WorldWideScience

Sample records for cardiovascular drug utilization

  1. A study on the drug utilization trends in the cardiovascular emergencies in a tertiary care hospital.

    Science.gov (United States)

    Pendhari, Shabbir Rafiq; Chaudhari, Devendra Ramesh; Burute, Shreyas Ramchandra; Bite, Bapurao Motiram

    2013-04-01

    To observe the cardiovascular emergencies which were most frequently treated and to quantify the drug utilization trends in the cardiovascular emergencies, in terms of the Defined Daily Doses [DDD] and the prescribing prevalence in the cardiovascular emergencies. This prescription based study was undertaken in the Medicine ICU of the government medical hospital. The age, sex, diagnosis (only cardiovascular) and the drugs which were prescribed, were recorded for each patient. Also, the brand names and the generic names of the prescribed drugs were noted. The collected data was analyzed to study the drug utilization trends. It was observed that the most commonly treated cardiovascular disease was IHD. The IHD was more in males than in females who were below 50 years of age and it was nearly equal in the age groups which were above 50 years. The use of Angiotensin Converting Enzyme (ACE) inhibitors was higher than that of the beta blockers and the calcium channel blockers. The patients with cardiovascular emergencies also had preceding associated diseases like diabetes mellitus and hypertension. The protocol of the management which was followed by the college in the treatment of cardiovascular emergencies was competent enough, as the clinical outcomes of the patients were favourable. But there was a guideline incongruent prescribing behaviour which was statistically significant, for which there is a need to undertake large scale studies.

  2. Driving forces behind the increasing cardiovascular treatment intensity.A dynamic epidemiologic model of trends in Danish cardiovascular drug utilization.

    DEFF Research Database (Denmark)

    Kildemoes, Helle Wallach; Andersen, Morten

    . Objectives: To investigate the driving forces behind the increasing treatment prevalence of cardiovascular drugs, in particular statins, by means of a dynamic epidemiologic drug utilization model. Methods: Material: All Danish residents older than 20 years by January 1, 1996 (4.0 million inhabitants), were...

  3. Driving forces behind the increasing cardiovascular treatment intensity.A dynamic epidemiologic model of trends in Danish cardiovascular drug utilization.

    DEFF Research Database (Denmark)

    Kildemoes, Helle Wallach; Andersen, Morten

    . Objectives: To investigate the driving forces behind the increasing treatment prevalence of cardiovascular drugs, in particular statins, by means of a dynamic epidemiologic drug utilization model. Methods: Material: All Danish residents older than 20 years by January 1, 1996 (4.0 million inhabitants), were...

  4. [Pharmacoeconomic indicators of cardiovascular drug utilization in the Republic of Croatia and city of Zagreb in 2008].

    Science.gov (United States)

    Stimac, Danijela; Stambuk, Ivanka

    2010-12-01

    In comparison with original drugs, generic drugs have the same efficacy but considerably lower price and should therefore be preferred to original drugs on prescribing. The aim of the present study was to assess outpatient utilization and rationality of cardiovascular drug prescribing in the City of Zagreb and Republic of Croatia based on the generic to original drug prescribing ratio. Data on the financial indicators and number of cardiovascular drug packages issued in 2008 were obtained from the Croatian Institute of Health Insurance. These data were used to calculate the number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day). The index of generic/original drug utilization was determined for Zagreb and Croatia as a measure for assessment of prescribing rationality; the significance of difference was determined by X2-test. The rate of prescribing original cardiovascular drugs was significantly higher in Zagreb as compared with Croatia as a whole. The index of prescribing generic versus original drugs was 1.20 (249/208 DDD/1000/day) in Zagreb and 1.65 (249/151 DDD/1000/day) in Croatia. Difference in the utilization of generic drugs between Zagreb and Croatia as determined by X2-test (the level of statistical significance was set at PZagreb and 2.02 in Croatia; and hypolipemics with the generic/original drug index of 0.96 in Zagreb and 1.34 in Croatia. According to financial indicators, the generic/original drug index was 1.44 in Croatia and only 0.96 in Zagreb. The significantly greater influence of pharmaceutical industry marketing in Zagreb entailed the significantly higher rate of original drug prescribing, which is associated with considerably greater drug expenses. Measures to stimulate prescribing generic drugs should be launched at the national level.

  5. Drug Utilization Review of parenteral opioid analgesics in cardiovascular surgery department of Shahid Modarres Hospital, Tehran

    Directory of Open Access Journals (Sweden)

    Vatanpour H, Soltani M,

    2016-08-01

    Full Text Available Persistent pain continues to be a common problem among patients undergoing cardiac operations and the need for controlling such pain is believed to be as a prime necessity in terms of the patient’s well being, health care costs and avoiding negative consequences provoked by the pain itself. Regarding to the newly established guidelines, opioid analgesic agents are considered as the mainstay of moderate to severe acute pain. Nonetheless, the underutilization of opioids for pain relief is still a persisting huge challenge. This survey, applying as a concurrent Drug Utilization Review using ATC/DDD system provided and recommended by the DUR group of the World Health Organization, conducted on 108 inpatients who received opioid drugs by parenteral route during 9 months from February to November 2013 at the post-ICU ward of Shahid Modarres Cardiovascular Hospital, affiliated to Shahid Beheshti University of Medical Science, in Tehran. Our findings revealed that morphine was the most commonly prescribed parenteral opioid in the hospitalized patients and pethidine usage was in the lowest level for the geriatric patients, resulting in satisfaction with the analgesic procedure among most of the cases in our study. Both of the mentioned drugs were prescribed by intramuscular route, regarding PRN way of injecting as well. Comparative results of our study with the literature revealed relatively moderate and roughly rational consumption of morphine (10.282 DDD/100bed-days and pethidine (0.013 DDD/100bed-days. Applying multivariate conditional regression modeling on the question of determining independent predictors for opioid usage, disclosed a direct correlation between the patient’s weight and daily dose of parenteral opioid consumption.

  6. The impact of ageing and changing utilization patterns on future cardiovascular drug expenditure: a pharmacoepidemiological projection approach

    DEFF Research Database (Denmark)

    Kildemoes, Helle Wallach; Andersen, Morten; Støvring, Henrik

    2010-01-01

    To develop a method for projecting the impact of ageing and changing drug utilization patterns on future drug expenditure.......To develop a method for projecting the impact of ageing and changing drug utilization patterns on future drug expenditure....

  7. Diabetes Drugs and Cardiovascular Safety

    Directory of Open Access Journals (Sweden)

    Ji Cheol Bae

    2016-06-01

    Full Text Available Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.

  8. Discontinued drugs in 2012: cardiovascular drugs.

    Science.gov (United States)

    Zhao, Hong-Ping; Jiang, Hong-Min; Xiang, Bing-Ren

    2013-11-01

    The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products.

  9. MSIS Drug Utilization Datamart

    Data.gov (United States)

    U.S. Department of Health & Human Services — This page provides background needed to take advantage of the capabilities of the MSIS Drug Utilization Datamart. This mart allows the user to develop high-level...

  10. State Drug Utilization Data 2003

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  11. State Drug Utilization Data 2011

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  12. State Drug Utilization Data 2009

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  13. State Drug Utilization Data 2016

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  14. State Drug Utilization Data 2017

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  15. State Drug Utilization Data 1996

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  16. State Drug Utilization Data 2008

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  17. State Drug Utilization Data 1992

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  18. State Drug Utilization Data 1995

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  19. State Drug Utilization Data 1998

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  20. State Drug Utilization Data 2014

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  1. State Drug Utilization Data 2005

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  2. State Drug Utilization Data 2002

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  3. State Drug Utilization Data 2004

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  4. State Drug Utilization Data 1993

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  5. State Drug Utilization Data 2006

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  6. State Drug Utilization Data 2012

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  7. State Drug Utilization Data 1999

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  8. State Drug Utilization Data 2015

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  9. State Drug Utilization Data 1997

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  10. State Drug Utilization Data 1991

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  11. State Drug Utilization Data 2001

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  12. State Drug Utilization Data 2007

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  13. State Drug Utilization Data 2013

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  14. State Drug Utilization Data 1994

    Data.gov (United States)

    U.S. Department of Health & Human Services — Drug utilization data are reported by states for covered outpatient drugs that are paid for by state Medicaid agencies since the start of the Medicaid Drug Rebate...

  15. Cardiovascular drugs and erectile dysfunction

    Directory of Open Access Journals (Sweden)

    Terzić Branka M.

    2014-01-01

    Full Text Available Erectile dysfunction (ED is a disorder, which basically can have organic nature, psychological or mixed. ED is not a rarity, and data on its prevalence vary, depending on the areas in which the survey was conducted, followed by a period of research and the definition of the disorder. Most of the men associate ED problem with using drugs, especially cardiac. Even though there is some truth in it, mainly the real causes of ED are not well known even to professionals. Contemporary studies of risk factors for cardiovascular disease, particularly coronary heart disease, have shown the clear link between erectile dysfunction and coronary heart disease, wherein ED first manifests. While, ED precedes the onset of symptoms of coronary heart disease and show to the patient and the physician a clear signal of the direction for conducting diagnostic tests and further treatment in the interest of the health of patients. Endocrine, and neurological disorders, as well as bad habits in addition to the cardiac and kidney disease, lead to ED. It is known also, that the use of cardiac medicines may contribute to ED occurrence. Better knowledge of adverse reactions to medicines, a better understanding of the nature of the disease and the implementation of necessary diagnostic procedures, with a good choice of medication, contribute to solving problems related to ED. If all mentioned do not help, there is the possibility of using new drugs to correct ED.

  16. Retrospective monitoring of drug utilisation in cardiovascular ...

    African Journals Online (AJOL)

    This retrospective study was carried out to established drug prescribing trends in the management of cardiovascular diseases (CVDs) in the cardiovascular unit of the Department of Medicine, University of Port Harcourt Teaching Hospital, Rivers State, Nigeria. 100 folders of patients with various CVDs were randomly ...

  17. Adverse drug reactions induced by cardiovascular drugs in outpatients

    Directory of Open Access Journals (Sweden)

    Gholami K

    2008-03-01

    Full Text Available Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs induced by this class of medicinal products seems necessary.Objectives: To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. Methods: This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. Results: The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3% patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5% and the lowest rate with Atenolol (3%. Headache was the most frequent detected ADR (23%. Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05. ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05. With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05. Conclusion: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  18. Adverse drug reactions induced by cardiovascular drugs in outpatients.

    Science.gov (United States)

    Gholami, Kheirollah; Ziaie, Shadi; Shalviri, Gloria

    2008-01-01

    Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary. To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3%) patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate with Atenolol (3%). Headache was the most frequent detected ADR (23%). Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, PPearson=0.259, P<0.05). Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  19. Characteristics and drug utilization patterns for heavy users of prescription drugs among the elderly

    DEFF Research Database (Denmark)

    Øymoen, Anita; Pottegård, Anton; Almarsdóttir, Anna Birna

    2015-01-01

    drug users accounted for 75.4% of their use in 2012, and five of these were cardiovascular drugs. The development over time for the ten most used drug classes followed the same pattern among heavy drug users and in the general population. CONCLUSION: There is a skewed utilization of prescription drugs...... frequently used drugs among heavy drug users and development in use over time. METHOD: This is a descriptive study. Heavy drug users were defined as the accumulated top 1 percentile who accounted for the largest share of prescription drug use measured in number of dispensed defined daily doses (DDDs...

  20. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...

  1. Gender differences in the effects of cardiovascular drugs

    DEFF Research Database (Denmark)

    Tamargo, Juan; Rosano, G.; Thomas, W

    2017-01-01

    . A better understanding of these sex-related differences is fundamental to improve the safety and efficacy of cardiovascular drugs and for developing proper individualized cardiovascular therapeutic strategies both in men and women. This review briefly summarize gender differences in the pharmacokinetics......Although sex-specific differences in cardiovascular medicine are well-known, the exact influences of sex on the effect of cardiovascular drugs remain unclear. Women and men differ in body composition and physiology (hormonal influences during the menstrual cycle, menopause and pregnancy...... and pharmacodynamics of cardiovascular drugs and provides recommendations to close the gaps in our understanding of sex-specific differences in drug efficacy and safety....

  2. Systems biology approaches to the study of cardiovascular drugs

    NARCIS (Netherlands)

    Nikolsky, Y.; Kleemann, R.

    2010-01-01

    Atherogenic lipids and chronic inflammation drive the development of cardiovascular disorders such as atherosclerosis. Many cardiovascular drugs target the liver which is involved in the formation of lipid and inflammatory risk factors. With robust systems biology tools and comprehensive

  3. Revisiting Terminalia arjuna – An Ancient Cardiovascular Drug

    Directory of Open Access Journals (Sweden)

    Shridhar Dwivedi

    2014-10-01

    Full Text Available Terminalia arjuna, commonly known as arjuna, belongs to the family of Combretaceae. Its bark decoction is being used in the Indian subcontinent for anginal pain, hypertension, congestive heart failure, and dyslipidemia, based on the observations of ancient physicians for centuries. The utility of arjuna in various cardiovascular diseases needs to be studied further. Therefore, the present review is an effort to give a detailed survey of the literature summarizing the experimental and clinical studies pertinent to arjuna in cardiovascular disorders, which were particularly performed during the last decade. Systematic reviews, meta-analyses, and clinical studies of arjuna were retrieved through the use of PubMed, Google Scholar, and Cochrane databases. Most of the studies, both experimental and clinical, have suggested that the crude drug possesses anti-ischemic, antioxidant, hypolipidemic, and antiatherogenic activities. Its useful phytoconstituents are: Triterpenoids, β-sitosterol, flavonoids, and glycosides. Triterpenoids and flavonoids are considered to be responsible for its beneficial antioxidant cardiovascular properties. The drug has shown promising effect on ischemic cardiomyopathy. So far, no serious side effects have been reported with arjuna therapy. However, its long-term safety still remains to be elucidated. Though it has been found quite useful in angina pectoris, mild hypertension, and dyslipidemia, its exact role in primary/secondary coronary prevention is yet to be explored.

  4. Cardiovascular Effects of Performance-Enhancing Drugs.

    Science.gov (United States)

    La Gerche, André; Brosnan, Maria J

    2017-01-03

    Exercise and competitive sports should be associated with a wide range of health benefits with the potential to inspire a positive community health legacy. However, the reputation of sports is being threatened by an ever-expanding armamentarium of agents with real or perceived benefits in performance enhancement. In addition to the injustice of unfair advantage for dishonest athletes, significant potential health risks are associated with performance-enhancing drugs. Performance-enhancing drugs may have an effect on the cardiovascular system by means of directly altering the myocardium, vasculature, and metabolism. However, less frequently considered is the potential for indirect effects caused through enabling athletes to push beyond normal physiological limits with the potential consequence of exercise-induced arrhythmias. This review will summarize the known health effects of PEDs but will also focus on the potentially greater health threat posed by the covert search for performance-enhancing agents that have yet to be recognized by the World Anti-Doping Agency. History has taught us that athletes are subjected to unmonitored trials with experimental drugs that have little or no established efficacy or safety data. One approach to decrease drug abuse in sports would be to accept that there is a delay from when athletes start experimenting with novel agents to the time when authorities become aware of these drugs. This provides a window of opportunity for athletes to exploit with relative immunity. It could be argued that all off-label use of any agent should be deemed illegal. © 2016 American Heart Association, Inc.

  5. Pharmacogenomics to Revive Drug Development in Cardiovascular Disease.

    Science.gov (United States)

    Dubé, Marie-Pierre; de Denus, Simon; Tardif, Jean-Claude

    2016-02-01

    Investment in cardiovascular drug development is on the decline as large cardiovascular outcomes trials require considerable investments in time, efforts and financial resources. Pharmacogenomics has the potential to help revive the cardiovascular drug development pipeline by providing new and better drug targets at an earlier stage and by enabling more efficient outcomes trials. This article will review some of the recent developments highlighting the value of pharmacogenomics for drug development. We discuss how genetic biomarkers can enable the conduct of more efficient clinical outcomes trials by enriching patient populations for good responders to the medication. In addition, we assess past drug development programs which support the added value of selecting drug targets that have established genetic evidence supporting the targeted mechanism of disease. Finally, we discuss how pharmacogenomics can provide valuable evidence linking a drug target to clinically relevant outcomes, enabling novel drug discovery and drug repositioning opportunities.

  6. Mind the gap : predicting cardiovascular risk during drug development

    NARCIS (Netherlands)

    Chain, Anne S. Y.

    2012-01-01

    Cardiovascular safety issues, specifically drug-induced QT/QTc-interval prolongation, remain a major cause of drug attrition during clinical development and is one of the main causes for post-market drug withdrawals accounting for 15-34% of all drug discontinuation. Given the potentially fatal

  7. Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2013-01-01

    Conclusion: This study confirms that there is a substantial drug lag in approval of new cardiovascular drugs in India compared with the United States and European Union. The impact of drug lag on health outcomes remains to be established.

  8. Cardiovascular evaluation in Turner syndrome: utility of MR imaging

    International Nuclear Information System (INIS)

    Dawson-Falk, K.; Bakker, B.; Rosenfeld, R.G.

    1992-01-01

    Forty patients with karyotypically proven Turner syndrome were prospectively studied using magnetic resonance imaging (MRI) and echocardiography in order to determine the frequency of cardiovascular anomalies and to assess the utility of both imaging modalities as methods for cardiovascular evaluation in Turner syndrome. Cardiovascular anomalies were found in 45% of patients. A high absolute prevalence of bicuspid aortic valve (17.5%) and aortic coarctation (12.5%) were observed relative to comparable series. Of clinically significant abnormalities, three of five aortic coarctations and four of five ascending aortic dilatations were solely MRI detected and not evident at echocardiographic examination. MRI is thus seen as a valuable adjunct to echocardiography in the cardiovascular evaluation of Turner syndrome patients. The usefulness of MRI primarily relates to its ability to provide excellent visualisation of the entire thoracic aorta where a large proportion of clinically significant anomalies occur in Turner syndrome. 23 refs., 2 tabs., 5 figs

  9. Cardiovascular evaluation in Turner syndrome: utility of MR imaging

    Energy Technology Data Exchange (ETDEWEB)

    Dawson-Falk, K; Bakker, B; Rosenfeld, R G [Stanford Univ., CA (United States). School of Medicine

    1992-08-01

    Forty patients with karyotypically proven Turner syndrome were prospectively studied using magnetic resonance imaging (MRI) and echocardiography in order to determine the frequency of cardiovascular anomalies and to assess the utility of both imaging modalities as methods for cardiovascular evaluation in Turner syndrome. Cardiovascular anomalies were found in 45% of patients. A high absolute prevalence of bicuspid aortic valve (17.5%) and aortic coarctation (12.5%) were observed relative to comparable series. Of clinically significant abnormalities, three of five aortic coarctations and four of five ascending aortic dilatations were solely MRI detected and not evident at echocardiographic examination. MRI is thus seen as a valuable adjunct to echocardiography in the cardiovascular evaluation of Turner syndrome patients. The usefulness of MRI primarily relates to its ability to provide excellent visualisation of the entire thoracic aorta where a large proportion of clinically significant anomalies occur in Turner syndrome. 23 refs., 2 tabs., 5 figs.

  10. Cardiovascular Risk, Drugs and Erectile Function -A Systematic Analysis

    OpenAIRE

    Baumhäkel , Magnus; Schlimmer , Nils; Kratz , Mario; Hackett , Geoffrey; Jackson , Graham; Böhm , Michael

    2011-01-01

    Abstract Aims Erectile dysfunction is a major problem with an increasing prevalence in cardiovascular high-risk patients due to the association with cardiovascular risk factors. Drugs used for evidenced based treatment of cardiovascular diseases have been reported to decrease erectile function, but possible mechanisms are poorly characterized. Methods MEDLINE, EMBASE and Cochrane Registry search was performed including manuscripts until January 2010. Searching terms are: ...

  11. Can Patients with Cardiovascular Disease Take Nonsteroidal Antiinflammatory Drugs?

    Science.gov (United States)

    ... of the American Heart Association Cardiology Patient Page Can Patients With Cardiovascular Disease Take Nonsteroidal Antiinflammatory Drugs? ... It also does not upset the gastrointestinal tract. Can People With CVD Take an NSAID? If you ...

  12. Quantifying the utility of taking pills for cardiovascular prevention.

    Science.gov (United States)

    Hutchins, Robert; Viera, Anthony J; Sheridan, Stacey L; Pignone, Michael P

    2015-03-01

    The decrease in utility attributed to taking pills for cardiovascular prevention can have major effects on the cost-effectiveness of interventions but has not been well studied. We sought to measure the utility of daily pill-taking for cardiovascular prevention. We conducted a cross-sectional Internet-based survey of 1000 US residents aged ≥30 in March 2014. We calculated utility values, using time trade-off as our primary method and standard gamble and willingness-to-pay techniques as secondary analyses. Mean age of respondents was 50 years. Most were female (59%) and white (63%); 28% had less than a college degree; and 79% took ≥1 pills daily. Mean utility using the time trade-off method was 0.990 (95% confidence interval, 0.988-0.992), including ≈70% not willing to trade any amount of time to avoid taking a preventive pill daily. Using the standard gamble method, mean utility was 0.991 (0.989-0.993), with 62% not willing to risk any chance of death. Respondents were willing to pay an average of $1445 to avoid taking a pill daily, which translated to a mean utility of 0.994 (0.940-0.997), including 41% unwilling to pay any amount. Time trade-off-based utility varied by age (decreasing utility as age increased), sex, race, numeracy, difficulty with obtaining pills, and number of pills taken per day but did not vary by education level, literacy, or income. Mean utility for taking a pill daily for cardiovascular prevention is ≈0.990 to 0.994. © 2015 American Heart Association, Inc.

  13. Drug utilization research and risk management

    NARCIS (Netherlands)

    Mazzaglia, Giampiero; Mol, Peter G. M.; Elseviers, Monique; Wettermark, Björn; Almarsdóttir, Anna Birna; Andersen, Morten; Benko, Ria; Bennie, Marion; Eriksson, Irene; Godman, Brian; Krska, Janet; Poluzzi, Elisabetta; Taxis, Katja; Vlahovic-Palcevski, Vera; Stichele, Robert Vander

    2016-01-01

    Good risk management requires continuous evaluation and improvement of planned activities. The evaluation impact of risk management activities requires robust study designs and carefully selected outcome measures. Key learnings and caveats from drug utilization research should be applied to the

  14. Cardiovascular disease among people with drug use disorders

    DEFF Research Database (Denmark)

    Thylstrup, Birgitte; Clausen, Thomas; Hesse, Morten

    2015-01-01

    Objectives To present the prevalence and incidence of cardiovascular disease (CVD) in a national cohort of patients seeking treatment for drug use disorders (DUD). Methods This is a longitudinal record linkage study of consecutive DUD treatment admissions between 2000 and 2006 from Denmark. Results...... treatment (SHR = 1.15, p = 0.022). The use of amphetamines was negatively associated with the risk of CVD within this cohort (SHR = 0.75, p = 0.001). Conclusions Patients injecting drugs using prescribed methadone were at elevated risk for cardiovascular disease and should be monitored for CVD. Opioid...... medications should be evaluated in terms of their cardiovascular sequelae....

  15. Cardiovascular effects of current and future anti-obesity drugs

    DEFF Research Database (Denmark)

    Comerma Steffensen, Simon Gabriel; Grann, Martin; Andersen, Charlotte U

    2014-01-01

    cardiovascular risk, while an inverse agonist at cannabinoid type 1 (CB1) receptors, rimonobant was withdrawn due to serious psychiatric problems. At present there are only few treatments available including orlistat and, phentermine alone or in combination with topiramate and lorcaserin, although cardiovascular...... side effects need to be clarified regarding phentermine and lorcaserin. Drugs approved for type 2 diabetes including glucagon like peptide (GLP-1) analogues and metformin also cause moderate weight losses and have a favourable cardiovascular profile, while the anti-obesity potential of nebivolol...

  16. Geriatric drug therapy and healthcare utilization in the United kingdom.

    Science.gov (United States)

    Kennerfalk, Anita; Ruigómez, Ana; Wallander, Mari-Ann; Wilhelmsen, Lars; Johansson, Saga

    2002-05-01

    To describe the use of prescription drug therapy, especially polypharmacy, in an elderly general population; to relate that use to age, gender, and different types of healthcare utilization; and to investigate the influence of selection of different time windows on the result of the quantity as well as the categories of drugs used. Data on a sample of 5000 patients aged 65-90 years in 1996 were derived from the General Practice Research Database (GPRD). The population covered by GPRD is broadly representative of the UK population treated in general practice. Drug use was assessed using 2 time windows - current use of individual drugs on a random day (index date) and 1 month following the index date. Healthcare utilization was analyzed by use of information on visits to general practitioners (GPs), hospitalizations, and referrals to specialists. Women used more drugs than men; however, the prevalence of polypharmacy, defined as concomitant use of > or =5 drugs, was similar in both genders. The most frequently used therapeutic groups were cardiovascular, central nervous, and gastrointestinal system drugs. Almost 80% of both women and men visited a GP at least once a year. Overall, women used more ambulatory care services and men were hospitalized more often. Use of random date compared with 1-month period resulted in a significant underestimation of the amount of drugs used for acute conditions and, consequently, the risk of polypharmacy. The overall results confirm the findings in earlier studies suggesting that the GPRD might be a useful tool in further studies on prescription drug use among elderly persons. More information on the appropriateness of drug use is needed to prevent overuse as well as underuse of medications among the elderly.

  17. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  18. Sex Differences in Cardiovascular Drug Response

    NARCIS (Netherlands)

    E.M. Rodenburg (Eline)

    2012-01-01

    textabstractIn the early sixties, a prominent professor in Clinical Pharmacology at the University College in London, D.R. Laurence, stated: “There are no clinically important sex differences in drug action, except, of course, to sex steroid hormones, but the subject is poorly documented. Women

  19. Cardiovascular drugs inducing QT prolongation: facts and evidence.

    Science.gov (United States)

    Taira, Carlos A; Opezzo, Javier A W; Mayer, Marcos A; Höcht, Christian

    2010-01-01

    Acquired QT syndrome is mainly caused by the administration of drugs that prolong ventricular repolarization. On the other hand, the risk of drug-induced torsades de pointes is increased by numerous predisposing factors, such as genetic predisposition, female sex, hypokalemia and cardiac dysfunction. This adverse reaction is induced by different chemical compounds used for the treatment of a variety of pathologies, including arrhythmias. As it is known, antiarrhythmic agents and other cardiovascular drugs can prolong the QT interval, causing this adverse reaction. Of the 20 most commonly reported drugs, 10 were cardiovascular agents and these appeared in 348 of the reports (46%). Class Ia antiarrhythmic agents have frequently been linked to inducing arrhythmia, including torsades de pointes. Sotalol and amiodarone, class III antiarrhythmics, are known to prolong the QT interval by blocking I(Kr). Due to the severity of events caused by the therapeutic use of these drugs, in this work of revision the cardiovascular drugs that present this property and the factors and evidence will be mentioned.

  20. Microemulsion utility in pharmaceuticals: Implications for multi-drug delivery.

    Science.gov (United States)

    Callender, Shannon P; Mathews, Jessica A; Kobernyk, Katherine; Wettig, Shawn D

    2017-06-30

    Emulsion technology has been utilized extensively in the pharmaceutical industry. This article presents a comprehensive review of the literature on an important subcategory of emulsions, microemulsions. Microemulsions are optically transparent, thermodynamically stable colloidal systems, 10-100nm diameter, that form spontaneously upon mixing of oil, water and emulsifier. This review is the first to address advantages and disadvantages, as well as considerations and challenges in multi-drug delivery. For the period 1 January 2011-30 April 2016, 431 publications related to microemulsion drug delivery were identified and screened according to microemulsion, drug classification, and surfactant types. Results indicate the use of microemulsions predominantly in lipophilic drug delivery (79.4%) via oil-in-water microemulsions and non-ionic surfactants (90%) for oral or topical administration. Cancer is the disease state most targeted followed by inflammatory diseases, microbial infections and cardiovascular disease. Key generalizations from this analysis include: 1) microemulsion formulation is largely based on trial-and-error despite over 1200 publications related to microemulsion drug delivery since their discovery in 1943; 2) characterization using methods including interfacial tension, droplet size, electrical conductivity, turbidity and viscosity may provide additional information for greater predictability; 3) microemulsion drug delivery publications arise primarily from China (27%) and India (21%) suggesting additional research opportunities elsewhere. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. ANALYZES OF ANTIPLATELETS AND ANTICOAGULANTS UTILIZATION IN PATIENTS TREATED IN CARDIOVASCULAR REHABILITATION CENTER FROM CROATIA

    Directory of Open Access Journals (Sweden)

    Boban Marko

    2016-07-01

    Full Text Available Purpose: Discordance with the guidelines and underutilization of pharmacotherapy for secondary prevention frequently exists in clinical practice. Aim of our study was to assess the prescription routine and drug utilization patterns for antiplatelets and peroral anticoagulants in tertiary medical center specialized for cardiovascular rehabilitation. Methods: study included 96 consecutive patients scheduled for cardiovascular rehabilitation in period 1-6 months after the acute treatment for ischemic 87(80.2% and valvular heart disease 18(19.8%. Patients were divided according to etiology of heart disease and type of acute cardiovascular treatments (conservative, percutaneous coronary interventions (PCI and surgery. Results: Dual antiplatelet therapy was the most commonly applied regimen in 84(87.5% of conservatively treated myocardial infarctions, 47(61.9% of percutaneous coronary interventions (PCI and 13(58.9% of surgically treated group (p>0.05. Among studied group of patients significant differences in utilization were found for warfarin, or combinations of antiplatelets with warfarin(p0.05. All four of patients that received triple therapy (4.17% were from surgical group. Underutilization of antiplatelets in ischemic heart disease was at 11(14.3% what was congruent with the developed industrial nations. Conclusions: Acute cardiovascular treatment type, but not heart disease etiology, had significant influence on subsequent prescription routine. Decreased use of pharmacological agents for secondary prevention in surgical patients was revealed. Drug utilization analyzes can offer improvement in optimizing medical treatments, quality of care and decrease unnecessary polypragmasia, as well as improve economical efficiency of medical management.

  2. Qualitative Methods in Drug Utilization Research

    DEFF Research Database (Denmark)

    Almarsdóttir, Anna Birna; Bastholm Rahmner, Pia

    2016-01-01

    Qualitative research methods derive from the social sciences. Their use in drug utilization research is increasingly widespread, especially in understanding patient and prescriber perspectives. The main focus in qualitative research is exploration of a given phenomenon in order to get a wider...... understanding of why and how it appears. Qualitative research methods build on various theoretical underpinnings/schools of thought. The same validity and quality criteria cannot be used for both qualitative and quantitative methods....

  3. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...

  4. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...

  5. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-21

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...

  6. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-11-19

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...

  7. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-12

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...

  8. Generic versus brand-name drugs used in cardiovascular diseases.

    Science.gov (United States)

    Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

    2016-04-01

    This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider

  9. 77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...

  10. 77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  11. 78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  12. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  13. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  14. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  15. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  16. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  17. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  18. 76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  19. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  20. Induced pluripotent stem cell-derived cardiomyocytes for cardiovascular disease modeling and drug screening.

    Science.gov (United States)

    Sharma, Arun; Wu, Joseph C; Wu, Sean M

    2013-12-24

    Human induced pluripotent stem cells (hiPSCs) have emerged as a novel tool for drug discovery and therapy in cardiovascular medicine. hiPSCs are functionally similar to human embryonic stem cells (hESCs) and can be derived autologously without the ethical challenges associated with hESCs. Given the limited regenerative capacity of the human heart following myocardial injury, cardiomyocytes derived from hiPSCs (hiPSC-CMs) have garnered significant attention from basic and translational scientists as a promising cell source for replacement therapy. However, ongoing issues such as cell immaturity, scale of production, inter-line variability, and cell purity will need to be resolved before human clinical trials can begin. Meanwhile, the use of hiPSCs to explore cellular mechanisms of cardiovascular diseases in vitro has proven to be extremely valuable. For example, hiPSC-CMs have been shown to recapitulate disease phenotypes from patients with monogenic cardiovascular disorders. Furthermore, patient-derived hiPSC-CMs are now providing new insights regarding drug efficacy and toxicity. This review will highlight recent advances in utilizing hiPSC-CMs for cardiac disease modeling in vitro and as a platform for drug validation. The advantages and disadvantages of using hiPSC-CMs for drug screening purposes will be explored as well.

  1. Role of imaging techniques in the evaluation of cardiovascular drugs

    International Nuclear Information System (INIS)

    Sugishita, Yasuro; Matsuda, Mitsuo; Ajisaka, Ryuichi

    1985-01-01

    In order to investigate the role of imaging in the evaluation of medical treatment in heart diseases, radionuclide angiocardiography, echocardiography and Doppler echocardiography were applied in the cases of various kinds of heart diseases. Acute and chronic effects of antianginal drugs (nitrates, calcium antagonists and beta-blockers) could be evaluated by exercise radionuclide angiocardiography or exercise echocardiography in the cases of effort angina. The effects of the drugs changing myocardial contractility, preload or afterload could be evaluated by echocardiography in various kinds of heart diseases, including valvular heart biseases. The effect of calcium antagonists in improving diastolic function in hypertrophic cardiomyopathy could be evaluated by echocardiography or Doppler echocardiography. In conclusion, imaging techniqus are valuable and useful methods to evaluate the effects of cardiovascular drugs, by offering various informations. (author)

  2. EFECTOS DE LOS MEDICAMENTOS CARDIOVASCULARES SOBRE EL GLOBO OCULAR / Effects of cardiovascular drugs on the eyeball

    Directory of Open Access Journals (Sweden)

    Caridad Peraza Martínez

    2013-01-01

    ophthalmology offices, and many of drugs used for these conditions may cause undesirable effects on the eyeball. The objective of this research was to determine the adverse reactions caused by the consumption of these drugs in the visual organ, and highlight their contraindications in people affected by eye disease. Method: A literature search was performed using specialized texts, and the drugs that could produce ocular adverse reactions were identified, as well as those that were contraindicated in ophthalmic diseases. Results: A total of 276 medications were reviewed and 72 (26.08% were selected. Blurred vision (38/72, decreased visual acuity (21/72 and dizziness (16/72 were the most common adverse reactions associated with the use of cardiovascular drugs. The six medications that are contraindicated in these patients are exposed, as well as the 14 that should be prescribed with extreme caution in diseases such as glaucoma, optic atrophy, hypertensive retinopathy and migraine, among others. Conclusions: It was found that 72 drugs (26.08% used in cardiovascular disease may produce some ocular symptoms as an adverse reaction. Blurred vision, decreased visual acuity and dizziness were predominant. It is extremely important to conduct a good medical interview to know the patient´s medical history and avoid the use of drugs that are useful for a disease but harmful for another one. The doctor, knowingly, will weigh the risk / benefit of those drugs that are essential.

  3. Cardiovascular Drugs in Avian, Small Mammal, and Reptile Medicine.

    Science.gov (United States)

    Fitzgerald, Brenna Colleen; Dias, Sara; Martorell, Jaume

    2018-05-01

    Cardiovascular disease, including congestive heart failure, pericardial disease, and atherosclerosis, is becoming increasingly better recognized in companion birds, small mammals, and reptiles. A wide range of medications is available to treat these conditions, including diuretics, vasodilators, positive and negative inotropes, antiarrhythmic agents, and pentoxifylline. This review systematically discusses each of these drug classes and their potential applications in exotic species. Although treatment approaches remain largely empirical and extrapolated from small animal and human medicine, the management strategies presented here have the potential to both maintain quality of life and extend survival time for the exotic cardiac patient. Copyright © 2018 Elsevier Inc. All rights reserved.

  4. The utilization of nonprescription medications in Saudi patients with cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Eman M. Shorog

    2018-01-01

    Full Text Available Background: Cardiovascular diseases (CVDs are the most common cause of disease-related death in Saudi Arabia. The incidence of CVDs continues to increase, presenting a major health care problem. Nonprescription medications are widely used by patients with CVD and may cause adverse drug events, either by worsening the disease or by harmfully interacting with prescribed medications. We investigated the patterns of nonprescription medication utilization and the factors associated with their use in patients with CVD. Methods: This was a cross-sectional study conducted at the Cardiology Clinics of an academic tertiary health care center. Participants were asked about their sociodemographic characteristics, medical history and frequency of using nonprescription medications including over-the-counter (OTC products, dietary supplements, and herbal products. Moreover, we investigated the participants’ sources of information about nonprescription medications. Multivariate logistic regression analysis was conducted to examine the predictors of nonprescription medication use. Results: A total of 209 participants were interviewed. The mean age of the participants was 56 ± 15 years, and 110 (52.6% were female. Of the 209 participants, 116 (55% reported routine use of nonprescription medications. Black seeds and garlic were the most frequently used herbal products. Acetaminophen, cold/cough remedies, and ibuprofen were the most commonly reported OTC drugs. Of the surveyed patients, 54 (46.5% used nonprescription medications to manage cardiovascular conditions specifically. Compared with other comorbidities, diabetes mellitus was associated with a higher use of nonprescription medications. Conclusion: In patients with CVD, the routine use of nonprescription medications was common for a number of reasons. Health care providers should proactively discuss nonprescription use with their CVD patients to avoid potential harmful outcomes. Keywords

  5. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Science.gov (United States)

    2011-03-15

    ...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

  6. Colchicine in Pericardial Disease: from the Underlying Biology and Clinical Benefits to the Drug-Drug Interactions in Cardiovascular Medicine.

    Science.gov (United States)

    Schenone, Aldo L; Menon, Venu

    2018-06-14

    This is an in-depth review on the mechanism of action, clinical utility, and drug-drug interactions of colchicine in the management of pericardial disease. Recent evidence about therapeutic targets on pericarditis has demonstrated that NALP3 inflammasome blockade is the cornerstone in the clinical benefits of colchicine. Such benefits extend from acute and recurrent pericarditis to transient constriction and post-pericardiotomy syndrome. Despite the increased utilization of colchicine in cardiovascular medicine, safety concerns remains unsolved regarding the long-term use of colchicine in the cardiac patient. Moreover, recent evidence has demonstrated that numerous cardiovascular medications, ranging from antihypertensive medication to antiarrhythmics, are known to interact with the CYP3A4 and/or P-gp system increasing the toxicity potential of colchicine. The use of adjunctive colchicine in the management of inflammatory pericardial diseases is standard of care in current practice. It is advised that a careful medication reconciliation with emphasis on pharmacokinetic is completed before prescribing colchicine in order to avoid harmful interaction by finding an alternative regimen or adjusting colchicine dosing.

  7. Quality of the cardiovascular drugs prescribing in Zagreb during the period 2001- 2004

    Directory of Open Access Journals (Sweden)

    Dražen Stojanović

    2009-02-01

    Full Text Available Aim To investigate the outpatient utilisation of cardiovasculardrugs in Zagreb, during the 2001-2004 period, and to identify thepossible association between the increase in the utilisation of particulardrug groups and decrease in the number of hospital admissions.Methods The number of DDD per thousand inhabitants per day(DDDs/TID was calculated from data on the number and size ofdispensed drug packages, obtained from the Zagreb Pharmacies.Drug Utilisation 90% (DU90% method was used on assessmentof drug prescribing quality.Results Total utilisation of the cardiovascular drugs was high inZagreb during the 2001-2004 period (between 402.9 DDDs/TIDand 406.9 DDDs/TID. Agents acting on the renin-angiotensinsystem (C09 (121.3 DDDs/TID and calcium channel blockers(C08 (87.5 DDDs/TID accounted for more than 50% of drugsused for the treatment of hypertension in 2004. The greatest utilisationincrease was observed for statins (78.3%. Comparison ofDU90% segment between 2001 and 2004 revealed pentoxifyllineand amiodarone to be absent, whereas cilazapril and ramipril intheir combination with HCTZ, bisoprolol, valsartan and losartanalone or in their combination with HCTZ were added in 2004,DU90% segment still contain doxazosin and propafenone, whichhad no grounds in therapeutic guidelines.Conclusion The outpatient utilisation of cardiovascular drugs washigh during the 2001-2004 period. The utilization pattern was improved.The result was a decrease in the number of hospital admissionsfor main cardiovascular events.

  8. Trends in Medicaid fee-for-service outpatient drug utilization ...

    African Journals Online (AJOL)

    utilization, expenditures, and pharmacy reimbursement rates (2010–2012) .... the factors that affect drug utilization and .... Impact of a generic substitution reform on patients' and society's ... Journal of Law & Economics 1993; 36(1): 71-97. 22.

