestin could decrease its effectiveness as an emergency contraceptive. Initiation of hormonal contraception following levonorgestrel or the Yuzpe regimen for emergency contraception carries no similar concern for decreased method effectiveness. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Daily context matters: predictors of missed oral contraceptive pills among college and graduate students.

    Science.gov (United States)

    Hughey, Andrew B; Neustadt, Amy B; Mistretta, Stephanie Q; Tilmon, Sandra J; Gilliam, Melissa L

    2010-10-01

    The purpose of this study was to understand the relationship between daily contextual factors and oral contraceptive (OC) adherence among students who attend college or graduate school. Data on OC adherence, demographics, contextual factors, and side-effects were collected as part of the acceptability of the NuvaRing (Merck & Co, Whitehouse Station, NJ) vs OC study, in which students were assigned randomly to the contraceptive vaginal ring or to a low-dose OC. We performed bivariate and multivariable analyses to create an explanatory model for nonperfect OC adherence (missed at least 1 pill during 3 months of use). In a multivariable predictive model, missing a pill was associated positively with high perceived stress (odds ratio [OR], 3.16; P = .007), having ≥10 hours per week of paid employment (OR, 2.13; P = .075), and living with a partner (OR, 9.92; P = .040). Stressful and hectic lives contribute to poor OC adherence. When counseling women about contraception, clinicians should consider the influence of daily life on contraceptive adherence. Copyright © 2010 Mosby, Inc. All rights reserved.

  14. Shexiang Baoxin Pills for Coronary Heart Disease in Animal Models: Preclinical Evidence and Promoting Angiogenesis Mechanism

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    Ke-Jian Zhang

    2017-06-01

    Full Text Available Shexiang Baoxin Pill (SBP originated from a classical TCM Fufang Suhexiang Pill for chest pain with dyspnea in the Southern Song Dynasty (1107–110 AD. Here, we aimed to evaluate preclinical evidence and possible mechanism of SBP for experimental coronary heart disease (CHD. Studies of SBP in animal models with CHD were identified from 6 databases until April 2016. Study quality for each included article was evaluated according to the CAMARADES 10-item checklist. Outcome measures were myocardial infarction area, vascular endothelial growth factor (VEGF and microvessel count (MVC. All the data were analyzed by using RevMan 5.1 software. As a consequence, 25 studies with 439 animals were identified. The quality score of studies ranged from 2 to 5, with the median of 3.6. Meta-analysis of seven studies showed more significant effects of SBP on the reduction of the myocardial infarction area than the control (P < 0.01. Meta-analysis of eight studies showed significant effects of SBP for increasing VEGF expression compared with the control (P < 0.01. Meta-analysis of 10 studies indicated that SBP significantly improved MVC compared with the control (P < 0.01. In conclusion, these findings preliminarily demonstrated that SBP can reduce myocardial infarction area, exerting cardioprotective function largely through promoting angiogenesis.

  15. A Little Bit of Sugar Helps the Pill Go Down: Resilience, Peace, and Family Planning

    Science.gov (United States)

    De Souza, Roger-Mark

    2016-01-01

    The article by Potts et al, "The Pill is Mightier than the Sword," points out that family planning has an important role to play in building peace by increasing women’s empowerment and their agency, ultimately helping peacebuilding efforts. Evidence has demonstrated that family planning programs are cost effective, produce quick results, help women and couples meet their desired fertility levels, and produce a multitude of benefits around economic productivity, community engagement, conservation, resilience, and peacebuilding. In order for policy audiences from a variety of sectors, including conflict and peacebuilding, to appreciate these benefits, it is important to find common ground and articulate co-benefits that will help them appreciate and value the role of family planning, as it were, give them sugar to help the pill go down. This commentary examines how resilience, peacebuilding and family planning efforts need to focus on co-benefits in order to build on the successful interventions and opportunities that Potts et al highlight. PMID:26927398

  16. A "Suicide Pill" for Older People: Attitudes of Physicians, the General Population, and Relatives of Patients Who Died after Euthanasia or Physician-Assisted Suicide in the Netherlands

    Science.gov (United States)

    Rurup, Mette L.; Onwuteaka-Philipsen, Bregje D.; van der Wal, Gerrit; van der Heide, Agnes; van Der Maas, Paul J.

    2005-01-01

    In the Netherlands there has been ongoing debate in the past 10 years about the availability of a hypothetical "suicide pill", with which older people could end their life in a dignified way if they so wished. Data on attitudes to the suicide pill were collected in the Netherlands from 410 physicians, 1,379 members of the general…

  17. An assessment of the quality of advice provided by patent medicine vendors to users of oral contraceptive pills in urban Nigeria

    Directory of Open Access Journals (Sweden)

    Ujuju C

    2014-04-01

    Full Text Available Chinazo Ujuju,1 Samson B Adebayo,2 Jennifer Anyanti,3 Obi Oluigbo,3 Fatima Muhammad,4 Augustine Ankomah5 1Research and Evaluation Division, Society for Family Health, Abuja, Nigeria; 2Planning, Research and Statistics Directorate, National Agency for Food and Drug Administration and Control, Abuja, Nigeria; 3Technical Services Directorate, Society for Family Health, Abuja, Nigeria; 4Family Planning Directorate, Society for Family Health, Abuja, Nigeria; 5Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Legon, Accra, Ghana Introduction: In Nigeria about 50% of oral contraceptive pill users obtain their products from proprietary patent medicine vendors (PPMVs. This group of service providers are poorly trained and have very limited knowledge about contraception. This paper investigated the nature of the advice offered to simulated current and potential users of oral contraceptive pills. The main objective was to assess the nature and quality of advice provided by PPMVs to pill users. Method: This study is based on findings from a 'mystery client' approach in which three scenarios related to contraceptive pill use were simulated. Each of the 12 mystery clients simulated one of the following three scenarios: new pill users (new to family planning or switching from condom to pills; user seeking a resupply of pills; and dissatisfied pill users intending to discontinue use. Simple random sampling was used to select 410 PPMVs from a total of 1,826 in four states in Nigeria. Qualitative study using in-depth interviews was also conducted. Results: A majority of the PPMVs had pills in stock on the day of the survey and resupplied pills to the clients. PPMVs also understood the reason and importance of referring clients who were new adopters of oral contraceptive methods to a health facility; 30% of the PPMVs referred new adopters to a health facility. However, demand from clients who do not want to go

  18. Sex, tensions and pills : Young people’s use of contemporary reproductive and sexual health technologies in Addis Ababa, Ethiopia

    NARCIS (Netherlands)

    Both, R.E.C.

    2017-01-01

    This study sheds light on why some young men and women from diverse backgrounds in Addis Ababa use emergency contraceptive pills (ECs) and sildenafil citrate (Viagra) repeatedly, sometimes in a routinized manner. It unravels the reasons behind the frequent yet secretive purchasing of these two

  19. Mida teie oma tervise heaks teete? / Ly Jagor, Ülle Mihhailova, Ene Pill, Katrin Käbin...[jt.

    Index Scriptorium Estoniae

    2008-01-01

    Küsimusele vastavad Pärnu Õppenõustamiskeskuse psühholoog Ly Jagor, Maasika lasteaia juhataja asetäitja Ülle Mihhailova, Tallinna Perekeskuse ja Tähetorni lastekeskuse psühholoog Ene Pill, Tallinna Nõmme Noortemaja väikelaste ringijuht Katrin Käbin, Tääksi Põhikooli õpetaja Silva Kolk

  20. Real-World Scenario Improvements in Serum Phosphorus Levels and Pill Burden in Peritoneal Dialysis Patients Treated with Sucroferric Oxyhydroxide.

    Science.gov (United States)

    Kalantar-Zadeh, Kamyar; Parameswaran, Vidhya; Ficociello, Linda H; Anderson, Ludmila; Ofsthun, Norma J; Kwoh, Christopher; Mullon, Claudy; Kossmann, Robert J; Coyne, Daniel W

    2018-03-07

    A database analysis was conducted to assess the effectiveness of sucroferric oxyhydroxide (SO) on lowering serum phosphorus and phosphate binder (PB) pill burden among adult peritoneal dialysis (PD) patients prescribed SO as part of routine care. Adult PD patients (n = 258) prescribed SO through a renal pharmacy service were analyzed. Baseline was 3 months before SO prescription. SO-treated follow-up was for 6 months or until either a new PB was prescribed, SO was not refilled, PD modality changed, or patient was discharged. In-range serum phosphorus was defined as ≤5.5 mg/dL. At baseline, mean serum phosphorus was 6.59 mg/dL with 10 prescribed PB pills/day. The proportion of patients achieving in-range serum phosphorus increased by 72% from baseline to month 6. Prescribed PB pills/day decreased by 57% (10 at baseline to 4.3 at SO follow-up, p 5.5 mg/dL who achieved in-range serum phosphorus during SO follow-up for ≥1 quarter, a notable improvement in serum phosphorus (6.54 to 5.10 mg/dL, p 50% reduction in PB pills/day were observed. The Author(s). Published by S. Karger AG, Basel.

  1. Integrative description of two new species of Malagasy chirping giant pill-millipedes, genus Sphaeromimus (Diplopoda: Sphaerotheriida: Arthrosphaeridae

    Directory of Open Access Journals (Sweden)

    Leif Moritz

    2017-12-01

    Full Text Available The species-rich giant pill-millipedes (Sphaerotheriida often represent a microendemic component of Madagascar’s mega-invertebrate fauna. Of the chirping genus Sphaeromimus de Saussure & Zehntner, 1902, ten species have been described. Here, we describe two new species of Sphaeromimus integratively, combining light microscopy, scanning electron microscopy, DNA barcoding and micro-CT technology for the first time in a taxonomic description of a giant pill-millipede. S. kalambatritra sp. nov. and S. midongy sp. nov. are the first giant pill-millipedes collected and described from the mountainous rainforests of Kalambatritra and Midongy. Both species show island gigantism compared to their congeners. Our analysis of the mitochondrial COI gene shows that the two species are related to one another with a moderate genetic distance (9.4%, while they are more closely related to an undetermined specimen from the forest of Vevembe (6.3% and 8.4%. They stand in a basal position with S. ivohibe Wesener, 2014 and S. musicus (de Saussure & Zehntner, 1897. The four aforementioned species share a high number of stridulation ribs on the male harp. Our micro-CT analysis provides a look into the head of S. kalambatritra sp. nov. and shows that non-destructive CT methods are a useful tool for studying the inner morphology of giant pill-millipedes.

  2. Therapeutic effect of the compound Danshen dripping pill combined with laser acupoint irradiation on early diabetic retinopathy

    Science.gov (United States)

    Liu, Hui-Hui; Xiong, Guo-Xin; Zhang, Li-Ping

    2017-06-01

    To investigate the therapeutic effect of the compound Danshen dripping pill combined with laser acupoint irradiation on early diabetic retinopathy, 19 patients with early diabetic retinopathy were randomly divided into a treatment group and a control group. The TaiYang, YangBai, YuYao and ZanZhu acupoints of patients in the treatment group were irradiated with a semiconductor laser combined with the oral compound Danshen dropping pills, while those in the control group only used the oral compound Danshen dropping pills. The indicators of vision, mean defect of light sensitivity in the visual field, renal function and fasting blood glucose, were examined to evaluate the efficacy. After treatment, the above indicators of patients in the two groups were significantly improved and there was a significant difference between the two groups. This showed that the compound Danshen dripping pills combined with the laser acupoint irradiation can improve the ischemic and anoxic state of early diabetic retinopathy and improve the visual field.

  3. Õpilaskodud ei ole imerohi, aga rohi siiski / Rein Ansip, Pille Liblik, Kalev Saar...[jt.

    Index Scriptorium Estoniae

    2009-01-01

    Õpilaskodude kasvatajate suvekoolis Krabil arutlesid sotsiaalsete probleemidega kodudest pärit laste koolitamise üle Krabi põhikooli direktor Ale Sprenk, Varstu vallavanem Rein Ansip, Võru maavalitsuse haridusosakonna juhataja Pille Liblik, Viira kooli direktor Kalev Saar ja psühholoog Tõnu Ots

  4. Telemetry pill versus rectal and esophageal temperature during extreme rates of exercise-induced core temperature change

    NARCIS (Netherlands)

    Teunissen, L.P.J.; Haan, A. de; Koning, J.J. de; Daanen, H.A.M.

    2012-01-01

    Core temperature measurement with an ingestible telemetry pill has been scarcely investigated during extreme rates of temperature change, induced by short high-intensity exercise in the heat. Therefore, nine participants performed a protocol of rest, (sub)maximal cycling and recovery at 30 °C. The

  5. Using Caffeine Pills for Performance Enhancement. An Experimental Study on University Students' Willingness and Their Intention to Try Neuroenhancements.

    Science.gov (United States)

    Brand, Ralf; Koch, Helen

    2016-01-01

    Recent research has indicated that university students sometimes use caffeine pills for neuroenhancement (NE; non-medical use of psychoactive substances or technology to produce a subjective enhancement in psychological functioning and experience), especially during exam preparation. In our factorial survey experiment, we manipulated the evidence participants were given about the prevalence of NE amongst peers and measured the resulting effects on the psychological predictors included in the Prototype-Willingness Model of risk behavior. Two hundred and thirty-one university students were randomized to a high prevalence condition (read faked research results overstating usage of caffeine pills amongst peers by a factor of 5; 50%), low prevalence condition (half the estimated prevalence; 5%) or control condition (no information about peer prevalence). Structural equation modeling confirmed that our participants' willingness and intention to use caffeine pills in the next exam period could be explained by their past use of neuroenhancers, attitude to NE and subjective norm about use of caffeine pills whilst image of the typical user was a much less important factor. Provision of inaccurate information about prevalence reduced the predictive power of attitude with respect to willingness by 40-45%. This may be because receiving information about peer prevalence which does not fit with their perception of the social norm causes people to question their attitude. Prevalence information might exert a deterrent effect on NE via the attitude-willingness association. We argue that research into NE and deterrence of associated risk behaviors should be informed by psychological theory.

  6. Cure for empire: the 'Conquer-Russia-Pill', pharmaceutical manufacturers, and the making of patriotic Japanese, 1904-45.

    Science.gov (United States)

    Kim, Hoi-Eun

    2013-04-01

    Seirogan, a popular anti-diarrhoeal pill, is arguably one of the most successful pharmaceutical products of modern Japan. What is less known is that the Japanese army initially developed Seirogan during the Russo-Japanese War as the ‘Conquer-Russia-Pill’, which was later marketed to the public by private manufacturers. Previous scholars have emphasised the top–down governmental method of mobilising private sectors to manipulate public opinion for the cause of external imperialist expansion and domestic stability during wartime Japan. But the matrix that the Conquer-Russia-Pill allows us to glimpse is an inverted power relation among the state, commercial sectors, and imperial citizens. While the Japanese government remained indifferent if not hostile to jingoistic pharmaceutical manufacturers who could easily disrupt international relations, pharmaceutical companies quickly recognised and exploited the opportunities that the Conquer-Russia-Pill and its symbolism provided under the banner of the empire. In turn, Japanese consumers reacted to commercial sermons carefully anchored in patriotic and militaristic discourses and images by opening their wallets. In other words, the popularity of the Conquer-Russia-Pill was a culmination of the convergence of a governmental initiative to enhance military capabilities, the commercial ingenuity of pharmaceutical manufacturers, and a consumer response to patriotic exhortations.

  7. [Effects of dioscorea modified pill on cognitive impairment of patients with VCIND: an preliminary study of proton magnetic resonance spectroscopy].

    Science.gov (United States)

    Liu, Jinhuan; Chen, Jun; Tan, Zihu; Yang, Qiong; Lan, Hanchao; Zhao, Yilin; Liu, Changsheng; Qiu, Li

    2014-10-28

    To explore the therapeutic effect evaluation of proton magnetic resonance spectroscopy ((1)H-MRS) in patients with vascular cognitive impairment no dementia (VCIND) with dioscorea modified pill. A total of 100 patients with VCIND were randomly assigned into the dioscorea modified pill group (n = 50) and the aricept group (n = 50). And 50 healthy volunteers were recruited as normal group. Each patient was examined with (1)H-MRS and scored with mini-mental state examination (MMSE) and clinical dementia rating (CDR) scale pre- and post-treatment. After therapy, the NAA/Cr ratios and the itemized scores of cognitive scale compared with that of pre-therapy had significantly difference (P dioscorea modified pill group (MMSE (26.5 ± 2.0), CDR(0.14 ± 0.23))vs(MMSE(25.1 ± 2.3), CDR(0.5)). But no difference existed in the aricept group (P > 0.05). (1)H-MRS may objectively reflect cognitive dysfunction in VCIND patients. And it has important values in the therapeutic effect evaluation of VCIND with dioscorea modified pill.