  9. Evaluation of Drug Utilization Pattern for Patients of Bronchial ...

    African Journals Online (AJOL)

    Evaluation of Drug Utilization Pattern for Patients of Bronchial Asthma in a Government Hospital of Saudi Arabia. ... Background: Bronchial asthma is a social and economic healthcare burden. Drug utilization studies are ... Salbutamol and budesonide were the most common from each group, respectively. 89.5% of the ...

  10. Cause-specific cardiovascular risk associated with nonsteroidal antiinflammatory drugs among healthy individuals

    DEFF Research Database (Denmark)

    Fosbøl, Emil Loldrup; Folke, Fredrik; Jacobsen, Søren

    2010-01-01

    Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

  11. Cardiovascular drugs consumption--comparison between two Croatian regions, City of Zagreb and Lika-Senj County.

    Science.gov (United States)

    Jurković, Drazen; Stimac, Danijela; Bajramović, Dubravko; Tiljak, Hrvoje; Stevanović, Ranko

    2014-06-01

    The aim of this paper is to determine the differences in the outpatient consumption of cardiovascular drugs between Croatian regions: the City of Zagreb and Lika-Senj County. The data on the number of packages and the purchase price for each drug have been obtained from all pharmacies in Lika-Senj County and all pharmacies in the City of Zagreb. Defined daily doses/1000 inhabitants/day (DDD/1000/day) was calculated for every drug in accordance with its code name and Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) index of the World Health Organization (WHO) for 2007. For drug combinations without defined daily doses, equivalent doses (ED) were used. The quality of drug prescribing within the group of cardiovascular drugs was assessed using the Drug Utilization (DU90%) method and the adherence of the DU90% segment to the guidelines for prescribing individual drug groups. The statistical significance of differences in results between the City of Zagreb and Lika-Senj County was tested using the chi-square test at the level of statistical significance p Zagreb (chi2 = 28.93, df = 4, p Zagreb and Lika-Senj County differs significantly. The consumption, quality of prescribing drugs and cost/DDD in the City of Zagreb is higher than in Lika-Senj County; in the City of Zagreb, newer and more expensive drugs are prescribed to a higher extent.

  12. Fall-Risk-Increasing Drugs: A Systematic Review and Meta-Analysis: I. Cardiovascular Drugs.

    Science.gov (United States)

    de Vries, Max; Seppala, Lotta J; Daams, Joost G; van de Glind, Esther M M; Masud, Tahir; van der Velde, Nathalie

    2018-04-01

    Use of certain medications is recognized as a major and modifiable risk factor for falls. Although the literature on psychotropic drugs is compelling, the literature on cardiovascular drugs as potential fall-risk-increasing drugs is conflicting. The aim of this systematic review and meta-analysis is to provide a comprehensive overview of the associations between cardiovascular medications and fall risk in older adults. Design: A systematic review and meta-analysis. Medline, Embase, and PsycINFO. Key search concepts were "fall," "aged," "causality," and "medication." Studies that investigated cardiovascular medications as risk factors for falls in participants ≥60 years old or participants with a mean age of 70 or older were included. A meta-analysis was performed using the generic inverse variance method, pooling unadjusted and adjusted odds ratios (ORs) separately. In total, 131 studies were included in the qualitative synthesis. Meta-analysis using adjusted ORs showed significant results (pooled OR [95% confidence interval]) for loop diuretics, OR 1.36 (1.17, 1.57), and beta-blocking agents, OR 0.88 (0.80, 0.97). Meta-analysis using unadjusted ORs showed significant results for digitalis, OR 1.60 (1.08, 2.36); digoxin, OR 2.06 (1.56, 2.74); and statins, OR 0.80 (0.65, 0.98). Most of the meta-analyses resulted in substantial heterogeneity that mostly did not disappear after stratification for population and setting. In a descriptive synthesis, consistent associations were not observed. Loop diuretics were significantly associated with increased fall risk, whereas beta-blockers were significantly associated with decreased fall risk. Digitalis and digoxin may increase the risk of falling, and statins may reduce it. For the majority of cardiovascular medication groups, outcomes were inconsistent. Furthermore, recent studies indicate that specific drug properties, such as selectivity of beta-blockers, may affect fall risk, and drug-disease interaction also may play

  13. 7 Strategies for Improving Drug Utilization.

    Science.gov (United States)

    Schlosser, Michael; Chamberlain, Ronald; Dortch, Marcus

    2017-06-01

    When new pharmaceutical products enter the market, the lack of real-world experience with these drugs creates quandaries for payers and providers alike. Often, all there is to go on is the minimum required for FDA approval-non-inferiority to a comparator product in terms of efficacy and safety. Here are a few promising strategies to end this ambiguity.

  14. DRUG-UTILIZATION STUDY ON CURACAO

    NARCIS (Netherlands)

    VISSER, LE; OOSTERVELD, MH; DEJONGVANDENBERG, LTW

    1993-01-01

    The drug use on Curacao was evaluated with the help of the prescription forms of twelve community pharmacies at Curacao over a period of three months, The emphasis of the study was on three therapeutic groups: the systemic antibiotics, the psycholeptics and the anti-inflammatory and antirheumatic

  15. Old Drugs for New Indications in Cardiovascular Medicine.

    Science.gov (United States)

    Arbel, Yaron; Abuzeid, Wael; Rosenson, Robert S; Weisman, Alanna; Farkouh, Michael E

    2018-04-10

    Inflammation participates in the initiation and progression of atherosclerotic cardiovascular disease, and it is a critical inciting factor leading to acute ischemic events. Evidence has shown that certain anti-inflammatory medications used to treat non-atherosclerotic inflammatory diseases reduce cardiovascular events. This article reviews evidence that commonly used anti-inflammatory therapies (colchicine, allopurinol, methotrexate), reduce cardiovascular events. We discuss potential mechanisms of action, efficacy, and safety of these therapies and propose a clinical trials design to investigate their efficacy.

  16. Potential and clinical utility of stem cells in cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Korff Krause

    2010-03-01

    Full Text Available Korff Krause, Carsten Schneider, Kai Jaquet, Karl-Heinz KuckHanseatic Heart Center Hamburg, Department of Cardiology, Asklepios Hospital St. Georg, Hamburg, GermanyAbstract: The recent identification of bone marrow-derived adult stem cells and other types of stem cells that could improve heart function after transplantation have raised high expectations. The basic mechanisms have been studied mostly in murine models. However, these experiments revealed controversial results on transdifferentiation vs transfusion of adult stem cells vs paracrine effects of these cells, which is still being debated. Moreover, the reproducibility of these results in precisely translated large animal models is still less well investigated. Despite these weaknesses results of several clinical trials including several hundreds of patients with ischemic heart disease have been published. However, there are no solid data showing that any of these approaches can regenerate human myocardium. Even the effectiveness of cell therapy in these approaches is doubtful. In future we need in this important field of regenerative medicine: i more experimental data in large animals that are closer to the anatomy and physiology of humans, including data on dose effects, comparison of different cell types and different delivery routes; ii a better understanding of the molecular mechanisms involved in the fate of transplanted cells; iii more intensive research on genuine regenerative medicine, applying genetic regulation and cell engineering.Keywords: stem cells, cardiovascular disease

  17. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis

    DEFF Research Database (Denmark)

    Ahlehoff, O; Skov, L; Gislason, G

    2014-01-01

    BACKGROUND: Psoriasis is a common disease and is associated with cardiovascular diseases. Systemic anti-inflammatory drugs may reduce risk of cardiovascular events. We therefore examined the rate of cardiovascular events, i.e. cardiovascular death, myocardial infarction and stroke, in patients...... with severe psoriasis treated with systemic anti-inflammatory drugs. METHODS: Individual-level linkage of administrative registries was used to perform a longitudinal nationwide cohort study. Time-dependent multivariable adjusted Cox regression was used to estimate hazard ratios (HRs) with 95% confidence...... intervals (CIs) of cardiovascular events associated with use of biological drugs, methotrexate, cyclosporine, retinoids and other antipsoriatic therapies, including topical treatments, phototherapy and climate therapy. RESULTS: A total of 6902 patients (9662 treatment exposures) with a maximum follow...

  18. [Drug treatment of erection disorders in patients with cardiovascular disease

    NARCIS (Netherlands)

    Meuleman, E.J.H.; Kingma, J.H.

    2001-01-01

    Erectile dysfunction is a frequent condition in cardiovascular patients. Since the arrival of oral erection-supporting medication, patients want to know how safe sexual activity is in cardiovascular disease in general and during use of erection-supporting medication in particular. Sexual intercourse

  19. Influencers of generic drug utilization: A systematic review.

    Science.gov (United States)

    Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

    2017-08-04

    With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. The impact of cardiovascular drugs on the efficacy of local anesthesia in dentistry.

    Science.gov (United States)

    Milosavljevic, Мarko J; Jankovic, Slobodan M

    2016-12-01

    Drugs used chronically by patients with diseases of the cardiovascular system (group C of the ATC classification) may act on adrenergic receptors and/or certain ion channels, which gives them the potential to interact with the action of local dental anesthetics. The aim of the study was to investigate the effect of systemically administered chronic cardiovascular medication (oral route) on the efficacy of intraoral local anesthesia in patients with diseases of the cardiovascular system. This was a prospective cohort study which analyzed the efficacy of local terminal anesthesia (onset of anesthesia, duration anesthetized area) in the upper jaw of 70 patients: 40 patients on medication for cardiovascular system disorders and 30 patients who were not using these drugs (the control group). The following cardiovascular drugs were used: beta blockers, angiotensin converting enzyme inhibitors, calcium channel blockers, vasodilatators, diuretics, angiotensin receptor blockers, antiarrhythmics, statins and alfa blockers. The onset of anesthesia on the vestibular side was faster in those taking cardiovascular drugs (40.50±19.87 s) than the control patients (58.93±31.07 s; P = 0.004) and duration of anesthesia on this side was shorter. Although the difference was not significant, it was evident that on vestibular and palatal side the anesthetized area was more rapidly reduced in the patients taking cardiovascular drugs. The duration of cardiovascular therapy also had a significant impact on the anesthetized area. Drugs acting on cardiovascular system may influence the effect of local anesthetics used in dentistry, possibly through interaction with autonomic receptors and ion channels.

  1. A Clinico-Epidemiological Study on Poisonings due to Cardiovascular Drugs in Ahvaz, Iran

    Directory of Open Access Journals (Sweden)

    Marzie Zeinvand

    2017-03-01

    Full Text Available Background: Overdoses with cardiovascular drugs are related with significant morbidity and mortality. Beta-adrenergic blockers, calcium-channel blockers (CCBs, thiazide, digoxin and angiotensin converting enzyme (ACE inhibitors represent five of the most important classes of cardiovascular drugs. Overdoses with cardiovascular drugs are typically caused by exploratory ingestion by children or intentional ingestion by suicidal adults. As no study has been performed about poisoning with this kind of drug in Khuzestan, this study aimed to investigate the frequency of cardiovascular drug poisoning and its clinical features in patients presenting in Razi Hospital of Ahvaz from 2005 to 2009. Methods: A retrospective review of medical records of patients poisoned with cardiovascular who were treated at Clinical Toxicology Department was executed. A total of 70 poisoning cases referred to Razi Hospital were identified. These unselected cases included intentional, accidental, criminal and occupational circumstances. Beta-blocker poisoning, digital poisoning, calcium-channel blockers poisoning, ACE inhibitor poisoning, thiazide poisoning and poisoning with other cardiovascular drugs were evaluated on the basis of recorded data. Poisoning with one or several agents, time of admission, type of poisoned agents, sex, age, therapeutic intervention and mortality were investigated. Results: This study revealed that most of the people poisoned with cardiovascular drugs were females, single people and urban population. Most of the patients were 15-25 years old. Most poisoning was with beta blocker and calcium channel blockers. Their first symptom was headache and most of them needed ICU admission. Most of the patient ECGs were normal. There were 2 cases of death. Conclusion: This study revealed that continuous health care and the administration of the exact dose of drugs in the appropriate time and also developing of the toxicology centers seem necessary.

  2. Drug utilization and teratogenicity risk categories during pregnancy.

    Science.gov (United States)

    Basgül, Alin; Akici, Ahmet; Uzuner, Arzu; Kalaça, Sibel; Kavak, Zehra N; Tural, Alper; Oktay, Sule

    2007-01-01

    A limited number of studies have investigated in detail the use of drugs during pregnancy. Researchers in the present study investigated the details of drug utilization in pregnant women during the month before pregnancy, at the time that they became aware of the pregnancy, and during the first trimester. Face-to-face interviews were conducted with 359 pregnant women who were admitted to the fetal medicine unit at a university hospital for diagnosis and follow-up. A questionnaire was used to document sociodemographic characteristics and details of drug use. Drugs were categorized according to the US Food and Drug Administration fetal risk classification. Mean maternal age was 29.9+/-5.1 y, and mean gestational age was 19.6+/-9.5 wk. Many of the pregnant women studied (46.6%) were university graduates, and most (61.9%) had a relatively high annual income. Mean gestational age when participants first learned of their pregnancy was 39.8+/-16.4 d. One hundred seventeen participants (32.6%) used drugs during the month before conception, 54 (15%) at the time when they learned of their pregnancy, 180 (50.1%) at the time of the interview, and 289 (80.5%) during the first trimester. The percentages of drugs in categories D and X used by these subjects were 14%, 13.5%, 2.9%, and 5.9%, respectively. Most of the drugs were hormones. The total rate of drug utilization was not high before and during the first trimester of pregnancy. A considerable number of women were using drugs from the D and X categories; however, these numbers decreased significantly when women learned of their pregnancies. Intake of folic acid, vitamins, and iron was very low during the preconception period and was not high enough during the first trimester; this suggests that particular attention should be paid to the use of beneficial "safe" drugs during the preconception and early pregnancy periods.

  3. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research... system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic...

  4. Drug utilization pattern during pregnancy in North India.

    Science.gov (United States)

    Sharma, Rashmi; Kapoor, Bhuvneshvar; Verma, Ujala

    2006-07-01

    Pregnancy is a special physiological condition, where drug treatment presents a special concern. To evaluate the drug utilization pattern during pregnancy and to evaluate the effect of the educational and economic status on it.. The retrospective cross-sectional study. The postgraduate Department of Pharmacology and Therapeutics of a medical college. and the antenatal clinic of the institution. Medical students filled 405 questionnaires after interviewing pregnant women (243 primigravida and 152 multigravida). All the collected questionnaires were analysed for various study parameters. Inter-group comparison was done using chi-square test. P value drugs, with an average of 1.73, 2.89 and 2.49 drugs per pregnant women, were used during first, second and third trimester of pregnancy, respectively. A majority of the drugs used, were from category-A, followed by category-B and category-D. However, category C and X drugs constituted 2.90 (20) and 5.71% (40) of drugs used during the third trimester and first trimester, respectively. Herbal/homeopathic drugs constituted 6.42 (45), 3.68 (40) and 1.46% (10) of the drugs used in the first, second and third trimester of pregnancy, respectively (P=649). 33.33% (135) women believed that drug use during pregnancy is dangerous to both mother and child and 37.03% (150) believed that drugs are dangerous throughout pregnancy. 55.55% (225) females advocated the use of iron/folic acid during pregnancy. 24.69% (100) of women had knowledge about barrier contraceptives. Self-medication and homeopathic/ herbal drugs use was found more in graduates than in undergraduates; as well as, it was more in the higher socioeconomic group than the lower socioeconomic group. There is a need to educate and counsel women of child-bearing age, regarding the advantages and disadvantages of drug use during pregnancies, with special reference to alternative therapies and self-medication.

  5. Are prescription drug insurance choices consistent with expected utility theory?

    Science.gov (United States)

    Bundorf, M Kate; Mata, Rui; Schoenbaum, Michael; Bhattacharya, Jay

    2013-09-01

    To determine the extent to which people make choices inconsistent with expected utility theory when choosing among prescription drug insurance plans and whether tabular or graphical presentation format influences the consistency of their choices. Members of an Internet-enabled panel chose between two Medicare prescription drug plans. The "low variance" plan required higher out-of-pocket payments for the drugs respondents usually took but lower out-of-pocket payments for the drugs they might need if they developed a new health condition than the "high variance" plan. The probability of a change in health varied within subjects and the presentation format (text vs. graphical) and the affective salience of the clinical condition (abstract vs. risk related to specific clinical condition) varied between subjects. Respondents were classified based on whether they consistently chose either the low or high variance plan. Logistic regression models were estimated to examine the relationship between decision outcomes and task characteristics. The majority of respondents consistently chose either the low or high variance plan, consistent with expected utility theory. Half of respondents consistently chose the low variance plan. Respondents were less likely to make discrepant choices when information was presented in graphical format. Many people, although not all, make choices consistent with expected utility theory when they have information on differences among plans in the variance of out-of-pocket spending. Medicare beneficiaries would benefit from information on the extent to which prescription drug plans provide risk protection. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  6. Tobacco, illicit drugs use and risk of cardiovascular disease in patients living with HIV.

    Science.gov (United States)

    Raposeiras-Roubín, Sergio; Abu-Assi, Emad; Iñiguez-Romo, Andrés

    2017-11-01

    There is a strong link between HIV, smoking and illicit drugs. This association could be clinically relevant as it may potentiate the risk of cardiovascular diseases (CVD). The purpose of this review is to bring readers up to date on issues concerning the cardiovascular risk associated with tobacco and illicit drugs in patients living with HIV (PLHIV), examining the studies related to this topic published in the last year. There is a strong association between smoking and atherosclerotic disease in PLHIV, reducing life expectancy secondary to CVD by up to 6 years. Illicit drugs were associated with increased risk of atherosclerotic problems but to a lesser extent than smoking. A significant association of drugs such as cocaine with subclinical coronary atherosclerosis been demonstrated. The relation of marijuana, heroin and amphetamines with atherosclerosis generates more controversy. However, those drugs are associated with cardiovascular morbidity, independently of smoking and other traditional risk factors. Tobacco and illicit drugs are linked to CVD in HIV patients. This leads to the need to create special programs to address the addiction to smoking and illicit drugs, in order to mitigate their consequences and reduce cardiovascular risk.

  7. Drug utilization in patients with OA: a population-based study.

    Science.gov (United States)

    Wilson, Nicholas; Sanchez-Riera, Lidia; Morros, Rosa; Diez-Perez, Adolfo; Javaid, M Kassim; Cooper, Cyrus; Arden, Nigel K; Prieto-Alhambra, Daniel

    2015-05-01

    Patients with OA use different drugs in their search for relief. We aimed to study the prevalence of use and combinations of different medications for OA in a population-based cohort of OA patients in Catalonia, Spain, while characterizing users of each of the drugs available, with a particular focus on cardiovascular risk factors. Data were obtained from the Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) database, which includes electronic medical records and pharmacy invoice data for >5 million people from Catalonia. Study participants were those with a clinical diagnosis of OA in 2006-10. Drugs studied included oral and topical NSAIDs, analgesics (paracetamol, metamizole), opioids (tramadol, fentanyl), cyclooxygenase 2 (COX-2) inhibitors and symptomatic slow-acting drugs in OA. Drug utilization was described using medication possession ratios (MPRs), equivalent to the proportion of days covered with the drug of interest. The annual incidence of new users in the first year after OA diagnosis from 2006 to 2010 was estimated for all studied drugs among newly diagnosed OA patients using Poisson regression. We identified 238 536 study participants. The most common regimen of treatment consisted of at least three drugs (53.9% of patients). The drugs most frequently used regularly (MPR ≥50%) were chondroitin (21.2%), glucosamine (15.8%) and oral NSAIDs (14.4%). The incidence of the use of opioids, COX-2 inhibitors and chondroitin increased over the 5 year period, whereas all others decreased. Drug combinations are common in the treatment of OA patients, who are thus exposed to potential drug interactions, with unknown impacts on their health. The increasing use of opioids and COX-2 inhibitors is noteworthy because of the potential impact on safety and costs. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email

  8. Naturapolyceutics: The Science of Utilizing Natural Polymers for Drug Delivery

    Directory of Open Access Journals (Sweden)

    Ndidi C. Ngwuluka

    2014-05-01

    Full Text Available Naturapolyceutics defines the emerging science and technology platform that blends natural polymers and pharmaceutics for the design and development of drug delivery systems. Natural polymers due to their biological properties, sustainability, chemical flexibility, human and eco-friendliness are promising in this field. As drug delivery advances, there will be need for more polymers. Given that polymers utilized in pharmaceuticals require regulatory approval, robust processes are undertaken to facilitate the production of pharmaceutical grade natural polymers. This review provides insight into the processes—extraction, purification, modifications and characterizations—involved in the eventual utilization of natural polymers for drug delivery. The versatility of natural polymers and particularly modified natural polymers in targeted drug delivery, micro-/nano-drug delivery, theranostics, BioMEMs and generally in research and development of highly efficient, safe and quality products is demonstrated. Natural polymers are polymers of today and tomorrow. Therefore, the shift to undertake training, extensive research and subsequent commercialization of more natural polymers—novel and underutilized—for drug delivery is now!

  9. Transporter-mediated natural product–drug interactions for the treatment of cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Weibin Zha

    2018-04-01

    Full Text Available The growing use of natural products in cardiovascular (CV patients has been greatly raising the concerns about potential natural product–CV drug interactions. Some of these may lead to unexpected cardiovascular adverse effects and it is, therefore, essential to identify or predict potential natural product–CV drug interactions, and to understand the underlying mechanisms. Drug transporters are important determinants for the pharmacokinetics of drugs and alterations of drug transport has been recognized as one of the major causes of natural product–drug interactions. In last two decades, many CV drugs (e.g., angiotensin II receptor blockers, beta-blockers and statins have been identified to be substrates and inhibitors of the solute carrier (SLC transporters and the ATP-binding cassette (ABC transporters, which are two major transporter superfamilies. Meanwhile, in vitro and in vivo studies indicate that a growing number of natural products showed cardioprotective effects (e.g., gingko biloba, danshen and their active ingredients are also substrates and inhibitors of drug transporters. Thus, to understand transporter-mediated natural product–CV drug interactions is important and some transporter-mediated interactions have already shown to have clinical relevance. In this review, we review the current knowledge on the role of ABC and SLC transporters in CV therapy, as well as transporter modulation by natural products used in CV diseases and their induced natural product–CV drug interactions through alterations of drug transport. We hope our review will aid in a comprehensive summary of transporter-mediated natural product–CV drug interactions and help public and physicians understand these type of interactions. Keywords: Cardiovascular drugs, Natural products, Drug transporters, Natural product–drug interaction, Pharmacokinetics

  10. Forecasting drug utilization and expenditure in a metropolitan health region

    Directory of Open Access Journals (Sweden)

    Korkmaz Seher

    2010-05-01

    Full Text Available Abstract Background New pharmacological therapies are challenging the healthcare systems, and there is an increasing need to assess their therapeutic value in relation to existing alternatives as well as their potential budget impact. Consequently, new models to introduce drugs in healthcare are urgently needed. In the metropolitan health region of Stockholm, Sweden, a model has been developed including early warning (horizon scanning, forecasting of drug utilization and expenditure, critical drug evaluation as well as structured programs for the introduction and follow-up of new drugs. The aim of this paper is to present the forecasting model and the predicted growth in all therapeutic areas in 2010 and 2011. Methods Linear regression analysis was applied to aggregate sales data on hospital sales and dispensed drugs in ambulatory care, including both reimbursed expenditure and patient co-payment. The linear regression was applied on each pharmacological group based on four observations 2006-2009, and the crude predictions estimated for the coming two years 2010-2011. The crude predictions were then adjusted for factors likely to increase or decrease future utilization and expenditure, such as patent expiries, new drugs to be launched or new guidelines from national bodies or the regional Drug and Therapeutics Committee. The assessment included a close collaboration with clinical, clinical pharmacological and pharmaceutical experts from the regional Drug and Therapeutics Committee. Results The annual increase in total expenditure for prescription and hospital drugs was predicted to be 2.0% in 2010 and 4.0% in 2011. Expenditures will increase in most therapeutic areas, but most predominantly for antineoplastic and immune modulating agents as well as drugs for the nervous system, infectious diseases, and blood and blood-forming organs. Conclusions The utilisation and expenditure of drugs is difficult to forecast due to uncertainties about the rate

  11. Cardiovascular drug discovery in the academic setting: building infrastructure, harnessing strengths, and seeking synergies.

    Science.gov (United States)

    Gardell, Stephen J; Roth, Gregory P; Kelly, Daniel P

    2010-10-01

    The flow of innovative, effective, and safe new drugs from pharmaceutical laboratories for the treatment and prevention of cardiovascular disease has slowed to a trickle. While the need for breakthrough cardiovascular disease drugs is still paramount, the incentive to develop these agents has been blunted by burgeoning clinical development costs coupled with a heightened risk of failure due to the unprecedented nature of the emerging drug targets and increasingly challenging regulatory environment. A fuller understanding of the drug targets and employing novel biomarker strategies in clinical trials should serve to mitigate the risk. In any event, these current challenges have evoked changing trends in the pharmaceutical industry, which have created an opportunity for non-profit biomedical research institutions to play a pivotal partnering role in early stage drug discovery. The obvious strengths of academic research institutions is the breadth of their scientific programs and the ability and motivation to "go deep" to identify and characterize new target pathways that unlock the specific mysteries of cardiovascular diseases--leading to a bounty of novel therapeutic targets and prescient biomarkers. However, success in the drug discovery arena within the academic environment is contingent upon assembling the requisite infrastructure, annexing the talent to interrogate and validate the drug targets, and building translational bridges with pharmaceutical organizations and patient-oriented researchers.

  12. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis.

    Science.gov (United States)

    Trelle, Sven; Reichenbach, Stephan; Wandel, Simon; Hildebrand, Pius; Tschannen, Beatrice; Villiger, Peter M; Egger, Matthias; Jüni, Peter

    2011-01-11

    To analyse the available evidence on cardiovascular safety of non-steroidal anti-inflammatory drugs. Network meta-analysis. Bibliographic databases, conference proceedings, study registers, the Food and Drug Administration website, reference lists of relevant articles, and reports citing relevant articles through the Science Citation Index (last update July 2009). Manufacturers of celecoxib and lumiracoxib provided additional data. All large scale randomised controlled trials comparing any non-steroidal anti-inflammatory drug with other non-steroidal anti-inflammatory drugs or placebo. Two investigators independently assessed eligibility. The primary outcome was myocardial infarction. Secondary outcomes included stroke, death from cardiovascular disease, and death from any cause. Two investigators independently extracted data. 31 trials in 116 429 patients with more than 115 000 patient years of follow-up were included. Patients were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction (rate ratio 2.12, 95% credibility interval 1.26 to 3.56), followed by lumiracoxib (2.00, 0.71 to 6.21). Ibuprofen was associated with the highest risk of stroke (3.36, 1.00 to 11.6), followed by diclofenac (2.86, 1.09 to 8.36). Etoricoxib (4.07, 1.23 to 15.7) and diclofenac (3.98, 1.48 to 12.7) were associated with the highest risk of cardiovascular death. Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug.

  13. Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-10-01

    Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices. Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition. Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46 and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47. Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  14. Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review

    Directory of Open Access Journals (Sweden)

    Kanji Salmaan

    2012-05-01

    Full Text Available Abstract Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s with the drug(s alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Results Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Conclusions Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets and garlic (plus nitrates or warfarin on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

  15. Update of green tea interactions with cardiovascular drugs and putative mechanisms

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    José Pablo Werba

    2018-04-01

    Full Text Available Many patients treated with cardiovascular (CV drugs drink green tea (GT, either as a cultural tradition or persuaded of its putative beneficial effects for health. Yet, GT may affect the pharmacokinetics and pharmacodynamics of CV compounds. Novel GT-CV drug interactions were reported for rosuvastatin, sildenafil and tacrolimus. Putative mechanisms involve inhibitory effects of GT catechins at the intestinal level on influx transporters OATP1A2 or OATP2B1 for rosuvastatin, on CYP3A for sildenafil and on both CYP3A and the efflux transporter p-glycoprotein for tacrolimus. These interactions, which add to those previously described with simvastatin, nadolol and warfarin, might lead, in some cases, to reduced drug efficacy or risk of drug toxicity. Oddly, available data on GT interaction with CV compounds with a narrow therapeutic index, such as warfarin and tacrolimus, derive from single case reports. Conversely, GT interactions with simvastatin, rosuvastatin, nadolol and sildenafil were documented through pharmacokinetic studies. In these, the effect of GT or GT derivatives on drug exposure was mild to moderate, but a high inter-individual variability was observed. Further investigations, including studies on the effect of the dose and the time of GT intake are necessary to understand more in depth the clinical relevance of GT-CV drug interactions. Keywords: Cardiovascular drugs, Green tea, Herb–drug interactions

  16. Cardiovascular risk and inhibition of cyclooxygenase: traditional nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors

    Directory of Open Access Journals (Sweden)

    M. Campanini

    2013-05-01

    Full Text Available BACKGROUND The development of non-selective nonsteroidal anti-inflammatory drugs (tNSAIDs and, more recently, of selective inhibitors of the cycloooxygenase-2 isoform (COXIBs, has contributed greatly towards the effective management of patients with arthritis and pain complaints. Although COXIBs have demonstrated an improved gastrointestinal tolerability compared with tNSAIDs, the cardiovascular effects of the two drugs types are much controversial. By blocking prostacyclin formation but leaving platelet-derived thromboxane A2 generation unopposed, the potential gastrointestinal benefit of COXIBs may come at cost of increased thrombotic risk. AIM OF THE STUDY This review aims at analysing the cardiovascular effects of the tNSAIDs and COXIBs. METHOD This review addresses the controversy of effects of COXIBs and tNSAIDs in 4 segments. It begins with a discussion about pathophysiological effects of cyclooxygenase inhibition on cardiovascular system. This is followed by a systematic review and meta-analysis of a control, randomized, double blind study and population-based matched case-control study to compare the risk of serious cardiovascular events with tNSAIDs and COXIBs. Then it answers to key questions with the aim to assist the clinicians for a systematic approach to evaluate the risk-benefit-ratio of NSAIDs in the clinical practice. Finally we analyse the open questions associated with the use of NSAIDs and the cardiovascular events. RESULTS The use of rofecoxib demonstrated an increase in adverse cardiovascular events. This toxic effect is not dose-related. The relationship between celecoxib and cardiovascular risk is less clear. The results of different clinical trials are conflicting: some didn’t demonstrate increase in cardiovascular toxicity but the APC study and recently a metanalysis reported a significant incidence of adverse cardiovascular events. Also valdecoxib and parecoxib appear to have increased risk for cardiovascular

  17. Cardiovascular drugs and the risk of suicide: a nested case-control study

    DEFF Research Database (Denmark)

    Callréus, Torbjörn; Agerskov Andersen, Ulla; Hallas, Jesper

    2007-01-01

    OBJECTIVE: During the past 30 years, various cardiovascular drugs have been implicated as causes of depression or suicide. Although the evidence for causal relationships has generally been conflicting, both beta-blockers and angiotensin-converting-enzyme inhibitors (ACE-inhibitors) have been...... related to depression. Lipid-lowering therapies and calcium-channel blockers have also been linked to an increased risk of suicide. In this study, we investigated the possible association between the use of cardiovascular drugs and suicide using population-based register data. METHODS: We performed...... a nested case-control study in the county of Funen, Denmark, that consisted of 743 cases of completed suicide identified in a Death Registry for the period 1991-1998 and 14,860 age- and sex-matched controls. Information on previous drug use was retrieved from prescription data and the association between...

  18. Transporter-mediated natural product-drug interactions for the treatment of cardiovascular diseases.

    Science.gov (United States)

    Zha, Weibin

    2018-04-01

    The growing use of natural products in cardiovascular (CV) patients has been greatly raising the concerns about potential natural product-CV drug interactions. Some of these may lead to unexpected cardiovascular adverse effects and it is, therefore, essential to identify or predict potential natural product-CV drug interactions, and to understand the underlying mechanisms. Drug transporters are important determinants for the pharmacokinetics of drugs and alterations of drug transport has been recognized as one of the major causes of natural product-drug interactions. In last two decades, many CV drugs (e.g., angiotensin II receptor blockers, beta-blockers and statins) have been identified to be substrates and inhibitors of the solute carrier (SLC) transporters and the ATP-binding cassette (ABC) transporters, which are two major transporter superfamilies. Meanwhile, in vitro and in vivo studies indicate that a growing number of natural products showed cardioprotective effects (e.g., gingko biloba, danshen and their active ingredients) are also substrates and inhibitors of drug transporters. Thus, to understand transporter-mediated natural product-CV drug interactions is important and some transporter-mediated interactions have already shown to have clinical relevance. In this review, we review the current knowledge on the role of ABC and SLC transporters in CV therapy, as well as transporter modulation by natural products used in CV diseases and their induced natural product-CV drug interactions through alterations of drug transport. We hope our review will aid in a comprehensive summary of transporter-mediated natural product-CV drug interactions and help public and physicians understand these type of interactions. Copyright © 2017. Published by Elsevier B.V.

  19. Clinical applications of fast liquid chromatography: a review on the analysis of cardiovascular drugs and their metabolites.

    Science.gov (United States)

    Baranowska, Irena; Magiera, Sylwia; Baranowski, Jacek

    2013-05-15

    One of the major challenges facing the medicine today is developing new therapies that enhance human health. To help address these challenges the utilization of analytical technologies and high-throughput automated platforms has been employed; in order to perform more experiments in a shorter time frame with increased data quality. In the last decade various analytical strategies have been established to enhance separation speed and efficiency in liquid chromatography applications. Liquid chromatography is an increasingly important tool for monitoring drugs and their metabolites. Furthermore, liquid chromatography has played an important role in pharmacokinetics and metabolism studies at these drug development stages since its introduction. This paper provides an overview of current trends in fast chromatography for the analysis of cardiovascular drugs and their metabolites in clinical applications. Current trends in fast liquid chromatographic separations involve monolith technologies, fused-core columns, high-temperature liquid chromatography (HTLC) and ultra-high performance liquid chromatography (UHPLC). The high specificity in combination with high sensitivity makes it an attractive complementary method to traditional methodology used for routine applications. The practical aspects of, recent developments in and the present status of fast chromatography for the analysis of biological fluids for therapeutic drug and metabolite monitoring, pharmacokinetic studies and bioequivalence studies are presented. Copyright © 2013 Elsevier B.V. All rights reserved.

  20. Induced pluripotent stem cell-derived cardiomyocytes for cardiovascular disease modeling and drug screening

    OpenAIRE

    Sharma, Arun; Wu, Joseph C; Wu, Sean M

    2013-01-01

    Human induced pluripotent stem cells (hiPSCs) have emerged as a novel tool for drug discovery and therapy in cardiovascular medicine. hiPSCs are functionally similar to human embryonic stem cells (hESCs) and can be derived autologously without the ethical challenges associated with hESCs. Given the limited regenerative capacity of the human heart following myocardial injury, cardiomyocytes derived from hiPSCs (hiPSC-CMs) have garnered significant attention from basic and translational scienti...

  1. The impact of cardiovascular drug innovation on the longevity of elderly residents of Switzerland, 2003-2012

    Directory of Open Access Journals (Sweden)

    Frank R Lichtenberg

    2015-03-01

    Full Text Available Previous investigators have argued that one of the two most important contributors to improved human survival is the treatment of cardiovascular disease. Among Swiss inhabitants age 65 and over, 90% of the 1994-2010 decline in the overall death rate was due to the decline in the rate of deaths from diseases of the circulatory system. Little if any of the decline in cardiovascular mortality is likely to have been due to changes in behavioral risk factors, especially tobacco use and obesity. This study examines the impact of cardiovascular drug innovation on the longevity of elderly residents of Switzerland using cross-sectional patient-level data on about 22 thousand patients insured by a major health insurer (CSS during the period 2003-2011. We investigate the effect of the vintage (world launch year of the cardiovascular drugs used by an individual in 2003 on his or her longevity (time till death, controlling for several demographic characteristics and indicators of health status. We are able to track a patient’s vital status until 12/31/2011: 8 years after the end of the period in which cardiovascular drug use (and other variables are measured. Our estimates indicate that people who used newer cardiovascular drugs in 2003 had longer time till death than people who used older cardiovascular drugs, controlling for the number of 2003 prescriptions and their distribution by main anatomical group, the number of 2003 doctor visits and their distribution by specialty, whether the person was hospitalized in 2003, sex, and age. Our most conservative estimates imply that cardiovascular drug innovation accounted for almost a quarter of the increase in longevity among elderly residents of Switzerland during 2003-2012, and that it increased their longevity by almost 3 months. Other estimates are about twice as large. All of the estimates are consistent with the hypothesis that newer classes of drugs tend to be therapeutically superior to older classes of

  2. An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system.

    Science.gov (United States)

    Zuppa, Athena; Vijayakumar, Sundararajan; Jayaraman, Bhuvana; Patel, Dimple; Narayan, Mahesh; Vijayakumar, Kalpana; Mondick, John T; Barrett, Jeffrey S

    2007-09-01

    Drug utilization in the inpatient setting can provide a mechanism to assess drug prescribing trends, efficiency, and cost-effectiveness of hospital formularies and examine subpopulations for which prescribing habits may be different. Such data can be used to correlate trends with time-dependent or seasonal changes in clinical event rates or the introduction of new pharmaceuticals. It is now possible to provide a robust, dynamic analysis of drug utilization in a large pediatric inpatient setting through the creation of a Web-based hospital drug utilization system that retrieves source data from our accounting database. The production implementation provides a dynamic and historical account of drug utilization at the authors' institution. The existing application can easily be extended to accommodate a multi-institution environment. The creation of a national or even global drug utilization network would facilitate the examination of geographical and/or socioeconomic influences in drug utilization and prescribing practices in general.

  3. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    Science.gov (United States)

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

  4. Patient participation in decision-making about cardiovascular preventive drugs - resistance as agency.

    Science.gov (United States)

    Hultberg, Josabeth; Rudebeck, Carl Edvard

    2017-09-01

    The aim of the study was to describe and explore patient agency through resistance in decision-making about cardiovascular preventive drugs in primary care. Six general practitioners from the southeast of Sweden audiorecorded 80 consultations. From these, 28 consultations with proposals from GPs for cardiovascular preventive drug treatments were chosen for theme-oriented discourse analysis. The study shows how patients participate in decision-making about cardiovascular preventive drug treatments through resistance in response to treatment proposals. Passive modes of resistance were withheld responses and minimal unmarked acknowledgements. Active modes were to ask questions, contest the address of an inclusive we, present an identity as a non-drugtaker, disclose non-adherence to drug treatments, and to present counterproposals. The active forms were also found in anticipation to treatment proposals from the GPs. Patients and GPs sometimes displayed mutual renouncement of responsibility for decision-making. The decision-making process appeared to expand both beyond a particular phase in the consultations and beyond the single consultation. The recognition of active and passive resistance from patients as one way of exerting agency may prove valuable when working for patient participation in clinical practice, education and research about patient-doctor communication about cardiovascular preventive medication. We propose particular attentiveness to patient agency through anticipatory resistance, patients' disclosures of non-adherence and presentations of themselves as non-drugtakers. The expansion of the decision-making process beyond single encounters points to the importance of continuity of care. KEY POINTS Guidelines recommend shared decision-making about cardiovascular preventive treatment. We need an understanding of how this is accomplished in actual consultations.This paper describes how patient agency in decision-making is displayed through different forms

  5. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Science.gov (United States)

    2010-10-01

    ... PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.153 Drug utilization... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE...

  6. Danish register-based study on the association between specific cardiovascular drugs and fragility fractures

    DEFF Research Database (Denmark)

    Torstensson, Maia; Hansen, Annette Højmann; Leth-Møller, Katja

    2015-01-01

    OBJECTIVE: To determine whether drugs used in treatment of cardiovascular diseases (CVD-drugs), including hypertension, increase the risk of fragility fractures in individuals above the age of 65 years. DESIGN: Retrospective nationwide cohort study. SETTING: Danish nationwide national registers...... and statins) was determined by prescription claims from pharmacies. The association between use of specific CVD-drugs and fragility fractures was assessed using multivariable Poisson regression models, and adjusted incidence rate ratios (IRRs) were calculated. RESULTS: Overall, 1 586 554 persons were included......, of these 16.1% experienced a fall-related fracture. The multivariable Poisson regression analysis showed positive associations between fracture and treatment with furosemide, thiazide and digoxin. IRRs during the first 14 days of treatment were for furosemide IRR 1.74 (95% CI 1.61 to 1.89) and for thiazides...

  7. NSAIDs utilization for musculoskeletal indications in elderly patients with cerebro/cardiovascular disease.

    Science.gov (United States)

    Roberto, Giuseppe; Bartolini, Claudia; Rea, Federico; Onder, Graziano; Vitale, Cristiana; Trifirò, Gianluca; Kirchmayer, Ursula; Chinellato, Alessandro; Lucenteforte, Ersilia; Corrao, Giovanni; Mugelli, Alessandro; Lapi, Francesco; Gini, Rosa

    2018-05-01

    To describe NSAID utilization for musculoskeletal conditions in a large cohort of Italian elderly with cerebro/cardiovascular disease, a population in which NSAIDs should be generally avoided due to the prothrombotic potential. Administrative data from five Italian geographic areas were analyzed. Patients aged ≥ 65 with a cerebro/cardiovascular event recorded between 2008 and 2011 (cohort entry) were selected. Prescription NSAIDs reimbursed for musculoskeletal conditions and dispensed during 1 year follow-up were retrieved to describe (i) prevalence of use, (ii) average amount of defined daily doses of NSAIDs claimed by users per day of follow-up, and (iii) distribution of the received daily dose (RDD) among patients with ≥ 2 dispensings. Among new users, i.e., patients without NSAID dispensings during 2 years before cohort entry, the first dispensed NSAID molecule was observed. Overall, 511,989 patients were selected. Across the five geographic areas, prevalence of use ranged from 48 to 21% and average consumption ranged between 30 and 67 DDD/1000 users/day. Around 10% of patients in the overall cohort had a RDD > 1. Nimesulide (9.6%) and diclofenac (7.5%) had the highest prevalence of use. The most consumed NSAIDs were nimesulide and coxibs with 10.6 and 7.5 DDD/1000 users/day, respectively. Among new users recruited in 2011, 30% had diclofenac or a coxibs as the first prescription. NSAID use was common in the study cohort, particularly in central-southern areas. In contrast with current recommendations, coxibs and diclofenac were among the most prescribed active principles, even in new users. Interventions to promote appropriateness of use are warranted.

  8. A comparison of cardiovascular risk factors for ten antipsychotic drugs in clinical practice

    Directory of Open Access Journals (Sweden)

    Bodén R

    2013-03-01

    Full Text Available Robert Bodén,1,2 Gunnar Edman,3,4 Johan Reutfors,2 Claes-Göran Östenson,3 Urban Ösby3,4 1Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden; 2Department of Medicine Solna, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden; 3Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; 4Department of Psychiatry, Tiohundra AB, Norrtälje, Sweden Abstract: It is well known that abdominal obesity, dyslipidemia, and insulin resistance are highly prevalent in patients receiving maintenance treatment with antipsychotics, but there is limited knowledge about the association between cardiovascular risk factors and treatment with antipsychotic drugs. In this naturalistic study we investigated a sample of 809 antipsychotic-treated patients from Swedish psychosis outpatient teams. Cardiovascular risk factors (eg, metabolic syndrome, homeostasis model assessment of insulin resistance, and low-density lipoprotein values were measured, and their associations to current antipsychotic pharmacotherapy were studied. Ten antipsychotic drugs were compared in a stepwise logistic regression model. For the patients, the presence of the components of metabolic syndrome ranged from 35% for hyperglycemia to 64% for elevated waist circumference. Hypertriglyceridemia was associated with clozapine (odds ratio [OR] = 1.81, 95% confidence interval [CI] 1.08–3.04, reduced high-density lipoprotein with both clozapine and olanzapine (OR = 1.73, 95% CI 1.01–2.97; and OR = 2.03, 95% CI 1.32–3.13, hypertension with perphenazine (OR = 2.00, 95% CI 1.21–3.59, and hyperglycemia inversely with ziprasidone (OR = 0.21, 95% CI 0.05–0.89 and positively with haloperidol (OR = 2.02, 95% CI 1.18–3.48. There were no significant relationships between any of the antipsychotic drugs and increased waist circumference, homeostasis model assessment of insulin resistance, or low-density lipoprotein levels. In

  9. The internet as a source of drug information: a profile of utilization by ...

    African Journals Online (AJOL)

    Open Access DOWNLOAD FULL TEXT ... Introduction: The internet is a useful tool which could provide quality drug information if well applied. Its utilization as a source of drug information by junior doctors in Nigeria is not well documented.

  10. Study of the Effects of Drugs upon the Cardiovascular and Respiratory Systems

    Science.gov (United States)

    1986-06-01

    gave no response (See figures la & 1b). Blood plasma samples have been taken before and after each injection of liposome suspension and may be sent...cholinesterase activity with cardiovascular and pulmonary function before, during and after administracion of pyridostigmine. The formulation of this drug...Composite Summaries - Beagles Note: All variation bars represent S.E.M. Best Available Copy C% C 0 % C% 0(1C) C0 C C 0 C 0 0 C% % 0 0 % - - - - - - . 84 CT LA

  11. Comparative Resuscitation Measures for Drug Toxicities Utilizing Lipid Emulsions

    Science.gov (United States)

    2015-01-13

    CARPA like reactions (major cardiovascular depression) after lipid infusions. Other studies have shown a transient increase in pulmonary hypertension ...reuptake inhibitor. The most common symptoms from overdose include sinus tachycardia, hypertension , drowsiness, lethargy, agitation, nausea and vomiting...Walker R (2007) Pain and combat injuries in soldiers returning from Operations Enduring Freedom and Iraqi Freedom: Implications for research and

  12. Suicide loss, changes in medical care utilization, and hospitalization for cardiovascular disease and diabetes mellitus.

    Science.gov (United States)

    Cho, Jaelim; Jung, Sang Hyuk; Kim, Changsoo; Suh, Mina; Choi, Yoon Jung; Sohn, Jungwoo; Cho, Seong-Kyung; Suh, Il; Shin, Dong Chun; Rexrode, Kathryn M

    2016-03-01

    The impact of suicide loss on family members' cardiometabolic health has little been evaluated in middle-aged and elderly people. We investigated the effect of suicide loss on risks for cardiovascular disease (CVD) and diabetes mellitus (DM) in suicide completers' family members using a national representative comparison group. The study subjects were 4253 family members of suicide completers and 9467 non-bereaved family members of individuals who were age and gender matched with the suicide completers in the Republic of Korea. National health insurance data were used to identify medical care utilization during the year before and after a suicide loss. A recurrent-events survival analysis was performed to estimate the hazard ratios (HRs) of hospitalizations for CVD, DM, or psychiatric disorders, after adjusting for age, residence, and socioeconomic status. Among subjects without a past history of CVD, DM, or psychiatric disorders, the increased risks of recurrent hospitalizations were observed for CVD [HR 1.343, 95% confidence interval (CI) 1.001-1.800 in men; HR 1.240, 95% CI 1.025-1.500 in women] and DM (HR 2.238, 95% CI 1.379-3.362 in men; HR 1.786, 95% CI 1.263-2.527 in women). In subjects with a past history of CVD, DM, or psychiatric disorders, the number of medical care visits decreased after a suicide loss, and suicide completers' family members showed lower rates of hospitalization for CVD and DM than the comparison group. Compared with non-bereaved family members, suicide completers' family members without a past history of CVD, DM, or psychiatric disorder showed a high risk of hospitalization for those conditions. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  13. Potassium channels as drugs targets in therapy of cardiovascular diseases: 25 years later

    Directory of Open Access Journals (Sweden)

    Protić Dragana

    2013-03-01

    Full Text Available Potassium channels are the most variable ion channel group. They participate in numerous cardiovascular functions, for example regulation of vascular tone, maintenance of resting cardiac membrane potential and excitability of cardiac conduction tissue. Both drugs and endogenous ligands could modulate potassium channel function, belonging to the potassium channel blockers or openers. Modulation of potassium channels could be a therapeutic or adverse drug action. Class III antiarrhythmic agents block the potassium channels, thereby prolonging repolarization phase of action potential with resulting prolongation of effective refractory period. Their effectiveness against supraventricular and ventricular arrhythmias should be weighted against their proarrhythmogenic potential. In addition, numerous other antiarrhythmic agents could modulate potassium channels as well. Diazoxide, minoxidil and nicorandil (well known arterial vasodilators, as well as numerous newly synthesized substances with still unknown therapeutic potential, belong to the potassium channel activators/openers. Therapeutic use of such vasodilators may involve treatment of hypertension (diazoxide, minoxidil and stable angina (nicorandil. Their use might be accompanied with side effects, such as vasodilation, edema, hypotension and reflex tachycardia. Potassium channel openers have also an important role in the treatment of peripheral vascular disease and pulmonary hypertension. In the future, drugs with selective effects on the vascular or cardiac potassium channels could be useful therapeutic agents.

  14. POTASSIUM CHANNELS AS DRUGS TARGETS IN THERAPY OF CARDIOVASCULAR DESEASES: 25 YEARS LATER

    Directory of Open Access Journals (Sweden)

    Protić Dragana

    2013-01-01

    Full Text Available Potassium channels are the most variable ion channel group. They participate in numerous cardiovascular functions, for example regulation of vascular tone, maintenance of resting cardiac membrane potential and excitability of cardiac conduction tissue. Both drugs and endogenous ligands could modulate potassium channel function, belonging to the potassium channel blockers or openers. Modulation of potassium channels could be a therapeutic or adverse drug action. Class III antiarrhythmic agents block the potassium channels, thereby prolonging repolarization phase of action potential with resulting prolongation of effective refractory period. Their effectiveness against supraventricular and ventricular arrhythmias should be weighted against their proarrhythmogenic potential. In addition, numerous other antiarrhythmic agents could modulate potassium channels as well. Diazoxide, minoxidil and nicorandil (well known arterial vasodilators, as well as numerous newly synthesized substances with still unknown therapeutic potential, belong to the potassium channel activators/ openers. Therapeutic use of such vasodilators may involve treatment of hypertension (diazoxide, minoxidil and stable angina (nicorandil. Their use might be accompanied with side effects, such as vasodilation, edema, hypotension and reflex tachycardia. Potassium channel openers have also an important role in the treatment of peripheral vascular disease and pulmonary hypertension. In the future, drugs with selective effects on the vascular or cardiac potassium channels could be useful therapeutic agents.

  15. DrugSig: A resource for computational drug repositioning utilizing gene expression signatures.

    Directory of Open Access Journals (Sweden)

    Hongyu Wu

    Full Text Available Computational drug repositioning has been proved as an effective approach to develop new drug uses. However, currently existing strategies strongly rely on drug response gene signatures which scattered in separated or individual experimental data, and resulted in low efficient outputs. So, a fully drug response gene signatures database will be very helpful to these methods. We collected drug response microarray data and annotated related drug and targets information from public databases and scientific literature. By selecting top 500 up-regulated and down-regulated genes as drug signatures, we manually established the DrugSig database. Currently DrugSig contains more than 1300 drugs, 7000 microarray and 800 targets. Moreover, we developed the signature based and target based functions to aid drug repositioning. The constructed database can serve as a resource to quicken computational drug repositioning. Database URL: http://biotechlab.fudan.edu.cn/database/drugsig/.

  16. Prognostic utility of novel biomarkers of cardiovascular stress: the Framingham Heart Study.

    Science.gov (United States)

    Wang, Thomas J; Wollert, Kai C; Larson, Martin G; Coglianese, Erin; McCabe, Elizabeth L; Cheng, Susan; Ho, Jennifer E; Fradley, Michael G; Ghorbani, Anahita; Xanthakis, Vanessa; Kempf, Tibor; Benjamin, Emelia J; Levy, Daniel; Vasan, Ramachandran S; Januzzi, James L

    2012-09-25

    Biomarkers for predicting cardiovascular events in community-based populations have not consistently added information to standard risk factors. A limitation of many previously studied biomarkers is their lack of cardiovascular specificity. To determine the prognostic value of 3 novel biomarkers induced by cardiovascular stress, we measured soluble ST2, growth differentiation factor-15, and high-sensitivity troponin I in 3428 participants (mean age, 59 years; 53% women) in the Framingham Heart Study. We performed multivariable-adjusted proportional hazards models to assess the individual and combined ability of the biomarkers to predict adverse outcomes. We also constructed a "multimarker" score composed of the 3 biomarkers in addition to B-type natriuretic peptide and high-sensitivity C-reactive protein. During a mean follow-up of 11.3 years, there were 488 deaths, 336 major cardiovascular events, 162 heart failure events, and 142 coronary events. In multivariable-adjusted models, the 3 new biomarkers were associated with each end point (Pstatistic (P=0.005 or lower) and net reclassification improvement (P=0.001 or lower). Multiple biomarkers of cardiovascular stress are detectable in ambulatory individuals and add prognostic value to standard risk factors for predicting death, overall cardiovascular events, and heart failure.

  17. Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway.

    Science.gov (United States)

    Fog, Amura Francesca; Kvalvaag, Gunnar; Engedal, Knut; Straand, Jørund

    2017-12-01

    We describe the drug-related problems (DRPs) identified during medication reviews (MRs) and the changes in drug utilization after MRs at nursing homes in Oslo, Norway. We explored predictors for the observed changes. Observational before-after study. Forty-one nursing homes. MRs performed by multidisciplinary teams during November 2011 to February 2014. In all, 2465 long-term care patients. DRPs identified by explicit criteria (STOPP/START and NORGEP) and drug-drug interaction database; interventions to resolve DRPs; drug use changes after MR. A total of 6158 DRPs were identified, an average of 2.6 DRPs/patient, 2.0 for regular and 0.6 for pro re nata (prn) drugs. Of these patients, 17.3% had no DRPs. The remaining 82.7% of the patients had on average 3.0 DRPs/patient. Use of unnecessary drugs (43.5%), excess dosing (12.5%) and lack of monitoring of the drug use (11%) were the most frequent DRPs. Opioids and psychotropic drugs were involved in 34.4% of all DRPs. The mean number of drugs decreased after the MR from 6.8 to 6.3 for regular drugs and from 3.0 to 2.6 for prn drugs. Patients with DRPs experienced a decrease of 1.1 drugs after MR (0.5 for regular and 0.6 for prn drugs). The reduction was most pronounced for the regular use of antipsychotics, antidepressants, hypnotics/sedatives, diuretics, antithrombotic agents, antacid drugs; and for prn use of anxiolytics, opioids, hypnotics/sedatives, metoclopramide and NSAIDs. The medication review resulted in less drug use, especially opioids and psychotropic drugs.

  18. Interaction between corticosteroid and beta-agonist drugs. Biochemical and cardiovascular effects in normal subjects.

    Science.gov (United States)

    Taylor, D R; Wilkins, G T; Herbison, G P; Flannery, E M

    1992-08-01

    The aim of this study was to investigate whether the administration of prednisone potentiates any of the acute biochemical and cardiovascular effects of high-dose inhaled beta-agonist drugs. These agents are known to cause dose-related changes in plasma potassium and glucose, as well as ECG changes in heart rate, corrected QT interval (QTc), T wave, and U wave. On theoretical grounds, the concomitant use of systemic corticosteroids might enhance these actions. Twenty-four healthy subjects were randomized to receive one of three treatments: salbutamol 5 mg or fenoterol 5 mg or normal saline solution. Each drug was administered twice, 30 min apart by nebulizer, and the procedure was repeated after each subject had received prednisone 30 mg daily for one week. Plasma potassium and glucose levels were measured, and ECGs were obtained after each treatment, together with 12-h Holter monitoring for arrhythmias. Changes in plasma potassium and glucose following nebulized beta-agonist were significantly greater after treatment with prednisone. Baseline potassium level fell from 3.75 mmol/L (95 percent CI 3.61, 3.89) to 3.50 mmol/L (95 percent CI 3.36, 3.64), and thereafter all values were significantly lower at each time point (p = 0.003). The lowest mean plasma potassium was obtained 90 min after fenoterol administration with prednisone pretreatment: 2.78 mmol/L (95 percent CI 2.44, 3.13). Increases in heart rate and QTc interval following both beta-agonist drugs were significant, but T-wave amplitude reductions did not reach significance. Prednisone treatment did not significantly alter the cardiovascular responses. Supraventricular and ventricular ectopic activity was related to beta-agonist use, but no potentiating effect was noted following steroid treatment. We conclude that the acute biochemical effects of beta-agonist administration are augmented by prior treatment with prednisone, but this is not the case for ECG effects. However, the degree of hypokalemia noted as

  19. Anti Diabetic Drug Utilization by Elderly Patients in a Tertiary ...

    African Journals Online (AJOL)

    This study is intended to determine the pattern and rational use of drugs in the elderly diabetic patients in a tertiary health care facility in Western Nigeria. ... Metformin was the most commonly prescribed antidiabetic medication for the patients followed by glimepiride (52.8%) (highest within age 50-59 years) and then ...

  20. Clinical relevance of the gap between pre-marketing trials and medical practice : the case of the cardiovascular drugs

    NARCIS (Netherlands)

    Wieringa, N F; Denig, P; de Graeff, P A; Vos, R

    OBJECTIVES/BACKGROUND: The external validity of trial results of new cardiovascular drugs is limited, because the short-term studies are performed with relatively small, highly selected populations. Using qualitative methods, we examined the clinical relevance of under-representation of subgroups of

  1. Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo

    2016-07-01

    The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  2. Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan.

    Science.gov (United States)

    Lee, Shin Haeng; Shin, Ju-Young; Park, Mi-Ju; Park, Byung-Joo

    2014-04-01

    Drug label is a common source of information; however, the content varies widely. This study aims to evaluate label information on cardiovascular drugs regarding pregnancy for their similarities in Korea, USA, UK, and Japan. Study drugs were selected as following (1) cardiovascular drugs according to the WHO ATC code (C01-C09) and (2) drugs currently marketed in all four countries were included. Evidence level was classified into five categories ('Definite', 'Probable', 'Possible', 'Unlikely', and 'Unclassified') and recommendation level was classified into four categories ('Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'). Frequency and proportion were presented. Percent agreement and kappa coefficient with 95% confidence interval (CI) were calculated using SAS ver. 9.3. Total of 50 cardiovascular drugs were included. 'Unclassified' was represented the most in Korea, followed by Japan and UK (58%, 54%, and 46%, pdrugs in all four countries were classified as 'contraindicated' or 'cautious'. Japanese labels had the largest proportion of 'contraindicated' level (62%), and Korea and UK followed (58%, 44%, pdrugs were 'compatible' whereas, there were none in Korea, UK, and Japan (pdrugs in pregnancy differed widely. Reliable safety information in pregnancy should be provided through regular updates. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Drug utilization pattern of Chinese herbal medicines in a general hospital in Taiwan.

    Science.gov (United States)

    Chen, L C; Wang, B R; Chou, Y C; Tien, J H

    2005-09-01

    Drug utilization studies are important for the optimization of drug therapy and have received a great attention in recent years. Most of the information on drug use patterns has been derived from studies in modern Western medicines; however, studies regarding the drug utilization of traditional Chinese medicine (CM) are few. The present study was the first clinical research to evaluate the drug utilization patterns of Chinese herbal medicines in a general hospital in Taiwan. Data were collected prospectively from the patients attending the Traditional Medicine Center of Taipei Veteran General Hospital under CM drug treatments. The study was carried out over a period of 1 year, from January 2002 to December 2002. Core drug use indicators, such as the average number of drugs per prescriptions, the dosing frequency of prescriptions, and the most common prescribed CM herbs and formulae were evaluated. The primary diagnosis and the CM drugs prescribed for were also revealed. All data were analyzed by descriptive statistics. A total of 10 737 patients, representing 52 255 CM drugs, were screened during the study period. Regarding the prescriptions, the average number of drugs per prescription was 4.87 and 37.21% of prescriptions were composed by five drugs. Most of prescriptions (91.38%) were prescribed for three times a day. The most often prescribed Chinese herb was Hong-Hwa (5.76%) and the most common Chinese herbal formula was Jia-Wey-Shiau-Yau-San (3.80%). The most frequent main diagnosis was insomnia (15.58%), followed by menopause (5.22%) and constipation (5.09%). The survey revealed the drug use pattern of CMs in a general hospital. The majority of CM prescriptions were composed by 3-6 drugs and often prescribed for three times a day. Generally, the rational drug uses of CM drugs were provided with respect to the various diagnoses. (c) 2005 John Wiley & Sons, Ltd.

  4. Drug utilization research in primary health care as exemplified by physicians' quality assessment groups.

    Science.gov (United States)

    von Ferber, L; Luciano, A; Köster, I; Krappweis, J

    1992-11-01

    Drugs in primary health care are often prescribed for nonrational reasons. Drug utilization research investigates the prescription of drugs with an eye to medical, social and economic causes and consequences of the prescribed drug's utilization. The results of this research show distinct differences in drug utilization in different age groups and between men and women. Indication and dosage appear irrational from a textbook point of view. This indicates nonpharmacological causes of drug utilization. To advice successfully changes for the better quality assessment groups of primary health care physicians get information about their established behavior by analysis of their prescriptions. The discussion and the comparisons in the group allow them to recognize their irrational prescribing and the social, psychological and economic reasons behind it. Guidelines for treatment are worked out which take into account the primary health care physician's situation. After a year with 6 meetings of the quality assessment groups the education process is evaluated by another drug utilization analysis on the basis of the physicians prescription. The evaluation shows a remarkable improvement of quality and cost effectiveness of the drug therapy of the participating physicians.

  5. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

    Science.gov (United States)

    Kesselheim, Aaron S; Misono, Alexander S; Lee, Joy L; Stedman, Margaret R; Brookhart, M Alan; Choudhry, Niteesh K; Shrank, William H

    2008-12-03

    Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was -0.03 (95% confidence interval, -0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Whereas evidence does not

  6. Utilization of psychotropic drugs prescribed to persons with and without HIV infection

    DEFF Research Database (Denmark)

    Rasmussen, L. D.; Obel, D; Kronborg, G

    2014-01-01

    on redeemed prescription of psychotropic drugs during 1995-2009. We primarily focused our analyses on HIV-infected individuals with no history of injecting drug use (IDU) or hepatitis C virus (HCV) infection. Drug utilization was expressed as defined daily doses per 1000 person-days (DDD/1000PD...... with exposure to HAART or efavirenz was found. CONCLUSIONS: HIV-infected individuals had a higher utilization of psychotropic drugs than the background population, which was not confined to individuals with a history of IDU or HCV infection. This emphasizes the need to focus on diagnosis of, and appropriate......OBJECTIVES: The objective was to estimate the utilization of psychotropic drugs in HIV-infected individuals compared with that in the background population. METHODS: Using data obtained from the Danish HIV Cohort Study and the Danish National Prescription Registry, we analysed aggregated data...

  7. Can Walmart make us healthier? Prescription drug prices and health care utilization.

    Science.gov (United States)

    Borrescio-Higa, Florencia

    2015-12-01

    This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Cause-specific cardiovascular risk associated with nonsteroidal anti-inflammatory drugs among myocardial infarction patients--a nationwide study.

    Directory of Open Access Journals (Sweden)

    Anne-Marie Schjerning Olsen

    Full Text Available BACKGROUND: Non steroidal anti-inflammatory drugs (NSAIDs increase mortality and morbidity after myocardial infarction (MI. We examined cause-specific mortality and morbidity associated with NSAIDs in a nationwide cohort of MI patients. METHODS AND RESULTS: By individual-level linkage of nationwide registries of hospitalization and drug dispensing from pharmacies in Denmark, patients aged >30 years admitted with first-time MI during 1997-2009 and their subsequent NSAID use were identified. The risk of three cardiovascular specific endpoints: cardiovascular death, the composite of coronary death and nonfatal MI, and the composite of fatal and nonfatal stroke, associated with NSAID use was analyzed by Cox proportional hazard analyses. Of 97,698 patients included 44.0% received NSAIDs during follow-up. Overall use of NSAIDs was associated with an increased risk of cardiovascular death (hazard ratio [HR] 1.42, 95% confidence interval [CI] 1.36-1.49. In particular use of the nonselective NSAID diclofenac and the selective cyclooxygenase-2 inhibitor rofecoxib was associated with increased risk of cardiovascular death (HR 1.96 [1.79-2.15] and HR1.66 [1.44-1.91], respectively with a dose dependent increase in risk. Use of ibuprofen was associated with increased risk of cardiovascular death (HR 1.34[1.26-1.44], whereas naproxen was associated with the lowest risk of (e.g., HR 1.27[1.01-1.59]. CONCLUSION: Use of individual NSAIDs is associated with different cause-specific cardiovascular risk and in particular rofecoxib and diclofenac were associated with increased cardiovascular morbidity and mortality. These results support caution with use of all NSAIDs in patients with prior MI.

  9. The waiting time distribution as a graphical approach to epidemiologic measures of drug utilization

    DEFF Research Database (Denmark)

    Hallas, J; Gaist, D; Bjerrum, L

    1997-01-01

    that effectively conveys some essential utilization parameters for a drug. The waiting time distribution for a group of drug users is a charting of their first prescription presentations within a specified time window. For a drug used for chronic treatment, most current users will be captured at the beginning...... of the window. After a few months, the graph will be dominated by new, incident users. As examples, we present waiting time distributions for insulin, ulcer drugs, systemic corticosteroids, antidepressants, and disulfiram. Appropriately analyzed and interpreted, the waiting time distributions can provide...... information about the period prevalence, point prevalence, incidence, duration of use, seasonality, and rate of prescription renewal or relapse for specific drugs. Each of these parameters has a visual correlate. The waiting time distributions may be an informative supplement to conventional drug utilization...

  10. Utilization of genomic signatures to identify phenotype-specific drugs.

    Directory of Open Access Journals (Sweden)

    Seiichi Mori

    2009-08-01

    Full Text Available Genetic and genomic studies highlight the substantial complexity and heterogeneity of human cancers and emphasize the general lack of therapeutics that can match this complexity. With the goal of expanding opportunities for drug discovery, we describe an approach that makes use of a phenotype-based screen combined with the use of multiple cancer cell lines. In particular, we have used the NCI-60 cancer cell line panel that includes drug sensitivity measures for over 40,000 compounds assayed on 59 independent cells lines. Targets are cancer-relevant phenotypes represented as gene expression signatures that are used to identify cells within the NCI-60 panel reflecting the signature phenotype and then connect to compounds that are selectively active against those cells. As a proof-of-concept, we show that this strategy effectively identifies compounds with selectivity to the RAS or PI3K pathways. We have then extended this strategy to identify compounds that have activity towards cells exhibiting the basal phenotype of breast cancer, a clinically-important breast cancer characterized as ER-, PR-, and Her2- that lacks viable therapeutic options. One of these compounds, Simvastatin, has previously been shown to inhibit breast cancer cell growth in vitro and importantly, has been associated with a reduction in ER-, PR- breast cancer in a clinical study. We suggest that this approach provides a novel strategy towards identification of therapeutic agents based on clinically relevant phenotypes that can augment the conventional strategies of target-based screens.

  11. Determinants of U.S. Prescription Drug Utilization using County Level Data.

    Science.gov (United States)

    Nianogo, Thierry; Okunade, Albert; Fofana, Demba; Chen, Weiwei

    2016-05-01

    Prescription drugs are the third largest component of U.S. healthcare expenditures. The 2006 Medicare Part D and the 2010 Affordable Care Act are catalysts for further growths in utilization becuase of insurance expansion effects. This research investigating the determinants of prescription drug utilization is timely, methodologically novel, and policy relevant. Differences in population health status, access to care, socioeconomics, demographics, and variations in per capita number of scripts filled at retail pharmacies across the U.S.A. justify fitting separate econometric models to county data of the states partitioned into low, medium, and high prescription drug users. Given the skewed distribution of per capita number of filled prescriptions (response variable), we fit the variance stabilizing Box-Cox power transformation regression models to 2011 county level data for investigating the correlates of prescription drug utilization separately for low, medium, and high utilization states. Maximum likelihood regression parameter estimates, including the optimal Box-Cox λ power transformations, differ across high (λ = 0.214), medium (λ = 0.942), and low (λ = 0.302) prescription drug utilization models. The estimated income elasticities of -0.634, 0.031, and -0.532 in high, medium, and low utilization models suggest that the economic behavior of prescriptions is not invariant across different utilization levels. Copyright © 2015 John Wiley & Sons, Ltd.

  12. Drug Utilization Study in Ophthalmology Out‑patient Department of a ...

    African Journals Online (AJOL)

    PROMOTING ACCESS TO AFRICAN RESEARCH. AFRICAN ... Abstract. Background: Drug utilization studies provide a pharmacoeconomic basis for making evidence‑based health‑care decisions. ... Results: A total of 640 prescriptions were analyzed with the average number of drugs per prescription being 2.4 (0.9).

  13. Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

    Directory of Open Access Journals (Sweden)

    Bander Balkhi

    2018-02-01

    Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

  14. Drug utilization according to reason for prescribing: a pharmacoepidemiologic method based on an indication hierarchy

    DEFF Research Database (Denmark)

    Kildemoes, Helle Wallach; Hendriksen, Carsten; Morten, Andersen

    2011-01-01

    ABSTRACT Purpose To develop a pharmacoepidemiologic method for drug utilization analysis according to indication, gender, and age by means of register-based information. Statin utilization in 2005 was applied as an example. Methods Following the recommendations for statin therapy, we constructed ...

  15. Comparative effectiveness of oral antidiabetic drugs in preventing cardiovascular mortality and morbidity: A network meta-analysis.

    Directory of Open Access Journals (Sweden)

    Gyeongsil Lee

    Full Text Available In the Guidance for Industry from the Food and Drug Administration in 2008, excess cardiovascular risk should be ruled out in trials of all new antidiabetic drugs; however, relatively few studies have focused on cardiovascular safety with antidiabetic drug use. We aimed to examine mortality and cardiovascular risk using a network meta-analysis. We searched the Medline, Embase, Cochrane, and ClinicalTrials.gov registry databases in March 2016 to identify randomized controlled trials reporting cardiovascular risk with the following oral antidiabetic drugs: metformin, sulfonylureas, thiazolidinedione (TZD, dipeptidyl peptidase-4 (DPP4 inhibitors, and sodium-glucose co-transporter-2 (SGLT2 inhibitors. We assessed the differences in the risks of all-cause mortality, cardiovascular-related mortality, acute coronary syndrome (ACS, and myocardial infarction (MI among antidiabetic drugs with fixed effect models for direct pairwise comparisons and Bayesian network meta-analyses to integrate direct and indirect comparisons. Of the 101,183 patients in 73 randomized controlled trials, 3,434 (3.4% died. The relative risks of all-cause mortality with SGLT2 inhibitor use were 0.68 (95% credible interval: 0.57-0.80, 0.74 (0.49-1.10, 0.63 (0.46-0.87, 0.71 (0.55-0.90, and 0.65 (0.54-0.78, compared with placebo, metformin, sulfonylurea, TZD, and DPP4 inhibitor, respectively. The relative risks of cardiovascular-related mortality with SGLT2 inhibitor use were 0.61 (0.50-0.76, 0.81(0.36-1.90, 0.52(0.31-0.88, 0.66(0.49-0.91, and 0.61(0.48-0.77, compared with placebo, metformin, sulfonylurea, TZD, and DPP4 inhibitor, respectively. The relative risks of ACS with SGLT2 inhibitor use was consistent with that of all-cause mortality. SGLT2 inhibitor use was associated with a lower risk of ACS than the other OADs and placebo. The relative risks of MI with SGLT2 inhibitor use were 0.77 (0.63-0.93 and 0.75 (0.60-0.94, compared with placebo and DPP4 inhibitor, respectively. The

  16. The continuum of monocyte phenotypes: Experimental evidence and prognostic utility in assessing cardiovascular risk.

    Science.gov (United States)

    Cignarella, Andrea; Tedesco, Serena; Cappellari, Roberta; Fadini, Gian Paolo

    2018-03-30

    The monocyte-macrophage cell lineage represents a major player in innate immunity, and is involved in many physiologic and pathologic conditions. Particularly, monocyte-macrophages play a very important role in atherosclerosis and cardiovascular disease. Monocyte heterogeneity is well recognized but the biologic and clinical meaning of the various monocyte subtypes is not entirely understood. Traditionally, monocytes can be divided in classical, intermediate, and nonclassical based on expression of the surface antigens CD14 and CD16. While macrophage diversity is now well recognized to organize as a continuum, monocyte subsets have long been considered as separated entities. However, mounting evidence obtained by tracking the ontology of human monocytes help clarifying that monocytes mature from classical to nonclassical ones, through an intermediate phenotype. This concept is therefore best depicted as a continuum, whereas the subdivision into discrete CD14/CD16 subsets appears an oversimplification. In this review, we discuss the evidence supporting the existence of a monocyte continuum along with the technical challenges of monocyte characterization. In particular, we describe the advantage of considering monocytes along a continuous distribution for the evaluation of cardiovascular risk. We make the point that small transition along the monocyte continuum better reflects cardiovascular risk than a simplified analysis of discrete monocyte subsets. Recognizing the monocyte continuum can be helpful to model other pathophysiologic conditions where these cells are involved. ©2018 Society for Leukocyte Biology.

  17. Cohort Study of ECG Left Ventricular Hypertrophy Trajectories: Ethnic Disparities, Associations With Cardiovascular Outcomes, and Clinical Utility.

    Science.gov (United States)

    Iribarren, Carlos; Round, Alfred D; Lu, Meng; Okin, Peter M; McNulty, Edward J

    2017-10-05

    ECG left ventricular hypertrophy (LVH) is a well-known predictor of cardiovascular disease. However, no prior study has characterized patterns of presence/absence of ECG LVH ("ECG LVH trajectories") across the adult lifespan in both sexes and across ethnicities. We examined: (1) correlates of ECG LVH trajectories; (2) the association of ECG LVH trajectories with incident coronary heart disease, transient ischemic attack, ischemic stroke, hemorrhagic stroke, and heart failure; and (3) reclassification of cardiovascular disease risk using ECG LVH trajectories. We performed a cohort study among 75 412 men and 107 954 women in the Northern California Kaiser Permanente Medical Care Program who had available longitudinal exposures of ECG LVH and covariates, followed for a median of 4.8 (range ECG LVH was measured by Cornell voltage-duration product. Adverse trajectories of ECG LVH (persistent, new development, or variable pattern) were more common among blacks and Native American men and were independently related to incident cardiovascular disease with hazard ratios ranging from 1.2 for ECG LVH variable pattern and transient ischemic attack in women to 2.8 for persistent ECG LVH and heart failure in men. ECG LVH trajectories reclassified 4% and 7% of men and women with intermediate coronary heart disease risk, respectively. ECG LVH trajectories were significant indicators of coronary heart disease, stroke, and heart failure risk, independently of level and change in cardiovascular disease risk factors, and may have clinical utility. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. Early discontinuation of attention-deficit/hyperactivity disorder drug treatment: a danish nationwide drug utilization study

    DEFF Research Database (Denmark)

    Pottegård, Anton; Bjerregaard, B. K.; Kortegaard, L. S.

    2015-01-01

    Knowledge of patterns of treatment discontinuation in attention-deficit/hyperactivity disorder (ADHD) drug treatment is of importance, for both the clinical practice and the study of long-term treatment outcomes. The purpose of this study was to describe early discontinuation of ADHD drug treatme...

  19. Drug utilization study of gynecology OPD: In a tertiary care hospital.

    Directory of Open Access Journals (Sweden)

    Baig MS, Bagle TR,Gadappa SN, Deshpande Sonali, Doifode SM

    2013-04-01

    Full Text Available Background: The treatment of diseases by use of essential medicines, prescribed by generic names, has been emphasized by WHO and National Health Policy of India. Drugs used in gynaecology are one of the top selling drugs in India; however they are least studied with respect to drug utilization. Thus present study was undertaken to analyze drug utilization pattern of gynecology OPD in a tertiary care hospital. Materials and Methods: A retrospective, cross sectional, observational study of prescriptions in Gynecology OPD. Data was obtained from an electronic medical record database of patients that attended Gynecology OPD during the study period. Prescription records of patients were screened as per inclusion and exclusion criteria and 300 prescriptions were randomly selected by Openepi software. Patient related and drug related information was collected on a customized data collection sheet. Results: The mean age of patients was 30.19+9.83 years and common age of presentation was >18-30 years. In infective cases, vaginal discharge (10.33% was common, and in non-infective cases, menstrual disorders (24% were common. The average number of drugs per prescription was 3.47+1.53. In drug category, minerals (30.94% were most commonly prescribed, followed by antimicrobials (24.98%, and NSAIDs (13.37%. Polypharmacy was observed in 96.33% of the prescriptions. Conclusion: It is only by drug utilization studies that burden of diseases and corresponding utilization of drugs in gynecology can be measured. In our study majority of the drugs prescribed were generic which were from the essential medical list NLEM and WHO.

  20. Orbitrap technology for comprehensive metabolite-based liquid chromatographic–high resolution-tandem mass spectrometric urine drug screening – Exemplified for cardiovascular drugs

    International Nuclear Information System (INIS)

    Helfer, Andreas G.; Michely, Julian A.; Weber, Armin A.; Meyer, Markus R.; Maurer, Hans H.

    2015-01-01

    LC–high resolution (HR)-MS well established in proteomics has become more and more important in bioanalysis of small molecules over the last few years. Its high selectivity and specificity provide best prerequisites for its use in broad screening approaches. Therefore, Orbitrap technology was tested for developing a general metabolite-based LC–HR-MS/MS screening approach for urinalysis of drugs necessary in clinical and forensic toxicology. After simple urine precipitation, the drugs and their metabolites were separated within 10 min and detected by a Q-Exactive mass spectrometer in full scan with positive/negative switching, and subsequent data dependent acquisition (DDA) mode. Identification criteria were the presence of accurate precursor ions, isotopic patterns, five most intense fragment ions, and comparison with full HR-MS/MS library spectra. The current library contains over 1900 parent drugs and 1200 metabolites. The method was validated for typical drug representatives and metabolites concerning recovery, matrix effects, process efficiency, and limits showed acceptable results. The applicability was tested first for cardiovascular drugs, which should be screened for in poisoning cases and for medication adherence of hypertension patients. The novel LC–HR-MS/MS method allowed fast, simple, and robust urine screening, particularly for cardiovascular drugs showing the usefulness of Orbitrap technology for drug testing. - Highlights: • First study on the application of Orbitrap technology for comprehensive drug screening in clinical and forensic toxicology. • Simple workup, sufficient separation, and powerful screening and identification using modern high resolution MS. • Validation of the assay according to guidelines for qualitative approaches. • Elucidation of the power of new data evaluation software in combination with a new reference drug and metabolite library. • Great relevance for science and practice in clinical and forensic

  1. Orbitrap technology for comprehensive metabolite-based liquid chromatographic–high resolution-tandem mass spectrometric urine drug screening – Exemplified for cardiovascular drugs

    Energy Technology Data Exchange (ETDEWEB)

    Helfer, Andreas G.; Michely, Julian A.; Weber, Armin A.; Meyer, Markus R.; Maurer, Hans H., E-mail: hans.maurer@uks.eu

    2015-09-03

    LC–high resolution (HR)-MS well established in proteomics has become more and more important in bioanalysis of small molecules over the last few years. Its high selectivity and specificity provide best prerequisites for its use in broad screening approaches. Therefore, Orbitrap technology was tested for developing a general metabolite-based LC–HR-MS/MS screening approach for urinalysis of drugs necessary in clinical and forensic toxicology. After simple urine precipitation, the drugs and their metabolites were separated within 10 min and detected by a Q-Exactive mass spectrometer in full scan with positive/negative switching, and subsequent data dependent acquisition (DDA) mode. Identification criteria were the presence of accurate precursor ions, isotopic patterns, five most intense fragment ions, and comparison with full HR-MS/MS library spectra. The current library contains over 1900 parent drugs and 1200 metabolites. The method was validated for typical drug representatives and metabolites concerning recovery, matrix effects, process efficiency, and limits showed acceptable results. The applicability was tested first for cardiovascular drugs, which should be screened for in poisoning cases and for medication adherence of hypertension patients. The novel LC–HR-MS/MS method allowed fast, simple, and robust urine screening, particularly for cardiovascular drugs showing the usefulness of Orbitrap technology for drug testing. - Highlights: • First study on the application of Orbitrap technology for comprehensive drug screening in clinical and forensic toxicology. • Simple workup, sufficient separation, and powerful screening and identification using modern high resolution MS. • Validation of the assay according to guidelines for qualitative approaches. • Elucidation of the power of new data evaluation software in combination with a new reference drug and metabolite library. • Great relevance for science and practice in clinical and forensic

  2. Management of Hypercholesterolemia, Appropriateness of Therapeutic Approaches and New Drugs in Patients with High Cardiovascular Risk.