  8. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cui, Xue-Jun; Sun, Yue-Li; You, Sheng-Fu; Mo, Wen; Lu, Sheng; Shi, Qi; Wang, Yong-Jun

    2013-10-07

    Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and

  9. Review on the Applications and Molecular Mechanisms of Xihuang Pill in Tumor Treatment.

    Science.gov (United States)

    Guo, Qiujun; Lin, Jinyin; Liu, Rui; Gao, Yebo; He, Shulin; Xu, Xinyao; Hua, Baojin; Li, Conghuang; Hou, Wei; Zheng, Honggang; Bao, Yanju

    2015-01-01

    Xihuang pill (XH) is a complementary and alternative medicine that has been used in traditional Chinese medicine (TCM) for the treatment of tumors since the 18th century. XH has clinical effects on non-Hodgkin lymphoma, breast cancer, gastric cancer, liver cancer, and bone metastasis. XH can also inhibit the growth of tumor cells and cancer stem cells, prevent tumor invasion and angiogenesis, and regulate the tumor microenvironment. XH is composed of Ru Xiang (olibanum), Mo Yao (Commiphora myrrha), She Xiang (Moschus), and Niu Huang (Calculus bovis). Some of the compounds found in these ingredients exert multiple antitumor effects and may synergize with the other ingredients. We aimed to summarize the clinical applications and molecular mechanisms of XH and its chemical composition. This review will provide potential new strategies and alternative perspectives for tumor treatments and basic research into complementary and alternative medicine.

  10. Review on the Applications and Molecular Mechanisms of Xihuang Pill in Tumor Treatment

    Directory of Open Access Journals (Sweden)

    Qiujun Guo

    2015-01-01

    Full Text Available Xihuang pill (XH is a complementary and alternative medicine that has been used in traditional Chinese medicine (TCM for the treatment of tumors since the 18th century. XH has clinical effects on non-Hodgkin lymphoma, breast cancer, gastric cancer, liver cancer, and bone metastasis. XH can also inhibit the growth of tumor cells and cancer stem cells, prevent tumor invasion and angiogenesis, and regulate the tumor microenvironment. XH is composed of Ru Xiang (olibanum, Mo Yao (Commiphora myrrha, She Xiang (Moschus, and Niu Huang (Calculus bovis. Some of the compounds found in these ingredients exert multiple antitumor effects and may synergize with the other ingredients. We aimed to summarize the clinical applications and molecular mechanisms of XH and its chemical composition. This review will provide potential new strategies and alternative perspectives for tumor treatments and basic research into complementary and alternative medicine.

  11. Estrogen-free oral hormonal contraception: benefits of the progestin-only pill.

    Science.gov (United States)

    de Melo, Nilson Roberto

    2010-09-01

    Although combined oral contraceptives (COCs) are commonly used and highly effective in preventing pregnancy, they may not be suitable for some women. COC use is associated with increased rates of cardiovascular events and is not recommended in nonbreastfeeding women in the immediate postpartum period or in breastfeeding women during the initial 6 months of breastfeeding. Moreover, estrogen-related adverse effects, such as headache, are common. Estrogen-free progestin-only pills (POPs) are a valuable option in women who prefer to take an oral hormonal contraceptive, but are ineligible for, or choose not to use, COCs. Although some POPs have been associated with lower contraceptive effectiveness than COCs, the POP containing desogestrel has shown similar contraceptive effectiveness to COCs. The most commonly reported complaints in women using all POPs are bleeding problems. Counseling women interested in using POPs about the variable bleeding patterns associated with this method may improve compliance and acceptance.

  12. Poison pills: A defensive measure against a hostile takeover or a demonstration of power of the target company

    Directory of Open Access Journals (Sweden)

    Jovanović-Zattila Milena

    2014-01-01

    Full Text Available The balance of power is particularly at stake in hostile takeovers, which makes the issue of establishing the balance of power one of the most controversial issues in the contemporary company law. In the circumstances of direct market competition and the need to have a dominant market position, companies are necessarily forced to constantly upgrade and advance their offensive and defensive methods, techniques and strategies. In order to prevent a hostile takeover, the target company may resort to an array of defence mechanisms, the most prominent of which are 'poison pills'. In spite of being perceived as the most powerful tool for obstructing hostile takeovers (and commonly designated as the 'Holy Grail' among the defensive mechanisms, there are many pros and cons underlying their application. One of the positive effects of using the poison pills is that the fear of takeovers makes the target company management more disciplined and efficient in business operations. The negative consequences are reflected in the relationship between the company board of directors and the shareholders. The target company management makes a unilateral decision on using a poison pill and this decision does not have to be approved by the shareholders in the General Meeting; however, this is highly inconsistent with the basic principles of corporate governance. The asymmetry of information, where the management (an agent has disproportionately more relevant information at its disposal than the shareholders (principals, generates a conflict between the management and the shareholders. In company law, this agency problem is generally known as the principal-agent problem, which is most prominent in a takeover. Poison pills are often associated with the discrimination of the target company shareholders, but not necessarily. The controversial nature of this defensive measure which can be applied by the target company has given rise to numerous debates on the need to

  13. Evaluation of a telemetric gastrointestinal pill for continuous monitoring of gastrointestinal temperature in horses at rest and during exercise.

    Science.gov (United States)

    Verdegaal, Elisabeth-Lidwien J M M; Delesalle, Catherine; Caraguel, Charles G B; Folwell, Louise E; McWhorter, Todd J; Howarth, Gordon S; Franklin, Samantha H

    2017-07-01

    OBJECTIVE To evaluate use of a telemetric gastrointestinal (GI) pill to continuously monitor GI temperature in horses at rest and during exercise and to compare time profiles of GI temperature and rectal temperature. ANIMALS 8 Standardbred horses. PROCEDURES Accuracy and precision of the GI pill and a rectal probe were determined in vitro by comparing temperature measurements with values obtained by a certified resistance temperature detector (RTD) in water baths at various temperatures (37°, 39°, and 41°C). Subsequently, both GI and rectal temperature were recorded in vivo in 8 horses over 3 consecutive days. The GI temperature was recorded continuously, and rectal temperature was recorded for 3.5 hours daily. Comparisons were made between GI temperature and rectal temperature for horses at rest, during exercise, and after exercise. RESULTS Water bath evaluation revealed good agreement between the rectal probe and RTD. However, the GI pill systematically underestimated temperature by 0.14°C. In vivo, GI temperature data were captured with minimal difficulties. Most data loss occurred during the first 16 hours, after which the mean ± SD data loss was 8.6 ± 3.7%. The GI temperature was consistently and significantly higher than rectal temperature with an overall mean temperature difference across time of 0.27°C (range, 0.22° to 0.32°C). Mean measurement cessation point for the GI pill was 5.1 ± 1.0 days after administration. CONCLUSIONS AND CLINICAL RELEVANCE This study revealed that the telemetric GI pill was a reliable and practical method for real-time monitoring of GI temperature in horses.

  14. Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding.

    Science.gov (United States)

    Dahiya, Pushpa; Dalal, Monika; Yadav, Anu; Dahiya, Krishna; Jain, Shaveta; Silan, Vijay

    2016-08-01

    To compare the efficacy, acceptability and compliance of combined hormonal vaginal ring (CVR), with combined hormonal pills (CHP) in patients with heavy menstrual bleeding (HMB). This prospective study was conducted in 50 women with HMB in age group of 25-40 years. Patients were divided in two groups of 25 each and followed for six treatment cycles. In each group, cycle comprised of three weeks of CVR (releases 15μg of EE and 120μg of the etonogestrel per day) or CHP (containing 30μgm of EE and 150μgm of LNG) use, followed by one ring or pill free week. After each cycle, patients were evaluated about the amount of blood loss and duration of bleeding by the pictoral blood assessment chart (PBAC), early bleeding (EWB), continued bleeding (CWB), intermenstrual bleeding, intended bleeding, compliance, and user acceptability. The collected data were analyzed using the Chi square test, t-test and ANOVA test. Reduction in PBAC score for CVR (70.73%) and CHP group (70.02%), duration of bleeding and incidence of EWB was comparable among the two groups. The incidence of intermenstrual bleeding was lower in CVR than in CHP group in cycle 3 and 4 with significant p value. The incidence of CWB was significantly lower and the incidence of intended bleeding pattern in CVR group was significantly higher in cycle 3, 4, 5 and 6, signifying better cycle control. Compliance was also higher in CVR (88%) than CHC (75.33% of all cycles). This trial suggests that both the CVR and CHP are very effective short-term treatments for HMB in reproductive age group. However, women had better cycle control and compliance with CVR. This may be an attractive option among the wide variety of medications used to treat HMB. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Frequency of Candidiasis and Colonization of Candida albicans in Relation to Oral Contraceptive Pills.

    Science.gov (United States)

    Aminzadeh, Atousa; Sabeti Sanat, Ali; Nik Akhtar, Saeed

    2016-10-01

    Candidiasis, the infection caused by Candida albicans , is one of the most common infections of the oral cavity in humans. Candidiasis causes irritation and is known for its carcinogenic effects. Thus, it is important to recognize the predisposing factors for this opportunistic infection. Several previous studies have demonstrated an increased frequency of vaginal candidiasis in relation to oral contraceptive consumption. Only a few studies on the relation between oral contraceptives and oral candidiasis have been previously conducted. This study aims to evaluate the possible relation between oral contraceptive pills and oral candidiasis. This analytic, case-control study included 40 non-pregnant women divided into two groups: 20 who used oral contraceptive pills and 20 who did not. The groups were matched according to age, oral health, and past and present medical history. Samples were collected from the tongue's dorsum using a cotton swab and inoculated on CHROMagar culture plates. The frequency of positive cultures and the number of Candida colonies were compared between the two groups using independent t-tests and Mann-Whitney statistical tests with SPSS18 software. The frequency of positive cultures of Candida albicans was higher (P value = 0.03) for the case group. Also, the number of C. albicans and C. krusei was significantly higher for the case group compared to the control group (P value = 0.04, P value = 0.03). The results of the present study demonstrate that oral contraceptives containing estradiol can lead to Candida colonization in the oral cavity. It is recommended that further studies comparing the influence of oral contraceptives on Candida's adherence to the epithelium is highly recommended.

  16. Estradiol valerate and dienogest: a novel four-phasic oral contraceptive pill effective for pregnancy prevention and treatment of heavy menstrual bleeding.

    Science.gov (United States)

    Micks, Elizabeth; Jensen, Jeffrey T

    2011-09-01

    Estradiol valerate and dienogest have been combined to create a novel four-phasic oral contraceptive pill effective for both pregnancy prevention and treatment of heavy menstrual bleeding. This formulation represents the only oral contraceptive pill available in the USA containing an estrogen component that is biologically active as the endogenous estrogen 17β-estradiol. This medication was developed out of efforts to replace the most common estrogen in contraceptive pills, ethinyl estradiol, which is known to be a potent inducer of hepatic protein synthesis. Estradiol valerate has been available since the 1970s in oral and injectable forms indicated for the treatment of menopausal climacteric symptoms. Dienogest has been used in other oral contraceptive pills for over 10 years. Previous attempts to develop an oral contraceptive pill with natural estradiol or estradiol valerate were unsuccessful due to poor cycle control. A novel dynamic-dosing regimen was devised to improve the bleeding pattern. This medication has been shown in several clinical trials to have good contraceptive efficacy and cycle control. Recent studies have also demonstrated that this medication is effective for the treatment of heavy menstrual bleeding. However, compared with other oral contraceptive pills, this medication is associated with a higher frequency of absent withdrawal bleeding. Furthermore, the dynamic dosing regimen requires relatively complex instructions for users who miss pills.

  17. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Emmanuel eStip

    2013-08-01

    Full Text Available Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill® and the BARS, in order to verify whether the DoPill® provides reliable assessment of medication adherence. Methods: The DoPill® is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill® or Treatment As Usual group (TAU for six weeks. The BARS was used as a reference measure. Results: Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67 % after six weeks. DoPill® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. Conclusion: These results suggest that DoPill® is a valid tool that provides more reliable and objective data for the clinician about their patient’s adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  18. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia.

    Science.gov (United States)

    Stip, Emmanuel; Vincent, Philippe D; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill(®) improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill(®) and the BARS, in order to verify whether the DoPill(®) provides reliable assessment of medication adherence. The DoPill(®) is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill(®) or treatment as usual groups for 6 weeks. The BARS was used as a reference measure. Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67% after 6 weeks. DoPill(®) recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. These results suggest that DoPill(®) is a valid tool that provides more reliable and objective data for the clinician about their patient's adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  19. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Emmanuel eStip; Emmanuel eStip; Emmanuel eStip; Philippe D. Vincent; Philippe D. Vincent; Philippe D. Vincent; Catherine eGuevremont; Simon eZhornitsky; Constantin eTranulis; Constantin eTranulis; Constantin eTranulis; Juliette eSablier; Juliette eSablier

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improv...

  20. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Stip, Emmanuel; Vincent, Philippe D.; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR...

  1. Acceptability of the use of cellular telephone and computer pictures/video for "pill counts" in buprenorphine maintenance treatment.

    Science.gov (United States)

    Welsh, Christopher

    2016-01-01

    As part of a comprehensive plan to attempt to minimize the diversion of prescribed controlled substances, many professional organization and licensing boards are recommending the use of "pill counts." This study sought to evaluate acceptability of the use of cellular phone and computer pictures/video for "pill counts" by patients in buprenorphine maintenance treatment. Patients prescribed buprenorphine/naloxone were asked a series of questions related to the type(s) of electronic communication to which they had access as well as their willingness to use these for the purpose of performing a "pill/film count." Of the 80 patients, 4 (5 percent) did not have a phone at all. Only 28 (35 percent) had a "smart phone" with some sort of data plan and Internet access. Forty (50 percent) of the patients had a phone with no camera and 10 (12.5 percent) had a phone with a camera but no video capability. All patients said that they would be willing to periodically use the video or camera on their phone or computer to have buprenorphine/naloxone pills or film counted as long as the communication was protected from electronic tampering. With the advent of applications for smart phones that allow for Health Insurance Portability and Accountability Act of 1996-compliant picture/video communication, a number of things can now be done that can enhance patient care as well as reduce the chances of misuse/diversion of prescribed medications. This could be used in settings where a larger proportion of controlled substances are prescribed including medication assisted therapy for opioid use disorders and pain management programs.

  2. Effect of pill burden on dosing preferences, willingness to pay, and likely adherence among patients with type 2 diabetes.

    Science.gov (United States)

    Hauber, A Brett; Han, Steven; Yang, Jui-Chen; Gantz, Ira; Tunceli, Kaan; Gonzalez, Juan Marcos; Brodovicz, Kimberly; Alexander, Charles M; Davies, Michael; Iglay, Kristy; Zhang, Qiaoyi; Radican, Larry

    2013-01-01

    To quantify willingness-to-pay (WTP) for reducing pill burden and dosing frequency among patients with type 2 diabetes mellitus (T2DM), and to examine the effect of dosing frequency and pill burden on likely medication adherence. Participants were US adults with T2DM on oral antihyperglycemic therapy. Each patient completed an online discrete-choice experiment (DCE) with eight choice questions, each including a pair of hypothetical medication profiles. Each profile was defined by reduction in average glucose (AG), daily dosing, chance of mild-to-moderate stomach problems, frequency of hypoglycemia, weight change, incremental risk of congestive heart failure (CHF), and cost. Patients were asked to rate their likely adherence to the profiles presented in each question. Choice questions were based on a predetermined experimental design. Choice data were analyzed using random-parameters logit. Likely treatment adherence was analyzed using a Heckman two-stage model. Of the 1,114 patients who completed the survey, 90 had lower dosing burden (pills/day taken once/day or as needed) for all medications, and 1,024 had higher dosing burden (≥5 pills/day or more than once/day). Reduction in AG was valued most highly by patients. Hypoglycemia, chance of mild-to-moderate stomach problems, weight change, incremental risk of CHF, and daily dosing were less valued. Patients with higher current dosing burden had lower WTP for more convenient dosing schedules than patients with lower current dosing burden. Changes in dosing and cost impacted likely adherence. The magnitude of the impact of dosing on likely adherence was higher for patients with lower current dosing burden than for patients with higher current dosing burden. Patients with T2DM were willing to pay for improvements in efficacy, side effects, and dosing. Patients' WTP for more convenient dosing depended on current dosing burden, as did the effect of these attributes on likely adherence.

  3. Identification and determination of the major constituents in traditional Chinese medicine Longdan Xiegan Pill by HPLC-DAD-ESI-MS

    OpenAIRE

    Liu, Hui; Su, Juan; Liang, Xu; Zhang, Xi; He, Ya-Jun; Huang, Hai-Qiang; Ye, Ji; Zhang, Wei-Dong

    2011-01-01

    A novel and sensitive HPLC-UV method has been developed for the simultaneous determination of twelve major compounds in Longdan Xiegan Pill. The chemical profile of the twelve compounds, including geniposidic acid (1), geniposide(2), gentiopicroside(3), liquiritin(4), crocin(5), baicalin(6), wogonoside(7), baicalein(8), glycyrrhizic acid (9), wogonin (10), oroxylin A (11) and aristolochic acid A (12), was acquired using high-performance liquid chromatography-diode array detector coupled with ...

  4. Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill

    OpenAIRE

    di Spiezio Sardo, Attilio

    2010-01-01

    Maurizio Guida, Giuseppe Bifulco, Attilio Di Spiezio Sardo, Mariamaddalena Scala, Loredana Maria Sosa Fernandez, Carmine NappiDipartimento di Scienze Ostetriche Ginecologiche Urologiche e Medicina della Riproduzione Umana, Università degli Studi “Federico II”, Napoli, Italia Abstract: The aim of this review is to define the role of the combined dienogest (DNG)/­estradiol valerate (E2V) contraceptive pill, in terms of biochemistry, metabolic and ­...

  5. Using caffeine pills for performance enhancement. An experimental study on university students’ willingness and their intention to try neuroenhancements.

    Directory of Open Access Journals (Sweden)

    Ralf eBrand

    2016-02-01

    Full Text Available Recent research has indicated that university students sometimes use caffeine pills for neuroenhancement (NE; non-medical, non-addictive use of psychoactive substances or technology to produce a subjective enhancement in psychological functioning and experience, especially during exam preparation. In our factorial survey experiment we manipulated the evidence participants were given about the prevalence of NE amongst peers and measured the resulting effects on the psychological predictors included in the Prototype-Willingness Model of risk behavior. Two hundred and thirty-one university students were randomized to a high prevalence condition (read faked research results overstating usage of caffeine pills amongst peers by a factor of 5; 50%, low prevalence condition (half the estimated prevalence; 5% or control condition (no information about peer prevalence. Structural equation modeling confirmed that our participants’ willingness and intention to use caffeine pills in the next exam period could be explained by their past use of neuroenhancers, attitude to NE and subjective norm about use of caffeine pills whilst image of the typical user was a much less important factor. Provision of inaccurate information about prevalence reduced the predictive power of attitude with respect to willingness by 40 45%. This may be because receiving information about peer prevalence which does not fit with their perception of the social norm causes people to question their attitude. Prevalence information might exert a deterrent effect on NE via the attitude-willingness association. We argue that research into NE and deterrence of associated risk behaviors should be informed by psychological theory.

  6. Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill

    Science.gov (United States)

    Guida, Maurizio; Bifulco, Giuseppe; Sardo, Attilio Di Spiezio; Scala, Mariamaddalena; Fernandez, Loredana Maria Sosa; Nappi, Carmine

    2010-01-01

    The aim of this review is to define the role of the combined dienogest (DNG)/estradiol valerate (E2V) contraceptive pill, in terms of biochemistry, metabolic and pharmacological effects and clinical application as well. E2V is the esterified form of 17β-estradiol (E2), while dienogest is a fourth-generation progestin with a partial antiandrogenic effect. The cycle stability is achieved with 2 to 3 mg DNG, supporting contraceptive efficacy. In this new oral contraceptive, E2V is combined with DNG in a four-phasic dose regimen (the first two tablets contain 3 mg E2V; the next five tablets include 2 mg E2V + 2 mg DNG, followed by 17 tablets with 2 mg E2V + 3 mg DNG; followed by two tablets with 1 mg E2V only, and finally two placebo tablets). Duration and intensity of scheduled withdrawal bleeding are lower with this contraceptive pill, whereas the incidence and the intensity of intra-cyclic bleeding are similar to the other oral contraceptive. With this new pill the levels of high density lipoprotein increased, while the levels of prothrombin fragment 1 + 2 and D-dimer remained relatively unchanged; the levels of sex hormone binding globulin, cortisol binding globulin, thyroxine binding globulin increased. The most frequently reported adverse events are: breast pain, headache, acne, alopecia, migraine, increase of bodyweight. The satisfaction rate is about 79.4%. PMID:21151673

  7. Oral contraceptive pills: A risk factor for retinal vascular occlusion in in-vitro fertilization patients

    Directory of Open Access Journals (Sweden)

    Rohina S Aggarwal

    2013-01-01

    Full Text Available Retinal vascular occlusion is the most common cause of retinopathy leading to severe visual loss in all age groups. Central retinal vein occlusion (CRVO is usually seen in older age group and is often associated with systemic vascular diseases. Although the exact cause and effect relationship has not been proven, central retinal vein occlusion has been associated with various systemic pathological conditions, hence a direct review of systems toward the various systemic and local factors predisposing the central retinal vein occlusion is advocated. We describe the development of central retinal venous occlusion with associated cystoid macular edema (CME in two healthy infertile women who were recruited for in vitro fertilization cycle for infertility. Predisposing risk factors associated with central retinal vein occlusion are obesity, sedentary life style, smoking, and some systemic diseases such as hyperlipidemia, hypertension, associated autoimmune disorders e.g., antiphospholipid antibody syndrome, lupus, diabetes mellitus, cardiovascular disorders, bleeding or clotting disorders, vasculitis, closed-head trauma, alcohol consumption, primary open-angle glaucoma or angle-closure glaucoma.In our patients, they were ruled out afterdoing allpertaining investigations. The cases were managed with further avoidance of oral contraceptives and intra-vitreal injections of Bevacizumab (Avastin, an anti-vascular endothelial growth factor (anti-VEGF drug and Triamcinolone acetonide (a long acting synthetic steroid. Hence, even if no systemic diseases are detected. Physical examinations are recommended periodically for young women on oral contraceptive pills.

  8. Microscopic identification of the remnant hair or feather of five animal drug components in Shenrongbian pill

    Directory of Open Access Journals (Sweden)

    Tingguo Kang

    2012-06-01

    Full Text Available A comparative study was performed to identify the microscopic characteristics of hair or feather in the five animal drug components contained in Shenrongbian pill. Penis et Testis Canis is 40±0.07 in the medulla index, with long circular, banana or triangular circular shaped medulla cells arranged in one line or network, and the hair cuticle is in imbrication (d, m and flat wave (p shape. Penis et Testis Equi is 66±0.10 in the medulla index, with ellipse, spindle or long strip-shaped medulla cells arranged in network, and the hair cuticle is in flat wave shape. Penis et Testis Bovis is 67±0.05 in the medulla index, with rectangle, spindle or polygon-shaped medulla cells arranged in ladder or network form, and the hair cuticle is in flat wave shape. Penis et Testis Mustelae is 29±0.05 in the medulla index, with ellipse-like, square-like or circular shaped medulla cells arranged in one line generally, and the hair cuticle is in acuminate (d, m, imbrication (m,p and slightly flat wave (p shape. Musculus et Bonis Passeris is 24±0.05 in the medulla index, with bamboo joint-shaped barbs and unclear medulla cells, without hair cuticle.

  9. Impact of the 2013 French Pill Crisis on Women's Behaviour Regarding Contraception.

    Science.gov (United States)

    Lemaitre, Magali; Lastennet, Glenn; Syr, David; Emmerich, Joseph; Zureik, Mahmoud

    2015-03-01

    In the last decade, several epidemiological studies have shown the increased risk of venous thromboembolism associated with third- and fourth-generation oral contraceptives (C3Gs and C4Gs) versus older combined first- and second-generation oral contraceptives (C1Gs and C2Gs). In France, in December 2012, a lawsuit filed against the National Agency for the Safety of Medicines and Health Products (ANSM) by a patient who had experienced a stroke, possibly due to the use of a C3G, triggered a national 'pill crisis'. Consequently, a 'crisis cell' was set up and pre-existing health recommendations were reinforced. The main aim of this study was to evaluate, in real time, the impact of the French health authorities' recommendations and communications on French women's behaviour regarding contraception. Real-time monthly sales data reported during 2013 were compared with monthly sales data reported in 2012. Analyses were stratified according to the type of contraceptive and age. An index corresponding to the number of months of contraception sold was developed to facilitate comparison of the different contraceptives despite their distinct features and to assess the overall trend of contraception. After a 2-year analysis (2013 versus 2012), a significant 45 % decrease (p crisis. A longitudinal analysis is required in order to assess any real long-term changes.

  10. Emergency contraceptive pill users' risk perceptions for sexually transmitted infections and future unintended pregnancy.

    Science.gov (United States)

    Hickey, Mary T; Shedlin, Michele G

    2017-09-01

    The availability of emergency contraception pills (ECP) over the counter (OTC) has the potential to reduce the incidence of unintended pregnancy; however, the increased risk for sexually transmitted infection (STI) acquisition, related to unprotected intercourse, has not been adequately addressed. The purpose of this study is to gain insight into risk perceptions for STIs and subsequent unintended pregnancy in women who have purchased ECP OTC. Twenty-one women, aged 18-24, attending a private university in an urban setting, who purchased and used ECP OTC participated in 1-h, individual interviews. Narrative, descriptive findings indicated that these women did not consider themselves at risk for STI or unintended pregnancy, despite having used ECP OTC. Pregnancy prevention was paramount for these women, which overshadowed concerns regarding STIs. Women at risk for unintended consequences of sexual activity are not fully cognizant of those potential outcomes and do not take measures to prevent their occurrence. The availability of ECP OTC offers protection against unintended pregnancy; however, opportunities for health promotion and prevention counseling may be lost. ©2017 American Association of Nurse Practitioners.

  11. Yueju Pill Rapidly Induces Antidepressant-Like Effects and Acutely Enhances BDNF Expression in Mouse Brain

    Directory of Open Access Journals (Sweden)

    Wenda Xue

    2013-01-01

    Full Text Available The traditional antidepressants have a major disadvantage in delayed onset of efficacy, and the emerging fast-acting antidepressant ketamine has adverse behavioral and neurotoxic effects. Yueju pill, an herb medicine formulated eight hundred years ago by Doctor Zhu Danxi, has been popularly prescribed in China for alleviation of depression-like symptoms. Although several clinical outcome studies reported the relative short onset of antidepressant effects of Yueju, this has not been scientifically investigated. We, therefore, examined the rapid antidepressant effect of Yueju in mice and tested the underlying molecular mechanisms. We found that acute administration of ethanol extract of Yueju rapidly attenuated depressive-like symptoms in learned helpless paradigm, and the antidepressant-like effects were sustained for at least 24 hours in tail suspension test in ICR mice. Additionally, Yueju, like ketamine, rapidly increased the expression of brain-derived neurotrophic factor (BDNF in the hippocampus, whereas the BDNF mRNA expression remained unaltered. Yueju rapidly reduced the phosphorylation of eukaryotic elongation factor 2 (eEF2, leading to desuppression of BDNF synthesis. Unlike ketamine, both the BDNF expression and eEF2 phosphorylation were revered at 24 hours after Yueju administration. This study is the first to demonstrate the rapid antidepressant effects of an herb medicine, offering an opportunity to improve therapy of depression.

  12. Safety and effectiveness data for emergency contraceptive pills among women with obesity: a systematic review.

    Science.gov (United States)

    Jatlaoui, Tara C; Curtis, Kathryn M

    2016-12-01

    This study aims to determine whether emergency contraceptive pills (ECPs) are less safe and effective for women with obesity compared with those without obesity. We searched PubMed for articles through November 2015 regarding the safety and effectiveness of ECPs [ulipristal acetate (UPA), levonorgestrel (LNG) and combined estrogen and progestin] among obese users. We assessed study quality using the United States Preventive Services Task Force evidence grading system. We identified four pooled secondary analyses (quality: poor to fair), two of which examined UPA and three examined LNG formulations. Three analyses pooled overlapping data from a total of three primary studies and demonstrated significant associations between obesity and risk of pregnancy after ECP use. One analysis reported a 4-fold increased risk of pregnancy among women with obesity (BMI≥30kg/m 2 ) compared with women within normal/underweight categories (BMIcontraception; at weights less than 75 kg, the rate of pregnancy was less than 2%. Two analyses examining UPA suggested an approximate 2-fold increased risk of pregnancy among women with obesity compared with either normal/underweight women or nonobese (BMIemergency contraception options in order for them to understand their options, to receive advanced supplies of emergency contraception as needed and to understand how to access an emergency copper intrauterine device if desired. Copyright © 2016. Published by Elsevier Inc.

  13. Treatment of premenstrual worsening of depression with adjunctive oral contraceptive pills: a preliminary report.

    Science.gov (United States)

    Joffe, Hadine; Petrillo, Laura F; Viguera, Adele C; Gottshcall, Hannah; Soares, Claudio N; Hall, Janet E; Cohen, Lee S

    2007-12-01

    Despite the efficacy of antidepres-sants, depression can break through premenstrually. Oral contraceptive pills (OCPs) stabilize reproductive hormones and treat premenstrual dysphoric disorder. Management of depression that breaks through premenstrually has not been studied. Women taking antidepressants with successfully treated depression, except during the late luteal phase (Montgomery-Asberg Depression Rating Scale [MADRS] score >or= 15) and high late-luteal phase (Daily Rating of Severity of Problems scores) were randomly assigned to open-label ethinyl estradiol (EE) 30 mug/day plus drospirenone 3 mg/day (EE/DRSP) for 21 days and double-blinded treatment with EE 30 mug/day or placebo for days 22 through 28 of 2 cycles. Participants were recruited from community and psychiatry outpatient clinics and enrolled into this study in 2004-2005. Of 25 subjects who received EE/DRSP (N = 12 with EE and N = 13 with placebo), 21 completed treatment. For study completers, premenstrual MADRS (p = .0019) and Daily Rating of Severity of Problems scores (p = .0001) improved significantly in both groups. Outcome did not differ between groups. This study provides preliminary evidence that addition of EE/DRSP (+/- EE) to antidepressants may treat premenstrual breakthrough of depression. Stabilizing hormone levels with EE/DRSP may provide an important therapeutic option for women taking antidepressants whose symptoms break through premenstrually.

  14. Antiplatelet Effects of Qishen Yiqi Dropping Pill in Platelets Aggregation in Hyperlipidemic Rabbits

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    Yi Wang

    2012-01-01

    Full Text Available We investigated the effects of Qishen Yiqi Dropping Pill (QSYQ on platelets aggregation and its possible mechanisms. Hyperlipidemic model in rabbits was produced by a high fat/cholesterol diet for 6 weeks, the therapeutic effect of QSYQ with 2.0 g/kg, 1.0 g/kg, and 0.5 g/kg was observed. Fourteen days after drug treatment, platelet aggregation induced by adenosine diphosphate (ADP, arachidonic acid (AA, and collagen (COLL was significantly reduced in rabbits of model group. Moreover, β-thromboglobulin (β-TG level decreased obviously but no significant change in P-selectin and platelet factor 4 (PF4 level, while QSYQ significantly decreased the ratio of thromboxane B2 (TXB2 to 6-keto-prostaglandin F1α (6-Keto-PGF1α and increased cyclic adenosine monophosphate (cAMP level in rabbits. In summary, QSYQ can improve platelets aggregation and inhibit the over-release of β-TG in hyperlipidemic rabbits; and the increased cAMP level may be involved in this process. These results suggest that the antiplatelet aggregation effect of QSYQ may be due to its ability to increase cAMP level for improving cAMP metabolism.