    Science.gov (United States)

    Agabiti Rosei, Enrico; Salvetti, Massimo

    2016-09-01

    Control of lipid levels is one of the most effective strategies for cardiovascular (CV) event prevention. In fact, many clinical trials have clearly demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, primarily with statins, reduces major CV events and mortality. The evidence from these trials has been useful in designing the cholesterol treatment guidelines, which are mainly aimed at preventing and managing cardiovascular disease (CVD). However, available data indicate that a large proportion of patients fail to achieve lipid goals, and this is particularly frequent in patients at high or very high CV risk. Furthermore, owing to side effects, a significant percentage of patients cannot tolerate statin treatment. Hence, researchers have focused their attention on novel LDL-C-lowering agents that act via mechanisms distinct from that of statins. Among the new compounds under investigation, the monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9) seem particularly promising, having recently been shown to be well tolerated and highly effective at lowering LDL-C, with a possible effect on the occurrence of CV events. Currently, alirocumab is approved by the US Food and Drug Administration (FDA) as an adjunct to diet and maximally tolerated statin therapy for use in adults with heterozygous familial hypercholesterolemia (FH) or those with atherosclerotic CV disease who require additional LDL-C lowering; it has also been recently approved by the European Medicines Agency (EMA) for use in patients with heterozygous FH, non-familial hypercholesterolemia or mixed dyslipidemia in whom statins are ineffective or not tolerated. Evolocumab is approved by the FDA as an adjunct to diet and maximally tolerated statins for adults with hetero- and homozygous FH and those with atherosclerotic CV disease who require additional lowering of LDL-C, and by the EMA in adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct

  3. EFFICACY AND SAFETY OF LIPID-LOWERING DRUGS IN PRIMARY AND SECONDARY PREVENTION OF CARDIOVASCULAR DISEASES IN THE ELDERLY

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available Effect of hyperlipidemia on morbidity and mortality in elderly patients is considered. Authors also cover issues of efficacy and safety of lipid-lowering therapy in primary and secondary prevention of cardiovascular diseases in patients ≥80 years of age who are the most quickly growing group of population and have the highest cardiovascular risk. They stress the need to take into account polymorbidity and polypharmacy that increase the risk of adverse reactions due to the use of both statins and their drug-drug interactions, which requires an assessment of risk/benefit ratio. In addition, there is a need for development of reliable prognostic tools to predict relevant outcomes (e.g., stroke, decrease in functionality/independence, quality of life reduction and rationales for lipid-lowering therapy in the elderly and also their adherence to treatment.

  4. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    Science.gov (United States)

    2009-01-01

    Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD) and DDD/1000 persons/day/(DID). Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67) and average annual expense (€21.55 v. €41.14). Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID) being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline) and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities. PMID:19995453

  5. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    Directory of Open Access Journals (Sweden)

    Macipe-Costa Rosa

    2009-12-01

    Full Text Available Abstract Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD and DDD/1000 persons/day/(DID. Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67 and average annual expense (€21.55 v. €41.14. Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities.

  6. Favorable Cardiovascular Risk Profile Is Associated With Lower Healthcare Costs and Resource Utilization: The 2012 Medical Expenditure Panel Survey.

    Science.gov (United States)

    Valero-Elizondo, Javier; Salami, Joseph A; Ogunmoroti, Oluseye; Osondu, Chukwuemeka U; Aneni, Ehimen C; Malik, Rehan; Spatz, Erica S; Rana, Jamal S; Virani, Salim S; Blankstein, Ron; Blaha, Michael J; Veledar, Emir; Nasir, Khurram

    2016-03-01

    The American Heart Association's 2020 Strategic Goals emphasize the value of optimizing risk factor status to reduce the burden of morbidity and mortality. In this study, we aimed to quantify the overall and marginal impact of favorable cardiovascular risk factor (CRF) profile on healthcare expenditure and resource utilization in the United States among those with and without cardiovascular disease (CVD). The study population was derived from the 2012 Medical Expenditure Panel Survey (MEPS). Direct and indirect costs were calculated for all-cause healthcare resource utilization. Variables of interest included CVD diagnoses (coronary artery disease, stroke, peripheral artery disease, dysrhythmias, or heart failure), ascertained by International Classification of Diseases, Ninth Edition, Clinical Modification codes, and CRF profile (hypertension, diabetes mellitus, hypercholesterolemia, smoking, physical activity, and obesity). Two-part econometric models were used to study expenditure data. The final study sample consisted of 15 651 MEPS participants (58.5±12 years, 54% female). Overall, 5921 (37.8%) had optimal, 7002 (44.7%) had average, and 2728 (17.4%) had poor CRF profile, translating to 54.2, 64.1, and 24.9 million adults in United States, respectively. Significantly lower health expenditures were noted with favorable CRF profile across CVD status. Among study participants with established CVD, overall healthcare expenditures with optimal and average CRF profile were $5946 and $3731 less compared with those with poor CRF profile. The respective differences were $4031 and $2560 in those without CVD. Favorable CRF profile is associated with significantly lower medical expenditure and healthcare utilization among individuals with and without established CVD. © 2016 American Heart Association, Inc.

  7. Anti-inflamatórios não esteroides: Efeitos cardiovasculares, cérebro-vasculares e renais Antiinflamatorios no esteroides: efectos cardiovasculares, cerebrovasculares y renales Nonsteroidal anti-inflammatory drugs: cardiovascular, cerebrovascular and renal effects

    Directory of Open Access Journals (Sweden)

    Michel Batlouni

    2010-04-01

    inhibidores de la ciclo-oxigenase (COX, selectivos o no. Los AINEs no selectivos son los más antiguos, y designados como tradicionales o convencionales. Los AINEs selectivos para la COX-2 se designan COXIBEs. En los últimos años, ha sido cuestionada la seguridad del uso de los AINEs en la práctica clínica, particularmente de los inhibidores selectivos de la COX-2. Las evidencias sobre el aumento del riesgo cardiovascular con el uso de AINEs son todavía incompletas, debido a la ausencia de ensayos randomizados y controlados con poder para evaluar desenlaces cardiovasculares relevantes. Sin embargo, los resultados de estudios clínicos prospectivos y de metaanálisis indican que los inhibidores selectivos de la COX-2 ejercen importantes efectos cardiovasculares adversos, que incluyen aumento del riesgo de infarto del miocardio, accidente cerebrovascular, insuficiencia cardiaca, insuficiencia renal y hipertensión arterial. El riesgo de estos efectos adversos es mayor en pacientes con historia previa de enfermedad cardiovascular o con alto riesgo para desarrollarla. En estos pacientes, el uso de inhibidores de la COX-2 debe ser limitado a aquellos para los que no hay alternativa apropiada y, aun así, solamente en dosis bajas y por el menor tiempo necesario. Aunque los efectos adversos más frecuentes se relacionen a la inhibición selectiva de la COX-2, la ausencia de selectividad para esta isoenzima no elimina completamente el riesgo de eventos cardiovasculares, de modo que todos los fármacos del largo espectro de los AINEs se deben prescribir solamente tras consideración del balance riesgo/beneficio.The nonsteroidal anti-inflammatory drugs (NSAIDs are among the most often prescribed drugs in the world. This heterogeneous class of drugs includes aspirin and several other selective or non-selective cyclooxygenase (COX inhibitors. The non-selective NSAIDs are the oldest ones and are called traditional or conventional NSAIDs. The selective NSAIDs are called COX-2

  8. Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals

    DEFF Research Database (Denmark)

    Fosbøl, Emil Loldrup; Køber, Lars; Torp-Pedersen, Christian

    2010-01-01

    Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

  9. Prevalencia del consumo de medicamentos en la población adulta de Cataluña Prevalence of drug utilization in the adult population of Catalonia, Spain

    Directory of Open Access Journals (Sweden)

    S. Sans

    2002-04-01

    (35% men and 51% women; p < 0.001, alimentary tract (15% and the cardiovascular system (9% and 13%; p < 0.001. Most drugs (40% were prescribed by specialists and one quarter was self-prescribed. Conclusions: The prevalence of total drug utilization in the adult population of Catalonia is high, specially among women, who self-perceived worse health status. Policies of rationalization of drug expenditures should take the epidemiological pattern into account.

  10. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

    Energy Technology Data Exchange (ETDEWEB)

    Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.

    1983-07-01

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.

  11. Patterns of prescription antihypertensive drug utilization and adherence to treatment guidelines in the city of Novi Sad.

    Science.gov (United States)

    Tomas, Ana; Tomić, Zdenko; Milijasević, Boris; Ban, Milica; Horvat, Olga; Vukmirović, Sasa; Sabo, Ana

    2016-06-01

    Hypertension is one of the leading causes of cardiovascular morbidity and mortality and more than a half of all health insurance expenditures for reimbursed medicines are allocated to antihypertensive drugs in Serbia. The aim of this study was to identify the antihypertensive drug utilization patterns among hypertensive outpatients in the city of Novi Sad, Serbia, determine the adherence to clinical guidelines and address the economic aspects of current prescribing practices. This retrospective observational study was conducted in Novi Sad over a period of six months. The data on the number of packages, size their, and retail price of antihypertensives issued on prescription in outpatients with the diagnosis of essential arterial hypertension was collected from all state-owned pharmacies in Novi Sad. Drug consumption was analyzed using the Anatomical Therapeutic Chemical (ATC)/ defined daily dose (DDD) methodology. Total consumption of antihypertensives issued on prescription over a 6-month period in the city of Novi sad, Serbia was 283.48 DDD per 1,000 inhabitans per day (DID). Angiotensin converting enzyme inhibitors (ACEi) were most commonly prescribed drugs, and were used 3 times more often than calcium channel blockers and 5 times more than beta-blockers. The consumption of diuretics and angiotensin receptor antagonists was low within all the groups of outpatients. Both national and international guidelines state superiority and effectiveness of diuretics in treatment of hypertension in the elderly, but their consumption was unreasonable low despite the fact that over 70% of all antihypertensive drugs in the city of Novi Sad were dispensed in people aged > 60. The use of more expensive ACEi was observed despite the guidelines deeming all the drugs of this class equally effective in treatment of hypertension. Large differences in utilization of different groups of antihypertensive agents were noted in this study. Underutilization of valuable, efficacious, and

  12. Lifestyle, cardiovascular drugs and risk factors in younger and elder adults: The PEP family heart study

    Directory of Open Access Journals (Sweden)

    Peter Schwandt

    2010-01-01

    Full Text Available Objectives: This study aimed to compare cardiovascular disease (CVD risk factors, lifestyle habits and pharmacological treatment in two groups of elder adults with 20 years difference in their mean age. Methods: This study comprised 590 women including two groups with mean age of 42.4±5.5 vs. 66.5±4.0 years, and 486 men of two groups with mean age of 44.1±5.6 vs. 63.9±7.0 years. Data on physical examination, fasting blood analyses, 7-day dietary re-cords, physical activity, smoking and actual medication use were recorded. Results: Compared with younger individuals, seniors had a more adverse risk factor profile in terms of abdominal obesity, over-weight, hyperglycemia, hypertension, dyslipoproteinemia without differences in HDL-C. But this is not reflected by lifestyle behav-ior. Less than 2% of the elderly and 17% of the younger adults were current smoker. Furthermore, the pattern of physical activ-ity was different in terms of more continuous sports in seniors contrasting with extremes between no sports and more than twice a week in the younger group. Seniors consumed significantly less carbohydrates including more monosaccharide and less polysaccharides, more alcohol and water. The intake of fat and protein was higher in elder women than in all other groups. One third of seniors took antihypertensive medications and 12% used lipid modifying drugs. Conclusions: Different levels of prevention against CVDs and their risk factors shall be considered for various age groups of population. The findings of this study emphasize on the necessity of preventive measures against smoking and physical inactivity in younger adults and dietary habits in seniors.

  13. Lifestyle, Cardiovascular Drugs and Risk Factors in Younger and Elder Adults: The PEP Family Heart Study

    Directory of Open Access Journals (Sweden)

    Peter Schwandt

    2010-01-01

    Full Text Available Objectives: This study aimed to compare cardiovascular disease(CVD risk factors, lifestyle habits and pharmacological treatmentin two groups of elder adults with 20 years difference in theirmean age.Methods: This study comprised 590 women including two groupswith mean age of 42.4±5.5 vs. 66.5±4.0 years, and 486 men of twogroups with mean age of 44.1±5.6 vs. 63.9±7.0 years. Data onphysical examination, fasting blood analyses, 7-day dietary records,physical activity, smoking and actual medication use wererecorded.Results: Compared with younger individuals, seniors had a moreadverse risk factor profile in terms of abdominal obesity, overweight,hyperglycemia, hypertension, dyslipoproteinemia withoutdifferences in HDL-C. But this is not reflected by lifestyle behavior.Less than 2% of the elderly and 17% of the younger adultswere current smoker. Furthermore, the pattern of physical activitywas different in terms of more continuous sports in seniorscontrasting with extremes between no sports and more than twicea week in the younger group. Seniors consumed significantly lesscarbohydrates including more monosaccharide and less polysaccharides,more alcohol and water. The intake of fat and proteinwas higher in elder women than in all other groups. One third ofseniors took antihypertensive medications and 12% used lipidmodifying drugs.Conclusions: Different levels of prevention against CVDs andtheir risk factors shall be considered for various age groups ofpopulation. The findings of this study emphasize on the necessityof preventive measures against smoking and physical inactivity inyounger adults and dietary habits in seniors.

  14. Long-term cardiovascular risk of nonsteroidal anti-inflammatory drug use according to time passed after first-time myocardial infarction

    DEFF Research Database (Denmark)

    Olsen, Anne-Marie Schjerning; Fosbøl, Emil L; Lindhardsen, Jesper

    2012-01-01

    The cardiovascular risk after the first myocardial infarction (MI) declines rapidly during the first year. We analyzed whether the cardiovascular risk associated with using nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with the time elapsed following first-time MI....

  15. Levels and trends in cardiovascular risk factors and drug treatment in 4837 elderly Dutch myocardial infarction patients between 2002 and 2006

    NARCIS (Netherlands)

    Soedamah-Muthu, S. S.; Geleijnse, J. M.; Giltay, E. J.; de Goede, J.; Oude Griep, L. M.; Waterham, E.; Teitsma-Jansen, A. M.; Mulder, B. J. M.; de Boer, M.-J.; Deckers, J. W.; Zock, P. L.; Kromhout, D.

    2012-01-01

    It is important to gain insight into opportunities for secondary prevention of cardiovascular disease. Our aim was to investigate levels and trends in cardiovascular risk factors and drug treatment in Dutch post-myocardial infarction (MI) patients between 2002 and 2006 and to make comparisons with

  16. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations.

    Science.gov (United States)

    Jandoc, Racquel; Burden, Andrea M; Mamdani, Muhammad; Lévesque, Linda E; Cadarette, Suzanne M

    2015-08-01

    To describe the use and reporting of interrupted time series methods in drug utilization research. We completed a systematic search of MEDLINE, Web of Science, and reference lists to identify English language articles through to December 2013 that used interrupted time series methods in drug utilization research. We tabulated the number of studies by publication year and summarized methodological detail. We identified 220 eligible empirical applications since 1984. Only 17 (8%) were published before 2000, and 90 (41%) were published since 2010. Segmented regression was the most commonly applied interrupted time series method (67%). Most studies assessed drug policy changes (51%, n = 112); 22% (n = 48) examined the impact of new evidence, 18% (n = 39) examined safety advisories, and 16% (n = 35) examined quality improvement interventions. Autocorrelation was considered in 66% of studies, 31% reported adjusting for seasonality, and 15% accounted for nonstationarity. Use of interrupted time series methods in drug utilization research has increased, particularly in recent years. Despite methodological recommendations, there is large variation in reporting of analytic methods. Developing methodological and reporting standards for interrupted time series analysis is important to improve its application in drug utilization research, and we provide recommendations for consideration. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Prevention of cardiovascular disease guided by total risk estimations - challenges and opportunities for practical implementation: highlights of a CardioVascular Clinical Trialists (CVCT) Workshop of the ESC Working Group on CardioVascular Pharmacology and Drug Therapy.

    LENUS (Irish Health Repository)

    Zannad, Faiez

    2011-11-03

    This paper presents a summary of the potential practical and economic barriers to implementation of primary prevention of cardiovascular disease guided by total cardiovascular risk estimations in the general population. It also reviews various possible solutions to overcome these barriers. The report is based on discussion among experts in the area at a special CardioVascular Clinical Trialists workshop organized by the European Society of Cardiology Working Group on Cardiovascular Pharmacology and Drug Therapy that took place in September 2009. It includes a review of the evidence in favour of the \\'treat-to-target\\' paradigm, as well as potential difficulties with this approach, including the multiple pathological processes present in high-risk patients that may not be adequately addressed by this strategy. The risk-guided therapy approach requires careful definitions of cardiovascular risk and consideration of clinical endpoints as well as the differences between trial and \\'real-world\\' populations. Cost-effectiveness presents another issue in scenarios of finite healthcare resources, as does the difficulty of documenting guideline uptake and effectiveness in the primary care setting, where early modification of risk factors may be more beneficial than later attempts to manage established disease. The key to guideline implementation is to improve the quality of risk assessment and demonstrate the association between risk factors, intervention, and reduced event rates. In the future, this may be made possible by means of automated data entry and various other measures. In conclusion, opportunities exist to increase guideline implementation in the primary care setting, with potential benefits for both the general population and healthcare resources.

  18. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

    Science.gov (United States)

    Sequi, Marco; Campi, Rita; Clavenna, Antonio; Bonati, Maurizio

    2013-03-01

    To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population. Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation. A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

  19. Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-12-01

    Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  20. Health plan utilization and costs of specialty drugs within 4 chronic conditions.

    Science.gov (United States)

    Gleason, Patrick P; Alexander, G Caleb; Starner, Catherine I; Ritter, Stephen T; Van Houten, Holly K; Gunderson, Brent W; Shah, Nilay D

    2013-09-01

    Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD

  1. Design of a Dissolving Microneedle Platform for Transdermal Delivery of a Fixed-Dose Combination of Cardiovascular Drugs.

    Science.gov (United States)

    Quinn, Helen L; Bonham, Louise; Hughes, Carmel M; Donnelly, Ryan F

    2015-10-01

    Microneedles (MNs) are a minimally invasive drug delivery platform, designed to enhance transdermal drug delivery by breaching the stratum corneum. For the first time, this study describes the simultaneous delivery of a combination of three drugs using a dissolving polymeric MN system. In the present study, aspirin, lisinopril dihydrate, and atorvastatin calcium trihydrate were used as exemplar cardiovascular drugs and formulated into MN arrays using two biocompatible polymers, poly(vinylpyrrollidone) and poly(methylvinylether/maleic acid). Following fabrication, dissolution, mechanical testing, and determination of drug recovery from the MN arrays, in vitro drug delivery studies were undertaken, followed by HPLC analysis. All three drugs were successfully delivered in vitro across neonatal porcine skin, with similar permeation profiles achieved from both polymer formulations. An average of 126.3 ± 18.1 μg of atorvastatin calcium trihydrate was delivered, notably lower than the 687.9 ± 101.3 μg of lisinopril and 3924 ± 1011 μg of aspirin, because of the hydrophobic nature of the atorvastatin molecule and hence poor dissolution from the array. Polymer deposition into the skin may be an issue with repeat application of such a MN array, hence future work will consider more appropriate MN systems for continuous use, alongside tailoring delivery to less hydrophilic compounds. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  2. Drug adherence in treatment resistant and in controlled hypertension-Results from the Swedish Primary Care Cardiovascular Database (SPCCD).

    Science.gov (United States)

    Holmqvist, Lina; Boström, Kristina Bengtsson; Kahan, Thomas; Schiöler, Linus; Qvarnström, Miriam; Wettermark, Björn; Hjerpe, Per; Hasselström, Jan; Manhem, Karin

    2018-03-01

    To assess drug adherence in patients treated with ≥3 antihypertensive drug classes, with both controlled and uncontrolled blood pressure and describe associated factors for nonadherence. Patients with hypertension, without cardiovascular comorbidity, aged >30 years treated with ≥3 antihypertensive drug classes were followed for 2 years. Both patients with treatment resistant hypertension (TRH) and patients with controlled hypertension were included. Clinical data were derived from a primary care database. Pharmacy refill data from the Swedish Prescribed drug registry was used to calculate proportion of days covered (PDC). Patients with a PDC level ≥ 80% were included. We found 5846 patients treated ≥3 antihypertensive drug classes, 3508 with TRH (blood pressure ≥ 140/90), and 2338 with controlled blood pressure (drug therapy had similar decline in adherence over time regardless of initial blood pressure control. Diabetes was associated with better adherence, which may imply that the structured caregiving of these patients enhances antihypertensive drug treatment. Copyright © 2018 John Wiley & Sons, Ltd.

  3. Cyclo-oxygenase-2 selective inhibitors and nonsteroidal anti-inflammatory drugs: balancing gastrointestinal and cardiovascular risk

    Directory of Open Access Journals (Sweden)

    McQuay Henry J

    2007-08-01

    Full Text Available Abstract Background Differences between gastrointestinal and cardiovascular effects of traditional NSAID or cyclooxygenase-2 selective inhibitor (coxib are affected by drug, dose, duration, outcome definition, and patient gastrointestinal and cardiovascular risk factors. We calculated the absolute risk for each effect. Methods We sought studies with large amounts of information to calculate annualised rates for clearly defined gastrointestinal (complicated upper gastrointestinal perforations, ulcers, or bleeds, but not symptomatic or endoscopic ulcers and serious cardiovascular outcomes (antiplatelet trial collaborators – APTC – outcome of fatal or nonfatal myocardial infarction or stroke, or vascular death. Results Meta-analyses and large randomised trials specifically analysing serious gastrointestinal bleeding or cardiovascular events occurring with five different coxibs had appropriate data. In total there were 439 complicated upper gastrointestinal events in 49,006 patient years of exposure and 948 serious cardiovascular events in 99,400 patient years of exposure. Complicated gastrointestinal events occurred less frequently with coxibs than NSAIDs; serious cardiovascular events occurred at approximately equal rates. For each coxib, the reduction in complicated upper gastrointestinal events was numerically greater than any increase in APTC events. In the overall comparison, for every 1000 patients treated for a year with coxib rather than NSAID, there would be eight fewer complicated upper gastrointestinal events, but one more fatal or nonfatal heart attack or stroke. Three coxib-NSAID comparisons had sufficient numbers of events for individual comparisons. For every 1000 patients treated for a year with celecoxib rather than an NSAID there would be 12 fewer upper gastrointestinal complications, and two fewer fatal or nonfatal heart attacks or strokes. For rofecoxib there would be six fewer upper gastrointestinal complications, but three

  4. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies.

    Directory of Open Access Journals (Sweden)

    Patricia McGettigan

    2011-09-01

    Full Text Available BACKGROUND: Randomised trials have highlighted the cardiovascular risks of non-steroidal anti-inflammatory drugs (NSAIDs in high doses and sometimes atypical settings. Here, we provide estimates of the comparative risks with individual NSAIDs at typical doses in community settings. METHODS AND FINDINGS: We performed a systematic review of community-based controlled observational studies. We conducted comprehensive literature searches, extracted adjusted relative risk (RR estimates, and pooled the estimates for major cardiovascular events associated with use of individual NSAIDs, in different doses, and in populations with low and high background risks of cardiovascular events. We also compared individual drugs in pair-wise (within study analyses, generating ratios of RRs (RRRs. Thirty case-control studies included 184,946 cardiovascular events, and 21 cohort studies described outcomes in >2.7 million exposed individuals. Of the extensively studied drugs (ten or more studies, the highest overall risks were seen with rofecoxib, 1.45 (95% CI 1.33, 1.59, and diclofenac, 1.40 (1.27, 1.55, and the lowest with ibuprofen, 1.18 (1.11, 1.25, and naproxen, 1.09 (1.02, 1.16. In a sub-set of studies, risk was elevated with low doses of rofecoxib, 1.37 (1.20, 1.57, celecoxib, 1.26 (1.09, 1.47, and diclofenac, 1.22 (1.12, 1.33, and rose in each case with higher doses. Ibuprofen risk was seen only with higher doses. Naproxen was risk-neutral at all doses. Of the less studied drugs etoricoxib, 2.05 (1.45, 2.88, etodolac, 1.55 (1.28, 1.87, and indomethacin, 1.30 (1.19, 1.41, had the highest risks. In pair-wise comparisons, etoricoxib had a higher RR than ibuprofen, RRR = 1.68 (99% CI 1.14, 2.49, and naproxen, RRR = 1.75 (1.16, 2.64; etodolac was not significantly different from naproxen and ibuprofen. Naproxen had a significantly lower risk than ibuprofen, RRR = 0.92 (0.87, 0.99. RR estimates were constant with different background risks for

  5. The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

    Science.gov (United States)

    Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

    2016-01-01

    With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. Does rosmarinic acid underestimate as an experimental cardiovascular drug? Seria o ácido rosmarínico subestimado como droga cardiovascular experimental?

    Directory of Open Access Journals (Sweden)

    Luciana Garros Ferreira

    2013-01-01

    Full Text Available PURPOSE: The rationale of the present review is to analize the activity of Rosmarinus officinalis in the the cardiovascular system METHODS: A MEDLINE database search (from January 1970 to December 2011 using only rosmarinic acid as searched term. RESULTS: The references search revealed 509 references about rosmarinic acid in 40 years (the first reference is from 1970. There is a powerful prevalence of antioxidant and cancer studies. Other diseases are few cited, as inflammation, brain (Alzheimer and Parkinson disease and, memory; allergy; diabetes; atherosclerosis, and; hypertension. It is necessary to consider the complete absence of studies on coronary artery disease, myocardial ischemia, heart failure or ischemia/reperfusion injury. CONCLUSION: Rosmarinic acid is underestimated as an experimental cardiovascular drug and deserves more attention.OBJETIVO: A justificativa da revisão é analisar a atividade de Rosmarinus officinalis no sistema cardiovascular MÉTODOS: Uma busca de banco de dados MEDLINE (de janeiro de 1970 a dezembro de 2011, utilizando apenas o ácido rosmarínico como termo pesquisado. RESULTADOS: A busca referências revelou 509 referências sobre o ácido rosmarínico em 40 anos (a primeira referência é de 1970. Há uma prevalência poderoso antioxidante e estudos do câncer. Outras doenças são citados alguns, como o cérebro, inflamação (de Alzheimer e doença de Parkinson e, a memória, hipertensão, alergia, diabetes, aterosclerose, e. É necessário ter em conta a ausência completa de estudos sobre a doença de artéria coronária, isquemia do miocárdio, insuficiência cardíaca ou isquemia / lesão de reperfusão. CONCLUSÃO: O ácido rosmarínico é subestimado como uma droga experimental cardiovascular e merece mais atenção.

  7. Clinical utility of rosuvastatin and other statins for cardiovascular risk reduction among the elderly

    Directory of Open Access Journals (Sweden)

    Sydney B Long

    2010-12-01

    Full Text Available Sydney B Long, Michael J Blaha, Roger S Blumenthal, Erin D MichosJohns Hopkins Ciccarone Center for the Prevention of Heart Disease, Baltimore, MD, USAAbstract: Age is one of the strongest predictors of cardiovascular disease (CVD risk. Treatment with statins can significantly reduce CVD events and mortality in both primary and secondary prevention. Yet despite the high CVD risk among the elderly, there is underutilization of statins in this population (ie, the treatment-risk paradox. Few studies have investigated the use of statins in the elderly, particularly for primary prevention and, as a result, guidelines for treating the elderly are limited. This is likely due to: uncertainties of risk assessment in older individuals where the predictive value of individual risk factors is decreased; the need to balance the benefits of primary prevention with the risks of polypharmacy, health care costs, and adverse medication effects in a population with decreased life expectancy; the complexity of treating patients with many other comorbidities; and increasingly difficult social and economic concerns. As life expectancy increases and the total elderly population grows, these issues become increasingly important. JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin is the largest primary prevention statin trial to date and enrolled a substantial number of elderly adults. Among the 5695 JUPITER participants ≥70 years of age, the absolute CVD risk reduction associated with rosuvastatin was actually greater than for younger participants. The implications of this JUPITER subanalysis and the broader role of statins among older adults is the subject of this review.Keywords: JUPITER, rosuvastatin, elderly, risk

  8. The metabolic syndrome: validity and utility of clinical definitions for cardiovascular disease and diabetes risk prediction.

    Science.gov (United States)

    Cameron, Adrian

    2010-02-01

    The purpose of clinical definitions of the metabolic syndrome is frequently misunderstood. While the metabolic syndrome as a physiological process describes a clustering of numerous age-related metabolic abnormalities that together increase the risk for cardiovascular disease and type 2 diabetes, clinical definitions include obesity which is thought to be a cause rather than a consequence of metabolic disturbance, and several elements that are routinely measured in clinical practice, including high blood pressure, high blood glucose and dyslipidaemia. Obesity is frequently a central player in the development of the metabolic syndrome and should be considered a key component of clinical definitions. Previous clinical definitions have differed in the priority given to obesity. Perhaps more importantly than its role in a clinical definition, however, is obesity in isolation before the hallmarks of metabolic dysfunction that typify the syndrome have developed. This should be treated seriously as an opportunity to prevent the consequences of the global diabetes epidemic now apparent. Clinical definitions were designed to identify a population at high lifetime CVD and type 2 diabetes risk, but in the absence of several major risk factors for each condition, are not optimal risk prediction devices for either. Despite this, the metabolic syndrome has several properties that make it a useful construct, in conjunction with short-term risk prediction algorithms and sound clinical judgement, for the identification of those at high lifetime risk of CVD and diabetes. A recently published consensus definition provides some much needed clarity about what a clinical definition entails. Even this, however, remains a work in progress until more evidence becomes available, particularly in the area of ethnicity-specific waist cut-points. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  9. Drug utilization study of antibiotics for urinary tract infections in a ...

    African Journals Online (AJOL)

    A drug utilization pattern of antibiotics for urinary tract infections in 200 cases above 18 years of age was done at Katuri Medical College Hospital, Guntur, India. The antibiotic sensitivity profile of the microorganism causing urinary tract infections was studied in cases diagnosed as urinary tract infection. The patients with ...

  10. Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

    Science.gov (United States)

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

    Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

  11. Internalized HIV and Drug Stigmas: Interacting Forces Threatening Health Status and Health Service Utilization Among People with HIV Who Inject Drugs in St. Petersburg, Russia

    Science.gov (United States)

    Burke, Sara E.; Dovidio, John F.; Levina, Olga S.; Uusküla, Anneli; Niccolai, Linda M.; Heimer, Robert

    2016-01-01

    Marked overlap between the HIV and injection drug use epidemics in St. Petersburg, Russia, puts many people in need of health services at risk for stigmatization based on both characteristics simultaneously. The current study examined the independent and interactive effects of internalized HIV and drug stigmas on health status and health service utilization among 383 people with HIV who inject drugs in St. Petersburg. Participants self-reported internalized HIV stigma, internalized drug stigma, health status (subjective rating and symptom count), health service utilization (HIV care and drug treatment), sociodemographic characteristics, and health/behavioral history. For both forms of internalized stigma, greater stigma was correlated with poorer health and lower likelihood of service utilization. HIV and drug stigmas interacted to predict symptom count, HIV care, and drug treatment such that individuals internalizing high levels of both stigmas were at elevated risk for experiencing poor health and less likely to access health services. PMID:26050155

  12. Awareness of Mothers and Doctors about Drug Utilization Pattern for Illnesses Encountered during Pregnancy.

    Science.gov (United States)

    Kureshee, Nargis Ibrahim; Dhande, Priti Pravin

    2013-11-01

    Careful consideration of the benefit to the mother and risk to the foetus, is required, while prescribing drugs during pregnancy. To assess the pattern of drug utilization during pregnancy and to explore the knowledge, attitude and awareness on drug use by the antenatal mother in a tertiary care hospital setup in western India. Observational, cross-sectional study involved holding interviews on 501 pregnant women, in OPD and IPD of Obstetrics-Gynaecology Department using a pilot-based questionnaire, was done. Data from prescriptions and case-files were also collected. Drugs were classified pharmacologically and according to teratogenic potential using U.S.FDA classification. Study population was classified according to the trimester of pregnancy and educational and socioeconomic status. Intergroup comparison was done using Chi-square test. Majority of the drugs were from Category A(71.2%) and Category B (16.5%), followed by those from Categories C(9.09%), D(1.12%) and X(0.7%). Category A drugs were significantly used more in first trimester, while Category C and D drugs were used in the last two trimesters (pwomen believed that drug use in pregnancy could be harmful to both mother and baby, while 35.52% believed that drug use could be dangerous throughout pregnancy. Patients' educational and socio-economic statuses influenced their compliance for nutritional supplements prescribed during pregnancy and their awareness on common contraceptive methods. Higher education and socioeconomic class provided information on safety of barrier contraception during pregnancy. Study revealed careful prescribing behaviour of physicians. Lack of awareness on safety of drugs in pregnancy and contraceptive use advocates a need for educating and counselling women of child bearing ages.

  13. Cardiovascular mechanisms of SSRI drugs and their benefits and risks in ischemic heart disease and heart failure.

    Science.gov (United States)

    Andrade, Chittaranjan; Kumar, Chethan B; Surya, Sandarsh

    2013-05-01

    Depression and heart disease are commonly comorbid. Selective serotonin reuptake inhibitors (SSRIs) are commonly used to treat depression. In March 2011, we carried out a 15-year search of PubMed for preclinical and clinical publications related to SSRIs and ischemic heart disease (IHD) or congestive heart failure (CHF). We identify and discuss a number of mechanisms by which SSRIs may influence cardiovascular functioning and health outcomes in patients with heart disease; many of the mechanisms that we present have received little attention in previous reviews. We examine studies with positive, neutral, and negative outcomes in IHD and CHF patients treated with SSRIs. SSRIs influence cardiovascular functioning and health through several different mechanisms; for example, they inhibit serotonin-mediated and collagen-mediated platelet aggregation, reduce inflammatory mediator levels, and improve endothelial function. SSRIs improve indices of ventricular functioning in IHD and heart failure without adversely affecting electrocardiographic parameters. SSRIs may also be involved in favorable or unfavorable drug interactions with medications that influence cardiovascular functions. The clinical evidence suggests that, in general, SSRIs are safe in patients with IHD and may, in fact, exert a cardioprotective effect. The clinical data are less clear in patients with heart failure, and the evidence for benefits with SSRIs is weak.

  14. Drug-Gene Interactions of Antihypertensive Medications and Risk of Incident Cardiovascular Disease

    DEFF Research Database (Denmark)

    Bis, Joshua C; Sitlani, Colleen; Irvin, Ryan

    2015-01-01

    BACKGROUND: Hypertension is a major risk factor for a spectrum of cardiovascular diseases (CVD), including myocardial infarction, sudden death, and stroke. In the US, over 65 million people have high blood pressure and a large proportion of these individuals are prescribed antihypertensive medica...

  15. Comparing the Medicaid Retrospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies.

    Science.gov (United States)

    Prada, Sergio I

    2017-12-01

    The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR and involves ongoing and periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug-drug interaction, or medically unnecessary care, implementing corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure prescription drug cost-savings generated from its DUR programs on an annual basis, but it provides no guidance or unified methodology for doing so. To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid retrospective DUR program in federal fiscal years 2014 and 2015. For each state, the cost-savings methodologies included in the Medicaid DUR 2014 and 2015 reports were downloaded from Medicaid's website. The reports were then reviewed and synthesized. Methods described by the states were classified according to research designs often described in evaluation textbooks. In 2014, the most often used prescription drugs cost-savings estimation methodology for the Medicaid retrospective DUR program was a simple pre-post intervention method, without a comparison group (ie, 12 states). In 2015, the most common methodology used was a pre-post intervention method, with a comparison group (ie, 14 states). Comparisons of savings attributed to the program among states are still unreliable, because of a lack of a common methodology available for measuring cost-savings. There is great variation among states in the methods used to measure prescription drug utilization cost-savings. This analysis suggests that there is still room for improvement in terms of

  16. Drug delivery systems--2. Site-specific drug delivery utilizing monoclonal antibodies.

    Science.gov (United States)

    Ranade, V V

    1989-10-01

    for studies of chromosome structure and function, gene mapping, embryogenesis, characterization and biosynthesis of developmental and differentiation antigens. These antigens are those that are specific for various cell types and tissues, species specific antigen, antigens involved in chemotaxis, immunogenetics and clinical genetics including genetically inherited disorders, chromosome aberrations and transplantation antigens. Besides these monoclonal antibodies, their complexes have recently been investigated as exquisitely sensitive probes to be guided to target cells or organs. They have been used to deliver cytotoxic drugs to malignant cells or enzymes to specific cell types.(ABSTRACT TRUNCATED AT 400 WORDS)

  17. Association between unemployment rates and prescription drug utilization in the United States, 2007–2010

    Science.gov (United States)

    2012-01-01

    Background While extensive evidence suggests that the economic recession has had far reaching effects on many economic sectors, little is known regarding its impact on prescription drug utilization. The purpose of this study is to describe the association between state-level unemployment rates and retail sales of seven therapeutic classes (statins, antidepressants, antipsychotics, angiotensin-converting enzyme [ACE] inhibitors, opiates, phosphodiesterase [PDE] inhibitors and oral contraceptives) in the United States. Methods Using a retrospective mixed ecological design, we examined retail prescription sales using IMS Health Xponent™ from September 2007 through July 2010, and we used the Bureau of Labor Statistics to derive population-based rates and mixed-effects modeling with state-level controls to examine the association between unemployment and utilization. Our main outcome measure was state-level utilization per 100,000 people for each class. Results Monthly unemployment levels and rates of use of each class varied substantially across the states. There were no statistically significant associations between use of ACE inhibitors or SSRIs/SNRIs and average unemployment in analyses across states, while for opioids and PDE inhibitors there were small statistically significant direct associations, and for the remaining classes inverse associations. Analyses using each state as its own control collectively exhibited statistically significant positive associations between increases in unemployment and prescription drug utilization for five of seven areas examined. This relationship was greatest for statins (on average, a 4% increase in utilization per 1% increased unemployment) and PDE inhibitors (3% increase in utilization per 1% increased unemployment), and lower for oral contraceptives and atypical antipsychotics. Conclusion We found no evidence of an association between increasing unemployment and decreasing prescription utilization, suggesting that any

  18. Drug utilization study in a burn care unit of a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Santoshkumar R Jeevangi

    2011-03-01

    Full Text Available Objective: To evaluate drug utilization and associated costs for the treatment of patients admitted in burn care unit of a tertiary care hospital. Methods: A prospective cross sectional study was conducted for a period of 15 months at Basaweshwara Teaching and General Hospital (BTGH, Gulbarga and the data collected was analyzed for various drug use indicators. Results: A total of 100 prescriptions were collected with 44% belonging to males and 56% to females. The average number of drugs per prescription ranged from 4.5 to 9.5. 9.5% of generics and 92% of essential drugs were prescribed. The opioid analgesics and sedatives were prescribed to all the patients who were admitted in burn care unit. The (Defined daily dose DDD/1 000/day for amikacin (359 was the highest followed by diclofenac sodium (156, pantoprazole (144, diazepam (130, ceftazidime (124, tramadol (115, ceftriaxone (84 and for paracetamol (4 which was the lowest. Conclusions: Significant amount of the money was spent on procurement of drugs. Most of the money was spent on prescribed antibiotics. The prescription of generic drugs should be promoted, for cost effective treatment. Hence the results of the present study indicate that there is a considerable scope for improvement in the prescription pattern.

  19. Healthcare Policy Statement on the Utility of Coronary Computed Tomography for Evaluation of Cardiovascular Conditions and Preventive Healthcare: From the Health Policy Working Group of the Society of Cardiovascular Computed Tomography.

    Science.gov (United States)

    Slim, Ahmad M; Jerome, Scott; Blankstein, Ron; Weigold, Wm Guy; Patel, Amit R; Kalra, Dinesh K; Miller, Ryan; Branch, Kelley; Rabbat, Mark G; Hecht, Harvey; Nicol, Edward D; Villines, Todd C; Shaw, Leslee J

    The rising cost of healthcare is prompting numerous policy and advocacy discussions regarding strategies for constraining growth and creating a more efficient and effective healthcare system. Cardiovascular imaging is central to the care of patients at risk of, and living with, heart disease. Estimates are that utilization of cardiovascular imaging exceeds 20 million studies per year. The Society of Cardiovascular CT (SCCT), alongside Rush University Medical Center, and in collaboration with government agencies, regional payers, and industry healthcare experts met in November 2016 in Chicago, IL to evaluate obstacles and hurdles facing the cardiovascular imaging community and how they can contribute to efficacy while maintaining or even improving outcomes and quality. The summit incorporated inputs from payers, providers, and patients' perspectives, providing a platform for all voices to be heard, allowing for a constructive dialogue with potential solutions moving forward. This article outlines the proceedings from the summit, with a detailed review of past hurdles, current status, and potential solutions as we move forward in an ever-changing healthcare landscape. Copyright © 2017 Society of Cardiovascular Computed Tomography. All rights reserved.