  15. Clinical risk factors for venous thromboembolus in users of the combined oral contraceptive pill

    Science.gov (United States)

    Black, Corri; Kaye, James A; Jick, Hershel

    2002-01-01

    Aims To estimate the risk of venous thromboembolism among women prescribed the oral contraceptive pill who have acute clinical conditions such as lower limb fractures, compared with women with idiopathic venous thromboembolism. Methods A nested case-control analysis using the General Practice Research Database, January 1993 to December 1999 was carried out. The participants were women aged 15–39 years, prescribed third generation oral contraceptives (gestodene and desogestrel) or oral contraceptives containing levonorgestrel. The main outcome measures were odds ratios as a measure of the relative risk estimate for venous thromboembolism in women with clinical conditions that predispose to VTE. Results The adjusted relative risk estimate for venous thromboembolism among patients with the acute clinical conditions, compared with those without such illness, and adjusted for oral contraceptive use, was 17 (95% CI 6.5, 46). Conclusions This paper documents the strong independent association between certain acute clinical conditions and venous thromboembolism in women prescribed oral contraceptives. Failure to accurately identify and exclude such patients from a study of the effect of oral contraceptives on the risk of venous thromboembolism would result in an underestimate of the risk of venous thromboembolism associated with oral contraceptives. PMID:12047488

  16. Severe Erosive Pill Esophagitis Induced by Crizotinib Therapy: A Case Report and Literature Review

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    Patrick Jung

    2016-01-01

    Full Text Available Previous case reports have described esophagitis thought to be secondary to crizotinib, an oral tyrosine-kinase inhibitor used in the treatment of anaplastic lymphoma kinase- (ALK- positive non-small cell lung cancer (NSCLC. In those reports, the interval development of esophagitis was between two days and three months after initiating or reinitiating crizotinib therapy. We present a woman who developed ulcerative esophagitis ten months after beginning crizotinib therapy, which is highly unusual. We believe the provoking factor was a change in her medication administration routine, done to accommodate religious practices during the period of Ramadan. This case illustrates the mechanism of pill esophagitis and reinforces the importance of patient education when it comes to medication administration. Clinicians may consider early imaging or investigations in patients with concerning symptomatology in the context of crizotinib therapy or other offending medications. Future research may help to uncover additional risk factors for this exceedingly rare diagnosis in this patient population. Most importantly, this case highlights nonpharmacologic ways to improve tolerability and decrease adverse effects of a highly effective chemotherapeutic agent.

  17. Evaluation of Distributive Frequency of Oral Contraceptive Pills Consumption in Women with Cerebrovascular Events Admitted in Farshchian Hospital of Hamadan between 1997-2007

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    Mehrdokht Mazdeh

    2011-06-01

    Full Text Available Background & Objectives: Although there is no prolonged time elapsed from propagation of oral contraceptive pills (OCP, case reports demonstrated occurrence of pulmonary embolism and cerebral infarction in women using these pills. Present study was done to specify distributive frequency of oral contraceptive pills consumption in women with cerebrovascular events admitted in Farshchian hospital of Hamadan between 1997 to 2007. Materials & Methods: Every woman with cerebrovascular events during years 1997-2007 who was admitted in Farshchian hospital of Hamadan and her dossier was present in archive of hospital, were carefully checked and those who hadn’t exclusion criteria, were include in this study, a total of 1587 of them with respect to their Characteristics such as type of cerebrovascular event, age, type of oral contraceptive pill and duration of pill use were extracted from patient dossier and registered in respective checklist. Results: 24.1% of patient used oral contraceptive pill and 76.9% of patients were non users. Mean age of OCP users and non users were 45 years. Mean duration of pill use among these patients was 33 months. In assessing type of vascular events, in the group OCP users 73.1% and non users 66.4% had ischemic stroke.Which was statistically significant. In the group OCP users 24.6% and non users 29.1% were hemorrhagic stroke.. Also in the group OCP users 2.3% and non users 4.5% were affected sagital sinuses thrombosis that showed no significant difference. Among OCP users 85% of the patients used OCP, LD and 15% of the patients OCP, HD. Conclusion: The present study showed, the ischemic stroke rate of the patients with OCP consumption were significantly more than those of non users.

  18. Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

    Science.gov (United States)

    Lee, J Y; Kusek, J W; Greene, P G; Bernhard, S; Norris, K; Smith, D; Wilkening, B; Wright, J T

    1996-08-01

    The Medication Event Monitoring System (MEMS), an electronic monitor which records the date and time of bottle cap openings, and pill counts were used to assess patterns of adherence for the primary antihypertensive drug in the African American Study of Kidney Disease and Hypertension Pilot Study (AASK). Blacks with hypertension and moderately reduced renal function were randomized to one of two levels of blood pressure control and to one of three antihypertensive drug regimens: primary therapy with a calcium channel blocker, an angiotension converting enzyme inhibitor, or a beta-blocker. Of the 94 participants in AASK, 91 had MEMS recordings and pill counts for 313 regularly scheduled monthly follow-up visits. The average length of follow-up was 4.6 months. An acceptable level of adherence by pill count was achieved if 80% to 100% of the prescribed pills were not returned to the clinic. Adherence by MEMS to a once-a-day drug dosing schedule was acceptable if 80% of the time intervals between MEMS openings were within 24 +/- 6 h. Acceptable adherence by pill count was observed at 68% of the follow-up visits; MEMS indicated nonadherence at 47% of those visits. Blood pressure was within goal in 50% of the participants who were adherent by both pill count and MEMS throughout their follow-up visits, and only 14% of the participants who were identified nonadherent by one or both methods. These findings suggest that electronic monitoring is a useful adjunct to pill counts in assessing adherence to antihypertensive drugs. Feedback of electronically collected information on dosing intervals to participants and staff may enhance adherence.

  19. From Kaua'i to Hawai'i Island: Interisland Differences in Emergency Contraceptive Pill Availability.

    Science.gov (United States)

    Bullock, Holly; Tschann, Mary; Elia, Jennifer; Kaneshiro, Bliss; Salcedo, Jennifer

    2017-07-01

    Emergency contraceptive pills (ECPs) are medications used after unprotected intercourse, underprotected intercourse, or sexual assault to decrease the risk of pregnancy. Availability of ECPs in Hawai'i's retail pharmacies was last assessed in 2007, following over-the-counter access to levonorgestrel ECPs (LNG-ECP) for women age 18 years or older and prior to U.S. Food and Drug Administration (FDA) approval of prescription-only ulipristal acetate (UPA). We conducted a county-by-county subanalysis from a larger observational population-based study on statewide availability of ECPs in Hawai'i's pharmacies. In the original study, researchers called all 198 unique retail pharmacies in Hawai'i between December 2013 and June 2014. Only 3% of pharmacies had UPA immediately available on-site in the state, with UPA available on Kaua'i and O'ahu only. At least one form of LNG-ECPs was available in 82% of pharmacies in 2013-2014, roughly the same as 2007 (81%) (P=0.9) when Lana'i and Moloka'i lacked access. Currently, only Moloka'i lacks retail pharmacy access to ECPs. When controlling for general inflation, the 2013-2014 mean price for name brand LNG-ECP fell within the reported range of 2007 prices. Generic LNG-ECPs were substantially lower in price than name brand LNG-ECPs in 2007 and 2013-2014. Availability of UPA is limited and significantly lower compared to LNG-ECPs. Availability of LNG-ECPs statewide has remained stable and the arrival of generics has decreased prices.

  20. Efficacy of a combined contraceptive regimen consisting of condoms and emergency contraception pills.

    Science.gov (United States)

    Zhao, Rui; Wu, Jun-Qing; Li, Yu-Yan; Zhou, Ying; Ji, Hong-Lei; Li, Yi-Ran

    2014-04-14

    To evaluate and compare the effectiveness of the combined regimen (consisting of condoms and emergency contraception pills (ECP)) and using condoms only for the purpose of preventing pregnancy. One-thousand-five-hundred-and-sixty-two (1,562) couples as volunteers enrolled at nine centers in Shanghai. Eight-hundred-and-twelve (812) were randomized to use male condoms and ECP (i.e., Levonorgestrel) as a back-up to condoms (the intervention group) and 750 to use male condoms only(the control group), according to their working unit. Participants were visited at admission and at the end of 1, 3, 6, 9, and 12 months. The cumulative life table rates were calculated for pregnancy and other reasons for discontinuation. The gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were 7.76 ± 0.94 and 6.61 ± 0.91, respectively, per 100 women (χ2 = 0.41, p = 0.5227). The cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were 2.17 ± 0.52 and 1.25 ± 0.41, respectively, per 100 women (χ2 = 1.93, p = 0.1645). The Pearl Index in the condoms plus emergency contraception group and the condoms only group were 2.21% and 1.26%, respectively. Male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used. In addition, the lowest pregnancy rate followed from perfect use condom.

  1. Effect of long-term combined oral contraceptive pill use on endometrial thickness.

    Science.gov (United States)

    Talukdar, Nayana; Bentov, Yaakov; Chang, Paul T; Esfandiari, Navid; Nazemian, Zohreh; Casper, Robert F

    2012-08-01

    To estimate whether there is any association of long-term use of combined oral contraceptive pills (OCP) with adverse endometrial growth. We reviewed the charts of 137 patients with history of OCP use undergoing endometrial preparation with estrogen for frozen embryo transfer. Endometrial thickness was measured by transvaginal ultrasonography on day 10 after menses and patients were divided into two groups (less than 7 mm and 7 mm or more). Thirty patients had endometrial thickness less than 7 mm and 107 had thickness of 7 mm or more. Mean years of combined OCP use in each group were 9.8±4.54 and 5.8±4.52, respectively (Pday 10 in patients using combined OCP for less than 10 years and 10 years or more were 9.54±1.88 mm and 8.48±2.33 mm, respectively, with P=.007. The mean endometrial thickness was 9.72±1.69 mm in less than 5 years and 8.81±2.23 mm in 5 or more years of use, respectively (P=.008). Cycle cancellation rates in the less than 7 mm group and 7 mm or greater endometrial thickness group were 23% and 4%, respectively (P=.002), but there was no difference in the clinical pregnancy rates between the two groups (13% compared with 27%, respectively; P=.15). Long-term combined OCP use (5 years or more) can potentially affect optimal endometrial growth, leading to a higher cancellation rate and longer stimulation in frozen embryo transfer cycles. These findings suggest a previously unidentified adverse effect of long-term combined OCP use in women who are anticipating future fertility. II.

  2. Knowledge and opinion of pharmacists on emergency contraceptive pills in Hungary.

    Science.gov (United States)

    Vanya, Melinda; Matuz, Maria; Benko, Ria; Viola, Reka; Horvath-Sziklai, Attila; Soos, Gyongyvér; Bartfai, Gyorgy

    2017-06-01

    Background Emergency contraceptive pills (ECPs) are used to prevent unintended pregnancy. There is a worldwide intention to improve access to ECPs; therefore, identifying potential barriers to introducing over-the counter (OTC) access is of utmost importance. As pharmacists are the key personnel to convey accurate drug information, their knowledge and attitude on ECPs is important. Objective We aimed to conduct a nationwide study to assess pharmacists' knowledge on ECPs and to survey their opinion on sales category change of ECPs (i.e. to introduce OTC access in pharmacies). Setting Registered pharmacists in Hungary. Method A prospective cross-sectional study was conducted with an anonymous, web-based questionnaire. Univariate analysis (Mann-Whitney U test and Fischer's exact test) was used to identify factors associated with supportive opinion toward OTC provision. Main outcome measure Knowledge level of pharmacists, proportion of pharmacists with supportive opinion on OTC access. Results 357 out of 2019 pharmacists completed the questionnaire, yielding a 17.7% response rate. Almost 30% of pharmacists (N = 99) agreed that ECPs should have an OTC availability in Hungary. More than 40% of pharmacists (N = 145) considered ECPs as contraceptives. On average, 55.18% (standard deviation: ±12.40%) of the answers were correct, showing moderate knowledge of the pharmacists. Age and rating ECPs as contraceptives were significantly associated with supportive opinion toward OTC provision (p opinion was significant in young pharmacists (p = 0.02). Conclusion Pharmacists' knowledge and opinion on ECPs should be improved, especially that of the young ones. Currently the attitude of pharmacists does not favor sales category changes of ECPs in Hungary.

  3. Treatment of Premenstrual Breakthrough of Depression With Adjunctive Oral Contraceptive Pills Compared With Placebo.

    Science.gov (United States)

    Peters, Whitney; Freeman, Marlene P; Kim, Semmie; Cohen, Lee S; Joffe, Hadine

    2017-10-01

    Two-thirds of women with depressive disorders report reemergence of depression premenstrually, or premenstrual exacerbation (PME), despite effective treatment of the underlying mood disorder during the remainder of the cycle. There is a paucity of studies that rigorously assess treatments targeting PME. Open-label data suggest that augmentation of antidepressants with the oral contraceptive pill (OCP) drospirenone and ethinyl estradiol (DRSP/EE) improves depressive symptoms that break through treatment premenstrually. We now report results of a randomized placebo-controlled OCP augmentation trial. Women with unipolar depressive disorders in remission on stable antidepressant doses with a 30% increase in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from the follicular to luteal phase were randomized to double-blind augmentation of antidepressant with either DRSP/EE or placebo for 2 months. The MADRS and Daily Record of Severity of Problems (DRSP) measures were anchored to the menstrual cycle phase. Of 32 women randomized, 25 (n = 12 DRSP/EE, n = 13 placebo) completed the trial. Premenstrual MADRS scores declined by a median of 43.6% and 38.9% (P = 0.59), and premenstrual DRSP scores declined by a median of 23.5% and 20.9% (P = 0.62) in the DRSP/EE and placebo groups, respectively. There was a trend toward greater improvement in premenstrual DRSP scores for women with fewer lifetime depressive episodes (r = -0.40, P = 0.06). Findings from this small randomized trial suggest that OCP augmentation of antidepressants may not be effective for treating premenstrual breakthrough of depression. Future studies should target women established to have hormonal sensitivity prior to antidepressant therapy and those with fewer lifetime depressive episodes.

  4. Magic Learning Pill: Ontological and Instrumental Learning in Order to Speed Up Education.

    Science.gov (United States)

    Matusov, Eugene; Baker, Daniella; Fan, Yueyue; Choi, Hye Jung; L Hampel, Robert

    2017-09-01

    The purpose of this research is to investigate the phenomenology of learning - people"s attitudes toward their learning experiences that have inherent worth in themselves (i.e., ontological learning) or have value outside of the learning itself (i.e., instrumental learning). In order to explore this topic, 58 participants from the U.S., Russia, and Brazil were interviewed with a central question derived from the science fiction writer Isaac Asimov's short story "Profession": whether participants would take a "Magic Learning Pill" (MLP) to avoid the process of learning, and instead magically acquire the knowledge. The MLP would guarantee the immediate learning by skipping the process of learning while achieving the same effect of gaining skills and knowledge. Almost all participants could think of some learning experiences for which they would take MLP and others for which they would not. Many participants would not take MLP for ontological learning, which is learning experiences that have inherent value for the people, while they would take MLP for instrumental learning, which is learning that mainly serves some other non-educational purposes. The main finding suggests that both instrumental and ontological types of learning are recognized by a wide range of people from diverse cultures as present and valued in their lives. This is especially significant in light of the overwhelmingly instrumental tone of public discourse about education. In the context of formal education, ontological learning was mentioned 35 times (28.0%) while instrumental learning was mentioned 74 times (60.2%). Although ontological learning was often mentioned as taking place outside of school, incorporating pedagogy supporting ontological learning at school deserves consideration.

  5. Danqi Pill regulates lipid metabolism disorder induced by myocardial ischemia through FATP-CPTI pathway.

    Science.gov (United States)

    Wang, Yong; Li, Chun; Wang, Qiyan; Shi, Tianjiao; Wang, Jing; Chen, Hui; Wu, Yan; Han, Jing; Guo, Shuzhen; Wang, Yuanyuan; Wang, Wei

    2015-02-21

    Danqi Pill (DQP), which contains Chinese herbs Salvia miltiorrhiza Bunge and Panax notoginseng, is widely used in the treatment of myocardial ischemia (MI) in China. Its regulatory effects on MI-associated lipid metabolism disorders haven't been comprehensively studied so far. We aimed to systematically investigate the regulatory mechanism of DQP on myocardial ischemia-induced lipid metabolism disorders. Myocardial ischemia rat model was induced by left anterior descending coronary artery ligation. The rat models were divided into three groups: model group with administration of normal saline, study group with administration of DanQi aqueous solution (1.5 mg/kg) and positive-control group with administration of pravastatin aqueous solution (1.2 mg/kg). In addition, another sham-operated group was set as negative control. At 28 days after treatment, cardiac function and degree of lipid metabolism disorders in rats of different groups were measured. Plasma lipid disorders were induced by myocardial ischemia, with manifestation of up-regulation of triglyceride (TG), low density lipoprotein (LDL), Apolipoprotein B (Apo-B) and 3-hydroxy-3-methyl glutaryl coenzyme A reductase (HMGCR). DQP could down-regulate the levels of TG, LDL, Apo-B and HMGCR. The Lipid transport pathway, fatty acids transport protein (FATP) and Carnitine palmitoyltransferase I (CPTI) were down-regulated in model group. DQP could improve plasma lipid metabolism by up-regulating this lipid transport pathway. The transcription factors peroxisome proliferator-activated receptor α (PPARα) and retinoid X receptors (RXRs), which regulate lipid metabolism, were also up-regulated by DQP. Furthermore, DQP was able to improve heart function and up-regulate ejection fraction (EF) by increasing the cardiac diastolic volume. Our study reveals that DQP would be an ideal alternative drug for the treatment of dyslipidemia which is induced by myocardial ischemia.

  6. Adherence to and persistence with non-vitamin K-antagonist oral anticoagulants: does the number of pills per day matter?

    Science.gov (United States)

    Rubboli, Andrea

    2015-01-01

    Once daily dosing schedule is associated with increased adherence to and persistence with cardiovascular therapies. Such feature has been claimed responsible for the significantly lower (both temporary and permanent) discontinuation of oral anticoagulation with rivaroxaban (which is given once daily) compared to dabigatran (which is given twice daily) in a large, real-world dataset of patients with atrial fibrillation (AF) in the United States. While a cause-effect relationship between dosing schedule and adherence and persistence could not be established, the above finding supports nonetheless the preferential selection of the non vitamin-K-antagonists oral anticoagulant (NOAC) with the easiest and most convenient regimen. Given however, the differences in efficacy and safety observed with the various NOACs compared to warfarin in the phase III clinical trials in non-valvular AF, careful individualization of treatment should be pursued, being dosing schedule only one of the variables to be taken into account. Maximal effort instead, should be put in implementing measures to enhance patient's adherence to and persistence with treatment.

  7. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception.

    Science.gov (United States)

    Brache, V; Cochon, L; Duijkers, I J M; Levy, D P; Kapp, N; Monteil, C; Abitbol, J L; Klipping, C

    2015-12-01

    Is there a pharmacodynamic interaction between ulipristal acetate (UPA) 30 mg for emergency contraception and a daily progestin-only contraceptive pill, desogestrel (DSG) 0.75 mg, when initiated the next day? In this study, DSG impaired the ability of UPA to delay ovulation, but UPA had little impact on the onset of contraceptive effects due to DSG. UPA is a progesterone receptor modulator used for emergency contraceptive (EC) at the dose of 30 mg. UPA delays ovulation by at least 5 days when administered in the mid to late follicular phase. In theory, potent progestins could reactivate progesterone signaling that leads to follicle rupture, thereby impacting the effectiveness of UPA as EC. In addition, UPA could alter the onset of the contraceptive effect of progestin-containing contraceptives started immediately after UPA. A single-blind (for observer), placebo-controlled, partial crossover study was conducted in two sites [Dominican Republic (DR) and the Netherlands (NDL)] over 11 months from October 2012 to September 2013. Healthy female volunteers participated in two of the three treatment cycles separated by a washout cycle. Treatment combinations studied were as follows: (i) a single 30 mg dose of UPA followed by 75 µg per day DSG for 20 days, (ii) a single 30 mg dose of UPA followed by 20 days of placebo matching that of DSG (PLB2) or (iii) one tablet of placebo-matching UPA (PLB1) followed by 75 µg per day DSG for 20 days. Participants were randomized to one of the three treatment sequences (UPA + DSG/UPA + PLB2, PLB1 + DSG/UPA + DSG and UPA + PLB2/PLB1 + DSG) when a lead follicle was ≥ 14 to day after UPA significantly reduced the ovulation delaying effect of UPA (P = 0.0054). While ovulation occurred in only one of the 29 UPA-only cycles (3%) in the first 5 days, it occurred in 13 of the 29 (45%) UPA + DSG cycles. This was a small, descriptive, pharmacodynamic study in which some findings differed by study site. Distinguishing between a cystic corpus

  8. The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis

    Science.gov (United States)

    van Galen, Katy A.; Nellen, Jeannine F.; Nieuwkerk, Pythia T.

    2014-01-01

    Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a quantitative estimate of treatment adherence, without restriction to medical condition. The odds ratio (OR) of optimal adherence with FDCs versus separate pills was used as common effect size and aggregated into a pooled effect estimate using a random effect model with inverse variance weights. Out of 1258 articles screened, only six studies fulfilled inclusion criteria. Across medical conditions, administering drugs as FDC significantly increased the likelihood of optimal adherence (OR 1.33 (95% CI, 1.03–1.71)). Within subgroups of specific medical conditions, the favourable effect of FDCs on adherence was of borderline statistical significance for HIV infection only (OR 1.46 (95% CI, 1.00–2.13)). We observed a remarkable paucity of RCTs comparing the effect on adherence of administering drugs as FDC versus as separate pills. Administering drugs as FDC improved medication adherence. However, this conclusion is based on a limited number of RCTs only. PMID:25276422

  9. Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill

    Directory of Open Access Journals (Sweden)

    Maurizio Guida

    2010-08-01

    Full Text Available Maurizio Guida, Giuseppe Bifulco, Attilio Di Spiezio Sardo, Mariamaddalena Scala, Loredana Maria Sosa Fernandez, Carmine NappiDipartimento di Scienze Ostetriche Ginecologiche Urologiche e Medicina della Riproduzione Umana, Università degli Studi “Federico II”, Napoli, Italia Abstract: The aim of this review is to define the role of the combined dienogest (DNG/­estradiol valerate (E2V contraceptive pill, in terms of biochemistry, metabolic and ­pharmacological effects and clinical application as well. E2V is the esterified form of 17β-estradiol (E2, while dienogest is a fourth-generation progestin with a partial antiandrogenic effect. The cycle stability is achieved with 2 to 3 mg DNG, supporting contraceptive efficacy. In this new oral contraceptive, E2V is combined with DNG in a four-phasic dose regimen (the first two tablets contain 3 mg E2V; the next five tablets include 2 mg E2V + 2 mg DNG, followed by 17 tablets with 2 mg E2V + 3 mg DNG; followed by two tablets with 1 mg E2V only, and finally two placebo tablets. Duration and intensity of scheduled withdrawal bleeding are lower with this ­contraceptive pill, whereas the incidence and the intensity of intra-cyclic bleeding are similar to the other oral contraceptive. With this new pill the levels of high density lipoprotein increased, while the levels of prothrombin fragment 1 + 2 and D-dimer remained relatively unchanged; the levels of sex hormone binding globulin, cortisol binding globulin, thyroxine binding globulin increased. The most frequently reported adverse events are: breast pain, headache, acne, alopecia, migraine, increase of ­bodyweight. The satisfaction rate is about 79.4%.Keywords: estradiol valerate, dienogest, combined oral contraceptive, four-phasic regimen, contraceptive safety

  10. Identification and determination of the major constituents in traditional Chinese medicine Longdan Xiegan Pill by HPLC-DAD-ESI-MS

    Directory of Open Access Journals (Sweden)

    Hui Liu

    2011-02-01

    Full Text Available A novel and sensitive HPLC-UV method has been developed for the simultaneous determination of twelve major compounds in Longdan Xiegan Pill. The chemical profile of the twelve compounds, including geniposidic acid (1, geniposide(2, gentiopicroside(3, liquiritin(4, crocin(5, baicalin(6, wogonoside(7, baicalein(8, glycyrrhizic acid (9, wogonin (10, oroxylin A (11 and aristolochic acid A (12, was acquired using high-performance liquid chromatography-diode array detector coupled with an electrospray tandem mass spectrometer (HPLC-DAD-ESI-MS. The analysis was performed on a Dikma Platisil ODS C18 column (250 mm × 4. 6 mm, 5 μm with a gradient solvent system of acetonitrile-0. 1% aqueous formic acid. The validation was carried out and the linearities (r > 0. 9996, repeatability (RSD<1. 8%, intra- and inter-day precision (RSD< 1. 3%, and recoveries (ranging from 96. 6% to 103. 4% were acceptable. The limits of detection (LOD of these compounds ranged from 0.29 to 4. 17 ng. Aristolochic acid A, which is the toxic ingredient, was not detected in all the batches of Longdan Xiegan Pill. Furthermore, hierarchical cluster analysis was used to evaluate the variation of the herbal prescription. The proposed method is simple, effective and suitable for the quality control of this traditional Chinese medicine (TCM. Keywords: Longdan Xiegan Pill, high-performance liquid chromatography-diode array detector coupled with an electrospray tandem mass spectrometer (HPLC-DAD-ESI-MS, qualitative evaluation, aristolochic acid A, hierarchical cluster analysis

  11. The beta-hCG+erythropoietin in acute stroke (BETAS) study: a 3-center, single-dose, open-label, noncontrolled, phase IIa safety trial.

    Science.gov (United States)

    Cramer, Steven C; Fitzpatrick, Camille; Warren, Michael; Hill, Michael D; Brown, David; Whitaker, Laura; Ryckborst, Karla J; Plon, Lawrence

    2010-05-01

    Animal data suggest the use of beta-human chorionic gonadotropin followed by erythropoietin to promote brain repair after stroke. The current study directly translated these results by evaluating safety of this sequential growth factor therapy through a 3-center, single-dose, open-label, noncontrolled, Phase IIa trial. Patients with ischemic stroke 24 to 48 hours old and National Institutes of Health Stroke Scale score of 6 to 24 started a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation). This study also evaluated performance of serially measured domain-specific end points. A total of 15 patients were enrolled. Two deaths occurred, neither related to study medications. No safety concerns were noted among clinical or laboratory measures, including screening for deep vein thrombosis and serial measures of serum hemoglobin. In several instances, domain-specific end points provided greater insight into impairments as compared with global outcome measures. Results support the safety of this sequential, 2-growth factor therapy initiated 24 to 48 hours after stroke onset.

  12. The influence of medical education level on the Jagiellonian University Collegium Medicum medical students' knowledge concerning oral hormonal contraceptive pills.

    Science.gov (United States)

    Polak, Karina; Pityński, Kazimierz; Banaś, Tomasz; Bubel, Magdalena; Kałwa, Maria; Jamroga, Joanna; Knysak, Magdalena; Kusior, Magdalena; Truszkiewicz, Katarzyna; Oleksy, Piotr

    In December 2014 the authors carried out a research among Jagiellonian University Collegium Medicum medical students in a form of a questionnaire which consisted of two parts: personal information and multiple choice test concerning student's knowledge on OCPs. It showed that the level of medical education, defined as the year of study, increases student's knowledge about oral hormonal contraceptive pills. New program of study introduced from academic year 2012/2013 gives students wider knowledge on OCPs at earlier stage of education. Factors as female sex, usage of OCPs by student or his partner, positive attitude towards recommending OCPs to future patients show positive correlation with student's knowledge.

  13. Retained Pill Camera at an Entero-Uracho-Vesical Fistula Site in a Patient with Crohn's Disease

    OpenAIRE

    Yheulon, Christopher G; Derosa, Daniel C; Gagliano, Ronald A

    2013-01-01

    An 18-year-old female patient with Crohn's disease had abdominal pain secondary to a retained pill camera. After several weeks of medical management, the camera spontaneously passed. However, the patient also had an intra-abdominal abscess that worsened, despite medical therapy. Surgical therapy was recommended and a 5cm infected urachal cyst with entero-urachal and vesico-urachal fistulas was discovered. An en-bloc resection of the entire area was performed to include the urachal cyst, the a...

  14. Effect of pill burden on dosing preferences, willingness to pay, and likely adherence among patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Hauber AB

    2013-09-01

    Full Text Available A Brett Hauber,1 Steven Han,2,3 Jui-Chen Yang,1 Ira Gantz,2 Kaan Tunceli,2 Juan Marcos Gonzalez,1 Kimberly Brodovicz,2 Charles M Alexander,2 Michael Davies,2 Kristy Iglay,2 Qiaoyi Zhang,2 Larry Radican2 1Health Preference Assessment, Research Triangle Institute (RTI Health Solutions, Research Triangle Park, NC, USA; 2Merck Sharp and Dohme Corporation, Whitehouse Station, NJ, USA; 3Temple University, Philadelphia, PA, USA Purpose: To quantify willingness-to-pay (WTP for reducing pill burden and dosing frequency among patients with type 2 diabetes mellitus (T2DM, and to examine the effect of dosing frequency and pill burden on likely medication adherence. Patients and methods: Participants were US adults with T2DM on oral antihyperglycemic therapy. Each patient completed an online discrete-choice experiment (DCE with eight choice questions, each including a pair of hypothetical medication profiles. Each profile was defined by reduction in average glucose (AG, daily dosing, chance of mild-to-moderate stomach problems, frequency of hypoglycemia, weight change, incremental risk of congestive heart failure (CHF, and cost. Patients were asked to rate their likely adherence to the profiles presented in each question. Choice questions were based on a predetermined experimental design. Choice data were analyzed using random-parameters logit. Likely treatment adherence was analyzed using a Heckman two-stage model. Results: Of the 1,114 patients who completed the survey, 90 had lower dosing burden (<5 pills/day taken once/day or as needed for all medications, and 1,024 had higher dosing burden (≥5 pills/day or more than once/day. Reduction in AG was valued most highly by patients. Hypoglycemia, chance of mild-to-moderate stomach problems, weight change, incremental risk of CHF, and daily dosing were less valued. Patients with higher current dosing burden had lower WTP for more convenient dosing schedules than patients with lower current dosing burden

  15. Effects of the coadministration of Huatuo Zaizao pills and aspirin on hemorrheology and blood coagulation in rabbits

    OpenAIRE

    QU, SHUJUN; WANG, TIAN; ZHANG, JIANQIAO; SUN, XUE; YU, PENGFEI; KONG, LIANG; CHONG, YATING; QIU, XIAOLEI; FU, FENGHUA

    2013-01-01

    Huatuo Zaizao pills (HT) is a compound used in Chinese medicine for the treatment of cerebrovascular diseases. The present study aimed to investigate the effects of the coadministration of HT and aspirin on hemorrheology and blood coagulation in rabbits. Rabbits were randomly divided into the control, HT, aspirin and HT plus aspirin groups (n=5 animals per group). The rabbits were treated with HT at a dose of 1 g/kg, aspirin at a dose of 5 mg/kg or HT (1 g/kg) plus aspirin (5 mg/kg) administe...

  16. A danger of induction of Brugada syndrome during pill-in-the-pocket therapy for paroxysmal atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Yoshiyasu Aizawa

    2010-08-01

    Full Text Available Yoshiyasu Aizawa, Tomohiro Matsuhashi, Toshiaki Sato, Seiji Takatsuki, Keiichi FukudaDivision of Cardiology, Keio University School of Medicine, Tokyo, JapanAbstract: Rhythm control therapy by sodium channel blockers is widely performed for the ­treatment of paroxysmal atrial fibrillation. Here, we present a case of acquired Brugada ­syndrome by pill-in-the-pocket treatment using pilsicainide. It is important that this therapy should be applied only after confirming the drug safety to the patients.Keywords: syncope, sudden death, drug, rhythm control, pilsicainide, atrial flutter

  17. "Pregnancy and labour cause more deaths than oral contraceptives": The debate on the pill in the Spanish press in the 1960s and 1970s.

    Science.gov (United States)

    Ortiz-Gómez, Teresa; Ignaciuk, Agata

    2015-08-01

    From 1941 to 1978, Franco's regime in Spain banned all contraceptive methods. The pill started circulating in Spain from the 1960s, officially as a drug used in gynaecological therapy. However, in the following decade it was also increasingly used and prescribed as a contraceptive. This paper analyses debates about the contraceptive pill in the Spanish daily newspaper ABC and in two magazines, Blanco y Negro and Triunfo, in the 1960s and 1970s. It concludes that the debate on this contraceptive method was much more heterogeneous than might be expected given the Catholic-conservative character of the dictatorship. The daily press focused on the adverse effects of the drug and magazines concentrated on the ethical and religious aspects of the pill and discussed it in a generally positive light. Male doctors and Catholic authors dominated the debate. © The Author(s) 2013.

  18. Low-Thermal Conductivity Suspensions Used in the Isolation of the Salt Pills Aboard the Astro-H Adiabatic Demagnetization Refrigerator

    Science.gov (United States)

    Kimball, Mark O.; Shirron, Peter J.; Wegel, Donald C.; James, Bryan L.; Galassi, Nicholas M.; Faulkner, Richard L.; San Sebastian, Marcelino

    2011-01-01

    An adiabatic demagnetization refrigerator (ADR) utilizes the magnetocholoric effect in a paramagnetic salt to produce sub-Kelvin temperatures. It is a solid-state device that has no moving parts and does not rely upon a density gradient in a working fluid. This makes it ideal for cooling space-based instruments. ·Typically the salt is enclosed in a cylindrical pill that is suspended within the bore of a magnet. The suspension between the salt pill and magnet must be robust enough to survive a launch yet have a thermal conductance that minimizes heat from the magnet that is mechanically, and thermally, anchored to a stage at a higher temperature. Here we detail such a design that uses Kevlar(Trade Mark) as the supporting media in a system that limits motion of the salt pill axial as well as laterally with respect to the magnet bore.