  20. Cost-utility analysis of antithyroid drug therapy versus 131I therapy for Graves' disease

    International Nuclear Information System (INIS)

    Hayashi, Katsumi; Abe, Katsumi; Sakata, Ikuko; Sakaguchi, Chiharu; Yamamoto, Kentaro; Kosuda, Shigeru

    2005-01-01

    There is no comparative cost-utility study between 131 I therapy and antithyroid drugs (ATD) therapy for Graves' disease, though 131 I therapy has higher remission rate and less side effects. The objective of the study was to analyze the cost-utility of ATD therapy versus 131 I therapy by calculating life-long medical costs and utility, based on the responses of Graves' disease patients to questionnaires. To determine the expected cost and expected utility, a decision tree analysis was designed on the basis of the 2 competing strategies of ATD therapy versus 131 I therapy. A simulation of 1,000 female patients weighing≥50 kg who assumed to experience the onset of Graves' disease at the age of 30, to first complain of thyrotoxic symptoms and moderate goiter 2-3 mo. previously, and to undergo a 40-years-long cohort study, was created for each strategy using a decision tree and baselines of other relevant variables. The variables and costs were based on the literature and hospital bills. The maximum and minimum values of utility were defined as 1.0 and 0.0, respectively. Future costs and utilities were discounted 5%. The medical costs and utilities were 85,739-88,650 yen/patient/40 years and 16.47-16.56/patient/40 years, respectively, for the ATD therapy strategy, and 81,842 yen/patient/40 years and 17.41/patient/40 years, respectively, for the 131 I therapy strategy. These results quantitatively demonstrated that the 131 I therapy strategy was superior to the ATD therapy strategy in terms of both cost and utility. 131 I therapy should be used more widely in Japan because of its greater utility and lower cost. (author)

  1. Drug-Gene Interactions of Antihypertensive Medications and Risk of Incident Cardiovascular Disease: A Pharmacogenomics Study from the CHARGE Consortium.

    Directory of Open Access Journals (Sweden)

    Joshua C Bis

    Full Text Available Hypertension is a major risk factor for a spectrum of cardiovascular diseases (CVD, including myocardial infarction, sudden death, and stroke. In the US, over 65 million people have high blood pressure and a large proportion of these individuals are prescribed antihypertensive medications. Although large long-term clinical trials conducted in the last several decades have identified a number of effective antihypertensive treatments that reduce the risk of future clinical complications, responses to therapy and protection from cardiovascular events vary among individuals.Using a genome-wide association study among 21,267 participants with pharmaceutically treated hypertension, we explored the hypothesis that genetic variants might influence or modify the effectiveness of common antihypertensive therapies on the risk of major cardiovascular outcomes. The classes of drug treatments included angiotensin-converting enzyme inhibitors, beta-blockers, calcium channel blockers, and diuretics. In the setting of the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE consortium, each study performed array-based genome-wide genotyping, imputed to HapMap Phase II reference panels, and used additive genetic models in proportional hazards or logistic regression models to evaluate drug-gene interactions for each of four therapeutic drug classes. We used meta-analysis to combine study-specific interaction estimates for approximately 2 million single nucleotide polymorphisms (SNPs in a discovery analysis among 15,375 European Ancestry participants (3,527 CVD cases with targeted follow-up in a case-only study of 1,751 European Ancestry GenHAT participants as well as among 4,141 African-Americans (1,267 CVD cases.Although drug-SNP interactions were biologically plausible, exposures and outcomes were well measured, and power was sufficient to detect modest interactions, we did not identify any statistically significant interactions from the four

  2. Numerical Simulation of Hemodynamic and Physiological Responses of Human Cardiovascular and Respiratory System under Drugs Administration

    Czech Academy of Sciences Publication Activity Database

    Převorovská, Světlana; Maršík, František

    2004-01-01

    Roč. 4, č. 4 (2004), s. 295-304 ISSN 1567-8822 R&D Projects: GA ČR(CZ) GA106/03/1073; GA ČR(CZ) GA106/03/0958 Institutional research plan: CEZ:AV0Z2076919 Keywords : human cardiovascular and respiratory system * baroreflex and chemoreflex control * physiologically based pharmacokinetic model Subject RIV: BK - Fluid Dynamics

  3. Minimizing Cardiovascular Adverse Effects of Atypical Antipsychotic Drugs in Patients with Schizophrenia

    Directory of Open Access Journals (Sweden)

    Fadi T. Khasawneh

    2014-01-01

    Full Text Available The use of atypical antipsychotic agents has rapidly increased in the United States and worldwide in the last decade. Nonetheless, many health care practitioners do not appreciate the significance of the cardiovascular side effects that may be associated with their use and the means to minimize them. Thus, atypical antipsychotic medications can cause cardiovascular side effects such as arrhythmias and deviations in blood pressure. In rare cases, they may also cause congestive heart failure, myocarditis, and sudden death. Patients with schizophrenia have a higher risk of cardiovascular mortality than healthy individuals, possibly because of excessive smoking, the underlying disorder itself, or a combination of both factors. Increased awareness of these potential complications can allow pharmacists and physicians to better manage and monitor high risk patients. Accurate assessments are very important to avoid medications from being given to patients inappropriately. Additionally, monitoring patients regularly via blood draws and checking blood pressure, heart rate, and electrocardiogram can help catch any clinical problems and prevent further complications. Finally, patient and family-member education, which pharmacists in particular can play key roles in, is central for the management and prevention of side effects, which is known to reflect positively on morbidity and mortality in these patients.

  4. Cardiovascular outcomes associated with canagliflozin versus other non-gliflozin antidiabetic drugs: population based cohort study.

    Science.gov (United States)

    Patorno, Elisabetta; Goldfine, Allison B; Schneeweiss, Sebastian; Everett, Brendan M; Glynn, Robert J; Liu, Jun; Kim, Seoyoung C

    2018-02-06

    To evaluate the cardiovascular safety of canagliflozin, a sodium-glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes mellitus, in direct comparisons with DPP-4 inhibitors (DPP-4i), GLP-1 receptor agonists (GLP-1RA), or sulfonylureas, as used in routine practice. Population based retrospective cohort study. Nationwide sample of patients with type 2 diabetes from a large de-identified US commercial healthcare database (Optum Clinformatics Datamart). Three pairwise 1:1 propensity score matched cohorts of patients with type 2 diabetes 18 years and older who initiated canagliflozin or a comparator non-gliflozin antidiabetic agent (ie, a DPP-4i, a GLP-1RA, or a sulfonylurea) between April 2013 and September 2015. The primary outcomes were heart failure admission to hospital and a composite cardiovascular endpoint (comprised of being admitted to hospital for acute myocardial infarction, ischemic stroke, or hemorrhagic stroke). Hazard ratios and 95% confidence intervals were estimated in each propensity score matched cohort controlling for more than 100 baseline characteristics. During a 30 month period, the hazard ratio for heart failure admission to hospital associated with canagliflozin was 0.70 (95% confidence interval 0.54 to 0.92) versus a DPP-4i (n=17 667 pairs), 0.61 (0.47 to 0.78) versus a GLP-1RA (20 539), and 0.51 (0.38 to 0.67) versus a sulfonylurea (17 354 ). The hazard ratio for the composite cardiovascular endpoint associated with canagliflozin was 0.89 (0.68 to 1.17) versus a DPP-4i, 1.03 (0.79 to 1.35) versus a GLP-1RA, and 0.86 (0.65 to 1.13) versus a sulfonylurea. Results were similar in sensitivity analyses further adjusting for baseline hemoglobin A1c levels and in subgroups of patients with and without prior cardiovascular disease or heart failure. In this large cohort study, canagliflozin was associated with a lower risk of heart failure admission to hospital and with a similar risk of myocardial infarction or stroke in

  5. ChEMBL web services: streamlining access to drug discovery data and utilities.

    Science.gov (United States)

    Davies, Mark; Nowotka, Michał; Papadatos, George; Dedman, Nathan; Gaulton, Anna; Atkinson, Francis; Bellis, Louisa; Overington, John P

    2015-07-01

    ChEMBL is now a well-established resource in the fields of drug discovery and medicinal chemistry research. The ChEMBL database curates and stores standardized bioactivity, molecule, target and drug data extracted from multiple sources, including the primary medicinal chemistry literature. Programmatic access to ChEMBL data has been improved by a recent update to the ChEMBL web services (version 2.0.x, https://www.ebi.ac.uk/chembl/api/data/docs), which exposes significantly more data from the underlying database and introduces new functionality. To complement the data-focused services, a utility service (version 1.0.x, https://www.ebi.ac.uk/chembl/api/utils/docs), which provides RESTful access to commonly used cheminformatics methods, has also been concurrently developed. The ChEMBL web services can be used together or independently to build applications and data processing workflows relevant to drug discovery and chemical biology. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

  6. Utilization of diagnostic ultrasound and intravenous lipid-encapsulated perfluorocarbons in non-invasive targeted cardiovascular therapeutics.

    Science.gov (United States)

    Porter, Thomas R; Choudhury, Songita A; Xie, Feng

    2016-01-01

    Diagnostic ultrasound (DUS) pressures have the ability to induce inertial cavitation (IC) of systemically administered microbubbles; this bioeffect has many diagnostic and therapeutic implications in cardiovascular care. Diagnostically, commercially available lipid-encapsulated perfluorocarbons (LEP) can be utilized to improve endocardial and vascular border delineation as well as assess myocardial perfusion. Therapeutically, the liquid jets induced by IC can alter endothelial function and dissolve thrombi within the immediate vicinity of the cavitating microbubbles. The cavitating LEP can also result in the localized release of any bound therapeutic substance at the site of insonation. DUS-induced IC has been tested in pre-clinical studies to determine what effect it has on acute vascular and microvascular thrombosis as well as nitric oxide (NO) release. These pre-clinical studies have consistently shown that DUS-induced IC of LEP is effective in restoring coronary vascular and microvascular flow in acute ST segment elevation myocardial infarction (STEMI), with microvascular flow improving even if upstream large vessel flow has not been achieved. The initial clinical trials examining the efficacy of short pulse duration DUS high mechanical index impulses in patients with STEMI are underway, and preliminary studies have suggested that earlier epicardial vessel recanalization can be achieved prior to arriving in the cardiac catheterization laboratory. DUS high mechanical index impulses have also been effective in pre-clinical studies for targeting DNA delivery that has restored islet cell function in type I diabetes and restored vascular flow in the extremities downstream from a peripheral vascular occlusion. Improvements in this technique will come from three dimensional arrays for therapeutic applications, more automated delivery techniques that can be applied in the field, and use of submicron-sized acoustically activated LEP droplets that may better permeate the

  7. Utility of coloured hair for the detection of drugs and alcohol.

    Science.gov (United States)

    Agius, Ronald

    2014-06-01

    The aim of this paper is to assess the utility of coloured hair for the detection of drugs and alcohol in a large statistically significant population. The positivity rate, the 1st, 5th, 50th, 95th, and 99th percentiles of five amphetamines, cannabinoids, cocaine, four opiates, methadone, buprenorphine, seven benzodiazepines, and ethyl glucuronide (EtG) in 9488 non-treated and 1026 cosmetically treated (dyed or bleached) authentic hair samples was compared. Analytical methods used were accredited for forensic purposes at the cut-offs defined by the German driving licence re-granting medical and psychological assessment (MPA) guidelines. Considering only the drug classes for which at least 10 positive samples were detected, the positivity rate in non-treated hair was highest for alcohol (4.50%; measured using EtG at concentrations ≥ 7 pg/mg hair), followed by THC (2.00%), cocaine (1.75%), and amphetamine (0.59%). While the 1st to 99th percentile range was significantly lower for drugs in treated, compared to non-treated hair, no significant change was observed for EtG. Additionally, no significant difference in the positivity rate was observed between treated hair and non-treated hair for both drugs and EtG. This study is the first attempt to evaluate the influence of cosmetic treatment, mainly dying, on the positivity rate for both drugs and EtG in hair samples submitted routinely for abstinence testing and the first to indicate that dyed and eventually bleached hair is not necessarily useless in detecting drugs and/or alcohol consumption, thus making coloured hair analysis still useful, often being the only possibility to prove such misuse. Copyright © 2014 John Wiley & Sons, Ltd.

  8. Microdose clinical trial by use of radioisotope and perspective of its possible utilization in drug development

    International Nuclear Information System (INIS)

    Yano, Tsuneo; Watanabe, Yasuyoshi

    2009-01-01

    Many promising PET tracers have been developed by the progress of molecular imaging research, and new era could be opened by clinical trials using investigational products labeled by RI. Guidance for microdose clinical trial issued by MHLW in June, 2008, is the regulatory basis to develop PET tracer under clinical trial by the pharmaceutical affairs law. In this review, the discussion from the aspect of regulatory science is highlighted, particularly, on the topics of guidance for microdose and exploratory IND study including sub-therapeutic dose (type II) and therapeutic dose (type III), the revised GMP for investigational product including RI-labeled product, and to ward guidance for microdose clinical trial for biological product. Finally, the US FDA guidance developing medical imaging drug including biological product is introduced, and then perspective of possible utilization of in vivo radiopharmaceutical agents in drug development is discussed. (author)

  9. Anti-diabetic drug utilization of pregnant diabetic women in us managed care.

    Science.gov (United States)

    Knox, Caitlin A; Delaney, Joseph A C; Winterstein, Almut G

    2014-01-17

    With the increasing prevalence of type 2 diabetes in young adulthood, treatment of diabetes in pregnancy faces new challenges. Anti-diabetic drug utilization patterns of pregnant women with pre-existing diabetes are poorly described. We aim to describe anti-diabetic (AD) agent utilization among diabetic pregnant women. We utilized IMS LifeLink, including administrative claims data of patients in US managed care plans, to establish a retrospective cohort of women, age 18-46 years (N = 96,740) with billed procedures for a live birth, and a 12 month eligibility period before and 3 month after delivery. Diabetes mellitus was identified from ≥2 in- or outpatient claims with diagnoses (ICD-9-CM 250.XX) before pregnancy. We estimated the prevalence of AD drugs before, during and after pregnancy, and secular trends across the study period (1999-2009), using linear regression. A sensitivity analysis was conducted to identify the extent of misclassification of trimesters. Almost six percent (n = 5,581) of the live birth cohort had diabetes mellitus. Throughout the study, 48% (1999) and 78% (2009) (p metformin, sulfonylureas, thiazolidinediones (TZD), and combination AD. The annual prevalence of insulin use increased by only 1% from 39% (1999) to 40% (2009) (p = 0.589) during pregnancy, while use of sulfonylureas and metformin increased from 2.5% and 4.2% (1999) to 17.3% and 15.3% (2009) (p use steadily increased in prevalence from the 1st to 3rd trimester (16.5% and 3.3% to 33.0% and 7.5%), while metformin and TZD use decreased (11.4% and 1.6% to 3.8% and 0.2%). AD use during pregnancy demonstrates the need for additional investigation regarding safety and efficacy of AD drugs on maternal outcomes.

  10. Drug utilization and cost in a Medicaid population: A simulation study of community vs. mail order pharmacy

    Directory of Open Access Journals (Sweden)

    Seoane-Vazquez Enrique

    2007-07-01

    Full Text Available Abstract Background Outpatient drugs are dispensed through both community and mail order pharmacies. There is no empirical evidence that substitution of community pharmacy with mail order reduces overall drug expenditures. The need for evaluating the potential effects on utilization and costs of the possible extension of mail order services in Medicaid provides the rationale for conducting this study. This study compares drug utilization and drug product cost in community vs. mail order pharmacy dispensing services in a Medicaid population. Methods This study is a retrospective cohort study comparing utilization and cost patterns in community vs. mail order pharmacy. A simulation model was employed to assess drug utilization and cost in mail order pharmacy using community pharmacy claim data. The model assumed that courses of drug therapy (CDT in mail order pharmacy would have utilization patterns similar to those found in community pharmacy. A 95% confidence interval surrounding changes in average utilization and average cost were estimated using bootstrap analysis. A sensitivity analysis was performed by varying drug selection criteria and supply, fill point, and medication possession ratio (MPR. Sub-analyses were performed to address differences between mail order and community pharmacy related to therapeutic class and dual-eligible patients. Data for the study derived from pharmacy claims database of Ohio Medicaid State program for the period January 2000-September 2004. Drug claims were aggregated to obtain a set of CDTs representing unique patient IDs and unique drug products. Drug product cost estimates excluded dispensing fees and were used to estimate the cost reduction required in mail order to become cost neutral in comparison with community pharmacy. Results The baseline model revealed that the use of mail order vs. community pharmacy would result in a 5.5% increase in drug utilization and a 5.4% cost reduction required in mail order

  11. A call for the better utilization of physical activity and exercise training in the defense against cardiovascular disease.

    Science.gov (United States)

    Murlasits, Zsolt

    2015-11-01

    Statins, also known as 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, effectively reduce elevated levels of serum LDL-C concentration and in turn lower cardiovascular morbidity and mortality. Regular exercise and physical activity also have significant preventive effects against cardiovascular diseases by simultaneously reducing multiple risk factors. However, statins also produce a number of adverse events, including muscle pain, which increases dramatically in statin users who also exercise, likely limiting the cardiovascular benefits. Most importantly, reduced physical activity participation due to statin-related side effects can cancel out the benefits of the pharmacological treatment. Although exercise training offers more modest benefits compared to pharmacological therapy against traditional risk factors, considering the total impact of exercise on cardiovascular health, it is now evident that this intervention may offer a greater reduction of risks compared to statin therapy alone. However, primary recommendations regarding cardiovascular therapy still center around pharmacological approaches. Thus a new outlook is called for in clinical practice that provides room for physical activity and exercise training, thus lipid targets can be reached by a combined intervention along with improvements in other cardiovascular parameters, such as endothelial function and low-grade inflammation. Databases such as Pubmed and Google Scholar as well as the reference list of the relevant articles were searched to collect information for this opinion article.

  12. Selected mucolytic, anti-inflammatory and cardiovascular drugs change the ability of neutrophils to form extracellular traps (NETs).

    Science.gov (United States)

    Zawrotniak, Marcin; Kozik, Andrzej; Rapala-Kozik, Maria

    2015-01-01

    Neutrophils form the first line of host defense against infections that combat pathogens using two major mechanisms, the phagocytosis or the release of neutrophil extracellular traps (NETs). The netosis (NET formation) exerts additional, unfavorable effects on the fitness of host cells and is also involved at the sites of lung infection, increasing the mucus viscosity and in the circulatory system where it can influence the intravascular clot formation. Although molecular mechanisms underlying the netosis are still incompletely understood, a role of NADPH oxidase that activates the production of reactive oxygen species (ROS) during the initiation of NETs has been well documented. Since several commonly used drugs can affects the netosis, our current study was aimed to determine the effects of selected mucolytic, anti-inflammatory and cardiovascular drugs on NET formation, with a special emphasis on ROS production and NADPH oxidase activity. The treatment of neutrophils with N-acetylcysteine, ketoprofen and ethamsylate reduced the production of ROS by these cells in a dose-dependent manner. NET formation was also modulated by selected drugs. N-acetylcysteine inhibited the netosis but in the presence of H2O2 this neutrophil ability was restored, indicating that N-acetylcysteine may influence the NET formation by modulating ROS productivity. The administration of ethamsylate led to a significant reduction in NET formation and this effect was not restored by H2O2 or S. aureus, suggesting the unexpected additional side effects of this drug. Ketoprofen seemed to promote ROS-independent NET release, simultaneously inhibiting ROS production. The results, obtained in this study strongly suggest that the therapeutic strategies applied in many neutrophil-mediated diseases should take into account the NET-associated effects.

  13. Utility of Glioblastoma Patient-Derived Orthotopic Xenografts in Drug Discovery and Personalized Therapy

    Directory of Open Access Journals (Sweden)

    Michele Patrizii

    2018-02-01

    Full Text Available Despite substantial effort and resources dedicated to drug discovery and development, new anticancer agents often fail in clinical trials. Among many reasons, the lack of reliable predictive preclinical cancer models is a fundamental one. For decades, immortalized cancer cell cultures have been used to lay the groundwork for cancer biology and the quest for therapeutic responses. However, cell lines do not usually recapitulate cancer heterogeneity or reveal therapeutic resistance cues. With the rapidly evolving exploration of cancer “omics,” the scientific community is increasingly investigating whether the employment of short-term patient-derived tumor cell cultures (two- and three-dimensional and/or patient-derived xenograft models might provide a more representative delineation of the cancer core and its therapeutic response. Patient-derived cancer models allow the integration of genomic with drug sensitivity data on a personalized basis and currently represent the ultimate approach for preclinical drug development and biomarker discovery. The proper use of these patient-derived cancer models might soon influence clinical outcomes and allow the implementation of tailored personalized therapy. When assessing drug efficacy for the treatment of glioblastoma multiforme (GBM, currently, the most reliable models are generated through direct injection of patient-derived cells or more frequently the isolation of glioblastoma cells endowed with stem-like features and orthotopically injecting these cells into the cerebrum of immunodeficient mice. Herein, we present the key strengths, weaknesses, and potential applications of cell- and animal-based models of GBM, highlighting our experience with the glioblastoma stem-like patient cell-derived xenograft model and its utility in drug discovery.

  14. Drug utilization pattern in a pain clinic of a tertiary care teaching hospital in Eastern India

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    Debjyoti Dutta

    2013-01-01

    Full Text Available Background: Patients attend the Pain Clinic with varieties of complains of pain, like low back pain, knee pain, shoulder pain, headache, facial pain, different neuralgias and other neuropathic pain states. They receive a multimodal treatment for their pain, Multimodal pain therapy is an integrated multidisciplinary treatment in small groups with a closely coordinated therapeutic approach. Drugs that are prescribed for treatment are not only NSAIDS or Opioids, but also various groups of adjuvant pain medications like anti-epileptics, antidepressants etc. Aim: To find out the drug utilization pattern in the Pain Clinic of a tertiary care medical college hospital in Eastern India. Materials and Methods: A cross sectional; unicentric study was conducted in the Pain Clinic during April 2013 to June 2013. New patients who were willing to participate in the study were enrolled as per selection criteria. A copy of prescriptions were collected from the patients. The drugs prescription patterns were analyzed. Result: 319 patients were included in this study in three months period and their prescriptions were analyzed. Female patients (222 were more in number than male (97. As single prescription and also as combination therapy, paracetamol was found to be the most frequently prescribed drug. Frequently used adjuvant pain medications were found to be pregabalin (21.63% and amitriptyline (16.92%.. Antacid was commonly prescribed as gastroprotective agent. Among drug combinations paracetamol (325 mg + tramadol (37.5 mg combination was used most frequently. (55.17%. Conclusion: In this uncentric study we found that patacetamol, tramadol, pregabalin and amitriptyline are the commonly used medications in a pain clinic. We need more multi-centric and comparative Indian studies.

  15. Drug Utilization Pattern In Psychiatry Outdoor Patients At Tertiary Care Teaching Hospital Of Bastar Region

    Directory of Open Access Journals (Sweden)

    Ahmed Tabish

    2015-04-01

    Full Text Available Background: Psychotropic drugs have had a remarkable impact in psychiatric practice. However, their utilization in actualClinical practice, effectiveness and safety in real life situation need continuous study.Aim: To evaluate the utilization pattern of antipsychotics drugs in the OPD of Psychiatry department.Materials and Methods: A prospective cross-sectional study was     undertaken for a period of three months.   The total number of prescriptions that were analyzed were 264. Patients of all ages and both sexes were included in the study while inpatients,Referred patients and patients of epilepsy were excluded.Results: Out of 264 patients, 180(68.18% were males and84 (31.81% were females. Depression (30.6% was the commonest psychotic ailment. Fluoxetine (34% was the most common antidepressant prescribed for its treatment.Anxiety comprised the second commonest category of psychotic disorder (24.4% followed by Schizophrenia (22%. Lorazepam (43.4% was the most prescribed anxiolytic whereas      Risperidone (46.6% was used to treat it.Conclusion:  Depression was the commonest psychotic ailment followed by anxiety and schizophrenia. Polypharmacy was found in 45% of prescriptions. Risperidone + Trihexyphenidyl was the commonest fixed dose combination used for Schizophrenia and Psychosis followed by amitriptyline+Chlordiazepoxide for anxiety and depression.

  16. Promising cardiovascular and blood pressure effects of the SGLT2 inhibitors: a new class of antidiabetic drugs.

    Science.gov (United States)

    Chrysant, S G

    2017-03-01

    Patients with type 2 diabetes mellitus (T2DM) exhibit an increased risk of cardiovascular (CV) events. Treatment of these patients with traditional as well as newer glucose-lowering drugs has not demonstrated superiority in CV outcomes compared to placebo, despite effective control of diabetes. However, the recently FDA-approved sodium-glucose cotransporter 2 (SGLT2) inhibitors for the treatment of T2DM have demonstrated promising CV-protecting and blood pressure-lowering effects in addition to their effectiveness in glucose lowering, making them a novel class of drugs for the treatment of T2DM. So far, there are three SGLT2 inhibitors approved by the FDA and EMA for the treatment of T2DM: canagliflozin, dapagliflozin and empagliflozin. They exert their antihyperglycemic effect through inhibition of SGLT2 in the kidney and significantly reduce glucose reabsorption from the proximal renal tubule. By blocking glucose reabsorption, they lead to loss of calories, weight, abdominal and total body fat, blood pressure and CV complications. One CV outcomes randomized trial and several short-term studies have shown reductions in CV events and blood pressure in patients with T2DM. It is the hope that large ongoing long-term outcome studies will provide further much-needed information, when they are completed. Copyright 2017 Clarivate Analytics.

  17. Drug utilization profile in adult patients with refractory epilepsy at a tertiary referral center

    Directory of Open Access Journals (Sweden)

    Priscila de Freitas-Lima

    2013-11-01

    Full Text Available Objective To evaluate the utilization profile of antiepileptic drugs in a population of adult patients with refractory epilepsy attending a tertiary center. Method Descriptive analyses of data were obtained from the medical records of 112 patients. Other clinical and demographic characteristics were also registered. Results Polytherapies with ≥3 antiepileptic drugs were prescribed to 60.7% of patients. Of the old agents, carbamazepine and clobazam were the most commonly prescribed (72.3% and 58.9% of the patients, respectively. Among the new agents, lamotrigine was the most commonly prescribed (36.6% of the patients. At least one old agent was identified in 103 out of the 104 polytherapies, while at least one new agent was prescribed to 70.5% of the population. The most prevalent combination was carbamazepine + clobazam + lamotrigine. The mean AED load found was 3.3 (range 0.4–7.7. Conclusion The pattern of use of individual drugs, although consistent with current treatment guidelines, is strongly influenced by the public health system.

  18. Favorable cardiovascular risk factor profile is associated with lower healthcare expenditure and resource utilization among adults with diabetes mellitus free of established cardiovascular disease: 2012 Medical Expenditure Panel Survey (MEPS).

    Science.gov (United States)

    Feldman, David I; Valero-Elizondo, Javier; Salami, Joseph A; Rana, Jamal S; Ogunmoroti, Oluseye; Osondu, Chukwuemeka U; Spatz, Erica S; Virani, Salim S; Blankstein, Ron; Blaha, Michael J; Veledar, Emir; Nasir, Khurram

    2017-03-01

    Given the prevalence and economic burden of diabetes mellitus (DM), we studied the impact of a favorable cardiovascular risk factor (CRF) profile on healthcare expenditures and resource utilization among individuals without cardiovascular disease (CVD), by DM status. 25,317 participants were categorized into 3 mutually-exclusive strata: "Poor", "Average" and "Optimal" CRF profiles (≥4, 2-3, 0-1 CRF, respectively). Two-part econometric models were utilized to study cost data. Mean age was 45 (48% male), with 54% having optimal, 39% average, and 7% poor CRF profiles. Individuals with DM were more likely to have poor CRF profile vs. those without DM (OR 7.7, 95% CI 6.4, 9.2). Individuals with DM/poor CRF profile had a mean annual expenditure of $9,006, compared to $6,461 among those with DM/optimal CRF profile (p profile is associated with significantly lower healthcare expenditures and utilization in CVD-free individuals across DM status, suggesting that these individuals require aggressive individualized prescriptions targeting lifestyle modifications and therapeutic treatments. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

    Science.gov (United States)

    Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

    2006-01-01

    To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

  20. Utilization of antiepileptic drugs during pregnancy : Comparative patterns in 38 countries based on data from the EURAP registry

    NARCIS (Netherlands)

    Battino, D.; Bonizzoni, E.; Craig, J.; Lindhout, D.; Perucca, E.; Sabers, A.; Tomson, T.; Vajda, F.

    2009-01-01

    P>We assessed the utilization of antiepileptic drugs (AEDs), 1999-2005, in 4,798 prospective epilepsy pregnancies from 38 countries participating in EURAP, an international AED and pregnancy registry. Prominent differences in utilization patterns were observed across the various countries. Exposure

  1. Radioiodination and Bio evaluation of Some Cardiovascular Drugs for Nuclear Medicine Application

    International Nuclear Information System (INIS)

    El-Sharawy, D.M.M.

    2013-01-01

    Nuclear medicine specialists use safe, painless, and cost-effective techniques to image the body and treat disease. Nuclear medicine imaging is unique, because it provides doctors with information about both structure and function. It is a way to gather medical information that would otherwise be unavailable, require surgery, or necessitate more expensive diagnostic tests. Today, nuclear medicine offers procedures that are essential in many medical specialties, from pediatrics to cardiology to psychiatry. Radiopharmacy is the science that deals largely with the preparation, compounding, Quality Control (QC), and dispensing of radiopharmaceuticals and radioisotopes for human use. Radio pharmacists are the personnel who perform these functions at large hospitals or medical centers. They are involved in manufacturing cold kits and in developing new agents and procedures. In this thesis it was studied the labeling of Deltiazem , Nefidipine and Valsartan with iodine -125 via an electrophilic substitution reaction. The biological distribution of these tracers were studied and was found the possibility of their use in cardiovascular disorders.

  2. Chronic disease and recent addiction treatment utilization among alcohol and drug dependent adults

    Directory of Open Access Journals (Sweden)

    Samet Jeffrey

    2011-10-01

    Full Text Available Abstract Background Chronic medical diseases require regular and longitudinal care and self-management for effective treatment. When chronic diseases include substance use disorders, care and treatment of both the medical and addiction disorders may affect access to care and the ability to focus on both conditions. The objective of this paper is to evaluate the association between the presence of chronic medical disease and recent addiction treatment utilization among adults with substance dependence. Methods Cross-sectional secondary data analysis of self-reported baseline data from alcohol and/or drug-dependent adults enrolled in a randomized clinical trial of a disease management program for substance dependence in primary care. The main independent variable was chronic medical disease status, categorized using the Katz Comorbidity Score as none, single condition of lower severity, or higher severity (multiple conditions or single higher severity condition, based on comorbidity scores determined from self-report. Asthma was also examined in secondary analyses. The primary outcome was any self-reported addiction treatment utilization (excluding detoxification in the 3 months prior to study entry, including receipt of any addiction-focused counseling or addiction medication from any healthcare provider. Logistic regression models were adjusted for sociodemographics, type of substance dependence, recruitment site, current smoking, and recent anxiety severity. Results Of 563 subjects, 184 (33% reported any chronic disease (20% low severity; 13% higher severity and 111 (20% reported asthma; 157 (28% reported any addiction treatment utilization in the past 3 months. In multivariate regression analyses, no significant effect was detected for chronic disease on addiction treatment utilization (adjusted odds ratio [AOR] 0.88 lower severity vs. none, 95% confidence interval (CI: 0.60, 1.28; AOR 1.29 higher severity vs. none, 95% CI: 0.89, 1.88 nor for

  3. Effect of anti-obesity drug on cardiovascular risk factors: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yu-Hao Zhou

    Full Text Available BACKGROUND: Anti-obesity drugs are widely used to prevent the complications of obesity, however, the effects of anti-obesity drugs on cardiovascular risk factors are unclear at the present time. We carried out a comprehensively systematic review and meta-analysis to assess the effects of anti-obesity drugs on cardiovascular risk factors. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles and proceedings of major meetings for relevant literatures. We included randomized placebo-controlled trials that reported the effects of anti-obesity drugs on cardiovascular risk factors compared to placebo. Overall, orlistat produced a reduction of 2.39 kg (95%CI-3.34 to -1.45 for weight, a reduction of 0.27 mmol/L (95%CI: -0.36 to -0.17 for total cholesterol, a reduction of 0.21 mmol/L (95%CI: -0.30 to -0.12 for LDL, a reduction of 0.12 mmol/L (95%CI: -0.20 to -0.04 for fasting glucose, 1.85 mmHg reduction (95%CI: -3.30 to -0.40 for SBP, and a reduction of 1.49 mmHg (95%CI: -2.39 to -0.58 for DBP. Sibutramine only showed effects on weight loss and triglycerides reduction with statistical significances. Rimonabant was associated with statistically significant effects on weight loss, SBP reduction and DBP reduction. No other significantly different effects were identified between anti-obesity therapy and placebo. CONCLUSION/SIGNIFICANCE: We identified that anti-obesity therapy was associated with a decrease of weight regardless of the type of the drug. Orlistat and rimonabant could lead to an improvement on cardiovascular risk factors. However, Sibutramine may have a direct effect on cardiovascular risk factors.

  4. Trends in prescription drug utilization and spending for the Department of Defense, 2002-2007.

    Science.gov (United States)

    Devine, Joshua W; Trice, Shana; Spridgen, Stacia L; Bacon, Thomas A

    2009-09-01

    Examine trends in U.S. Department of Defense (DoD) outpatient drug spending and utilization between 2002 and 2007. We analyzed pharmacy claims data from the U.S. Military Health System (MHS), using a cross-sectional analysis at the prescription and patient-year level and measuring utilization in 30-day equivalent prescriptions and expenditures in dollars. Pharmaceutical spending more than doubled in DoD, from $3 billion in FY02 to $6.5 billion in FY07. The largest increase occurred in the DoD community pharmacy network, where utilization grew from 6 million 30-day equivalent prescriptions in the first quarter of FY02 to more than 16 million in the last quarter of FY07. The smallest increase in annual spending occurred in FY07 (5.5%), down from a high of 27.5% in FY03. The MHS has experienced rapid growth in pharmaceutical spending since FY02. However, there are signs that growth in pharmaceutical spending may be slowing.

  5. Utilizing Chemical Genomics to Identify Cytochrome b as a Novel Drug Target for Chagas Disease.

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    Shilpi Khare

    2015-07-01

    Full Text Available Unbiased phenotypic screens enable identification of small molecules that inhibit pathogen growth by unanticipated mechanisms. These small molecules can be used as starting points for drug discovery programs that target such mechanisms. A major challenge of the approach is the identification of the cellular targets. Here we report GNF7686, a small molecule inhibitor of Trypanosoma cruzi, the causative agent of Chagas disease, and identification of cytochrome b as its target. Following discovery of GNF7686 in a parasite growth inhibition high throughput screen, we were able to evolve a GNF7686-resistant culture of T. cruzi epimastigotes. Clones from this culture bore a mutation coding for a substitution of leucine by phenylalanine at amino acid position 197 in cytochrome b. Cytochrome b is a component of complex III (cytochrome bc1 in the mitochondrial electron transport chain and catalyzes the transfer of electrons from ubiquinol to cytochrome c by a mechanism that utilizes two distinct catalytic sites, QN and QP. The L197F mutation is located in the QN site and confers resistance to GNF7686 in both parasite cell growth and biochemical cytochrome b assays. Additionally, the mutant cytochrome b confers resistance to antimycin A, another QN site inhibitor, but not to strobilurin or myxothiazol, which target the QP site. GNF7686 represents a promising starting point for Chagas disease drug discovery as it potently inhibits growth of intracellular T. cruzi amastigotes with a half maximal effective concentration (EC50 of 0.15 µM, and is highly specific for T. cruzi cytochrome b. No effect on the mammalian respiratory chain or mammalian cell proliferation was observed with up to 25 µM of GNF7686. Our approach, which combines T. cruzi chemical genetics with biochemical target validation, can be broadly applied to the discovery of additional novel drug targets and drug leads for Chagas disease.

  6. Requirements for drug monitoring of verapamil: experience from an unselected group of patients with cardiovascular disease

    DEFF Research Database (Denmark)

    Husum, D; Johnsen, A; Jensen, Gorm Boje

    1990-01-01

    variation (variation coefficient 35.8, 1.9, and 7.4, at the dosage levels 120, 240 and 340 mg per day). No significant correlation was found between serum verapamil levels age, sex, or weight. No significant effect of digoxin on the concentration of serum verapamil was found. No relation was observed...... 620 and D 617 indicated saturation of the first-pass metabolism. In conclusion, therapeutic drug monitoring is not indicated during routine verapamil treatment, whereas single measurements of verapamil may be warranted in patients not responding to treatment in order to identify fast metabolizers...

  7. Differences in All-Cause Health Care Utilization and Costs in a Type 2 Diabetes Mellitus Population with and Without a History of Cardiovascular Disease.

    Science.gov (United States)

    Mehta, Sandhya; Ghosh, Sabyasachi; Sander, Stephen; Kuti, Effie; Mountford, William K

    2018-03-01

    Multiple studies have reported that type 2 diabetes mellitus (T2DM) is a major risk factor for cardiovascular diseases (CVD), and presence of T2DM and CVD increases risk of death. There is growing interest in examining the effects of antidiabetic treatments on the reduction of cardiovascular events in T2DM adults with a history of CVD and thus at higher risk of cardiovascular events. To estimate the incremental all-cause health care utilization and costs among adults with T2DM and a history of CVD compared with adults without a history of CVD, using a national linked electronic medical records (EMR) and claims database. Adults aged ≥ 18 years with evidence of at least 1 T2DM-related diagnosis code or antidiabetic medication (date of earliest occurrence was defined as the index date) in calendar year 2012 were identified. The population was divided into 2 cohorts (with and without a history of CVD) and followed until the end of their enrollment coverage, death, or 12 months, whichever came first. Multivariable generalized linear models were used to assess differences in health care utilization and per patient per month (PPPM) total costs (plan- and patient-paid amount for health care services) between the 2 groups during the post-index year, while adjusting for an a priori list of demographic and clinical characteristics. A total of 138,018 adults with T2DM was identified, of which 16,547 (12%) had a history of CVD. The unadjusted resource utilization (outpatient: 27.5 vs. 17.8; emergency room [ER]: 0.8 vs. 0.4; inpatient: 0.4 vs. 0.2 days; and total unique drug prescriptions: 10.1 vs. 8.3) and PPPM total health care costs ($2,655.1 vs. $1,435.0) were significantly higher in T2DM adults with a history of CVD versus T2DM adults without a history of CVD. The adjusted models revealed that T2DM adults with a history of CVD had a 31% higher number of ER visits (rate ratio [RR] = 1.31, 95% CI = 1.25-1.37); 27% more inpatient visits (RR = 1.27, 95% CI = 1.21-1.34); 15

  8. Clinical Perspective on Antihypertensive Drug Treatment in Adults With Grade 1 Hypertension and Low-to-Moderate Cardiovascular Risk

    DEFF Research Database (Denmark)

    Morales Salinas, Alberto; Coca, Antonio; Olsen, Michael H.

    2017-01-01

    Hypertension is a leading risk factor for disease burden globally. An unresolved question is whether grade 1 hypertension (140-159/90-99. mm. Hg) with low (cardiovascular mortality <1% at 10 years) to moderate (cardiovascular mortality ≥1% and <5% at 10 years) absolute total cardiovascular risk (...

  9. Utilizing nutritional genomics to tailor diets for the prevention of cardiovascular disease: a guide for upcoming studies and implementations

    Science.gov (United States)

    Introduction: Personalized diets based on an individual's genome to optimize the success of dietary intervention and reduce genetic cardiovascular disease (CVD) risk, is one of the challenges most frequently discussed in the scientific community. Moreover, it has been widely welcomed and demanded by...

  10. Utilization of carbon 13-labelled stable isotopes for studying drug toxicity on cellular metabolism

    International Nuclear Information System (INIS)

    Herve, M.; Wietzerbin, J.; Tran-Dinh, S.

    1994-01-01

    A new approach for studying the effects of two drugs, amphotericine B (AMB), an anti-fungal antibiotic, and 2-deoxy-D-glucose (DG), on the glucose metabolism in brewer yeast cells (Saccharomyces cerevisiae), is presented; AMB interacts with the membrane sterols, inducing formation of pores through which ions and small molecules can pass. DG may enter in the cytosol, where it is phosphoryled by hexokinase into deoxy-D-glucose 6-phosphate (DG6P) which disappears very slowly. DG slows down the glycolysis process and induces the formation of new substances. This paper shows the advantages of utilizing carbon 13-labelled substrates combined to the NMR-13C and NMR-1H techniques. 6 figs., 5 refs

  11. e-Learning for the elderly on drug utilization: A pilot study.