  19. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study.

    Science.gov (United States)

    Pozniak, Anton; Arribas, Jose R; Gathe, Joseph; Gupta, Samir K; Post, Frank A; Bloch, Mark; Avihingsanon, Anchalee; Crofoot, Gordon; Benson, Paul; Lichtenstein, Kenneth; Ramgopal, Moti; Chetchotisakd, Ploenchan; Custodio, Joseph M; Abram, Michael E; Wei, Xuelian; Cheng, Andrew; McCallister, Scott; SenGupta, Devi; Fordyce, Marshall W

    2016-04-15

    Tenofovir alafenamide (TAF) is a novel tenofovir prodrug with improved renal and bone safety compared with TDF-containing regimens. We report the 48 week safety and efficacy of a once-daily single tablet regimen of elvitegravir 150 mg (E), cobicistat 150 mg (C), emtricitabine 200 mg (F), and TAF 10 mg (E/C/F/TAF) in HIV-1-infected patients with mild to moderate renal impairment. We enrolled virologically suppressed HIV-1-infected subjects with estimated creatinine clearance (CrCl) 30-69 mL/min in a single-arm, open-label study to switch regimens to E/C/F/TAF. The primary endpoint was the change from baseline in glomerular filtration rate estimated using various formulae. This study is registered with ClinicalTrials.gov, number NCT01818596. We enrolled and treated 242 patients with mean age 58 years, 18% Black, 39% hypertension, 14% diabetes. Through week 48, no significant change in estimated CrCl was observed. Two patients (0.8%) discontinued study drug for decreased creatinine clearance, neither had evidence of renal tubulopathy and both had uncontrolled hypertension. Subjects had significant improvements in proteinuria, albuminuria, and tubular proteinuria (P Proteinuria, albuminuria and bone mineral density significantly improved. These data support the efficacy and safety of once daily E/C/F/TAF in HIV+ patients with mild or moderate renal impairment without dose adjustment.

  20. Comparison of combined hormonal vaginal ring and low dose combined oral hormonal pill for the treatment of idiopathic chronic pelvic pain: a randomised trial.

    Science.gov (United States)

    Priya, Khushboo; Rajaram, Shalini; Goel, Neerja

    2016-12-01

    To compare the efficacy and acceptability of combined hormonal vaginal ring with combined oral hormonal pill in women with idiopathic chronic pelvic pain. Randomised prospective interventional trial conducted in 60 women with idiopathic chronic pelvic pain. Women were randomised into two groups of 30 each. In each group, treatment was given for 84 days using either combined vaginal ring or combined oral hormonal pill. Hormonal vaginal ring releases 15mcg of ethinyl estradiol and 120mcg of the etonogestrel per day while the hormonal pill contained 30mcg of ethinyl estradiol and 150mcg of levonorgestrel. There was no ring or pill free week. After every 28 days, pain relief was measured using visual analogue scale (VAS), and verbal rating score (VRS) calculated by summing dysmenorrhea, non-cyclic pelvic pain (NCCP) and deep dyspareunia scores. Side effects, compliance, satisfaction, and user acceptability were also measured. Data was analyzed using various parametric and non-parametric tests. Reduction in mean VAS score at end of treatment in ring group was 6.23 (95% confidence interval [CI], 5.45-7.01; ppill group (95% CI, 4.83-6.23; ppill users (95% CI, 3.63-5.10; ppill group at end of one month after stopping treatment. Compliance, satisfaction, and user acceptability were higher in ring users (80%) than pill users (70%) and a higher incidence of nausea was seen in pill group. Present study demonstrates for first time that both vaginal and oral hormonal therapy are effective in treatment of idiopathic chronic pelvic pain and vaginal ring may be a better choice with higher satisfaction rate and fewer side effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.

    Science.gov (United States)

    Shin, Donghoon; Lee, SeungHwan; Lim, Kyoung Soo; Park, Joong Shin; Shin, Sang-Goo; Jang, In-Jin; Yu, Kyung-Sang

    2013-06-01

    The progestin dienogest was developed for oral contraception, endometriosis treatment and menopause management. Dienogest's pharmacokinetics have been primarily studied in Caucasian women. This study evaluated the single- and multiple-dose pharmacokinetics of dienogest in Korean women. Sixteen healthy Korean adult women received a single administration of 2 mg dienogest, followed by multiple once-daily administrations for 14 days. The single-dose administration and the final dose of the multiple administrations were each followed by blood sampling over 60 h. The mean (SD) maximum serum concentration after multiple doses of dienogest was slightly increased compared with that after a single dose [from 51.6 (9.6) to 56.6 (11.9) ng/mL], as was the area under the concentration-time curves (AUC)0-24h [from 503 (56.3) to 613 (90.7) ng ∙ h/mL]. The linearity factor calculated by AUCs of single and multiple doses is 1.00 ± 0.14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared. The present study described the single- and multiple-dose pharmacokinetic profiles of dienogest in Korean women and showed linear pharmacokinetics of dienogest at steady state. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study.

    LENUS (Irish Health Repository)

    Sreenan, S

    2008-12-01

    The PREDICTIVE study is a multinational observational study designed to follow up patients with diabetes who started insulin detemir (IDet) in routine care. Recruitment started in June 2004 and is ongoing in some countries.

  3. Long term effectiveness of once-daily unboosted atazanavir plus abacavir/lamivudine as a switch strategy in subjects with virological suppression

    DEFF Research Database (Denmark)

    Llibre, Josep M; Cozzi-Lepri, Alessandro; La Rosa, Jorge Antonio Valencia

    2014-01-01

    routine however are scant. METHODS: We evaluated treatment outcomes of ATV400+ABC/3TC in pre-treated subjects in the EuroSIDA cohort with undetectable HIV-1 RNA, and previous ABC experience or assumed previous HLA B57*01 testing. We performed a time to loss of virologic response (TLOVR below 50 c....../mL) and a snapshot analysis at 48, 96 and 144 weeks. Virological failure (VF) was defined as a confirmed plasma HIV-1 RNA >50 c/mL. RESULTS: We included 258 subjects: 176 (68%) male, median age 46 (IQR 41, 53) y, 225 (87.2%) white, hepatitis virus co-infection 36%, median baseline CD4 at switch 540 cells (360, 700......, respectively, 89.5 [95% CI 85.1, 92.9]/88 [83.4, 91.7]/86.3% [81.6, 90.4] (TLOVR, composite endpoint failure or stop for any reason) and the risk of VF was 8.3/7.6/7.6%. In the snapshot analysis HIV-RNA was below 50 c/mL in 72.5/65.9/51.6%, respectively, and >50 c/mL in 6.6/5.4/4.3%. Only 0...

  4. Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM: Crossover pilot study (J-VICTORIA study

    Directory of Open Access Journals (Sweden)

    Sakamoto Masaya

    2012-08-01

    Full Text Available Abstract Background No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM and cardiovascular parameters. Methods Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1 mean (± standard deviation 24-hour blood glucose level, 2 mean amplitude of glycemic excursions (MAGE, 3 fasting blood glucose level, 4 highest postprandial blood glucose level and time, 5 increase in blood glucose level after each meal, 6 area under the curve (AUC for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7 area over the curve (AOC for daily blood glucose level Results The mean 24-hour blood glucose level was significantly lower in patients taking vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012. In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040, the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015, the AUC (≥180 mg/dL within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025, and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008 than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin. Conclusions CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin. Trial registration UMIN000007687

  5. Utilizing a Two-stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-daily Bupropion as a Treatment for Methamphetamine Use Disorder.

    Science.gov (United States)

    Mooney, Larissa J; Hillhouse, Maureen P; Thomas, Christie; Ang, Alfonso; Sharma, Gaurav; Terry, Garth; Chang, Linda; Walker, Robrina; Trivedi, Madhukar; Croteau, David; Sparenborg, Steven; Ling, Walter

    2016-01-01

    This 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder. The study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform. Participants met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for severe MA use disorder, self-reported ≥20 days of MA use in the 30 days prior to consent, and submitted 3 MA-positive urine drug screens (UDS) out of 4 collected during screening. Participants attended clinic twice weekly for observed BRP dosing, UDS testing, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9. Analyses evaluated effects of XR-NTX + BRP to determine the number of "responders" according to a statistically predefined response criterion (6 of 8 MA-negative UDS during the last 4 weeks of medication). The 2-stage design required that stage 1 yield ≥3 responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2). Under the statistical analysis plan, study "success" required ≥9 responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study.

  6. Once-daily intravenous busulfan with therapeutic drug monitoring compared to conventional oral busulfan improves survival and engraftment in children undergoing allogeneic stem cell transplantation

    NARCIS (Netherlands)

    Bartelink, Imke H.; Bredius, Robbert G. M.; Ververs, Tessa T.; Raphael, Martine F.; van Kesteren, Charlotte; Bierings, Marc; Rademaker, Carin M. A.; den Hartigh, J.; Uiterwaal, Cuno S. P. M.; Zwaveling, Juliette; Boelens, Jaap J.

    Because of intra- and interindividual variability, bioavailability, and pharmacokinetics of busulfan (Bu) in children, oral busulfan without therapeutic drug monitoring (TDM) is assumed to be associated with higher graft failure rates as well as higher toxicity (eg, veno-occlusive disease [VOD]).

  7. Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma

    DEFF Research Database (Denmark)

    Dahl, Ronald; Engel, Michael; Dusser, Daniel

    2016-01-01

    BACKGROUND: Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma. OBJECTIVE: To evaluate safety and tolerability of tiotro...

  8. Long term effectiveness of once-daily unboosted atazanavir plus abacavir/lamivudine as a switch strategy in subjects with virological suppression

    DEFF Research Database (Denmark)

    Llibre, Josep M; Cozzi-Lepri, Alessandro; La Rosa, Jorge Antonio Valencia

    2014-01-01

    BACKGROUND: Use of unboosted atazanavir (ATV400) is approved in the US but not in Europe (1). Due to pharmacokinetic interactions it should not be used with tenofovir but can be used with abacavir/lamivudine (ABC/3TC) (1, 2) (3). Effectiveness data of ATV400+ABC/3TC as a switch strategy in clinic...... 50 c/mL is associated with relatively low rates of VF and discontinuation due to adverse events. Use might be considered in those with long-term suppression and without prior PI failure. Larger cohorts are required to further define the appropriate selection criteria....

  9. Ketoconazole is inferior to ritonavir as an alternative booster for saquinavir in a once daily regimen in Thai HIV-1 infected patients

    NARCIS (Netherlands)

    Autar, Reshma Saskia; Wit, Ferdinand W. N. M.; Sankote, Jongkol; Sutthichom, Duanghathai; Kimenai, Elly; Hassink, Elly; Hill, Andrew; Cooper, David A.; Phanuphak, Praphan; Lange, Joep M. A.; Burger, David M.; Ruxrungtham, Kiat

    2007-01-01

    OBJECTIVE: To improve the pharmacokinetics of protease inhibitors, boosting with low-dose ritonavir is performed. However, toxicity, storage conditions and high costs of antiretroviral treatment may necessitate interruption of ritonavir. Ketoconazole was investigated as a potential booster of

  10. Ketoconazole is inferior to ritonavir as an alternative booster for saquinavir in a once daily regimen in Thai HIV-1 infected patients.

    NARCIS (Netherlands)

    Autar, R.S.; Wit, F.W.; Sankote, J.; Sutthichom, D.; Kimenai, E.; Hassink, E.A.M.; Hill, A.; Cooper, D.A.; Phanuphak, P.; Lange, J.M.A.; Burger, D.M.; Ruxrungtham, K.

    2007-01-01

    OBJECTIVE: To improve the pharmacokinetics of protease inhibitors, boosting with low-dose ritonavir is performed. However, toxicity, storage conditions and high costs of antiretroviral treatment may necessitate interruption of ritonavir. Ketoconazole was investigated as a potential booster of

  11. Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

    Science.gov (United States)

    Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

    2017-10-01

    Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%). The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Clinical efficacy of Zisheng pills in treatment of adverse reactions in patients with primary hepatocellular carcinoma after transcatheter arterial chemoembolization

    Directory of Open Access Journals (Sweden)

    LIU Xiaping

    2015-01-01

    Full Text Available ObjectiveTo investigate the clinical efficacy of Zisheng pills in the treatment of adverse reactions in patients with primary hepatocellular carcinoma (HCC after transcatheter arterial chemoembolization (TACE. MethodsThis study included 72 patients with liver cancer hospitalized in the Department of Liver Diseases and Department of Oncology, Wenzhou Hospital of Traditional Chinese Medicine, from June 2011 to May 2014. These cases were randomly divided into treatment group (n=37 and control group (n=35. All the patients were treated with TACE, as well as conventional symptomatic and supportive treatment. In addition, the treatment group was given Zisheng pills (one bag three times a day for at least three consecutive months. Comparison of categorical data was made by chi-square test, while comparison of continuous data (expressed as mean±SD was made by t test. Survival comparison was made by Kaplan-Meier method and log-rank test. ResultsAfter the first TACE, there were significant differences in poor appetite and abdominal distension between the treatment group and the control group (P<0.05; significant differences were also observed in CD3+ and CD4+ T lymphocytes between the two groups (P<0.05. After the second TACE, there were significant differences in postoperative fatigue, poor appetite, and abdominal distension, as well as postoperative Karnofsky score, between the treatment group and the control group (P<0.05; significant differences were also found in CD3+, CD4+, and CD8+ T lymphocytes and CD4+/CD8+ ratio between the two groups (P<0.05. The median survival time showed no significant differences between the treatment group and the control group (82 vs 74 weeks, P>0.05, but the 2-year overall survival rate was significantly higher in the treatment group than in the control group (43.2% vs 20%, P<0.05. ConclusionZisheng pills have good clinical efficacy in the treatment of adverse reactions in liver cancer patients after TACE

  13. Importance of a 5- versus 7-day pill-free interval in a GnRH antagonist protocol using corifollitropin alfa: a prospective cohort study in oocyte donors.

    Science.gov (United States)

    Pérez-Calvo, Alicia; Martínez, Francisca; Blockeel, Christophe; Clúa, Elisabeth; Rodríguez, Ignacio; Barri, Pere N; Coroleu, Buenaventura

    2017-10-01

    In this prospective cohort study, oocyte donors were recruited prospectively and assigned to receive corifollitropin alfa: 5 days after pill discontinuation (group D5; 42 donors), or 7 days after pill discontinuation (group D7; 50 donors) in a gonadotrophin-releasing hormone antagonist protocol. Fixed additional daily doses of 200 IU recombinent FSH (rFSH) were started after 7 days of corifollitropinalfa, until triggering. No significant differences in basal characteristics were observed between both groups. In group D5, mean (SD) total additional rFSH dose was 659 (452) IU; in group D7, total rFSH dose was 459 (356) IU (P = 0.022). Duration of stimulation was significantly longer in group D5 compared with group D7 (P = 0.002). No differences were found in total number of oocytes obtained. Total number of injections was significantly lower in group D7 compared with group D5 (9.8 [3.2] versus 11.9 [3.9], respectively; P = 0.004). Total cost of medication used for donor treatment was significantly higher in group D5 than in group D7 (P = 0.015). After more than 22 days of pill-taking, extending the pill-free interval to 7 days significantly reduces the total dose of gonadotrophins, duration of stimulation, total cost of medication and total number of injections. Copyright © 2017. Published by Elsevier Ltd.

  14. [Effect of Jingang Jiangu pill (see text) on expression of integrin beta1 and alphavbeta3 in ovariectomized osteoporosis model rats].

    Science.gov (United States)

    Yang, Shao-Feng; Li, Ling-Hui; Chen, Qing; Yao, Gong-He; Deng, Bo; Xiang, Jian-Feng; Nie, Ying; Luo, Zhen-Hua; Guo, Yan-Tao

    2013-02-01

    To investigate the regulatory effect of Jingang Jiangu pill (see text, JGJG) on expression of integrin in ovariectomized rats. Fifty ovariectomized 10 months old female rats were randomly divided into 5 groups: Fushanmei group (FSM), Jingang Jiangu pill (see text) group (JGJG), Gusongbao granule group (GSB), Model group (OVX), Sham group. After ovariectomized,the rats were raised in the same environment for 13 weeks. The rats in JGJG group took 0.13 g JGJG pill orally each day for each rat; the rats in GSB group took 0.86 g GSB granule orally each day for each rat; the rats in FSM group took 0.28 mg FSM orally each day for each rat; and the rats in OVX and sham groups took sodium. The treatment duration of rats in above 5 groups was 13 weeks. Bone mineral density (BMD) and the expression of integrin beta1 and alphavbeta3 were detected in each group after the treatment. RESYKTS: The BMD and the expression of integrin beta1 in FSM group, JGJG group and GSB group improved obviously than that of OVX group. There were statistical difference between these groups (P<0.05). The expression of integrin alphavbeta3 of the three treating groups significantly depressed. The JGJG pill improves BMD and express of integrin beta1, in ovariectomized rats and reduces express of integrin alphavbeta3 through the regulation of the coupling of osteoblasts and osteoclasts.

  15. Investigating Birth Control: Comparing Oestrogen Levels in Patients Using the Ortho Evra[R] Patch versus the Ortho-Cyclen[R] Pill

    Science.gov (United States)

    Laurent, Theresa A.

    2008-01-01

    Recent drug studies have investigated the incidence of blood clots among patients using the Ortho Evra[R] birth control patch. In this article, the author describes an investigation of oestrogen levels in the body resulting from the application of the Ortho Evra[R] birth control patch versus daily use of Ortho-Cyclen[R] birth control pills.…

  16. Emergency Contraceptive Pill (ECP) Use and Experiences at College Health Centers in the Mid-Atlantic United States: Changes since ECP Went Over-the-Counter

    Science.gov (United States)

    Miller, Laura M.

    2011-01-01

    Objective: To investigate the availability of emergency contraceptive pills (ECPs) at college health centers since ECP went over-the-counter (OTC) in 2006. Related issues, such as distribution procedure, existence of a written protocol, personnel involved, contraindications, follow-up procedures, methods of advertising, and staff attitudes, were…

  17. Emergency Contraceptive Pills: A 10-Year Follow-up Survey of Use and Experiences at College Health Centers in the Mid-Atlantic United States

    Science.gov (United States)

    Miller, Laura McKeller; Sawyer, Robin G.

    2006-01-01

    The authors conducted a 10-year follow-up study using a telephone survey to investigate the availability of emergency contraceptive pills (ECPs) at college health centers in the mid-Atlantic region of the United States. They also examined related issues, such as distribution procedure, existence of a written protocol, personnel involved,…

  18. How-To-Do-It: Snails, Pill Bugs, Mealworms, and Chi-Square? Using Invertebrate Behavior to Illustrate Hypothesis Testing with Chi-Square.

    Science.gov (United States)

    Biermann, Carol

    1988-01-01

    Described is a study designed to introduce students to the behavior of common invertebrate animals, and to use of the chi-square statistical technique. Discusses activities with snails, pill bugs, and mealworms. Provides an abbreviated chi-square table and instructions for performing the experiments and statistical tests. (CW)

  19. Zhenbao pill protects against acute spinal cord injury via miR-146a-5p regulating the expression of GPR17

    Science.gov (United States)

    Lv, Bokang; Huan, Yanqiang; Liu, Bin; Li, Yutang; Jia, Lizhou; Qu, Chenhui; Wang, Dongsheng; Yu, Hai

    2018-01-01

    The aim of the present study was to observe the effect of zhenbao pill on the motor function of acute spinal cord injury (ASCI) rats and the molecular mechanisms involving miR-146a-5p and G-protein-coupled receptor 17 (GPR17). ASCI rat model was established by modified Allen method, and then the rats were divided into three groups. SH-SY5Y cells were cultured overnight in hypoxia condition and transfected with miR-146a-5p mimic or miR-146a-5p inhibitor. The hind limb motor function of the rats was evaluated by Basso, Beattie, Bresnahan (BBB) scoring system. Quantitative real-time PCR (qRT-PCR) and Western blot were used to detect the expression of miR-146a-5p, GPR17, inducible nitric oxide synthase (iNOS), interleukin 1β (IL-1β), and tumor necrosis factor α (TNF-α). Neuronal apoptosis was measured using flow cytometry assay. Luciferase reporter assay was performed to determine the regulation of miR-146a-5p on GPR17. Zhenbao pill could enhance hind limb motor function and attenuate the inflammatory response caused by ASCI. Moreover, zhenbao pill increased the level of miR-146a-5p and decreased GPR17 expression in vivo and in vitro. Bioinformatics software predicted that GPR17 3′-UTR had a binding site with miR-146a-5p. Luciferase reporter assay showed that miR-146a-5p had a negative regulatory effect on GPR17 expression. Knockdown of miR-146a-5p could reverse the effect of zhenbao pill on the up-regulation of GPR17 induced by hypoxia, reversed the inhibitory effect of zhenbao pill on the cell apoptosis induced by hypoxia and the recovery of zhenbao pill on hind limb motor function in ASCI rats. Zhenbao pill could inhibit neuronal apoptosis by regulating miR-146a-5p/GPR17 expression, and then promoting the recovery of spinal cord function. PMID:29187582

  20. Overdose of oral contraceptive pills as a means of intentional self-poisoning amongst young women in Sri Lanka

    DEFF Research Database (Denmark)

    Weerasinghe, Manjula; Konradsen, Flemming; Eddleston, Michael

    2017-01-01

    OBJECTIVE: Oral contraceptive pills (OCPs) are one of the most popular family planning methods in Sri Lanka. As part of two hospital-based studies on self-harm, the use of OCPs was identified, from yet unpublished results, as a means of intentional self-poisoning. To inform future guidelines......-four patients (52 women and two men) with an overdose of OCP as a means of intentional self-poisoning were admitted to one of the surveyed hospitals. The median age of the patients was 19 (interquartile range, 5) years. None of the patients were severely sick from their overdose and two-thirds of the patients...... were discharged within a day of admission. Intentional self-poisoning with OCPs represented less than 5% of all types of intentional medicine self-poisonings recorded at the hospitals. Information available for a subset of female patients indicates that many cases (13/23, 56.5%) were in their first...

  1. Effect of QiShenYiQi Pill on Myocardial Collagen Metabolism in Rats with Partial Abdominal Aortic Coarctation

    Directory of Open Access Journals (Sweden)

    Shichao Lv

    2015-01-01

    Full Text Available This study investigated the effect of QiShenYiQi pill (QSYQ on myocardial collagen metabolism in rats with partial abdominal aortic coarctation and explored its mechanism of action. A series of assays were used to detect the effect and mechanism of QSYQ on systolic blood pressure, heart mass index, left ventricle mass index, HYP, expression of PICP, PIIINT, and CTX-I in serum, MMP-1, and TIMP-1 expression in myocardium. We observed that QSYQ can reduce the rate of myocardial collagen synthesis and increase the rate of myocardial collagen degradation. It also effectively improved the degree of myocardial fibrosis in partial abdominal aortic rats and it had a tendency to have a greater effect with longer treatment duration, which is related to the mechanism of regulation of MMP-1 and TIMP-1 expression in the myocardial rat.

  2. Project Octo-Pills - A practice model engaging community pharmacists in the care of patients from a tertiary hospital.

    Science.gov (United States)

    Ong, Kheng Yong; Chung, Wing Lam; Mamun, Kaysar; Chen, Li Li

    2017-10-13

    Even while pharmacy practice evolves to a more patient-centric mode of practice, local hospitals, due to high patient load as well as space and resource constraints, find it challenging to conduct thorough medication review and physical medication reconciliation for all patients. In light of this, optimizing the local current healthcare system to involve community pharmacists in the care of patients from public hospitals could potentially better cater to the healthcare needs of the older population. Due to easy accessibility, community pharmacies are often the first point of contact in the healthcare system. Project Octo-Pills aims to engage community pharmacists in the collaborative care of patients from a tertiary hospital, providing patients with quality medication reconciliation and review services from a more convenient location within their neighborhood. This paper describes the model for this pilot initiative. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Using Pill Identification Calls to Poison Centers as a Marker of Drug Abuse at Three Texas Military Bases.

    Science.gov (United States)

    Ng, Patrick C; Maddry, Joseph K; Sessions, Daniel; Borys, Douglas J; Bebarta, Vikhyat S

    2017-11-01

    Opioid abuse is a growing problem in civilian communities, and it has developed in the military as well. Telephone calls to poison centers requesting pill identification (ID) is a marker of drug abuse. This study identifies the number of pill ID calls made to the poison centers from areas containing and surrounding three Texas military bases during an 8-year period. We performed a retrospective observational study identifying calls to certified poison centers in Texas from 2002 to 2009 that identified hydrocodone tablets and other pain medications. We noted the calls made from ZIP codes containing and surrounding the three largest military bases in Texas. We reviewed 75,537 drug ID calls for any drug from the ZIP codes of interest. Total drug ID calls increased 105% and the number of calls for hydrocodone increased 463%. In our study most of the drug ID calls from military communities in Texas were for hydrocodone. The rate of calls for hydrocodone increased more than the rate of calls for other analgesics from 2002 to 2009. Using drug ID calls as a surrogate of drug abuse, our results suggest that hydrocodone abuse has increased within military communities and that poison center data can be a reliable surrogate for prescription drug abuse near military bases. Future studies are needed to further understand the extent of this problem in military and civilian communities. We can use this information to heighten awareness, influence prescription practices, establish practice guidelines, and develop educational programs to mitigate the increasing rate of prescription analgesic abuse in the United States.

  4. Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill: A proof-of-concept trial.

    Science.gov (United States)

    Chen, Melissa J; Hsia, Jennifer K; Creinin, Mitchell D

    2018-02-26

    We evaluated a novel concept of initiating the etonogestrel implant as a "back-up" method in women who desire using combined oral contraceptives (COC) but want to decrease their risk of unintended pregnancy with a more effective method. In this prospective cohort study, we planned to include 20 women as a proof-of-concept. We enrolled both new COC starters and continuing COC users and placed an etonogestrel implant. Participants completed daily bleeding diaries and attended follow-up visits at 1, 3, and 6 months. We assessed implant continuation through six months of study participation and side effects with dual hormonal contraceptive use. Between September and December 2016, we enrolled 10 new starters and 10 current COC users. All participants completed 1-month follow-up, and 18 (90%) subjects completed the 3- and 6-month follow-up assessments. Two current COC users had the implant removed for mood changes before 6 months. At the 6-month follow-up visit, 10 women were using both pills and implant, seven relied on the implant only, and one was using a COC only. Three new starters chose implant removal at end of study participation; one for weight gain and acne, another for mood changes, and one for decreased libido. No subjects discontinued the implant for bleeding complaints. In this proof-of-concept study, women using COCs were willing to initiate the implant as a "back-up" method to improve pregnancy prevention. Most women continued the implant through 6 months and after completing study participation. Initiating the etonogestrel implant as a "back-up" method may be an option for women who desire more effective pregnancy prevention while using combined oral contraceptive pills for its bleeding profile or non-contraceptive benefits. Copyright © 2018. Published by Elsevier Inc.

  5. Safety, efficacy, actions, and patient acceptability of drospirenone/ethinyl estradiol contraceptive pills in the treatment of premenstrual dysphoric disorder

    Directory of Open Access Journals (Sweden)

    Lesley L Breech

    2009-08-01

    Full Text Available Lesley L Breech, Paula K BravermanDivision of Adolescent Medicine, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USAAbstract: Premenstrual dysphoric disorder (PMDD is estimated to affect 3%–8% of reproductive age women. Multiple therapeutic modalities have been evaluated with varying efficacy for the associated somatic and mood symptoms. The majority of older studies had shown that oral contraceptive pills (OCs were most effective for the physical symptoms. However, newer OCs containing a novel progestin, drospirenone, have shown promise in alleviating both the somatic and affective/behavioral symptoms. This progestin, which is a derivative of spironolactone, has both antimineralocorticoid and antiandrogenic activity. A 24/4 formulation containing 20 µg of ethinyl estradiol has been found effective in randomized double-blind placebo-controlled trials utilizing established scales documenting symptoms associated with PMDD. Multiple studies have shown that drospirenone-containing OCs are safe without evidence of clinically adverse effects on carbohydrate metabolism, lipids, blood pressure, weight, serum potassium or increased thrombotic events compared to other low dose OCs. In addition, significant improvements have been demonstrated in acne, hirsutism, and fluid retention symptoms. Several open label studies demonstrated good patient compliance and reported satisfaction with the method. Because of the significant placebo effect demonstrated in the blinded placebo-controlled trials, additional large randomized placebo-controlled trials are needed to confirm the efficacy of the drospirenone OCs in the treatment of PMDD. However, this OC formulation appears to be a promising therapeutic modality.Keywords: drospirenone, premenstrual dysphoric disorder, premenstrual syndrome, oral contraceptive pill

  6. A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen

    DEFF Research Database (Denmark)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique

    2015-01-01

    OBJECTIVES: Progestogen-only pills (POPs) are safer with respect to cardiovascular risks than contraceptives containing estrogens. Despite the increased contraceptive efficacy of a desogestrel-only pill compared with a traditional POP, POPs are still not widely used due to an unpredictable bleeding......, to assess the effects on cervical mucus permeability and bleeding. METHODS: Sixty-four healthy volunteers with proven ovulatory cycles were randomised and treated with either the drospirenone-only or the desogestrel-only pill during two 28-day cycles. Follicular diameter, endometrial thickness, and serum...

  7. Reaching the end of the line: Operational issues with implementing phone-based unannounced pill counts in resource-limited settings.

    Directory of Open Access Journals (Sweden)

    Yael Hirsch-Moverman

    Full Text Available Accurate measurement of adherence is necessary to ensure that therapeutic outcomes can be attributed to the recommended treatment. Phone-based unannounced pill counts were shown to be feasible and reliable measures of adherence in developed settings; and have been further used as part of medication adherence interventions. However, it is not clear whether this method can be implemented successfully in resource-limited settings, where cellular network and mobile phone coverage may be low. Our objective is to describe operational issues surrounding the use of phone-based unannounced pill counts in Lesotho and Ethiopia.Phone-based monthly unannounced pill counts, using an adaptation of a standardized protocol from previous US-based studies, were utilized to measure anti-TB and antiretroviral medication adherence in two implementation science studies in resource-limited settings, START (Lesotho and ENRICH (Ethiopia.In START, 19.6% of calls were completed, with 71.9% of participants reached at least once; majority of failed call attempts were due to phones not being available (54.8% or because participants were away from the pills (32.7%. In ENRICH, 33.5% of calls were completed, with 86.7% of participants reached at least once; the main reasons for failed call attempts were phones being switched off (31.5%, participants not answering (27.3%, participants' discomfort speaking on the phone (15.4%, and network problems (13.2%. Structural, facility-level, participant-level, and data collection challenges were encountered in these settings.Phone-based unannounced pill counts were found to be challenging, and response rates suboptimal. While some of these challenges were specific to local contexts, most of them are generalizable to resource-limited settings. In a research study context, a possible solution to ease operational challenges may be to focus phone-based unannounced pill count efforts on a randomly selected sample from participants who are

  8. SESK ja SEKK / Toomas Pill ; T. Pill

    Index Scriptorium Estoniae

    Pill, Toomas

    2007-01-01

    3. mail toimunud koosolekul tegi Heidi Aedma ettepaneku korraldada Sydney Eesti Seenioride Koondise kokkutulekud laupäeviti ja soovituse asendada endine nimi teisiti - Sydney Eesti Kultuuriklubi (SEKK)

  9. The impact of using the combined oral contraceptive pill for cycle scheduling on gene expression related to endometrial receptivity.