    Science.gov (United States)

    Throfast, Victoria; Hellström, Lina; Hovstadius, Bo; Petersson, Göran; Ericson, Lisa

    2017-05-01

    This study explores the attitudes of elderly people to the use of electronic educational technology (e-learning) on drug utilization, with particular emphasis on the layout, usability, content, and level of knowledge in the tool. e-Learning modules were evaluated by a group of elderly people (aged ⩾65 years, n = 16) via a questionnaire comprising closed and open-ended questions. Both qualitative and quantitative analyses of the responses showed mostly positive reviews. The results indicate that the e-learning modules are a suitable tool for distributing information and education and that they can be managed by elderly individuals who are familiar with computers, allowing them to learn more about medication use.

  12. Use of Pregabalin - A Nationwide Pharmacoepidemiological Drug Utilization Study with Focus on Abuse Potential

    DEFF Research Database (Denmark)

    Schjerning, O; Pottegård, A; Damkier, P

    2016-01-01

    INTRODUCTION: Pregabalin is currently approved for the treatment of epilepsy, generalized anxiety disorder and neuropathic pain with a licensed dosage range of 150 mg to 600 mg/day. Growing concern about the abuse potential of pregabalin is partly based on reports of pregabalin being used...... in dosages that exceed the approved therapeutic range. METHODS: To identify predictors of pregabalin use above recommended dosage, we conducted a pharmacoepidemological drug utilization study using the Danish nationwide registers. We deployed 4 measures of abuse: high use (≥600 mg/day) or very high use (≥1...... 200 mg/day) over a 6- or 12-month period, respectively. Multiple logistic regression was used to identify patient and treatment characteristics that were associated with either abuse marker. RESULTS: Out of 42 520 pregabalin users 4 090 (9.6%) were treated with more than 600 mg/day for 6 months and 2...

  13. Blood Glucose Reduction by Diabetic Drugs with Minimal Hypoglycemia Risk for Cardiovascular Outcomes

    DEFF Research Database (Denmark)

    Huang, Chi-Jung; Wang, Wei-Ting; Sung, Shih-Hsien

    2018-01-01

    of antidiabetic drugs with less hypoglycemia risk were comprehensively searched in MEDLINE, Embase, and the Cochrane Library up to January 27, 2018. Mixed-effects meta-regression analysis was conducted to explore the relationship between haemoglobin A1c (HbA1c) reduction and the risk of major adverse...... concentration was 0.42% lower (median, 0.27-0.86%) for participants given antihyperglycemic agents than those given placebo. The meta-regression analysis demonstrated that HbA1c reduction was significantly associated with a decreased risk of MACE (β value, -0.39 to -0.55; P...-40%) for MACE. By contrast, the meta-regression analysis for trials using conventional agents failed to demonstrate a significant relationship between achieved HbA1c difference and MACE risk (P>0.74). CONCLUSIONS: Compared with placebo, newer T2D agents with less hypoglycemic hazard significantly reduced...

  14. Screening of cardiovascular risk factors in patients with schizophrenia and patients treated with antipsychotic drugs: are we equally exhaustive as with the general population?

    Science.gov (United States)

    Castillo-Sánchez, Miguel; Fàbregas-Escurriola, Mireia; Bergè-Baquero, Daniel; Fernández-SanMartín, MªIsabel; Goday-Arno, Albert

    2017-01-01

    Many studies have previously shown increased cardiovascular risk factors related to schizophrenia independently from the use of antipsychotic drugs. However, a poorer effort in clinical detection and management of cardiovascular risk in patients with severe mental illness could also explain these results. To test this hypothesis, we analyzed the differences in screening and incidence of cardiovascular risk factors between schizophrenia, non-schizophrenic patients on treatment with antipsychotic drugs (NS-TAD) and the general population. Data from adult subjects assessed by high-quality register general practitioners from 2006 to 2011 were extracted from the Catalonian SIDIAP database. The schizophrenia, NS-TAD, and control groups were compared in terms of measurements and incidence of diabetes, dyslipidemia, obesity, hypertension, and smoking. A total of 4911 patients in the schizophrenia group, 4157 in NS-TAD group, and 98644 in the control group were included. Schizophrenia patients were screened for dyslipidemia and diabetes more frequently than the control group, while for obesity or hypertension, they were screened equal to controls. Also, as compared to the control group, the NS-TAD group was more frequently screened for obesity with no differences in dyslipidemia and diabetes and less frequently for hypertension. Smoking was less frequently screened in both study groups. The incidence of all risk factors studied in both study groups was higher than or equal to the control group, except for hypertension, which had lower incidence. The lack of screening of risk factors does not appear decisive in the increased cardiovascular risk of patients diagnosed with schizophrenia seen in primary care. Studies evaluating the possible under diagnosis of the risk factors are required. Schizophrenia (SZ); Treatment with antipsychotic drugs (TAD); Cardiovascular risk factor/s (CVRF); Without schizophrenia but on therapy with antipsychotic drugs (NS-TAD); Defined Daily Dose

  15. Women's Initiative for Nonsmoking-VII: evaluation of health service utilization and costs among women smokers with cardiovascular disease.

    Science.gov (United States)

    Froelicher, Erika Sivarajan; Sohn, Min; Max, Wendy; Bacchetti, Peter

    2004-01-01

    The Women's Initiative for Nonsmoking (WINS), a randomized clinical trial of a smoking cessation intervention for women with cardiovascular disease, permitted an assessment of the types and costs of health services women used during the 30 months after their hospitalization with cardiovascular disease. A prospective design nested within WINS was used for this study. A structured telephone interview guide included questions about medical services and 15 categories of prevention services, including cardiac rehabilitation at 6, 12, 24, and 30 months. Costs were estimated from state and national databases. The 277 women studied had a mean age of 60.7 +/- 10 years. They had smoked approximately 40 +/- 11.4 years. More than 50% of the women had one or more risk factors for cardiovascular disease. During the first 6 months after the index hospitalization, 94% had a physician visit, 39% had an emergency-room visit, and 36% had a hospital admission. Prevention services used were home healthcare by nurse or home health aide (26%), a cardiac rehabilitation program, including Multifit and Heart Smart (19%), and physical therapy (14%). Usage decreased over the 30 months. For the women who used any service, the mean total monthly cost per woman was 913 dollars +/- 1204 dollars. This is the first report on health service use by women smokers with cardiovascular disease. Data collection using a telephone interview guide proved feasible for evaluating health service use. The greatest costs resulted from hospital admissions and physician and emergency-room visits. Considering the high prevalence of risk factors in this cohort, secondary prevention services were severely underutilized. By increasing referrals to such services, physicians and nurses might influence women to reduce their risk for subsequent cardiovascular disease.

  16. Evaluating the Effects of Pioneer Accountable Care Organizations on Medicare Part D Drug Spending and Utilization.

    Science.gov (United States)

    Zhang, Yuting; Caines, Kadin J; Powers, Christopher A

    2017-05-01

    The improvement of medication use is a critical mechanism that accountable care organization (ACO) could use to save overall costs. Currently pharmaceutical spending is not part of the calculation for ACO-shared savings and risks. Thus, ACO providers may have strong incentives to prescribe more medications hoping to avoid expensive downstream medical costs. We designed a quasinatural experiment study to evaluate the effects of Pioneer ACOs on Medicare Part D spending and utilization. Medicare fee-for-service beneficiaries with Part D drug coverage who were aligned to a Pioneer ACO were compared with a random 5% sample of non-ACO beneficiaries. Outcomes included changes in Part D spending, number of prescription fills, percent of brand medications, and total Part A and B medical spending. We utilized a generalized linear model with a difference-in-differences approach to estimate 2011-2012 changes in these outcomes among beneficiaries aligned with Pioneer ACOs, adjusting for all beneficiary-level demographics, income and insurance status, clinical characteristics, and regional fixed effects. Being in an ACO did not significantly affect Part D spending (-$23.52; P=0.19), total prescriptions filled (-0.12; P=0.27), and the percent of claims for brand-name drugs (0.06%; P=0.23). The ACO group was associated with savings in Parts A and B spending of $345 (PPioneer ACOs were not associated with changes in pharmaceutical spending and use, but were associated with savings in Parts A and B spending in 2012.

  17. Drug Utilization Patterns and Costs of Erythropoiesis-Stimulating Agents in an Outpatient Setting in Greece.

    Science.gov (United States)

    Papachristos, Apostolos; Kani, Chara; Litsa, Panagiota; Valsami, Georgia; Souliotis, Kyriakos; Saridi, Maria; Markantonis, Sophia

    2016-05-01

    Anemia in the elderly is often related to a higher prevalence of chronic diseases such as chronic kidney failure, arthritis, and malignancy. Erythropoiesis-stimulating agents (ESAs) have been used for years to effectively treat anemia and when used appropriately can substantially improve the health status and quality of life of older adults. Following the 2008 recession in Greece, the government introduced ESA price control restrictions, but no prescribing restrictions, in an effort to reduce drug expenditure. ESA prescribing patterns and treatment costs were analyzed to determine inappropriate or appropriate use of these agents and related health care resources in Greece. A retrospective register-based drug utilization study was carried out using data from prescriptions dispensed at the public pharmacy of the largest social insurance fund (IKA-ETAM), for patients receiving ESAs over a six-month period. For each patient, demographic data, ESA dosage regimen, treatment indication and cost, prescriber specialty, and prescription origin were recorded. A total of 14,387 prescriptions from 6,074 patients (median age 74 years) were reviewed. A substantial number of patients (13.5%) were treated for off-label indications, for which the average cost per patient per indication was higher. ESA dosage/frequency of administration varied but was in accordance with recommendations. The percentage of patients who received innovator and biosimilar erythropoietin (EPO) was 88% and 12%, respectively. For the optimization of ESA utilization and the reduction of treatment costs, strict ESA prescription monitoring, development of registries, and criteria for off-label indications and biosimilar use in naive patients under the umbrella of risk-sharing agreements should be proposed.

  18. Drug utilization review of cephalosporins in a secondary care hospital in United Arab Emirates.

    Science.gov (United States)

    Abou-Shaaban, Mohammad; Ali, Areeg Anwer; Rao, Padma G M; Majid, Asif

    2016-12-01

    Background Cephalosporins are one of the most commonly used antibiotics in United Arab Emirates (UAE). Few studies have been carried out to evaluate the antibiotic utilization pattern in UAE in spite of the obvious increase in cephalosporins resistance during the past decade. Objective To assess the prescriptions pattern of cephalosporins among physicians at a secondary care hospital in Ras Al Khaimah, UAE. Method This observational prospective study was carried out during October 2013 to April 2014. The data of in patients were documented in the predesigned patient profile form and was analyzed for patient's, drug's and drug's therapy related parameters. Results The 3rd generation cephalosporins constituted 83.6 % of the prescriptions, with ceftriaxone being the most commonly used one (81.1 %). They were mainly prescribed for the treatment of the lower respiratory tract infections (60.2 %). Seven (3.5 %) different ADRs linked to cephalosporin use were observed ranging from oral thrush to clostridium difficile infection. A total of 1039 antimicrobial and nonantimicrobial medications were prescribed concomitantly with cephalosporins. Conclusion The 3rd generation cephalosporins were commonly prescribed by parenteral route. Thus, there is a strong need for rationalizing their use to preserve their efficacy and prevent the development of resistance in the region.

  19. Levosimendan: a cardiovascular drug to prevent liver ischemia-reperfusion injury?

    Directory of Open Access Journals (Sweden)

    Peter Onody

    Full Text Available INTRODUCTION: Temporary occlusion of the hepatoduodenal ligament leads to an ischemic-reperfusion (IR injury in the liver. Levosimendan is a new positive inotropic drug, which induces preconditioning-like adaptive mechanisms due to opening of mitochondrial KATP channels. The aim of this study was to examine possible protective effects of levosimendan in a rat model of hepatic IR injury. MATERIAL AND METHODS: Levosimendan was administered to male Wistar rats 1 hour (early pretreatment or 24 hours (late pretreatment before induction of 60-minute segmental liver ischemia. Microcirculation of the liver was monitored by laser Doppler flowmeter. After 24 hours of reperfusion, liver and blood samples were taken for histology, immuno- and enzyme-histochemistry (TUNEL; PARP; NADH-TR as well as for laboratory tests. Furthermore, liver antioxidant status was assessed and HSP72 expression was measured. RESULTS: In both groups pretreated with levosimendan, significantly better hepatic microcirculation was observed compared to respective IR control groups. Similarly, histological damage was also reduced after levosimendan administration. This observation was supported by significantly lower activities of serum ALT (p early = 0.02; p late = 0.005, AST (p early = 0.02; p late = 0.004 and less DNA damage by TUNEL test (p early = 0.05; p late = 0.034 and PAR positivity (p early = 0.02; p late = 0.04. Levosimendan pretreatment resulted in significant improvement of liver redox homeostasis. Further, significantly better mitochondrial function was detected in animals receiving late pretreatment. Finally, HSP72 expression was increased by IR injury, but it was not affected by levosimendan pretreatment. CONCLUSION: Levosimendan pretreatment can be hepatoprotective and it could be useful before extensive liver resection.

  20. Non-steroidal anti-inflammatory drugs and risk of cardiovascular disease in patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Lindhardsen, Jesper; Gislason, Gunnar Hilmar; Jacobsen, Søren

    2013-01-01

    infarction, stroke or cardiovascular mortality was assessed in multivariable survival models. RESULTS: During follow-up (median 4.9 years) 6283 events occurred. The cardiovascular risk associated with overall NSAID use was significantly lower in RA patients than in controls (HR 1.22 (95% CI 1.09 to 1.37) vs...... with increased cardiovascular risk. NSAID use should be assessed in the individual patient based on the indication for pain relief and risk factors for adverse effects, and not automatically be avoided due to concerns of severe cardiovascular outcomes alone....

  1. What is known about the cost-effectiveness of orphan drugs? Evidence from cost-utility analyses.

    Science.gov (United States)

    Picavet, E; Cassiman, D; Simoens, S

    2015-06-01

    In times of financial and economic hardship, governments are looking to contain pharmaceutical expenditure by focusing on cost-effective drugs. Because of their high prices and difficulties in demonstrating effectiveness in small patient populations, orphan drugs are often perceived as not able to meet traditional reimbursement threshold value for money. The aim of this study was to provide an overview of the available evidence on the cost-effectiveness of orphan drugs. All orphan drugs listed as authorized on the website of the European Medicines Agency on 21 November 2013 were included in the analysis. Cost-utility analyses (CUAs) were identified by searching the Tufts Medical Center Cost-Effectiveness Analysis Registry and Embase. For each CUA, a number of variables were collected. The search identified 23 articles on the Tufts registry and 167 articles on Embase. The final analysis included 45 CUAs and 61 incremental cost-utility ratios (ICURs) for 19 orphan drugs. Of all ICURS, 16·3% were related to dominant drugs (i.e. more effective and less expensive than the comparator), 70·5% were related to drugs that are more effective, but at a higher cost, and 13·1% were related to dominated drugs (i.e. less effective and more expensive than the comparator). The median overall ICUR was €40 242 per quality-adjusted life year (QALY) with a minimum ICUR of €6311/QALY and a maximum ICUR of €974,917/QALY. This study demonstrates that orphan drugs can meet traditional reimbursement thresholds. Considering a threshold of £30,000/QALY, in this study, ten (52·6%) of a total of 19 orphan drugs for which data were available meet the threshold. As much as fifteen orphan drugs (78·9%) are eligible for reimbursement if a threshold of €80,000/QALY is considered. © 2015 John Wiley & Sons Ltd.

  2. Retrospective drug utilization review: impact of pharmacist interventions on physician prescribing

    Directory of Open Access Journals (Sweden)

    Angalakuditi M

    2011-06-01

    Full Text Available Mallik Angalakuditi1, Joseph Gomes21Georgia State University, Atlanta, GA, USA; 2Baxter Health Care, Deerfield, IL, USAObjectives: To evaluate the impact of retrospective drug utilization review (RDUR, pharmacist’s interventions on physician prescribing, and the level of spillover effect on future prescriptions following the intervention.Methods: A retrospective case–control study was conducted at a pharmacy benefits management company using the available prescription data from April 2004 to August 2005. RDUR conflicts evaluated and intervened by a clinical pharmacist served as a case group, whereas conflicts that were not evaluated and intervened by a clinical pharmacist served as a control group.Results: A total of 40,284 conflicts in cases and 13,044 in controls were identified. For cases, 32,780 interventions were considered nonrepetitive, and 529 were repetitive. There were 22,870 physicians in cases that received intervention letters and 2348 physicians in the control group that would have received intervention letters during the study period. Each physician received on average 1.4 interventions for cases vs 3.0 for controls. Among the case physicians who were intervened during the study period, 2.2% (505 were involved in a repeated intervention vs 18.2% (428 in controls (P < 0.001, which is an eight-fold difference. The most common conflict intervened on in cases was therapeutic appropriateness (8277, 25.3%, and for controls it was drug–drug interactions (1796, 25.4%. The overall interventional spillover effect in cases was 98.4% vs 89.4% in controls (P = 0.01.Conclusion: RDUR is an effective interventional program which results in decreased numbers of interventions per physician and provides a significant impact on future prescribing habits.Keywords: pharmacy management, spillover effect, RDUR, DUR

  3. Cannabis Use and Drug Related Problems Among Adolescents in 27 European Countries: The Utility of the Prevention Paradox

    Directory of Open Access Journals (Sweden)

    Romelsjö Anders

    2014-10-01

    Full Text Available AIMS – To study the prevalence of cannabis use and drug-related problems among European adolescents and the utility of the prevention paradox. METHODS – Survey data from the European School Survey Project on Alcohol and Other Drugs (ESPAD in 2007 in the 27 countries with information about drug use and drug-related problems was used. We analysed the proportion of all drug-related problems that occurred in a high risk group and among others who had used cannabis in the previous 12 months. The cut-off for the high risk group was chosen to include 10-15 % of the most frequent cannabis users. RESULTS – The high risk groups accounted for a substantial, but a minority, of drug-related problems among boys as well as girls. A minority of those who had used cannabis reported any drug-related problem. The proportion of adolescents with drug-related problems and the average number of problems increased with frequency of cannabis use. CONCLUSIONS – We find support for policy measures of more general character, supported by the prevention paradox. However, this does not exclude a policy supporting frequent drug users if they can be identified

  4. Impact of doctors' resistance on success of drug utilization review system.

    Science.gov (United States)

    Choi, Jong Soo; Yun, Seong Hyeon; Kim, Dongsoo; Park, Seung Woo

    2014-04-01

    The drug utilization review (DUR) system, which checks any conflict event of medications, contributes to improve patient safety. One of the important barriers in its adoption is doctors' resistance. This study aimed to analyze the impacts of doctors' resistance on the success of the DUR system. This study adopted an augmented the DeLone and McLean Information System (D&M IS) Success Model (2003), which used doctors' resistance as a socio-technological measure. This study framework is the same as that of the D&M IS Success Model in that it is based on qualities, such as system, information, and services. The major difference is that this study excluded the variable 'use' because it was not statistically significant for mandatory systems. A survey of doctors who used computers to enter prescriptions was conducted at a Korean tertiary hospital in February 2012. This study is very meaningful in that it is the first study to explore the success factors of the DUR system associated with doctors' resistance. Doctors' resistance to the DUR system was not statistically associated with user usefulness, whereas it affected user satisfaction. The results indicate that doctors still complain of discomfort in using the DUR system in the outpatient clinical setting, even though they admit that it contributes to patient safety. To mitigate doctors' resistance and raise user satisfaction, more opinions from doctors regarding the DUR system have to be considered and have to be reflected in the system.

  5. Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013.

    Science.gov (United States)

    Lipska, Kasia J; Yao, Xiaoxi; Herrin, Jeph; McCoy, Rozalina G; Ross, Joseph S; Steinman, Michael A; Inzucchi, Silvio E; Gill, Thomas M; Krumholz, Harlan M; Shah, Nilay D

    2017-04-01

    To examine temporal trends in utilization of glucose-lowering medications, glycemic control, and rate of severe hypoglycemia among patients with type 2 diabetes (T2DM). Using claims data from 1.66 million privately insured and Medicare Advantage patients with T2DM from 2006 to 2013, we estimated the annual 1 ) age- and sex-standardized proportion of patients who filled each class of agents; 2 ) age-, sex-, race-, and region-standardized proportion with hemoglobin A 1c (HbA 1c ) use increased for metformin (from 47.6 to 53.5%), dipeptidyl peptidase 4 inhibitors (0.5 to 14.9%), and insulin (17.1 to 23.0%) but declined for sulfonylureas (38.8 to 30.8%) and thiazolidinediones (28.5 to 5.6%; all P use of glucose-lowering drugs has changed dramatically among patients with T2DM. Overall glycemic control has not improved and remains poor among nearly a quarter of the youngest patients. The overall rate of severe hypoglycemia remains largely unchanged. © 2017 by the American Diabetes Association.

  6. Cysteine reversal of the novel neuromuscular blocking drug CW002 in dogs: pharmacodynamics, acute cardiovascular effects, and preliminary toxicology.

    Science.gov (United States)

    Sunaga, Hiroshi; Malhotra, Jaideep K; Yoon, Edward; Savarese, John J; Heerdt, Paul M

    2010-04-01

    CW002 is a neuromuscular blocking drug that is inactivated by endogenous L-cysteine. This study determined the exogenous L-cysteine dose-response relationship for CW002 reversal along with acute cardiovascular effects and organ toxicity in dogs. Six dogs were each studied four times during isoflurane-nitrous oxide anesthesia and recording of muscle twitch, arterial pressure, and heart rate. CW002 (0.08 mg/kg or 9 x ED95) was injected, and the time to spontaneous muscle recovery was determined. CW002 was then administered again followed 1 min later by 10, 20, 50, or 100 mg/kg L-cysteine (1 dose/experiment). After twitch recovery, CW002 was given a third time to determine whether residual L-cysteine influenced duration. Preliminary toxicology was performed in an additional group of dogs that received CW002 followed by vehicle (n = 8) or 200 mg/kg L-cysteine (n = 8). Animals were awakened and observed for 2 or 14 days before sacrificing and anatomic, biochemical, and histopathologic analyses. L-cysteine at all doses accelerated recovery from CW002, with both 50 and 100 mg/kg decreasing median duration from more than 70 min to less than 5 min. After reversal, duration of a subsequent CW002 dose was also decreased in a dose-dependent manner. Over the studied dose range, L-cysteine had less than 10% effect on blood pressure and heart rate. Animals receiving a single 200-mg/kg dose of L-cysteine showed no clinical, anatomic, biochemical, or histologic evidence of organ toxicity. The optimal L-cysteine dose for rapidly reversing the neuromuscular blockade produced by a large dose of CW002 in dogs is approximately 50 mg/kg, which has no concomitant hemodynamic effect. A dose of 200 mg/kg had no evident organ toxicity.

  7. Patient factors influencing the prescribing of lipid lowering drugs for primary prevention of cardiovascular disease in UK general practice: a national retrospective cohort study.

    Directory of Open Access Journals (Sweden)

    Jianhua Wu

    Full Text Available Guidelines indicate eligibility for lipid lowering drugs, but it is not known to what extent GPs' follow guidelines in routine clinical practice or whether additional clinical factors systematically influence their prescribing decisions.A retrospective cohort analysis was undertaken using electronic primary care records from 421 UK general practices. At baseline (May 2008 patients were aged 30 to 74 years, free from cardiovascular disease and not taking lipid lowering drugs. The outcome was prescription of a lipid lowering drug within the next two years. The proportions of eligible and ineligible patients prescribed lipid lowering drugs were reported and multivariable logistic regression models were used to investigate associations between age, sex, cardiovascular risk factors and prescribing.Of 365,718 patients with complete data, 13.8% (50,558 were prescribed lipid lowering drugs: 28.5% (21,101/74,137 of those eligible and 10.1% (29,457/291,581 of those ineligible. Only 41.7% (21,101/50,558 of those prescribed lipid lowering drugs were eligible. In multivariable analysis prescribing was most strongly associated with increasing age (OR for age ≥ 65 years 4.21; 95% CI 4.05-4.39; diabetes (OR 4.49; 95% CI 4.35-4.64; total cholesterol level ≥ 7 mmol/L (OR 2.20; 95% CI 2.12-2.29; and ≥ 4 blood pressure measurements in the past year (OR 4.24; 95% CI 4.06-4.42. The predictors were similar in eligible and ineligible patients.Most lipid lowering drugs for primary prevention are prescribed to ineligible patients. There is underuse of lipid lowering drugs in eligible patients.

  8. Trends in the Outpatient Utilization of Antipsychotic Drugs in the City of Zagreb in the Ten-Year Period as a Tool to Assess Drug Prescribing Rationality.

    Science.gov (United States)

    Polić-Vižintin, Marina; Tripković, Ingrid; Štimac, Danijela; Šostar, Zvonimir; Orban, Mirjana

    2016-12-01

    The aim was to determine distribution and trends in the outpatient utilization of antipsychotics to evaluate the rationality of antipsychotic drug prescribing during the ten year period. The epidemiological method of descriptive and analytical observation was used. Data on drug utilization from Zagreb Municipal Pharmacy were used to calculate the number of defined daily doses (DDD) and DDD per 1000 inhabitants per day (DDD/TID) using the World Health Organization Anatomical-Therapeutic-Chemical methodology. The ratio of typical versus atypical antipsychotics served as an indicator on assessing the rationality of the utilization. Data on the use of anticholinergics in the treatment of neuroleptic side effects were also included. Outpatient utilization of antipsychotics showed a declining pattern from 14.17 in 2001 to 8.42 DDD/TID in 2010. The utilization of atypical antipsychotics increased by 60% (from 3.68 to 5.89 DDD/TID), while the utilization of typical antipsychotics decreased by 76% (from 10.49 to 2.53 DDD/TID). The drugs showing the largest increase were olanzapine (from 1.21 to 2.78 DDD/TID) and quetiapine (from 0 to 0.68 DDD/TID). The typical/atypical antipsychotic ratio changed from 1:0.4 in 2001 to 1:2.3 in 2010. A 2.3-fold decrease was recorded in the utilization of anticholinergics (from 2.05 to 0.91 DDD/TID). Total consumption of neuroleptics significantly decreased. A decrease was also recorded in the utilization of anticholinergics. Study results pointed to two favorable features, i.e. low use of typical antipsychotics and the ratio of typical and atypical antipsychotics. Implementation of the new clinical guidelines for nervous system disorders and updating of the list of reimbursable drugs with the addition of new ones contributed to the observed improvement in the prescribing patterns during the study period. Using the WHO ATC/DDD methodology and rationality indicators in the assessment of trends in the outpatient utilization of

  9. Mental Health Service and Drug Treatment Utilization: Adolescents with Substance Use/Mental Disorders and Dual Diagnosis

    Science.gov (United States)

    Cheng, Tyrone C.; Lo, Celia C.

    2010-01-01

    This research is a secondary data analysis of the impact of adolescents' mental/substance-use disorders and dual diagnosis on their utilization of drug treatment and mental health services. By analyzing the same teenagers who participated in the NIMH Methods for the Epidemiology of Child and Adolescent Mental Disorders (MECA) study, logistic…

  10. Utilization of antiepileptic drugs during pregnancy: Comparative patterns in 38 countries based on data from the EURAP registry

    DEFF Research Database (Denmark)

    Battino, D.; Bonizzoni, E.; Craig, J.

    2009-01-01

    We assessed the utilization of antiepileptic drugs (AEDs), 1999-2005, in 4,798 prospective epilepsy pregnancies from 38 countries participating in EURAP, an international AED and pregnancy registry. Prominent differences in utilization patterns were observed across the various countries. Exposure...... to second-generation AEDs ranged from 3.5% in India and 7.3% in Italy to 75% in Denmark. Even wider variation was recorded in exposure to individual AEDs. The utilization of second-generation AEDs increased over time (for lamotrigine, from 9.9% of all pregnancies before 2001 to 29.6% after 2003......). The differences in use of individual AEDs across countries probably reflect lack of evidence concerning the optimal treatment of epilepsy in women of childbearing age, as well as variation in country-specific traditions, medication costs, and drug promotion. Our observations underscore the need for comparative...

  11. The Therapeutic Utility of Employment in Treating Drug Addiction: Science to Application

    OpenAIRE

    Silverman, Kenneth; Holtyn, August F.; Morrison, Reed

    2016-01-01

    Research on a model Therapeutic Workplace has allowed for evaluation of the use of employment in the treatment of drug addiction. Under the Therapeutic Workplace intervention, adults with histories of drug addiction are hired and paid to work. To promote drug abstinence or adherence to addiction medications, participants are required to provide drug-free urine samples or take prescribed addiction medications, respectively, to gain access to the workplace and/or to maintain their maximum rate ...

  12. Adenosine 5′-Triphosphate Metabolism in Red Blood Cells as a Potential Biomarker for Post-Exercise Hypotension and a Drug Target for Cardiovascular Protection

    Directory of Open Access Journals (Sweden)

    Pollen K. Yeung

    2018-05-01

    Full Text Available The importance of adenosine and ATP in regulating many biological functions has long been recognized, especially for their effects on the cardiovascular system, which may be used for management of hypertension and cardiometabolic diseases. In response to ischemia and cardiovascular injury, ATP is broken down to release adenosine. The effect of adenosine is very short lived because it is rapidly taken up by erythrocytes (RBCs, myocardial and endothelial cells, and also rapidly catabolized to oxypurine metabolites. Intracellular adenosine is phosphorylated back to adenine nucleotides via a salvage pathway. Extracellular and intracellular ATP is broken down rapidly to ADP and AMP, and finally to adenosine by 5′-nucleotidase. These metabolic events are known to occur in the myocardium, endothelium as well as in RBCs. Exercise has been shown to increase metabolism of ATP in RBCs, which may be an important mechanism for post-exercise hypotension and cardiovascular protection. The post-exercise effect was greater in hypertensive than in normotensive rats. The review summarizes current evidence in support of ATP metabolism in the RBC as a potential surrogate biomarker for cardiovascular protection and toxicities. It also discusses the opportunities, challenges, and obstacles of exploiting ATP metabolism in RBCs as a target for drug development and precision medicine.

  13. Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patients

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    Paolo Faccendini

    2017-09-01

    Full Text Available Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patientsObjectives:The aim of this analysis was to provide an estimate of drug utilization indicators (dose escalation and dose tapering related to biologic drugs in the chronic treatment of adult patients with Immune-Mediated Inflammatory Diseases (IMIDs.Methods:We conducted an observational retrospective cohort analysis using the Policlinico di Tor Vergata (PTV database. We considered all biologic drugs dispensed by the PTV hospital pharmacy between January 2010 and December 2015:abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab (originator and biosimilar, tocilizumab, and ustekinumab were included. Drug dose escalation and dose tapering were calculated and compared with their Defined Daily Dose (DDD.Results:A total of 1803 patients with IMID and biologic drug prescription were analyzed (male: 51.2%. The majority of patients were in the class 36-50 years (n = 612. The median follow-up was 33.8 months (IQR 14.43-56.20. Dermatology was the ward with the largest number of patients (n = 882; 48.9%, followed by rheumatology (n = 619; 34.3% and gastroenterology (n = 302; 16.8%. Dose escalation was observed in 406 patients (22.5%. Infliximab biosimilar (n = 51 was the biological drug with the highest dose escalation rate (86.3%, followed by infliximab originator (n = 28; 60.3% and ustekinumab (37.8%. Etanercept was the biological drug with the lowest dose escalation rate (7.4%, followed by golimumab (12.2% and adalimumab (13.8%. In 677 patients (37.5% a dose tapering was observed. Etanercept showed the highest rate of patients with dose tapering (41.6%, followed by adalimumab (33.6%.Conclusions:The results of this analysis show that dose modification is quite common in PTV clinical practice. Considering the strong focus on the pharmaceutical expenditure and the need of cost containment

  14. Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.

    Science.gov (United States)

    Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji

    2017-11-01

    Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.

  15. 2014 Korean Guidelines for Appropriate Utilization of Cardiovascular Magnetic Resonance Imaging: A Joint Report of the Korean Society of Cardiology and the Korean Society of Radiology

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Yeonyee E. [Department of Cardiology, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam 463-707 (Korea, Republic of); Hong, Yoo Jin [Department of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul 120-752 (Korea, Republic of); Kim, Hyung-Kwan [Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul 110-744 (Korea, Republic of); Kim, Jeong A [Department of Radiology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang 411-706 (Korea, Republic of); Na, Jin Oh [Cardiovascular Center, Korea University Guro Hospital, Korea University College of Medicine, Seoul 152-703 (Korea, Republic of); Yang, Dong Hyun [Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736 (Korea, Republic of); Kim, Young Jin [Department of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul 120-752 (Korea, Republic of); Choi, Eui-Young [Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 135-720 (Korea, Republic of)

    2014-07-01

    Cardiac magnetic resonance (CMR) imaging is now widely used in several fields of cardiovascular disease assessment due to recent technical developments. CMR can give physicians information that cannot be found with other imaging modalities. However, there is no guideline which is suitable for Korean people for the use of CMR. Therefore, we have prepared a Korean guideline for the appropriate utilization of CMR to guide Korean physicians, imaging specialists, medical associates and patients to improve the overall medical system performances. By addressing CMR usage and creating these guidelines we hope to contribute towards the promotion of public health. This guideline is a joint report of the Korean Society of Cardiology and the Korean Society of Radiology.

  16. 2014 Korean guidelines for appropriate utilization of cardiovascular magnetic resonance imaging: A joint report of the Korean Society of Cardiology and the Korean Society of Radiology

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Yeon Yee E. [Dept. of Cardiology, Cardiovascular Center, Seoul National University Bundang Hospital, Seoul (Korea, Republic of); Hong, Yoo Jin; Choi, Eui Young [Dept. of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); and others

    2015-04-15

    The use of cardiac magnetic resonance (CMR) imaging is increasing for the assessment of certain cardiovascular diseases, due to recent technical developments. CMR can give physicians information that cannot be found with other imaging modalities. However, there has been no guideline for the use of CMR in Korean people. Therefore, we have prepared a Korean guideline for the appropriate utilization of CMR to guide Korean physicians, imaging specialists, medical associates, and patients to improve the overall performances in medical system. By addressing CMR usage and creating these guidelines, we hope to contribute to the promotion of public health. This guideline is a joint report of the Korean Society of Cardiology and the Korean Society of Radiology.

  17. 2014 Korean guidelines for appropriate utilization of cardiovascular magnetic resonance imaging: A joint report of the Korean Society of Cardiology and the Korean Society of Radiology

    International Nuclear Information System (INIS)

    Yoon, Yeon Yee E.; Hong, Yoo Jin; Choi, Eui Young

    2015-01-01

    The use of cardiac magnetic resonance (CMR) imaging is increasing for the assessment of certain cardiovascular diseases, due to recent technical developments. CMR can give physicians information that cannot be found with other imaging modalities. However, there has been no guideline for the use of CMR in Korean people. Therefore, we have prepared a Korean guideline for the appropriate utilization of CMR to guide Korean physicians, imaging specialists, medical associates, and patients to improve the overall performances in medical system. By addressing CMR usage and creating these guidelines, we hope to contribute to the promotion of public health. This guideline is a joint report of the Korean Society of Cardiology and the Korean Society of Radiology.

  18. Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

    Directory of Open Access Journals (Sweden)

    Jennifer M Polinski

    2011-08-01

    . Blunt cost-containment features such as the coverage gap have an adverse impact on drug utilization that may conceivably affect health outcomes.

  19. Systematic review of model-based analyses reporting the cost-effectiveness and cost-utility of cardiovascular disease management programs.

    Science.gov (United States)

    Maru, Shoko; Byrnes, Joshua; Whitty, Jennifer A; Carrington, Melinda J; Stewart, Simon; Scuffham, Paul A

    2015-02-01

    The reported cost effectiveness of cardiovascular disease management programs (CVD-MPs) is highly variable, potentially leading to different funding decisions. This systematic review evaluates published modeled analyses to compare study methods and quality. Articles were included if an incremental cost-effectiveness ratio (ICER) or cost-utility ratio (ICUR) was reported, it is a multi-component intervention designed to manage or prevent a cardiovascular disease condition, and it addressed all domains specified in the American Heart Association Taxonomy for Disease Management. Nine articles (reporting 10 clinical outcomes) were included. Eight cost-utility and two cost-effectiveness analyses targeted hypertension (n=4), coronary heart disease (n=2), coronary heart disease plus stoke (n=1), heart failure (n=2) and hyperlipidemia (n=1). Study perspectives included the healthcare system (n=5), societal and fund holders (n=1), a third party payer (n=3), or was not explicitly stated (n=1). All analyses were modeled based on interventions of one to two years' duration. Time horizon ranged from two years (n=1), 10 years (n=1) and lifetime (n=8). Model structures included Markov model (n=8), 'decision analytic models' (n=1), or was not explicitly stated (n=1). Considerable variation was observed in clinical and economic assumptions and reporting practices. Of all ICERs/ICURs reported, including those of subgroups (n=16), four were above a US$50,000 acceptability threshold, six were below and six were dominant. The majority of CVD-MPs was reported to have favorable economic outcomes, but 25% were at unacceptably high cost for the outcomes. Use of standardized reporting tools should increase transparency and inform what drives the cost-effectiveness of CVD-MPs. © The European Society of Cardiology 2014.

  20. Utility of arterial blood gas, CBC, biochemistry and cardiac hormones as evaluation parameters of cardiovascular disease in nonhuman primates.

    Science.gov (United States)

    Nakayama, Shunya; Koie, Hiroshi; Kanayama, Kiichi; Katakai, Yuko; Ito-Fujishiro, Yasuyo; Sankai, Tadashi; Yasutomi, Yasuhiro; Ageyama, Naohide

    2018-06-11

    Cardiovascular disease (CVD) has a tremendous impact on the quality of life of humans. While experimental animals are valuable to medical research as models of human diseases, cardiac systems differ widely across various animal species. Thus, we examined a CVD model in cynomolgus monkeys. Laboratory primates are precious resources, making it imperative that symptoms of diseases and disorders are detected as early as possible. Thus, in this study we comprehensively examined important indicators of CVD in cynomolgus monkeys, including arterial blood gas, complete blood count (CBC), biochemistry, and cardiac hormones. The control group included 20 healthy macaques showing non-abnormal findings in screening tests, whereas the CVD group included 20 macaques with valvular disease and cardiomyopathy. An increase of red blood cell distribution width was observed in the CBC, indicating chronic inflammation related to CVD. An increase of HCO 3 was attributed to the correction of acidosis. Furthermore, development of the CVD model was supported by significant increases in natriuretic peptides. It is suggested that these results indicated a correlation between human CVD and the model in monkeys. Moreover, blood tests including arterial blood gas are non-invasive and can be performed more easily than other technical tests. CVD affected animals easily change their condition by anesthesia and surgical invasion. Pay attention to arterial blood gas and proper respond to their condition are important for research. This data may facilitate human research and aid in the management and veterinary care of nonhuman primates.

  1. The Utility of Ovotransferrin and Ovotransferrin-Derived Peptides as Possible Candidates in the Clinical Treatment of Cardiovascular Diseases

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    Shuang Chen

    2017-01-01

    Full Text Available Several of the most prevalent etiological factors which contribute towards global death rates are associated with cardiovascular diseases (CVDs, which include a range of conditions such as angina, rheumatic heart disease, and venous thrombosis. Extensive research has been conducted into the role played by oxidative stress and inflammation in the functional transformations associated with the progression of CVDs, while the research findings from these investigations have been both fruitful and informative. In view of the adverse secondary effects that result from the clinical administration of many synthetic medications, research which explored the treatment of severe and long-lasting conditions, including CVDs, has primarily centered on the potential benefits displayed by natural agents, one of which is food protein-based bioactive peptides. Most importantly, previous research has revealed the possible benefits associated with these products’ anti-inflammatory and antioxidant characteristics. In light of these considerations, this paper aims to review the degree to which ovotransferrin (otrf, also referred to as conalbumin and otrf-derived peptides, including IRW, IQW, and KVREGT, are, by virtue of their anti-inflammatory and antioxidant characteristics, viable treatment agents for endothelial dysfunction and the prevention of CVD.

  2. Exploring the Barriers to and Facilitators of Using Evidence-Based Drugs in the Secondary Prevention of Cardiovascular Diseases: Findings From a Multistakeholder, Qualitative Analysis.