    Science.gov (United States)

    Bermejo, Alfonso; Iglesias, Carlos; Ruiz-Alonso, María; Blesa, David; Simón, Carlos; Pellicer, Antonio; García-Velasco, Juan

    2014-06-01

    Does the combined oral contraceptive pill (COCP) change endometrial gene expression when used for cycle programming? COCP used for scheduling purposes does not have a significant impact on endometrial gene expression related to endometrial receptivity. Controversy exists around COCP pretreatment for IVF cycle programming, as some authors claim that it might be detrimental to the live birth rate. Microarray technology applied to the study of tissue gene expression has previously revealed the behavior of genes related to endometrial receptivity under different conditions. Proof-of-concept study of 10 young healthy oocyte donors undergoing controlled ovarian stimulation (COS) recruited between June 2012 and February 2013. Microarray data were obtained from endometrial biopsies from 10 young healthy oocyte donors undergoing COS with GnRH antagonists and recombinant FSH. In group A (n = 5), COCP pretreatment was used for 12-16 days, and stimulation began after a 5-day pill-free interval. Stimulation in group B (n = 5) was initiated on cycle day 3 after a spontaneous menses. Endometrial biopsies were collected 7 days after triggering with hCG. No individual genes exhibited increased or decreased expression (fold change (FC) >2) in patients with prior COCP treatment (group A) compared with controls (group B). However, the results of the functional analysis showed a total of 11 biological processes that were significantly enriched in group A compared with group B (non-COCP). The Endometrial Receptivity Array (ERA) has only been validated on endometrial samples obtained in natural cycles and after hormonal replacement treatment (HRT). Therefore, it was not possible in this study to classify the endometrial samples as receptive or non-receptive. We used the ERA to focus on 238 genes that are intimately related to endometrial receptivity, thus simplifying the analysis and understanding of the data. Cycle scheduling is common in IVF units and is used to avoid weekend

  10. Two new giant pill-millipede species of the genus Zoosphaerium endemic to the Bemanevika area in northern Madagascar (Diplopoda, Sphaerotheriida, Arthrosphaeridae).

    Science.gov (United States)

    Sagorny, Christina; Wesener, Thomas

    2017-05-09

    Madagascar is one of the world's most important hotspots of biodiversity and a center for localized endemism. Among the highly endemic faunal elements are the giant pill-millipedes, order Sphaerotheriida, which are severely understudied in Madagascar. Here we provide descriptions of two new species of endemic giant-pill millipedes of the genus Zoosphaerium Pocock, 1895: Zoosphaerium bemanevika n. sp. and Zoosphaerium minutus n. sp.. Zoosphaerium bemanevika n. sp. belongs to the Z. coquerelianum species-group, while Z. minutus n. sp. is not assignable to a species-group. An updated key to the 19 species of the Z. coquerelianum group is provided. Zoosphaerium minutus n. sp. has a body length of Madagascar, an only recently protected area that represents a Malagasy center of endemism.

  11. Effect of Compound Danshen Dripping Pill on circadian blood pressure, high sensitive C reactive protein and cardiac function in patients with non dipper hypertension

    Directory of Open Access Journals (Sweden)

    Zhi-wei HE

    2014-06-01

    Full Text Available Objective: To investigate the effect of Compound Danshen Dripping Pill on circadian blood pressure, high sensitive C reactive protein and cardiac function in patients with non dipper hypertension. Methods: According to ABPM nocturnal blood pressure decline rate < 10%, select 178 patients whose systolic pressure and diastolic pressure meet the standards, 88 cases were divided into treatment group, and the rest 90 cases were in control group. All patients were having the levoamlodipine maleate 2.5mg, 1 time a day, the blood pressure still > 140 / 90mmHg, the addition of Stan. The treatment group were treated with 10 Compound Danshen Dripping Pills, 3 times a day, June. ABPM and hs-CRP, ultrasonic Beckoning figure was examined before and after treatment.Results: All the patients completed the study in June, by antihypertensive drugs and compound Danshen dripping pills after treatment, consulting room (CSBP and CDBP and BP are parameters of ABPM increased significantly (P < 0.01. Partial parameters compared with the control group after treatment were significantly different (P < 0.05. Systolic blood pressure, diastolic blood pressure, circadian variation rate level, variation rate and high sensitive C reactive protein of the treatment group after treatment were significantly improved compared with the control group (P < 0.05. The treatment group after treatment of diastolic function improved significantly (P < 0.05, the control group after treatment had no obvious improvement. Systolic function of two groups before treatment increased slightly, no statistical significance (P > 0.05.Conclusion: Long-term use of Compound Danshen dripping pill can improve the circadian rhythm of blood pressure in patients with non dipper hypertension, reduce the high sensitive C reactive protein level, improve cardiac diastolic function.

  12. 1H NMR-Based Metabolomics Study of the Toxicological Effects in Rats Induced by ?Renqing Mangjue? Pill, a Traditional Tibetan Medicine

    OpenAIRE

    Xu, Can; Rezeng, Caidan; Li, Jian; Zhang, Lan; Yan, Yujing; Gao, Jian; Wang, Yingfeng; Li, Zhongfeng; Chen, Jianxin

    2017-01-01

    “RenqingMangjue” pill (RMP), as an effective prescription of Traditional Tibetan Medicine (TTM), has been widely used in treating digestive diseases and ulcerative colitis for over a thousand years. In certain classical Tibetan Medicine, heavy metal may add as an active ingredient, but it may cause contamination unintentionally in some cases. Therefore, the toxicity and adverse effects of TTM became to draw public attention. In this study, 48 male Wistar rats were orally administrated with di...

  13. Sleep improvement for restless legs syndrome patients. Part IV: meta-analysis comparison of effect sizes of vibratory stimulation sham pads and placebo pills

    Directory of Open Access Journals (Sweden)

    Burbank F

    2014-02-01

    Full Text Available Fred Burbank Salt Creek International Women's Health Foundation, San Clemente, CA, USA Purpose: To determine whether sham pads used as controls in randomized clinical trials of vibratory stimulation to treat patients with sleep loss associated with restless legs syndrome perform differently than placebo pills used in comparable restless legs syndrome drug trials. Patients and methods: Sham pad effect sizes from 66 control patients in two randomized clinical trials of vibratory stimulation were compared with placebo responses from 1,024 control patients in 12 randomized clinical drug trials reporting subjective sleep measurement scales. Control patient responses were measured as the standardized difference in means corrected for correlation between beginning and ending scores and for small sample sizes. Results: For parallel randomized clinical trials, sham effects in vibratory stimulation trials were not significantly different from placebo effects in drug trials (0.37 and 0.31, respectively, Qbetween subgroups =0.25, PQ≥0.62. Placebo effect sizes were significantly smaller in crossover drug trials than sham effect sizes in parallel vibratory stimulation trials (0.07 versus 0.37, respectively, Qbetween subgroups =4.59, PQ≤0.03 and placebo effect sizes in parallel drug trials (0.07 versus 0.31, respectively, Qbetween subgroups =5.50, PQ≤0.02. Conclusion: For subjective sleep loss assessments in parallel trials, sham pads in vibratory stimulation trials performed similarly to placebo pills in drug trials. Trial design (parallel versus crossover had a large influence on control effect sizes. Placebo pills in crossover drug trials had significantly smaller effect sizes than sham pads in parallel vibratory stimulation trials or placebo pills in parallel drug trials. Keywords: sham effect, placebo effect, trial design, crossover study, parallel study, counterstimulation

  14. Evaluating adherence to highly active antiretroviral therapy with use of pill counts and viral load measurement in the drug resources enhancement against AIDS and malnutrition program in Mozambique.

    Science.gov (United States)

    San Lio, Massimo Magnano; Carbini, Riccardo; Germano, Paola; Guidotti, Giovanni; Mancinelli, Sandro; Magid, Noorjehan Abdul; Narciso, Pasquale; Palombi, Leonardo; Renzi, Elsa; Zimba, Ines; Marazzi, Maria Cristina

    2008-05-15

    Maintaining treatment adherence among the growing number of patients receiving antiretroviral treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load measurement in an African setting. We performed a prospective, observational study involving patients who received first-line highly active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were used, and the results were analyzed with viral load measurements at the end of the observation period. The study involved 531 participants. During the 12 months of observation, 137 patients left the program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had >95% treatment adherence; of those 284 patients, 274 (96.5%) had a final viral load 95% treatment adherence and the final viral load was closer than that between >90% treatment adherence and viral load. Treatment adherence >95% maximizes the results of the nonnucleoside reverse-transcriptase inhibitor-based regimen. The pill count method appears to be a reliable and economic tool for monitoring treatment adherence in resource-limited settings.

  15. Effect of Guizhi Fuling Pill combined with GnRH analog on cell proliferation and invasion as well as MEK/ERK pathway in endometriosis lesions

    Directory of Open Access Journals (Sweden)

    Li-Qiong Chen

    2017-10-01

    Full Text Available Objective: To study the effect of Guizhi Fuling Pill combined with gonadotropin-releasing hormone analog (GnRH-a on cell proliferation and invasion as well as MEK/ERK pathway in endometriosis lesions. Methods: Patients who were diagnosed with endometriosis in Bazhong Hospital of Traditional Chinese Medicine between November 2014 and March 2017 were selected as the research subjects and randomly divided into two groups, observation group received preoperative Guizhi Fuling Pill combined with GnRH analog therapy, and control group received preoperative GnRH analog monotherapy. After surgical resection, the endometriosis lesion was collected to determine the mRNA expression of proliferation and invasion-related genes as well as the protein expression of MEK/ERK pathway molecules. Results: Id-1, Sema3A, c-IAP1, OPN and uPA mRNA expression as well as p-MEK, p-EKR1/2, caspase-3 and MMP2 protein expression in endometriosis lesion of observation group were significantly lower than those of control group while Bak, Smac, PAI-1, TIMP1 and TIMP2 mRNA expression as well as caspase-3 protein expression were significantly higher than those of control group. Conclusion: Guizhi Fuling Pill combined with GnRH analog can inhibit the cell proliferation and invasion as well as the MEK/ERK pathway activation in endometriosis lesions.

  16. Metabonomic Strategy to the Evaluation of Chinese Medicine Compound Danshen Dripping Pills Interfering Myocardial Ischemia in Rats

    Directory of Open Access Journals (Sweden)

    Xue Xin

    2013-01-01

    Full Text Available Coronary heart disease (CHD is one of the highest mortality diseases in the world. Traditional Chinese medicine compound Danshen dripping pills (CDDPs have currently made a great achievement in treating CHD. However, the therapeutic mechanism of CDDP is often poorly interpreted. In this study, a GC-MS-based metabonomic study was conducted to assess the holistic efficacy of CDDP for myocardial infarction in male Sprague-Dawley rats, which were divided into the control group, the sham group, the model group, the control + CDDP group, and the model + CDDP, with CDDP at a dose of 107 mg/kg·d (equal to 1.8 mL/kg·d. The metabonomic findings demonstrated great differences of metabolic pattern among sham, model, and the model + CDDP in the orthogonal partial least squares discriminant analysis (OPLS-DA models, which coordinated well with the assessment of plasma biochemistry and histopathological assay. Differentially expressed metabolites suggested that energy metabolism, glycolysis, and lipid metabolism might be disrupted by myocardial infarction. Both the potential metabolic biomarkers and the biochemical histopathological indices were regulated effectively by CDDP.

  17. QiShenYiQi Pills, a Compound Chinese Medicine, Prevented Cisplatin Induced Acute Kidney Injury via Regulating Mitochondrial Function

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    Li Zhou

    2017-12-01

    Full Text Available Nephrotoxicity is a serious adverse effect of cisplatin chemotherapy that limits its clinical application, to deal with which no effective management is available so far. The present study was to investigate the potential protective effect of QiShenYiQi Pills (QSYQ, a compound Chinese medicine, against cisplatin induced nephrotoxicity in mice. Pretreatment with QSYQ significantly attenuated the cisplatin induced increase in plasma urea and creatinine, along with the histological damage, such as tubular necrosis, protein cast, and desquamation of epithelial cells, improved the renal microcirculation disturbance as indicated by renal blood flow, microvascular flow velocity, and the number of adherent leukocytes. Additionally, QSYQ prevented mitochondrial dysfunction by preventing the cisplatin induced downregulation of mitochondrial complex activity and the expression of NDUFA10, ATP5D, and Sirt3. Meanwhile, the cisplatin-increased renal thiobarbituric acid-reactive substances, caspase9, cleaved-caspase9, and cleaved-caspase3 were all diminished by QSYQ pretreatment. In summary, the pretreatment with QSYQ remarkably ameliorated the cisplatin induced nephrotoxicity in mice, possibly via the regulation of mitochondrial function, oxidative stress, and apoptosis.

  18. Policy maker and provider knowledge and attitudes regarding the provision of emergency contraceptive pills within Lao PDR

    Directory of Open Access Journals (Sweden)

    Hansana Visanou

    2010-07-01

    Full Text Available Abstract Background The Ministry of Health (MOH launched the National Reproductive Health Policy in 2005, which included recommendations regarding the use of emergency contraceptive pills (ECP. However, ECP have not yet been introduced officially in the public sector of the Lao PDR. Thus, their availability is limited. Understanding the knowledge of ECP and attitudes about their provision, barriers to use, and availability among health providers and policy makers is essential to successfully incorporate ECP into reproductive health services. Methods Qualitative research methods using in-depth interviews were employed to collect data from policy makers and health providers (auxiliary medical staff, nurses, and medical doctors. Altogether, 10 policy makers, 22 public providers, and 10 providers at private clinics were interviewed. Content analysis was applied to analyze the transcribed data. Results The majority of policy makers and health care providers had heard about ECP and supported their introduction in the public sector. However, their knowledge was poor, many expressed inconsistent attitudes, and their ability to meet the demand of potential users is limited. Conclusions There is a need to train health providers and policy makers on emergency contraception and improve their knowledge about ECP, especially regarding the correct timing of use and the availability of methods. In addition, the general public must be informed of the attributes, side effects, and availability of ECP, and policy makers must facilitate the approval of ECP by the Lao Food and Drug Administration. These interventions could lead to increased access to and demand for ECP.

  19. Effect of modified Wuzi Yanzong Pill () on Tip60-mediated apoptosis in testis of male rats after microwave radiation.

    Science.gov (United States)

    Hu, Hai-Xiang; Sun, Jing; Gao, Ya-Jing; Fang, Hong; Xu, Shao-Qiang; Dong, Jing; Wei, Li-Zhao; Luo, Shao-Bo; Shen, Chuan-Yun; Zhang, Qi-Long; Xie, Ya-Lan

    2017-10-24

    To investigate the effect of a modified Wuzi Yanzong Pill (, WZYZP) on the male rats' testis after microwave radiation, as well as its potential mechanism. Forty-five male rats were randomly assigned to three groups: the control group, the radiation group, and the WZYZP group. The rats in the radiation group and WZYZP group were exposed to microwave radiation for 15 min once, while the rats in the control group were not exposed to any radiation. The rats in the WZYZP group were given a modified of WZYZP by gavage daily for 7 days. Apoptosis in the testis was evaluated using terminal-deoxynucleoitidyl transferase mediated nick end labeling (TUNEL) assay. Histopathological alterations of the testis were observed by haematoxylin-eosin (HE) staining. Tat-interactive protein, 60kD (Tip60) and p53 expressions were determined by Western blotting. The apoptosis index (AI) in the radiation group was higher than that of the WZYZP group and control group on day 1 (D1), day 7 (D7) day 14 (D14) after radiation (Pradiation group, the partial seminiferous tubules were collapsed, basement membranes of the seminiferous epithelia became detached. WZYZP could restore the morphological changes. There was no expression of Tip60 among the three groups on D7 and D14. The expression of p53 was higher in the radiation group than in the control group (Pradiation on D7 and D14 (Peffects may partly result from its ability to intervene in Tip60 mediated apoptosis.

  20. Knowledge and use of emergency contraceptive pill: An analysis of perception and practice among unmarried urban women

    Directory of Open Access Journals (Sweden)

    Neetu Purohit

    2013-01-01

    Full Text Available Objective: The objective of this study was to collect evidence with respect to perception and practice of unmarried women toward the use of emergency contraceptive pills (ECPs. Materials and Methods: Non-probability purposive sampling was used to select respondents. A total of 250 respondents were administered the tools for the study, of which 228 were considered for analysis. Results and Discussion: Descriptive statistics showed that nearly 87% of the respondents were aware of ECPs and there was a significant difference in the knowledge of ECP of the respondents by type of the institution they had studied. More than half of the (52% respondents admitted to have boyfriends of which 16% were sexually involved and were using some form of contraception. Nearly 84% of the respondents used ECP, which superseded the use of other contraceptives. It was further found that around two-third respondents were using ECP regularly. The reason that "ECP did not hinder pleasure" and that it was handy in case of "unplanned contact" were the most cited reasons for using ECP as a regular contraceptive. Conclusion: The fact that ECPs was preferred over condom and was used regularly shows that the respondents were at a risk of sexually transmitted infection/human immunodeficiency virus. Health-care providers could be the most authentic source of information for orienting young women toward the use of safe sexual practices.

  1. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Intira Sriprasert

    2015-01-01

    Full Text Available This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27 or COC (n = 25 for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice.

  2. Risk-benefit assessment of the combined oral contraceptive pill in women with a family history of female cancer.