    Science.gov (United States)

    Miller, Victoria; Nambiar, Lavanya; Saxena, Malvika; Leong, Darryl; Banerjee, Amitava; Werba, José Pablo; Faria Neto, Jose Rocha; Quinto, Katherine Curi; Moniruzzaman, Mohammed; Khandelwal, Shweta

    2018-03-01

    Health-system barriers and facilitators associated with cardiovascular medication adherence have seldom been studied, particularly in low- and middle-income countries where uptake rates are poorest. This study sought to explore the major obstacles and facilitators to the use of evidence-supported medications for secondary prevention of cardiovascular disease using qualitative analysis in 2 diverse countries across multiple levels of their health care systems. A qualitative descriptive study approach was implemented in Hamilton, Ontario, Canada, and Delhi, India. A purposeful sample (n = 69) of 23 patients, 10 physicians, 2 nurse practitioners, 5 Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy physicians, 11 pharmacists, 3 nurses, 4 hospital administrators, 1 social worker, 3 nongovernmental organization workers, 2 pharmaceutical company representatives, and 5 policy makers participated in interviews in Hamilton, Ontario, Canada (n = 21), and Delhi, India (n = 48). All interviews were digitally recorded and transcribed followed by directed content analysis to summarize and categorize the interviews. Themes that emerged across the stakeholder groups included: medication counseling; monitoring adherence; medication availability; medication affordability and drug coverage; time restrictions; and task shifting. The depth of verbal medication counseling provided varied substantially between countries, with prescribers in India unable to convey relevant information about drug treatments due to time constraint and high patient load. Canadian patients reported drug affordability as a common issue and very few patients were familiar with government subsidized drug programs. In India, patients purchased medications out-of-pocket from private, community pharmacies to avoid long commutes, lost wages, and unavailability of medications from hospitals formularies. Task shifting medication-refilling and titration to nonphysician health workers was

  3. Cost-utility analysis of varenicline, an oral smoking-cessation drug, in Japan.

    Science.gov (United States)

    Igarashi, Ataru; Takuma, Hiroki; Fukuda, Takashi; Tsutani, Kiichiro

    2009-01-01

    To conduct a cost-utility analysis of two 12-week smoking-cessation interventions in Japan: smoking-cessation counselling by a physician compared with use of varenicline, an oral smoking-cessation drug, in addition to counselling. A Markov model was constructed to analyse lifetime medical costs and QALYs from the perspective of the healthcare payer. The cycle length was 5 years. Both costs and QALYs were discounted at 3% annually. The cohort of smokers was classified by sex and age, and we assumed that smokers started smoking at the age of 20 years and received smoking-cessation therapy at the ages of 30, 40, 50, 60 or 70 years (five separate models were run). The healthcare costs and QALYs were calculated throughout the term until the age of 90 years. In the base-case analysis, success rates of varenicline plus counselling and counselling alone were assumed to be 37.9% and 25.5%, respectively, in male smokers, and 22.2% and 16.1%, respectively, in female smokers, based on a randomized controlled trial conducted in Japan. Both univariate and probabilistic sensitivity analyses were conducted. Prescribed varenicline was shown to be more effective and less costly than smoking-cessation counselling alone. Varenicline would save direct medical costs of Japanese Yen (yen)43 846 ($US381; $US1 = yen115; Oct 2007) and generate an increase of 0.094 QALYs in male smokers. In females the incremental cost-effectiveness ratio was yen346 143 per QALY gained. Varenicline is estimated to save yen23.7 billion ($US206 million) of the medical costs for tobacco-associated diseases for the whole population. Overall savings are yen9.5 billion. Sensitivity analyses suggested the robustness of the results. As with any data of this nature, there is some uncertainty in the results and further research is warranted. However, based on the results of this pharmacoeconomic evaluation, varenicline, the first non-nicotine, oral treatment developed for smoking cessation, appears to be cost

  4. The relationship between non-steroid anti-inflammatory drugs and cardiovascular risk - the myths, the misconceptions, the news, the realities -

    Directory of Open Access Journals (Sweden)

    Mirela-Anca STOIA

    2015-12-01

    Full Text Available While the number of clinical experiments investigating the effects of non-steroid anti-inflammatory drugs (NSAIDs on the cardiovascular (CV events has significantly increased over the last two decades, basic research related to the mechanism by which NSAIDs cause CV dysfunction is limited. High variability in the clinical trials conducted (different populations, dosages, exposure and types of NSAIDs has led to results which are difficult to interpret and compare between studies. Are there some NSAIDs safer than other from the standpoint of CV risk? We have try to answer at some aspects of this question.

  5. COMPARATIVE ASSESSMENT OF EFFECT OF COMBINED DRUGS OF ACE INHIBITOR AND DIURETIC (“NOLIPREL FORTE” AND “CAPOZIDE” ON CARDIOVASCULAR REMODELING IN HYPERTENSIVE PATIENTS

    Directory of Open Access Journals (Sweden)

    T. D. Kaplanov

    2015-12-01

    Full Text Available Aim. To assess antihypertensive efficacy and effect on cardio-vascular remodeling of combined drugs of ACE inhibitor and diuretic, “Noliprel forte” (NF and “Capozide” (CA, in hypertensive high risk patients.Material and methods. 50 hypertensive (II grade patients (25 men and 25 women, 19-65 years old with high cardio-vascular risk took part in comparative opened randomized study. No one of patients received antihypertensive therapy before study. All patients were randomized for therapy with one of combined drug of ACE inhibitors and diuretic. 25 patients took NF (perindopril 4 mg and indapamide 1,25 mg, and 25 patients -CA (captopril 50 mg and hydrochlorothiazide 25 mg. Duration of observation period was 6 months. Before study, after 3 and 6 months of therapy ambulatory blood pressure monitoring (ABPM, echocardiography, cardiac and vessel Dopplerography, ultrasound scanning of general carotid arteries with detection of intima-media thickness (IMT, pulse wave speed (PWS were held in all patients. Blood bio-chemical analysis was done also.Results. After 3 months 2 patients in NF group and 4 ones in CA group were required to reinforce of ther-apy with additional administration of perindoprile 4 mg and captopril 50 mg respectively. As a result of 6-month of therapy in NF group systolic dlood pressure (BP decreased in 14,0% (р<0,001 and diastolic BP – на 12,9% (р<0,001. CA reduced systolic BP by 17,9% (р<0,0001 and diastolic BP – by 17,5% (р<0,001. 76% and 70% of patients in NF and CA groups, respectively, reached target BP level. Positive dynamic of daily profile of BP was observed according to ABPM data. Cerebral blood flow did not worsen despite of BP decrease. Both drugs decreased in thickness of inter-ventricular septum and left ventricular mass. Besides, NF decreased in thickness of left ventricular posterior wall. Both drugs reduced in IMT and decreased in PWS. NF therapy did not change of blood biochemical parameters. CA

  6. COMPARATIVE ASSESSMENT OF EFFECT OF COMBINED DRUGS OF ACE INHIBITOR AND DIURETIC (“NOLIPREL FORTE” AND “CAPOZIDE” ON CARDIOVASCULAR REMODELING IN HYPERTENSIVE PATIENTS

    Directory of Open Access Journals (Sweden)

    T. D. Kaplanov

    2005-01-01

    Full Text Available Aim. To assess antihypertensive efficacy and effect on cardio-vascular remodeling of combined drugs of ACE inhibitor and diuretic, “Noliprel forte” (NF and “Capozide” (CA, in hypertensive high risk patients.Material and methods. 50 hypertensive (II grade patients (25 men and 25 women, 19-65 years old with high cardio-vascular risk took part in comparative opened randomized study. No one of patients received antihypertensive therapy before study. All patients were randomized for therapy with one of combined drug of ACE inhibitors and diuretic. 25 patients took NF (perindopril 4 mg and indapamide 1,25 mg, and 25 patients -CA (captopril 50 mg and hydrochlorothiazide 25 mg. Duration of observation period was 6 months. Before study, after 3 and 6 months of therapy ambulatory blood pressure monitoring (ABPM, echocardiography, cardiac and vessel Dopplerography, ultrasound scanning of general carotid arteries with detection of intima-media thickness (IMT, pulse wave speed (PWS were held in all patients. Blood bio-chemical analysis was done also.Results. After 3 months 2 patients in NF group and 4 ones in CA group were required to reinforce of ther-apy with additional administration of perindoprile 4 mg and captopril 50 mg respectively. As a result of 6-month of therapy in NF group systolic dlood pressure (BP decreased in 14,0% (р<0,001 and diastolic BP – на 12,9% (р<0,001. CA reduced systolic BP by 17,9% (р<0,0001 and diastolic BP – by 17,5% (р<0,001. 76% and 70% of patients in NF and CA groups, respectively, reached target BP level. Positive dynamic of daily profile of BP was observed according to ABPM data. Cerebral blood flow did not worsen despite of BP decrease. Both drugs decreased in thickness of inter-ventricular septum and left ventricular mass. Besides, NF decreased in thickness of left ventricular posterior wall. Both drugs reduced in IMT and decreased in PWS. NF therapy did not change of blood biochemical parameters. CA

  7. An overview of herbal supplement utilization with particular emphasis on possible interactions with dental drugs and oral manifestations.

    Science.gov (United States)

    Abebe, Worku

    2003-01-01

    Herbal medication in the United States is a popular form of therapy. This paper provides an overview of the utilization of herbal supplements with particular emphasis on possible interactions with oral health drugs and oral manifestations. Herbal supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA), which limits their regulation by the U.S Food and Drug Administration (FDA). A number of studies indicate that there is a progressive increase in the utilization of herbal supplements. The majority of consumers of these products are white, middle-aged women who have some college education. Many of the consumers use pharmaceutical drugs concurrently, but most do not inform their health-care providers about their use of herbal supplements. Various herbal supplements have been reported or are suspected to interact with certain oral health drugs, the most important one being 1) bromelain, cayenne, chamomile, feverfew, dong quai, eleuthro/Seberian ginseng, garlic, ginkgo, ginger, ginseng and licorice interacting with aspirin; 2) aloe latex, ephedra, ginseng, rhubarb, cascara sagrada, licorice, and senna interacting with corticosteriods; 3) kava, St. John's wort, chamomile, and valerian interacting with central nervous system (CNS) depressant drugs; and 4) herbs acting on the gastrointestinal system, altering the absorption of several orally administered drugs. Further, the use of some herbal supplements has been reported to be associated with oral manifestations, including aphthous ulcers, lip and tongue irritation, and swelling with feverfew; gingival bleeding with feverfew and ginkgo; tongue numbness with echinacea; xerostomia with St. John's wort; oral and lingual dyskinesia with kava; and salivation with yohimbe. These potential effects of herbal supplements in conjunction with factors related to regulation restrictions suggest that the use of these products may be associated with various adverse reactions that can affect oral health and

  8. Adverse cardiovascular effects of drugs in patients with heart failure: Pharmaco-epidemioiogicai studies on ibopamine and NSAIDs

    NARCIS (Netherlands)

    J. Feenstra

    2000-01-01

    textabstractHeart failure is one of the most common cardiovascular disorders in westem countries. Because (congestive) heart failure is a chronic, incapacitating disease with a poor prognosis and a substantial public health impact, the attention paid to this disorder in research and both scientific

  9. Illicit Drugs: Contaminants in the Environment and Utility in Forensic Epidemiology

    Science.gov (United States)

    The published literature surrounding the origin, occurrence, fate, and effects of illicit drug ingredients (IDIs) in the environment is examined. Similarities exist with medical pharmaceuticals, particularly with regard to the basic processes by which these ingredients enter the ...

  10. Health Care Resource Utilization for Outpatient Cardiovascular Disease and Diabetes Care Delivery Among Advanced Practice Providers and Physician Providers in Primary Care.

    Science.gov (United States)

    Virani, Salim S; Akeroyd, Julia M; Ramsey, David J; Deswal, Anita; Nasir, Khurram; Rajan, Suja S; Ballantyne, Christie M; Petersen, Laura A

    2017-10-10

    Although effectiveness of diabetes or cardiovascular disease (CVD) care delivery between physicians and advanced practice providers (APPs) has been shown to be comparable, health care resource utilization between these 2 provider types in primary care is unknown. This study compared health care resource utilization between patients with diabetes or CVD receiving care from APPs or physicians. Diabetes (n = 1,022,588) or CVD (n = 1,187,035) patients with a primary care visit between October 2013 and September 2014 in 130 Veterans Affairs facilities were identified. Using hierarchical regression adjusting for covariates including patient illness burden, the authors compared number of primary or specialty care visits and number of lipid panels and hemoglobinA1c (HbA1c) tests among diabetes patients, and number of primary or specialty care visits and number of lipid panels and cardiac stress tests among CVD patients receiving care from physicians and APPs. Physicians had significantly larger patient panels compared with APPs. In adjusted analyses, diabetes patients receiving care from APPs received fewer primary and specialty care visits and a greater number of lipid panels and HbA1c tests compared with patients receiving care from physicians. CVD patients receiving care from APPs received more frequent lipid testing and fewer primary and specialty care visits compared with those receiving care from physicians, with no differences in the number of stress tests. Most of these differences, although statistically significant, were numerically small. Health care resource utilization among diabetes or CVD patients receiving care from APPs or physicians appears comparable, although physicians work with larger patient panels.

  11. Favorable Cardiovascular Health Is Associated With Lower Health Care Expenditures and Resource Utilization in a Large US Employee Population: The Baptist Health South Florida Employee Study.

    Science.gov (United States)

    Osondu, Chukwuemeka U; Aneni, Ehimen C; Valero-Elizondo, Javier; Salami, Joseph A; Rouseff, Maribeth; Das, Sankalp; Guzman, Henry; Younus, Adnan; Ogunmoroti, Oluseye; Feldman, Theodore; Agatston, Arthur S; Veledar, Emir; Katzen, Barry; Calitz, Chris; Sanchez, Eduardo; Lloyd-Jones, Donald M; Nasir, Khurram

    2017-03-13

    To examine the association of favorable cardiovascular health (CVH) status with 1-year health care expenditures and resource utilization in a large health care employee population. Employees of Baptist Health South Florida participated in a health risk assessment from January 1 through September 30, 2014. Information on dietary patterns, physical activity, blood pressure, blood glucose level, total cholesterol level, and smoking were collected. Participants were categorized into CVH profiles using the American Heart Association's ideal CVH construct as optimal (6-7 metrics), moderate (3-5 metrics), and low (0-2 metrics). Two-part econometric models were used to analyze health care expenditures. Of 9097 participants (mean ± SD age, 42.7±12.1 years), 1054 (11.6%) had optimal, 6945 (76.3%) had moderate, and 1098 (12.1%) had low CVH profiles. The mean annual health care expenditures among those with a low CVH profile was $10,104 (95% CI, $8633-$11,576) compared with $5824 (95% CI, $5485-$6164) and $4282 (95% CI, $3639-$4926) in employees with moderate and optimal CVH profiles, respectively. In adjusted analyses, persons with optimal and moderate CVH had a $2021 (95% CI, -$3241 to -$801) and $940 (95% CI, -$1560 to $80) lower mean expenditure, respectively, than those with low CVH. This trend remained even after adjusting for demographic characteristics and comorbid conditions as well as across all demographic subgroups. Similarly, health care resource utilization was significantly lower in those with optimal CVH profiles compared with those with moderate or low CVH profiles. Favorable CVH profile is associated with significantly lower total medical expenditures and health care utilization in a large, young, ethnically diverse, and fully insured employee population. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  12. Cardiovascular events and hospital resource utilization pre- and post-transcatheter mitral valve repair in high-surgical risk patients.

    Science.gov (United States)

    Vemulapalli, Sreekanth; Lippmann, Steven J; Krucoff, Mitchell; Hernandez, Adrian F; Curtis, Lesley H; Foster, Elyse; Qasim, Atif; Wang, Andrew; Glower, Donald D; Feldman, Ted; Hammill, Bradley G

    2017-07-01

    MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied. Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 2010 US dollars, were calculated, and event rate ratios and cost ratios were estimated with multivariable modeling. Among 403 linked patients, the mean age was 80 years, 60% were male, mean baseline left ventricular ejection fraction was 49.6%, 83.3% were New York Heart Association class III/IV, 78.2% were MR grade 3+/4+, and 63.3% had functional MR. All-cause hospitalization decreased from 1,854 to 1,435/1,000 person-years (Pproviders seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. NEW DATA ON THE SAFETY OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: THE CONCEPT OF THE HIGH CLASS-SPECIFIC CARDIOVASCULAR RISK OF SELECTIVE CYCLOOXYGENASE-2 INHIBITORS IS OUTDATED

    Directory of Open Access Journals (Sweden)

    A. E. Karateev

    2017-01-01

    Full Text Available The results of the PRECISION trial were published in late 2016. During this trial, a total of 24,081 patients at high cardiovascular risk took celecoxib 200-400 mg/day, naproxen 750–1000 mg/day or ibuprofen 1800–2400 mg/day for more than 1.5 years (20.3±16.0 months. The findings show that the frequency of vascular catastrophes (death, nonfatal myocardial infarction, and stroke in patients receiving celecoxib was not higher than that of the similar complications in those taking the control drugs. At the same time, celecoxib demonstrated a statistically significant advantage in reducing the risk of serious gastrointestinal complications. New evidence refutes the concept of high cardiovascular risk that is common to all coxibs and confirms the provisions of national guidelines for the rational use of nonsteroidal anti-inflammatory drugs (NSAIDs, which were published in 2015. This review presents recent data on the risk of NSAID-related complications, including a brief description of the design and results of the PRECISION trial. 

  14. Liposomal Tumor Targeting in Drug Delivery Utilizing MMP-2- and MMP-9-Binding Ligands

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    Oula Penate Medina

    2011-01-01

    Full Text Available Nanotechnology offers an alternative to conventional treatment options by enabling different drug delivery and controlled-release delivery strategies. Liposomes being especially biodegradable and in most cases essentially nontoxic offer a versatile platform for several different delivery approaches that can potentially enhance the delivery and targeting of therapies to tumors. Liposomes penetrate tumors spontaneously as a result of fenestrated blood vessels within tumors, leading to known enhanced permeability and subsequent drug retention effects. In addition, liposomes can be used to carry radioactive moieties, such as radiotracers, which can be bound at multiple locations within liposomes, making them attractive carriers for molecular imaging applications. Phage display is a technique that can deliver various high-affinity and selectivity peptides to different targets. In this study, gelatinase-binding peptides, found by phage display, were attached to liposomes by covalent peptide-PEG-PE anchor creating a targeted drug delivery vehicle. Gelatinases as extracellular targets for tumor targeting offer a viable alternative for tumor targeting. Our findings show that targeted drug delivery is more efficient than non-targeted drug delivery.

  15. Identifying Programmatic Gaps: Inequities in Harm Reduction Service Utilization among Male and Female Drug Users in Dar es Salaam, Tanzania

    Science.gov (United States)

    Lambdin, Barrot H.; Bruce, R. Douglas; Chang, Olivia; Nyandindi, Cassian; Sabuni, Norman; Zamudio-Haas, Sophia; McCurdy, Sheryl; Masao, Frank; Ivo, Yovin; Msami, Amani; Ubuguy, Omar; Mbwambo, Jessie

    2013-01-01

    Introduction Current estimates suggest an HIV prevalence of 42% among people who inject drugs (PWIDs) in Dar es Salaam, while HIV prevalence is estimated to be 8.8% among the general population in the city. To address the HIV epidemic in this population, the government of Tanzania began establishing HIV prevention, treatment and care services including outreach and medication assisted treatment (MAT) for PWIDs in 2010. We assessed gender inequities in utilization of outreach and MAT services and evaluated differences in HIV risk behaviors between female and male PWIDs. Materials and Methods Routine outreach data between December 2010 to mid-August 2012 and baseline data on clients enrolling in methadone from February 2011 to August 2012 were utilized. Binomial regression was used to estimate adjusted relative risk estimates comparing females to males. Results From December 2010 to August 2012, 8,578 contacts were made to drug users; among them 1,898 were injectors. A total of 453 injectors were eligible and referred to MAT, of which, 443 enrolled in treatment. However, regarding total outreach contacts, outreach to PWID, referral to MAT and enrollment in MAT, 8% or less of drug users accessing services were women. In contrast, weighted estimations from surveys suggest that 34% of PWIDs are female, and this approximation is similar to recent population size estimations. Overall, 43% of traditional outreach workers conducting outreach with drug users were female. Though reporting higher levels of condom usage, female PWID were more likely to report multiple sex partners, anal sex, commercial sex work and struggle under a higher burden of addiction, mental disorders and abuse. Conclusions Services have not been mobilized adequately to address the clear needs of females who inject drugs. A clear and urgent need exists for women-centered strategies that effectively engage female PWID into HIV prevention services. PMID:23825620

  16. Identifying programmatic gaps: inequities in harm reduction service utilization among male and female drug users in Dar es Salaam, Tanzania.

    Directory of Open Access Journals (Sweden)

    Barrot H Lambdin

    Full Text Available INTRODUCTION: Current estimates suggest an HIV prevalence of 42% among people who inject drugs (PWIDs in Dar es Salaam, while HIV prevalence is estimated to be 8.8% among the general population in the city. To address the HIV epidemic in this population, the government of Tanzania began establishing HIV prevention, treatment and care services including outreach and medication assisted treatment (MAT for PWIDs in 2010. We assessed gender inequities in utilization of outreach and MAT services and evaluated differences in HIV risk behaviors between female and male PWIDs. MATERIALS AND METHODS: Routine outreach data between December 2010 to mid-August 2012 and baseline data on clients enrolling in methadone from February 2011 to August 2012 were utilized. Binomial regression was used to estimate adjusted relative risk estimates comparing females to males. RESULTS: From December 2010 to August 2012, 8,578 contacts were made to drug users; among them 1,898 were injectors. A total of 453 injectors were eligible and referred to MAT, of which, 443 enrolled in treatment. However, regarding total outreach contacts, outreach to PWID, referral to MAT and enrollment in MAT, 8% or less of drug users accessing services were women. In contrast, weighted estimations from surveys suggest that 34% of PWIDs are female, and this approximation is similar to recent population size estimations. Overall, 43% of traditional outreach workers conducting outreach with drug users were female. Though reporting higher levels of condom usage, female PWID were more likely to report multiple sex partners, anal sex, commercial sex work and struggle under a higher burden of addiction, mental disorders and abuse. CONCLUSIONS: Services have not been mobilized adequately to address the clear needs of females who inject drugs. A clear and urgent need exists for women-centered strategies that effectively engage female PWID into HIV prevention services.

  17. Intravenous Immunoglobulin: A Drug Utilization Review at Shahid Sadoughi Hospital in Yazd

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    SeyedMojtaba Sohrevardi

    2015-10-01

    Full Text Available  Background: Drug use evaluation (DUE aims at improving the patients’ care. Studying the administration pattern of intravenous immunoglobulin (IVIG is an important research topic due to its significant role in the treatment and controlling of many disorders, high prices, and limited availability of this drug.  Methods:This observational cross-sectional study was conducted at Shahid Sadoughi Hospital in Yazd, central Iran, from May to September 2014. The orders of different wards in the hospital for IVIG given to the hospital central pharmacy were surveyed. Also, a special form developed for evaluation the method of administration. The related physician and nurse were consulted on drug complications and the causes. Finally, the gleaned data were compared to the available standards on the prescription and administration of IVIG.Results:A total of 75 patients received IVIG during this study. 58.7% of the prescriptions belonged to the cases approved by Food and Drug Administration (FDA. The most frequent cause of the use of IVIG was idiopathic thrombocytopenic purpura (ITP. The rate and dose of administration was suitable in most of the patients, yet, the measurement of laboratory parameters required for IVIG were observed in only a few cases. Complications occurred in 26.7% of the patients receiving it, which was mostly related to infusion-related reactions. On the whole, 3922 g IVIG was used during this study of which 1848 g belonged to the cases approved by FDA.Conclusion:Regarding the high costs of IVIG, complications, and limited information on the quality of the effect of this drug in the treatment of many cases, physicians should be cautious enough with its appropriate use. Besides, the presence of a clinical pharmacist in the health-care team not only improves the quality of drug therapy and treatment results, but also plays an important part in decreasing the treatment costs for the patients.

  18. The Therapeutic Utility of Employment in Treating Drug Addiction: Science to Application.

    Science.gov (United States)

    Silverman, Kenneth; Holtyn, August F; Morrison, Reed

    2016-06-01

    Research on a model Therapeutic Workplace has allowed for evaluation of the use of employment in the treatment of drug addiction. Under the Therapeutic Workplace intervention, adults with histories of drug addiction are hired and paid to work. To promote drug abstinence or adherence to addiction medications, participants are required to provide drug-free urine samples or take prescribed addiction medications, respectively, to gain access to the workplace and/or to maintain their maximum rate of pay. Research has shown that the Therapeutic Workplace intervention is effective in promoting and maintaining abstinence from heroin, cocaine and alcohol and in promoting adherence to naltrexone. Three models could be used to implement and maintain employment-based reinforcement in the treatment of drug addiction: A Social Business model, a Cooperative Employer model, and a Wage Supplement model. Under all models, participants initiate abstinence in a training and abstinence initiation phase (Phase 1). Under the Social Business model, Phase 1 graduates are hired as employees in a social business and required to maintain abstinence to maintain employment and/or maximum pay. Under the Cooperative Employer model, cooperating community employers hire graduates of Phase 1 and require them to maintain abstinence to maintain employment and/or maximum pay. Under the Wage Supplement Model, graduates of Phase 1 are offered abstinence-contingent wage supplements if they maintain competitive employment in a community job. Given the severity and persistence of the problem of drug addiction and the lack of treatments that can produce lasting effects, continued development of the Therapeutic Workplace is warranted.

  19. Novel approach for a PTX/VEGF dual drug delivery system in cardiovascular applications-an innovative bulk and surface drug immobilization.

    Science.gov (United States)

    Wulf, Katharina; Teske, Michael; Matschegewski, Claudia; Arbeiter, Daniela; Bajer, Dalibor; Eickner, Thomas; Schmitz, Klaus-Peter; Grabow, Niels

    2018-06-01

    The successive incorporation of several drugs into the polymeric bulk of implants mostly results in loss of considerable quantity of one drug, and/or the loss in quality of the coating and also in changes of drug release time points. A dual drug delivery system (DDDS) based on poly-L-lactide (PLLA) copolymers combining the effective inhibition of smooth muscle cell proliferation while simultaneously promoting re-endothelialization was successfully developed. To overcome possible antagonistic drug interactions and the limitation of the polymeric bulk material as release system for dual drugs, a novel concept which combines the bulk and surface drug immobilization for a DDDS was investigated. The advantage of this DDDS is that the bulk incorporation of fluorescein diacetate (FDAc) (model drug for paclitaxel (PTX)) via spray coating enhanced the subsequent cleavable surface coupling of vascular endothelial growth factor (VEGF) via the crosslinker bissulfosuccinimidyl suberate (BS 3 ). In the presence of the embedded FDAc, the VEGF loading and release are about twice times higher than in absence. Furthermore, the DDDS combines the diffusion drug delivery (FDAc or PTX) and the chemical controlled drug release, VEGF via hydrolysable ester bonds, without loss in quantity and quality of the drug release curves. Additionally, the performed in vitro biocompatibility study showed the bimodal influences of PTX and VEGF on human endothelial EA.hy926 cells. In conclusion, it was possible to show the feasibility to develop a novel DDDS which has a high potential for the medical application due to the possible easy and short modification of a polymer-based PTX delivery system.

  20. Drug utilization and therapy provision patterns by prescriber types among patients with systemic lupus erythematosus in Korea

    Directory of Open Access Journals (Sweden)

    Shin S

    2017-10-01

    Full Text Available Sooyoung Shin College of Pharmacy and Research Institute of Pharmaceutical Science and Technology (RIPST, Ajou University, Yeongtong-gu, Suwon, Republic of Korea Background: Systemic lupus erythematosus (SLE poses a growing challenge for healthcare systems, affecting an increasing number of people in Korea. This study aimed to investigate the prescribing patterns of SLE therapies and to compare common drug regimens prescribed by provider types.Methods: Sampled national health insurance claims data in 2015 were used to select eligible SLE patients. Frequency analyses were carried out regarding patient characteristics related to relevant SLE prescriptions. Patient-days were calculated per substance and per drug class and then categorized by provider types. Differences in drug utilization trends among the main types of providers were examined with the chi-square test.Results: A total of 2,074 patients with SLE were selected for study inclusion. Systemic corticosteroid therapy was provided for up to 67.9% of patients, frequently in conjunction with other SLE therapies. About 33.2% and 18.7% of steroid users were treated for more than 150 days and 300 days during the study period, respectively. The provider group that most frequently prescribed systemic corticosteroids was dermatologists. Hydroxychloroquine, an antimalarial considered pivotal to SLE management, was prescribed for only 32.4% of patients, predominantly by rheumatologists. Antimalarial therapy was associated with the longest therapy duration (257.7±120.1 days, followed by immunosuppressant therapy (187.0±153.0 days. Prescription rates of antimalarials and immunosuppressants were substantially lower in primary care doctor group and particularly in dermatologist group, compared to rheumatologist group (P-value associated with prescription patterns by provider types was <0.001 for both drug classes.Conclusion: The drug utilization patterns among the main provider groups commonly

  1. Dynamic SIMS utilizing SF{sub 5}{sup +} polyatomic primary ion beams for drug delivery applications

    Energy Technology Data Exchange (ETDEWEB)

    Mahoney, Christine M.; Roberson, Sonya; Gillen, Greg

    2004-06-15

    The behavior of various biodegradable polymer films (e.g. polylactic acid, polyglycolic acid and polycaprolactone) as well as some model drugs (theophylline and 4-acetamidophenol) under dynamic SF{sub 5}{sup +} primary ion bombardment is explored. A series of polylactic acid films containing varying concentrations of 4-acetamidophenol are also analyzed under similar conditions. The resultant molecular depth profiles obtained from these polymer films doped with drug show very little degradation in molecular signal as a function of SF{sub 5}{sup +} primary ion dose, and it was found that the molecular ion signals of both polymer and drug remained constant for ion doses up to {approx}5x10{sup 15} ions/cm{sup 2}. In addition, the polymer film/Si interface was well defined which may imply that sputter-induced topography formation was not a significant limitation. These results suggest that the structure of the biodegradable polymers studied here which all have the common main chain structural unit, R-CO-O-R, allows for a greater ability to depth profile due to ease of bond cleavage. Most importantly, however, these results indicate that in these particular polymer systems, the distribution of the drug as a function of depth can be monitored.

  2. Utilizing Business, University, and Community Resources to Target Adolescent Prescription Drug Abuse

    Science.gov (United States)

    Wade-Mdivanian, R.; Anderson-Butcher, D.; Hale, K.; Kwiek, N.; Smock, J.; Radigan, D.; Lineberger, J.

    2012-01-01

    "Generation Rx" is a prescription drug abuse prevention strategy which includes a "toolkit" designed to be used with youth. Developed by Cardinal Health Foundation and the Ohio State University, it provides health care providers (especially pharmacists), parents, teachers, youth workers, and other community leaders with…

  3. Bioavailability assessment of hydroxymethylglutaryl coenzyme A reductase inhibitor utilizing pulsatile drug delivery system: a pilot study.

    Science.gov (United States)

    Taha, Ehab I

    2016-09-01

    Chronotherapy or pulsatile drug delivery system could be achieved by increasing drug plasma concentration exactly at the time of disease incidence. Cholesterol synthesis shows a circadian rhythm being high at late night and early in the morning. Simvastatin (SIM) inhibits hydroxymethylglutaryl coenzyme A reductase, which is responsible for cholesterol synthesis. In this study, SIM lipid-based formulation filled in gelatin capsules and coated with aqueous Eudragit® S100 dispersion was prepared for chronotherapeutic treatment of hypercholesterolemia. The pharmacokinetic parameters of SIM capsules were studied in human volunteers after a single oral dose and compared with that of Zocor® tablets as a reference in a randomized cross-over study. Pharmacokinetic parameters such as AUC 0-∞ , C max , T max , t 1/2 and elimination rate constant were determined from plasma concentration-time profile for both formulations. The tested formulation had the ability to delay drug absorption and provide higher drug concentrations from 3 up to 10 h after oral administration compared to that of commercial tablets. The data in this study revealed that the prepared formulation could be effective in chronotherapeutic treatment of hypercholesterolemia. Moreover, the tested formulation was found to enhance SIM bioavailability by 29% over the reference tablets.

  4. Anti-microorganism contamination measures for crude drugs utilizing radiation sterilization

    International Nuclear Information System (INIS)

    Kimura, Syojiro

    1998-01-01

    Crude drugs are manufactured by simple processing of natural mineral, animal or plant part materials, and are used in Chinese medicine. Because these components are originated by nature, they tend to have a much higher level of contaminating microorganisms than chemically synthesized compound. Many plant-derived crude drugs contain bacteria; 10 3 -10 5 cells/g and fungi; 10 2 -10 4 spores/g. Some animal-derived crude drugs contain bacteria levels of up to 10 8 cells/g, including dangerous varieties like E. coli or Salmonella. The survival rate and the required dose can be quantified as follows: N/No=e -kD and SD=D 10 x log (No/SAL), respectively. Where, k is the sterilization constant of microorganism, No is the initial count of bacteria, D is the absorbed dose, D 10 is the dose required to decrease the count to 1/10 and SAL is the count limit or sterilization assurance. The D 10 value for general microorganism is approximately 2 kGy for bacteria, 1 kGy for fungi, and 3-4 kGy for spore-forming bacteria. The results of our past studies have shown that the dose of 5-7 kGy is necessary to sterilize general microorganism that are attached to crude drugs. Besides, the D 10 value of specific bacteria ranges from 0.1 to 0.8 kGy, so the above dose should be sufficient for sterilizing the specific microorganism (SAL; 10 -6 ). The stability of crude drugs can be quantified be the following formula, C/Co=e -k'D . Where, C/Co is the residual rate of drug components, and k' is the loss coefficient. The value of k is 1-2, but that of k' is three to four figures smaller. The C/Co ratio of most drug components is more than 0.99 with a dose of 5-7 kGy. Furthermore, radiolysis materials that are decomposed by radiation are similar to compounds that are decomposed by ultraviolet rays or sunlight. 60 Co ray are suitable for sterilizing raw materials. On the other hand, electron beams are used to sterilize a thin layer of pulverized specimens, and can be incorporated into the

  5. Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

    Science.gov (United States)

    Newman, Charles; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

    2016-01-01

    India shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India's pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India. By purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis. Ten participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) 'Policy-derived Factors'; ii) 'Patient- derived Factors' with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India's potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access. Our stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a

  6. Metformin, other antidiabetic drugs, and endometrial cancer risk: a nested case-control study within Italian healthcare utilization databases.

    Science.gov (United States)

    Franchi, Matteo; Asciutto, Rosario; Nicotra, Federica; Merlino, Luca; La Vecchia, Carlo; Corrao, Giovanni; Bosetti, Cristina

    2017-05-01

    Metformin may reduce the risk of endometrial cancer whereas other drugs for the treatment of type 2 diabetes mellitus appear to increase it, although the evidence is still limited. We investigated this issue using data from a nested case-control study within the healthcare utilization databases of the Lombardy Region, Italy. This study included 376 diabetic women with endometrial cancer and 7485 diabetic controls matched for cases on age, date at cohort entry, and duration of follow-up. We used conditional logistic regression models to estimate the odds ratio (OR) of endometrial cancer in relation to use of antidiabetic drugs, adjusted for the Charlson's comorbidity index, selected medical conditions, prescription of selected drugs, and concomitant use of other antidiabetic drugs. At cohort entry, no significant associations were observed for metformin [OR=0.99, 95% confidence interval (CI) 0.80-1.23], sulfonylureas (OR=1.14, 95% CI 0.91-1.42), insulin (OR=0.72, 95% CI 0.34-1.56), and other antidiabetic drugs (OR=1.21, 95% CI 0.75-1.95). When we considered use during follow-up, a borderline significant excess risk was found for metformin (OR=1.30, 95% CI 1.00-1.70). However, this estimate decreased to 1.07 (95% CI 0.82-1.41) when taking into account BMI using a Monte Carlo sensitivity analysis. No significant associations were found for sulfonylureas (OR=1.16, 95% CI 0.91-1.47), thiazolidinediones (OR=0.77, 95% CI 0.48-1.24), repaglinide (OR=1.32, 95% CI 0.94-1.87), incretins (OR=1.21, 95% CI 0.63-2.32), and insulin (OR=1.19, 95% CI 0.82-1.71). Our data indicate that metformin, insulin, and other antidiabetic drugs did not meaningfully affect the risk of endometrial cancer.

  7. Clinical utility of therapeutic drug monitoring in biological disease modifying anti-rheumatic drug treatment of rheumatic disorders: a systematic narrative review.

    Science.gov (United States)

    Van Herwaarden, Noortje; Van Den Bemt, Bart J F; Wientjes, Maike H M; Kramers, Cornelis; Den Broeder, Alfons A

    2017-08-01

    Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have improved the treatment outcomes of inflammatory rheumatic diseases including Rheumatoid Arthritis and spondyloarthropathies. Inter-individual variation exists in (maintenance of) response to bDMARDs. Therapeutic Drug Monitoring (TDM) of bDMARDs could potentially help in optimizing treatment for the individual patient. Areas covered: Evidence of clinical utility of TDM in bDMARD treatment is reviewed. Different clinical scenarios will be discussed, including: prediction of response after start of treatment, prediction of response to a next bDMARD in case of treatment failure of the first, prediction of successful dose reduction or discontinuation in case of low disease activity, prediction of response to dose-escalation in case of active disease and prediction of response to bDMARD in case of flare in disease activity. Expert opinion: The limited available evidence does often not report important outcomes for diagnostic studies, such as sensitivity and specificity. In most clinical relevant scenarios, predictive value of serum (anti-) drug levels is absent, therefore the use of TDM of bDMARDs cannot be advocated. Well-designed prospective studies should be done to further investigate the promising scenarios to determine the place of TDM in clinical practice.

  8. A facile nanoaggregation strategy for oral delivery of hydrophobic drugs by utilizing acid-base neutralization reactions

    International Nuclear Information System (INIS)

    Chen Huabing; Wan Jiangling; Wang Yirui; Mou Dongsheng; Liu Hongbin; Xu Huibi; Yang Xiangliang

    2008-01-01

    Nanonization strategies have been used to enhance the oral availability of numerous drugs that are poorly soluble in water. Exploring a facile nanonization strategy with highly practical potential is an attractive focus. Here, we report a novel facile nanoaggregation strategy for constructing drug nanoparticles of poorly soluble drugs with pH-dependent solubility by utilizing acid-base neutralization in aqueous solution, thus facilitating the exploration of nanonization in oral delivery for general applicability. We demonstrate that hydrophobic itraconazole dissolved in acid solution formed a growing core and aggregated into nanoparticles in the presence of stabilizers. The nanoparticles, with an average diameter of 279.3 nm and polydispersity index of 0.116, showed a higher dissolution rate when compared with the marketed formulation; the average dissolution was about 91.3%. The in vivo pharmacokinetic studies revealed that the nanoparticles had a rapid absorption and enhanced oral availability. The diet state also showed insignificant impact on the absorption of itraconazole from nanoparticles. This nanoaggregation strategy is a promising nanonization method with a facile process and avoidance of toxic organic solvents for oral delivery of poorly soluble drugs with pH-dependent solubility and reveals a highly practical potential in the pharmaceutical and chemical industries

  9. Patterns and predictors of analgesic use in pregnancy: a longitudinal drug utilization study with special focus on women with migraine.

    Science.gov (United States)

    Harris, Gerd-Marie Eskerud; Wood, Mollie; Eberhard-Gran, Malin; Lundqvist, Christofer; Nordeng, Hedvig

    2017-07-14

    Few studies have investigated the drug utilization patterns and factors predicting drug use in pregnant women with migraine. This longitudinal drug utilization study aimed to describe patterns of analgesic use in a sample of Norwegian pregnant women according to their migraine history, and to identify predictors for analgesic use among these women. Pregnant women giving birth at Akershus University Hospital between 2008 and 2010 were recruited at ultrasound examination in gestational week 17. Data were collected by questionnaires in gestational weeks 17 and 32, and at 8 weeks postpartum, and linked to birth records. Women were grouped into four categories according to migraine history: no migraine history, previous migraine history, recent migraine history (within 1 year prior to pregnancy) and migraine in pregnancy. Patterns of use of analgesics were analyzed descriptively. Multivariable logistic regression was used to identify factors predicting analgesic use. Out of 1981 women, 5.0% reported having migraine in pregnancy, 13.2% had a recent history of migraine, 11.5% had a previous history of migraine, and 68.8% reported no history of migraine. Analgesic use declined during pregnancy. Many women switched from triptans and non-steroidal anti-inflammatory drugs to paracetamol, which constituted most of the analgesic use. Factors associated with analgesic use included recent migraine history (OR 1.6, 95% CI 1.2-2.2), more severe headache intensity (OR 1.3, 95% CI 1.3-1.4), smoking (OR 1.9, 95% CI 1.1-3.3) and multiparity (OR 1.4, 95% CI 1.1-1.7). Women with migraine stop or switch medications during pregnancy. Analgesic use in pregnancy is affected by migraine characteristics and intensity, and also by socio-demographic factors. Clinicians should bear this in mind when giving advice on adequate management of migraine in pregnancy and safe analgesic use.

  10. Illicit drugs: contaminants in the environment and utility in forensic epidemiology.

    Science.gov (United States)

    Daughton, Christian G

    2011-01-01

    The published literature that addresses the many facets of pharmaceutical ingredients as environmental contaminants has grown exponentially since the 1990s. Although there are several thousand active ingredients used in medical pharmaceuticals worldwide, illicit drug ingredients (IDIs) have generally been excluded from consideration. Medicinal and illicit drugs have been treated separately in environmental research even though they pose many of the same concerns regarding the potential for both human and ecological exposure. The overview presented here covers the state of knowledge up until mid-2010 regarding the origin, occurrence, fate, and potential for biological effects of IDIs in the environment. Similarities exist with medical pharmaceuticals, particularly with regard to the basic processes by which these ingredients enter the environment--excretion of unmetabolized residues (including via sweat), bathing, disposal, and manufacturing. The features of illicit drugs that distinguish them from medical pharmaceuticals are discussed. Demarcations between the two are not always clear, and a certain degree of overlap adds additional confusion as to what exactly defines an illicit drug; indeed, medical pharmaceuticals diverted from the legal market or used for non-medicinal purposes ar also captured in discussions of illicit drugs. Also needing consideration as par tof the universe of IDIs are the numerous adulterants and synthesis impurities often encountered in these very impure preparations. many of these extraneous chemicals have high biological activity themselves. In contract to medical pharmaceuticals, comparatively little is know about the fate and effects of IDIs in the environment. Environmental surveys for IDIs have revealed their presence in sewage wastewaters, raw sewage sludge and processed sludge (biosolids), and drinking water. Nearly nothing is known, however, regarding wildlife exposure to IDIs, especially aquatic exposure such as indicated by

  11. Assessing the utility of an anti-malarial pharmacokinetic-pharmacodynamic model for aiding drug clinical development

    Directory of Open Access Journals (Sweden)

    Zaloumis Sophie

    2012-08-01

    Full Text Available Abstract Background Mechanistic within-host models relating blood anti-malarial drug concentrations with the parasite-time profile help in assessing dosing schedules and partner drugs for new anti-malarial treatments. A comprehensive simulation study to assess the utility of a stage-specific pharmacokinetic-pharmacodynamic (PK-PD model for predicting within-host parasite response was performed. Methods Three anti-malarial combination therapies were selected: artesunate-mefloquine, dihydroartemisinin-piperaquine, and artemether-lumefantrine. The PK-PD model included parameters to represent the concentration-time profiles of both drugs, the initial parasite burden and distribution across the parasite life cycle, and the parasite multiplication factor due to asexual reproduction. The model also included the maximal killing rate of each drug, and the blood drug concentration associated with half of that killing effect (in vivo EC50, derived from the in vitro IC50, the extent of binding to 0.5% Albumax present in the in vitro testing media, and the drugs plasma protein binding and whole blood to plasma partitioning ratio. All stochastic simulations were performed using a Latin-Hypercube-Sampling approach. Results The simulations demonstrated that the proportion of patients cured was highly sensitive to the in vivo EC50 and the maximal killing rate of the partner drug co-administered with the artemisinin derivative. The in vivo EC50 values that corresponded to on average 95% of patients cured were much higher than the adjusted values derived from the in vitro IC50. The proportion clinically cured was not strongly influenced by changes in the parameters defining the age distribution of the initial parasite burden (mean age of 4 to 16 hours and the parasite multiplication factor every life cycle (ranging from 8 to 12 fold/cycle. The median parasite clearance times, however, lengthened as the standard deviation of the initial parasite burden increased (i

  12. Use of non-steroidal anti-inflammatory drugs that elevate cardiovascular risk: an examination of sales and essential medicines lists in low-, middle-, and high-income countries.

    Directory of Open Access Journals (Sweden)

    Patricia McGettigan

    Full Text Available BACKGROUND: Certain non-steroidal anti-inflammatory drugs (NSAIDs (e.g., rofecoxib [Vioxx] increase the risk of heart attack and stroke and should be avoided in patients at high risk of cardiovascular events. Rates of cardiovascular disease are high and rising in many low- and middle-income countries. We studied the extent to which evidence on cardiovascular risk with NSAIDs has translated into guidance and sales in 15 countries. METHODS AND FINDINGS: Data on the relative risk (RR of cardiovascular events with individual NSAIDs were derived from meta-analyses of randomised trials and controlled observational studies. Listing of individual NSAIDs on Essential Medicines Lists (EMLs was obtained from the World Health Organization. NSAID sales or prescription data for 15 low-, middle-, and high-income countries were obtained from Intercontinental Medical Statistics Health (IMS Health or national prescription pricing audit (in the case of England and Canada. Three drugs (rofecoxib, diclofenac, etoricoxib ranked consistently highest in terms of cardiovascular risk compared with nonuse. Naproxen was associated with a low risk. Diclofenac was listed on 74 national EMLs, naproxen on just 27. Rofecoxib use was not documented in any country. Diclofenac and etoricoxib accounted for one-third of total NSAID usage across the 15 countries (median 33.2%, range 14.7-58.7%. This proportion did not vary between low- and high-income countries. Diclofenac was by far the most commonly used NSAID, with a market share close to that of the next three most popular drugs combined. Naproxen had an average market share of less than 10%. CONCLUSIONS: Listing of NSAIDs on national EMLs should take account of cardiovascular risk, with preference given to low risk drugs. Diclofenac has a risk very similar to rofecoxib, which was withdrawn from worldwide markets owing to cardiovascular toxicity. Diclofenac should be removed from EMLs.

  13. Prodrugs in Cardiovascular Therapy

    Directory of Open Access Journals (Sweden)

    Maryam Tabrizian

    2008-05-01

    Full Text Available Prodrugs are biologically inactive derivatives of an active drug intended to solve certain problems of the parent drug such as toxicity, instability, minimal solubility and non-targeting capabilities. The majority of drugs for cardiovascular diseases undergo firstpass metabolism, resulting in drug inactivation and generation of toxic metabolites, which makes them appealing targets for prodrug design. Since prodrugs undergo a chemical reaction to form the parent drug once inside the body, this makes them very effective in controlling the release of a variety of compounds to the targeted site. This review will provide the reader with an insight on the latest developments of prodrugs that are available for treating a variety of cardiovascular diseases. In addition, we will focus on several drug delivery methodologies that have merged with the prodrug approach to provide enhanced target specificity and controlled drug release with minimal side effects.

  14. Antiepileptic drug utilization in Bangladesh: experience from Dhaka Medical College Hospital.

    Science.gov (United States)

    Habib, Mansur; Khan, Sharif Uddin; Hoque, Azhahul; Mondal, Badrul Alam; Hasan, A T M Hasibul; Chowdhury, Rajib Nayan; Haque, Badrul; Rahman, Kazi Mohibur; Chowdhury, Ahmed Hossain; Ghose, Swapon Kumar; Mohammad, Quazi Deen

    2013-11-18

    Epilepsy is a common health problem which carries a huge medical social psychological and economic impact for a developing country. The aim of this hospital-based study was to get an insight into the effectiveness and tolerability of low cost antiepileptic drugs (AEDs) in Bangladeshi people with epilepsy. This retrospective chart review was done from hospital records in weekly Epilepsy outdoor clinic of Department of Neurology, Dhaka Medical College Hospital (DMCH) from October 1998 to February 2013. A total of 854 epilepsy patients met the eligibility criteria (had a complete record of two years of follow up data) from hospital database. A checklist was used to take demographics (age and gender), epilepsy treatment and adverse event related data. At least two years of follow up data were considered for analysis. Out of 854 patients selected, majority of the patients attending outdoor clinic were >11-30 years age group (55.2%) with a mean age of 20.3 ± 9 years and with a male (53%) predominance. Focal epilepsy were more common (53%), among whom secondary generalized epilepsy was the most frequent diagnosis (67%) followed by complex partial seizure (21%). Among those with Idiopathic Generalized Epilepsy (46%), generalized tonic clonic seizure was encountered in 74% and absence seizure was observed in 13%. The number of patients on monotherapy and dual AED therapy were 67% and 24% respectively and polytherapy (i.e. >3 AEDs) was used only in 9%. CBZ (67%) was the most frequently prescribed AED, followed by VPA (43%), PHB (17%), and PHT (8%). CBZ was prescribed in 37% patients as monotherapy followed by VPA in 21% and PHB in 8% patients. Newer generation drugs eg lemotrigine and topiramate were used only as add on therapy in combination with CBZ and VPA in only 2% patients. The treatment retention rates over the follow up period for the AEDs in monotherapy varied between 86 and 91% and were highest for CBZ, followed by VPA. Most of the combination regimens had a

  15. Utility of humanized BLT mice for analysis of dengue virus infection and antiviral drug testing.

    Science.gov (United States)

    Frias-Staheli, Natalia; Dorner, Marcus; Marukian, Svetlana; Billerbeck, Eva; Labitt, Rachael N; Rice, Charles M; Ploss, Alexander

    2014-02-01

    Dengue virus (DENV) is the cause of a potentially life-threatening disease that affects millions of people worldwide. The lack of a small animal model that mimics the symptoms of DENV infection in humans has slowed the understanding of viral pathogenesis and the development of therapies and vaccines. Here, we investigated the use of humanized "bone marrow liver thymus" (BLT) mice as a model for immunological studies and assayed their applicability for preclinical testing of antiviral compounds. Human immune system (HIS) BLT-NOD/SCID mice were inoculated intravenously with a low-passage, clinical isolate of DENV-2, and this resulted in sustained viremia and infection of leukocytes in lymphoid and nonlymphoid organs. In addition, DENV infection increased serum cytokine levels and elicited DENV-2-neutralizing human IgM antibodies. Following restimulation with DENV-infected dendritic cells, in vivo-primed T cells became activated and acquired effector function. An adenosine nucleoside inhibitor of DENV decreased the circulating viral RNA when administered simultaneously or 2 days postinfection, simulating a potential treatment protocol for DENV infection in humans. In summary, we demonstrate that BLT mice are susceptible to infection with clinical DENV isolates, mount virus-specific adaptive immune responses, and respond to antiviral drug treatment. Although additional refinements to the model are required, BLT mice are a suitable platform to study aspects of DENV infection and pathogenesis and for preclinical testing of drug and vaccine candidates. IMPORTANCE Infection with dengue virus remains a major medical problem. Progress in our understanding of the disease and development of therapeutics has been hampered by the scarcity of small animal models. Here, we show that humanized mice, i.e., animals engrafted with components of a human immune system, that were infected with a patient-derived dengue virus strain developed clinical symptoms of the disease and mounted

  16. [Variations in antihypertensive drug utilization among primary care areas in the autonomous region of Valencia (Spain)].

    Science.gov (United States)

    Sanfélix-Gimeno, Gabriel; Peiró, Salvador; Librero, Julián

    2010-01-01

    To estimate consumption of five subgroups of antihypertensive drugs by primary care areas and to analyze its variation. We performed an ecological, descriptive study of antihypertensive consumption in 239 primary care areas in the autonomous region of Valencia in 2005 followed by analysis of the variability observed. The 239 primary care areas were studied by descriptive analysis of dispensation [defined daily dose (DDD) per 1,000 inhabitants/day in pensioners (DDD/1000p/day) and in the active population (DDD/1000a/day)] and standardized consumption ratios. Small-area variation analysis was used to analyze the observed variability. Associations among dispensations of the distinct therapeutic subgroups were also analyzed. Overall antihypertensive use in the autonomous region of Valencia in 2005 was 235.6DDD/1000/day. This consumption was concentrated in pensioners (800DDD/1000p/day vs. 73DDD/1000a/day). Consumption of antihypertensive subgroups oscillated from 442DDD/1000p/day for drugs with action on the renin-angiotensin system to 32DDD/1000p/day for doxazosin. The active population showed similar patterns. Variation in consumption was moderate, with coefficients of variation from 0.20 to 0.40 (slightly greater for the active population). Associations among dispensations of the different therapeutic subgroups were strong. This study shows major variations in the overall consumption of antihypertensive drugs among primary care areas of the autonomous region of Valencia. These results suggest that variation may be associated with problems of underutilization in areas with lower consumption. Copyright © 2010 SESPAS. Published by Elsevier Espana. All rights reserved.

  17. Mycotic aneurysms in intravenous drug abusers: the utility of intravenous digital subtraction angiography

    International Nuclear Information System (INIS)

    Shetty, P.C.; Krasicky, G.A.; Sharma, R.P.; Vemuri, B.R.; Burke, M.M.

    1985-01-01

    Two-hundred thirteen intravenous digital subtraction angiographic (DSA) examinations were performed on 195 intravenous drug abusers to rule out the possibility of a mycotic aneurysm in a groin, neck, or upper extremity infection. Twenty-three surgically proved cases of mycotic aneurysm were correctly identified with no false positive results. In addition, six cases of major venous occlusion were documented. The authors present the results of their experience and conclude that DSA is an effective and cost-efficient method of examining this high risk patient population

  18. Digesting a Path Forward: The Utility of Collagenase Tumor Treatment for Improved Drug Delivery.

    Science.gov (United States)

    Dolor, Aaron; Szoka, Francis C

    2018-06-04

    Collagen and hyaluronan are the most abundant components of the extracellular matrix (ECM) and their overexpression in tumors is linked to increased tumor growth and metastasis. These ECM components contribute to a protective tumor microenvironment by supporting a high interstitial fluid pressure and creating a tortuous setting for the convection and diffusion of chemotherapeutic small molecules, antibodies, and nanoparticles in the tumor interstitial space. This review focuses on the research efforts to deplete extracellular collagen with collagenases to normalize the tumor microenvironment. Although collagen synthesis inhibitors are in clinical development, the use of collagenases is contentious and clinically untested in cancer patients. Pretreatment of murine tumors with collagenases increased drug uptake and diffusion 2-10-fold. This modest improvement resulted in decreased tumor growth, but the benefits of collagenase treatment are confounded by risks of toxicity from collagen breakdown in healthy tissues. In this review, we evaluate the published in vitro and in vivo benefits and limitations of collagenase treatment to improve drug delivery.

  19. Studying the personality profile of drug addicts by utilizing two models of Cloninger and Eysneck

    Directory of Open Access Journals (Sweden)

    2008-11-01

    Full Text Available Objectives: Identifying personality factors of tendency to drugs can be helpful in better recognition and treatment of drug-dependency and also by providing consulting and psychological services can relatively prevents from vulnerable people to be addicted. This research therefore aims to investigate personality profile of substance dependent by using personality models of Cloninger and Eysenck. Methods: 100 substance-dependent and 100 normal men selected by available sampling method and completed Temperament and Character Inventory of Cloninger (TCI and Eysenck Personality Questionnaire _ Revised (EPQ-R. Also, some democratic information regarding substance- dependents collected. Research data were analyzed by inferential and descriptive statistics. Findings: This research showed that there are significant differences in temperament dimensions of novelty seeking and harm avoidance and character dimensions of self-direction and cooperativeness of Cloninger model and neuroticism and psychosis dimensions of Eysenck model between substance- dependent men and normal men. Results: Comparing in normal men, substance dependent men gained higher scores at novelty seeking and neuroticism and psychosis, and lower scores at self-direction and cooperativeness.

  20. Patterns of glucose lowering drugs utilization in Portugal and in the Netherlands. Trends over time.

    Science.gov (United States)

    Torre, Carla; Guerreiro, José; de Oliveira Martins, Sofia; Raposo, João Filipe; Martins, Ana Paula; Leufkens, Hubert

    2015-12-01

    To compare the temporal trends in the consumption patterns of glucose lowering drugs (GLD) between Portugal and the Netherlands from 2004 to 2013 and to examine possible reasons behind the cross-national variation found. All GLD (ATC pharmacological subgroup A10B) were selected for analysis. Consumption data were obtained for the 10-year period. Portuguese and Dutch drug estimates were obtained from nationwide databases. The consumption of GLD increased in Portugal from 52.9 defined daily dose per 1000 inhabitants per day (DHD) in 2004 to 70.0 DHD in 2013 and in the Netherlands from 44.9 DHD in 2004 to 50.7 DHD in 2013. In Portugal, the use of fixed-dose combinations, especially with dipeptidyl peptidase-4 inhibitors (DPP-4) increased remarkably and in 2013 represented almost a quarter of total GLD consumption. In the Netherlands, the use of combinations was residual. The consumption of GLD rose over the 10-year period in both countries. However, Portuguese overall consumption and costs of GLD were higher. The differentially rapid uptake of DPP-4 inhibitors in Portugal was the main driver of the cost difference. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  1. Long-term cardiovascular risk of nonsteroidal anti-inflammatory drug use according to time passed after first-time myocardial infarction: a nationwide cohort study.

    Science.gov (United States)

    Olsen, Anne-Marie Schjerning; Fosbøl, Emil L; Lindhardsen, Jesper; Folke, Fredrik; Charlot, Mette; Selmer, Christian; Bjerring Olesen, Jonas; Lamberts, Morten; Ruwald, Martin H; Køber, Lars; Hansen, Peter R; Torp-Pedersen, Christian; Gislason, Gunnar H

    2012-10-16

    The cardiovascular risk after the first myocardial infarction (MI) declines rapidly during the first year. We analyzed whether the cardiovascular risk associated with using nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with the time elapsed following first-time MI. We identified patients aged 30 years or older admitted with first-time MI in 1997 to 2009 and subsequent NSAID use by individual-level linkage of nationwide registries of hospitalization and drug dispensing from pharmacies in Denmark. We calculated the incidence rates of death and a composite end point of coronary death or nonfatal recurrent MIs associated with NSAID use in 1-year time intervals up to 5 years after inclusion and analyzed risk by using multivariable adjusted time-dependent Cox proportional hazards models. Of the 99 187 patients included, 43 608 (44%) were prescribed NSAIDs after the index MI. There were 36 747 deaths and 28 693 coronary deaths or nonfatal recurrent MIs during the 5 years of follow-up. Relative to noncurrent treatment with NSAIDs, the use of any NSAID in the years following MI was persistently associated with an increased risk of death (hazard ratio 1.59 [95% confidence interval, 1.49-1.69]) after 1 year and hazard ratio 1.63 [95% confidence interval, 1.52-1.74] after 5 years) and coronary death or nonfatal recurrent MI (hazard ratio, 1.30 [95% confidence interval,l 1.22-1.39] and hazard ratio, 1.41 [95% confidence interval, 1.28-1.55]). The use of NSAIDs is associated with persistently increased coronary risk regardless of time elapsed after first-time MI. We advise long-term caution in the use of NSAIDs for patients after MI.

  2. [Comparison of health education and drug therapy monitoring interventions in patients with cardiovascular risk factors attending a community pharmacy (FISFTES-PM Study)].

    Science.gov (United States)

    Bofí Martínez, Patricia; García Jiménez, Emilio; Martínez Martínez, Fernando

    2015-03-01

    To compare health education (HE) and drug therapy monitoring (DTM) interventions in patients with cardiovascular risk factors (CVRF). Randomised experimental studys: 100 patients per group. Playa-Miramar pharmacy (Valencia, Spain). March 2010-November 2011. Patients with one or more CVRF detected based on medication they were taking or questions they asked when drugs were dispensed. Patients were assigned to one of the two groups (HE or DTM) using a random number table. 100 patients by group were included. Six months of DTM (DTMG) or health education (HEG) per patient. The primary variables were modifiable CVRF: hypertension, dyslipidaemia, diabetes, smoking, obesity and low physical activity. Secondary variables were non modifiable CVRF (age, sex, cardiovascular disease), heart rate, body mass index, waist measurement, waist-to-hip ratio, waist-to-height ratio, body fat, treatment compliance. The differences in the reduction percentages were statistically greater in DTMG than in HEG for the following variables: systolic pressure 5.40% (p=0.001); heart rate 2.95%(p=0.015); weight 2.00% (p=0.002); BMI 2.24% (p=0.003); fasting glucose 8.65% (p=0.004); total cholesterol 6.45% (p=0.002); waist measurement 1.85% (p=0.010); and waist-to-height ratio 1.66% (p=0.002). Triglycerides and body fat were reduced by 12.78% (p<0.001) and 1.84% (p<0.001) more, respectively, in DTMG. These differences were not statistically significant. The reduction percentages were generally higher for all variables in DTMG except diastolic blood pressure, which decreased by 4.7% (P<.001) more in HEG because the baseline values were higher. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  3. Very large virtual compound spaces: construction, storage and utility in drug discovery.

    Science.gov (United States)

    Peng, Zhengwei

    2013-09-01

    Recent activities in the construction, storage and exploration of very large virtual compound spaces are reviewed by this report. As expected, the systematic exploration of compound spaces at the highest resolution (individual atoms and bonds) is intrinsically intractable. By contrast, by staying within a finite number of reactions and a finite number of reactants or fragments, several virtual compound spaces have been constructed in a combinatorial fashion with sizes ranging from 10(11)11 to 10(20)20 compounds. Multiple search methods have been developed to perform searches (e.g. similarity, exact and substructure) into those compound spaces without the need for full enumeration. The up-front investment spent on synthetic feasibility during the construction of some of those virtual compound spaces enables a wider adoption by medicinal chemists to design and synthesize important compounds for drug discovery. Recent activities in the area of exploring virtual compound spaces via the evolutionary approach based on Genetic Algorithm also suggests a positive shift of focus from method development to workflow, integration and ease of use, all of which are required for this approach to be widely adopted by medicinal chemists.

  4. Prolonged utilization of proton pump inhibitors in patients with ischemic and valvular heart disease is associated with surgical treatments, weight loss and aggravates anemia.

    Science.gov (United States)

    Boban, Marko; Zulj, Marinko; Persic, Viktor; Medved, Igor; Zekanovic, Drazen; Vcev, Aleksandar

    2016-09-15

    Proton pump inhibitors (PPIs) are among the commonest drugs used nowadays. The aim of our study was to analyze prolonged utilization of proton pump inhibitors in medical therapy of patients with ischemic and valvular heart disease. Secondly, profile of utilization was scrutinized to patient characteristics and type of cardiovascular treatments. The study included consecutive patients scheduled for cardiovascular rehabilitation 2-6months after index cardiovascular treatment. Two hundred ninety-four patients (n=294/604; 48.7%) have been using proton pump inhibitor in their therapy after index cardiovascular treatment. Cardiovascular treatments were powerfully connected with utilization of PPIs; surgery 5.77 (95%-confidence intervals [CI]: 4.05-8.22; pvalvular heart disease utilized proton pump inhibitor in prolonged courses. Prolonged courses of PPIs were connected with existence and worsening of red blood count indexes, older age, lesser weight of patients and underutilization of cardioprotective drugs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. Indicadores de riesgo de morbilidad prevenible causada por medicamentos Risk indicators of preventable morbidity related to drug utilization

    Directory of Open Access Journals (Sweden)

    Ana Dago Martínez

    2007-02-01

    Full Text Available Objetivos: Seleccionar y estudiar la aceptabilidad, en términos de relevancia y pertinencia, de ciertas situaciones clínicas que puedan usarse como indicadores de riesgo de morbilidad prevenible causada por medicamentos y que sean utilizables en las farmacias comunitarias. Método: Método Delphi, en 2 rondas, con un panel de 14 expertos médicos y farmacéuticos que valoraron la relevancia y pertinencia de 68 tipos de situaciones clínicas como indicadores de morbilidad potencial relacionada con medicamentos, detectable por el profesional en su medio, con evidencia científica de resultado adverso previsible, frecuentes en el medio ambulatorio y con causa y resultado controlables. Resultados: Se consideraron utilizables y pertinentes 43 de los 68 indicadores estudiados, que se referían a 3 ámbitos: tipo de medicamento (medicamentos de estrecho margen terapéutico, con dosis individualizada y con reacciones adversas frecuentes y graves, problema de salud (problemas crónicos, especialmente asma, enfermedad cardíaca, tiroidea, prostática y dolor y tipo de paciente (ancianos y/o polimedicados. Los farmacéuticos sobrevaloraron sistemáticamente ciertos indicadores en relación con los médicos, aunque las diferencias no fueron significativas. Conclusiones: Se identificaron 43 indicadores de morbilidad potencial relacionada con los medicamentos e identificables por los profesionales en su entorno.Objective: To select clinical situations that can be used as risk indicators of preventable morbidity caused by drugs at the community pharmacies, and to study their acceptability, in terms of pertinence and relevance. Methods: We used the Delphi technique, in 2 rounds, by a panel of 14 medical doctors and pharmacists experts, to study the relevance of 68 types of clinical situations as risk indicators of preventable morbidity related to drug utilization used by health professionals in community pharmacies, with scientific evidence of foreseeable

  6. Balancing cardiovascular and gastrointestinal risks in patients with osteoarthritis receiving nonsteroidal anti‑inflammatory drugs. A summary of guidelines from an international expert group.

    Science.gov (United States)

    Mosleh, Wassim; Farkouh, Michael E

    2016-01-01

    Over the past 2 decades, extensive research has assessed the use of traditional nonsteroidal anti‑inflammatory drugs (NSAIDs), and the newer cyclooxygenase‑2 (COX-2) inhibitor drugs, in the treatment of chronic pain syndromes. The proper use of NSAIDs has been the subject of significant debate, bringing together multidisciplinary researchers and clinicians to discuss the risks and benefits of these therapies. Current guidelines discussing the proper use of NSAIDs do not address the issue of the risks of COX‑2‑selective NSAIDs and nonselective NSAIDs for both the gastrointestinal (GI) and cardiovascular (CV) systems in patients on low‑dose aspirin. Accordingly, a multidisciplinary expert group was organized to review the current evidence with the aim of developing statements devoted to guide clinicians in making evidence‑based and individualized selections of NSAIDs. This review will discuss and summarize the most recent evidence on this topic to give an insight into the most effective and safest therapeutic options, thus preventing serious adverse CV and GI events. NSAIDs should be used cautiously and as infrequently as possible, with nonpharmacological approaches prescribed first. If the use of NSAIDs is required, the choice should balance the possible CV and GI risks.

  7. Triglycerides and cardiovascular disease

    DEFF Research Database (Denmark)

    Nordestgaard, Børge G; Varbo, Anette

    2014-01-01

    cholesterol might not cause cardiovascular disease as originally thought has now generated renewed interest in raised concentrations of triglycerides. This renewed interest has also been driven by epidemiological and genetic evidence supporting raised triglycerides, remnant cholesterol, or triglyceride......-rich lipoproteins as an additional cause of cardiovascular disease and all-cause mortality. Triglycerides can be measured in the non-fasting or fasting states, with concentrations of 2-10 mmol/L conferring increased risk of cardiovascular disease, and concentrations greater than 10 mmol/L conferring increased risk...... of acute pancreatitis and possibly cardiovascular disease. Although randomised trials showing cardiovascular benefit of triglyceride reduction are scarce, new triglyceride-lowering drugs are being developed, and large-scale trials have been initiated that will hopefully provide conclusive evidence...

  8. Toxicological study of DTPA as a drug, (4). Effect of intravenously injected DTPA on cardiovascular system in beagle dogs

    Energy Technology Data Exchange (ETDEWEB)

    Fukuda, Satoshi; Iida, Haruzo

    1988-09-01

    We have previously reported that the side effects on cardiovascular system such as the heart failure, increases of blood pressure and pulse accompanied with hypocalcemia occurred in rats when Zn-DTPA was injected intravenously, but those did not occur by Ca-DTPA. This is in the reverse that it is generally said that Zn-DTPA is more safe than Ca-DTPA. This study was carried out to examine whether the same side effects occurred in different animal species or not. Zn-DTPA or Ca-DTPA (30, 150, 300 and 600 ..mu..mol/kg) was injected intravenously to beagle dogs. The hypocalcemia was observed in the dogs by Zn-DTPA injection, but it was not by Ca-DTPA. After Zn-DTPA injection, the increase of blood pressure and pulse, and heart failure was observed in 3 out of 5 dogs at 300 ..mu..mol/kg dose, and in 3 out of 8 dogs at 600 ..mu..mol/kg dose. These changes were the same degrees as those in rats. In the present study, it is suggested that the side effects induced by Zn-DTPA intravenous injection occur independently of animal species and the data obtained from animal experiments can be available to estimate DTPA toxicity in humans.

  9. Effect of drug utilization reviews on the quality of in-hospital prescribing: a quasi-experimental study

    Directory of Open Access Journals (Sweden)

    Chabot Isabelle

    2006-03-01

    Full Text Available Abstract Background Drug utilization review (DUR programs are being conducted in Canadian hospitals with the aim of improving the appropriateness of prescriptions. However, there is little evidence of their effectiveness. The objective of this study was to assess the impact of both a retrospective and a concurrent DUR programs on the quality of in-hospital prescribing. Methods We conducted an interrupted time series quasi-experimental study. Using explicit criteria for quality of prescribing, the natural history of cisapride prescription was established retrospectively in three university-affiliated hospitals. A retrospective DUR was implemented in one of the hospitals, a concurrent DUR in another, whereas the third hospital served as a control. An archivist abstracted records of all patients who were prescribed cisapride during the observation period. The effect of DURs relative to the control hospital was determined by comparing estimated regression coefficients from the time series models and by testing the statistical significance using a 2-tailed Student's t test. Results The concurrent DUR program significantly improved the appropriateness of prescriptions for the indication for use whereas the retrospective DUR brought about no significant effect on the quality of prescribing. Conclusion Results suggest a retrospective DUR approach may not be sufficient to improve the quality of prescribing. However, a concurrent DUR strategy, with direct feedback to prescribers seems effective and should be tested in other settings with other drugs.

  10. Lipid control and use of lipid-regulating drugs for prevention of cardiovascular events in Chinese type 2 diabetic patients: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Tong Peter CY

    2010-11-01

    Full Text Available Abstract Background Dyslipidaemia is an important but modifiable risk factor of cardiovascular disease (CVD in type 2 diabetes. Yet, the effectiveness of lipid regulating drugs in Asians is lacking. We examined the effects of lipid control and treatment with lipid regulating drugs on new onset of CVD in Chinese type 2 diabetic patients. Methods In this prospective cohort consisting of 4521 type 2 diabetic patients without history of CVD and naïve for lipid regulating treatment recruited consecutively from 1996 to 2005, 371 developed CVD after a median follow-up of 4.9 years. We used Cox proportional hazard regression to obtain the hazard ratios (HR of lipids and use of lipid regulating drugs for risk of CVD. Results The multivariate-adjusted HR (95% confidence interval of CVD in patients with high LDL-cholesterol (≥ 3.0 mmol/L was 1.36 (1.08 - 1.71, compared with lower values. Using the whole range value of HDL-cholesterol, the risk of CVD was reduced by 41% with every 1 mmol/L increase in HDL-cholesterol. Plasma triglyceride did not predict CVD. Statins use was associated with lower CVD risk [HR = 0.66 (0.50 - 0.88]. In sub-cohort analysis, statins use was associated with a HR of 0.60 (0.44 - 0.82 in patients with high LDL-cholesterol (≥ 3.0 mmol/L and 0.49 (0.28 - 0.88 in patients with low HDL-cholesterol. In patients with LDL-cholesterol Conclusions In Chinese type 2 diabetic patients, high LDL-cholesterol and low HDL-cholesterol predicted incident CVD. Overall, patients treated with statins had 40-50% risk reduction in CVD compared to non-users.

  11. Reinforced chitosan-based heart valve scaffold and utility of bone marrow-derived mesenchymal stem cells for cardiovascular tissue engineering

    Science.gov (United States)

    Albanna, Mohammad Zaki

    utility for cardiovascular tissue engineering applications. Moreover, we evaluated the effect of various glycosaminoglycans (GAGs) on MSCs morphology and proliferation. Lastly, we studied the effect of stiffness of mechanically improved chitosan fibers on MSCs viability, attachment and proliferation. Results showed that MSCs proliferation improved in proportion to fiber stiffness.

  12. Ten-Year Trends in the Morbidity of Diabetes Mellitus and Antidiabetic Drug Utilization in Croatia: A Study Based on Routinely Collected Data.

    Science.gov (United States)

    Pavlov, Renata; Topličan, Ivančica; Vrcić Keglević, Mladenka

    2016-01-01

    Objectives. To investigate trends of diabetes mellitus (DM) morbidity and antidiabetic drug utilization in Croatian primary health care (PHC) from 2005 to 2014. Method. Routinely collected morbidity data from all PHC units, presented in Croatian health-statistics yearbooks, were retrieved. Data on drug utilization were retrieved from the Annual Reports of the Croatian Agency for Medicinal Products and Medical Devices (ATC/DDD, antidiabetic, A10). Results. Total morbidity increased by 33.3% and DM increased by 65.6%, mostly in patients over age 65 (from 50% to 57%). Estimated DM prevalence in adults increased from 3.9% to 6.4%. Increased morbidity was followed by an even higher increase in drug utilization (120%). Metformin was first, with a constant increase (from 18% to 39%), followed by glimepiride, while glibenclamide use decreased. Total utilization of insulin increased even more, mostly for aspart (600%) and newly introduced glargine and detemir, while human insulin usage sharply decreased. Spending also increased, mostly for aspart (from 21% to 61% of total). Conclusions. Increased DM is followed by a higher increase in antidiabetic drug utilization; this trend will continue in the future. In Croatian PHC, metformin has primacy along with insulin analogues.

  13. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; Merlino, Luca; Mancia, Giuseppe

    2014-10-01

    Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

  14. Use of direct oral anticoagulants in the first year after market entry of edoxaban: A Danish nationwide drug utilization study.

    Science.gov (United States)

    Pottegård, Anton; Grove, Erik L; Hellfritzsch, Maja

    2018-02-01

    To describe the early uptake of edoxaban; the fourth direct oral anticoagulant (DOAC) to enter the market. Using the Danish nationwide health registries, we identified new users of edoxaban (n = 609) from June 6 (day of marketing) through June 2017. For comparison, we also identified new users of dabigatran (n = 2211), rivaroxaban (n = 19 227), and apixaban (n = 14 736). Users were described regarding indication of use, previous anticoagulant experience, comorbidity, and co-medication. The rate of edoxaban initiation increased to 2.0 per 100 000 person months in June 2017, compared with 6.3, 37.5, and 27.0 for dabigatran, rivaroxaban, and apixaban. Atrial fibrillation was the most common registered indication for edoxaban (67%) as well as the other DOACs (41-55%). Overall, users of edoxaban were comparable to users of other DOACs (median age 75 vs 72-76 years and 57% vs 53-59% males), except for a generally lower concomitant use of other drugs. Noticeably, 95% of edoxaban users had previously received anticoagulant treatment compared with 31% to 43% for new users of other DOACs, with 77% switching directly from another anticoagulant treatment to edoxaban (45% directly from VKA and 32% directly from DOACs). While the use of edoxaban is still limited compared with other DOACs, it is increasing. The majority of edoxaban users switch to edoxaban from other anticoagulant treatments. Continued monitoring of the utilization of DOACs, including effectiveness and safety, is considered essential to the safe and rational use of these drugs. Copyright © 2017 John Wiley & Sons, Ltd.

  15. The utility of the zebrafish model in conditioned place preference to assess the rewarding effects of drugs.

    Science.gov (United States)

    Collier, Adam D; Echevarria, David J

    2013-09-01

    Substance abuse is a significant public health concern both domestically and worldwide. The persistent use of substances regardless of aversive consequences forces the user to give higher priority to the drug than to normal activities and obligations. The harmful and hazardous use of psychoactive substances can lead to a dependence syndrome. In this regard, the genetic and neurobiological underpinnings of reward-seeking behavior need to be fully understood in order to develop effective pharmacotherapies and other methods of treatment. Animal models are often implemented in preclinical screening for testing the efficacy of novel treatments. Several paradigms exist that model various facets of addiction including sensitization, tolerance, withdrawal, drug seeking, extinction, and relapse. Self-administration and, most notably, conditioned place preference (CPP) are relatively simple tests that serve as indicators of the aforementioned aspects of addiction by means of behavioral quantification. CPP is a commonly used technique to evaluate the motivational effects of compounds and experiences that have been associated with a positive or negative reward, which capitalizes on the basic principles of Pavlovian conditioning. During training, the unconditioned stimulus is consistently paired with a neutral set of environmental stimuli, which obtain, during conditioning, secondary motivational properties that elicit approach behavior in the absence of the unconditioned stimulus. For over 50 years, rodents have been the primary test subjects. However, the zebrafish (Danio rerio) is gaining favor as a valuable model organism in the fields of biology, genetics, and behavioral neuroscience. This paper presents a discussion on the merits, advantages, and limitations of the zebrafish model and its utility in relation to CPP.

  16. Dietary Intake as a Link between Obesity, Systemic Inflammation, and the Assumption of Multiple Cardiovascular and Antidiabetic Drugs in Renal Transplant Recipients

    Directory of Open Access Journals (Sweden)

    Bruna Guida

    2013-01-01

    Full Text Available We evaluated dietary intake and nutritional-inflammation status in ninety-six renal transplant recipients, years after transplantation. Patients were classified as normoweight (NW, overweight (OW, and obese (OB, if their body mass index was between 18.5 and 24.9, 25.0 and 29.9, and ≥30 kg/m2, respectively. Food composition tables were used to estimate nutrient intakes. The values obtained were compared with those recommended in current nutritional guidelines. 52% of the patients were NW, 29% were OW, and 19% were OB. Total energy, fat, and dietary n-6 PUFAs intake was higher in OB than in NW. IL-6 and hs-CRP were higher in OB than in NW. The prevalence of multidrug regimen was higher in OB. In all patients, total energy, protein, saturated fatty acids, and sodium intake were higher than guideline recommendations. On the contrary, the intake of unsaturated and n-6 and n-3 polyunsaturated fatty acids and fiber was lower than recommended. In conclusion, the prevalence of obesity was high in our patients, and it was associated with inflammation and the assumption of multiple cardiovascular and antidiabetic drugs. Dietary intake did not meet nutritional recommendations in all patients, especially in obese ones, highlighting the need of a long-term nutritional support in renal transplant recipients.

  17. Optimizing drug therapy in patients with cardiovascular disease: the impact of pharmacist-managed pharmacotherapy clinics in a primary care setting.

    Science.gov (United States)

    Geber, Jean; Parra, David; Beckey, Nick P; Korman, Lisa

    2002-06-01

    We evaluated the effectiveness of pharmacist-managed pharmacotherapy clinics in implementing and maximizing therapy with agents known to reduce the morbidity and mortality associated with cardiovascular disease. This was a retrospective chart review of 150 patients who were treated for coronary artery disease in primary care clinics. Appropriate treatment of hypercholesterolemia occurred in 96% of patients referred to a clinical pharmacy specialist, compared with 68% of those followed by primary care providers alone (p<0.0001). Eighty-five percent and 50%, respectively, achieved goal low-density lipoprotein (LDL) values below 105 mg/dl (p<0.0001). Appropriate therapy with aspirin or other antiplatelet or anticoagulant drugs was prescribed in 97% and 92%, respectively (p=0.146). As appropriate therapy with these agents was high in both groups, the ability to detect a difference between groups was limited. Among patients with an ejection fraction below 40%, appropriate therapy with an angiotensin-converting enzyme inhibitor or acceptable alternative was 89% and 69%, respectively (p<0.05). Twenty-seven cardiac events were documented in the clinical pharmacy group, versus 22 in the primary care group (p=0.475). Despite the relatively high percentage of patients reaching goal LDL in the primary care group, referral to clinical pharmacy specialists resulted in statistically significant increases in the number of patients appropriately treated for hypercholesterolemia and achieving goal LDL.

  18. Monitoring Utilization of a Large Scale Addiction Treatment System: The Drug and Alcohol Treatment Information System (DATIs

    Directory of Open Access Journals (Sweden)

    Nooshin Khobzi Rotondi

    2012-01-01

    Full Text Available Client-based information systems can yield data to address issues of system accountability and planning, and contribute information related to changing patterns of substance use in treatment and, indirectly, general populations. The Drug and Alcohol Treatment Information System (DATIS monitors the number/types of clients treated in approximately 170 publicly-funded addiction treatment agencies in Ontario. The purpose of this study was to estimate the caseload of addiction treatment agencies, and describe important characteristics of clients, their patterns of service utilization and trends over-time from 2005 to 2010. In 2009–2010, 47,065 individuals were admitted to treatment. Since 2005–2006, there has been an increase in adolescents/youth in treatment, and a decrease in the male-female gender ratio. Alcohol problems predominated, but an increasing proportion of clients used cannabis and prescription opioids. DATIS is an evolving system and an integral component of Ontario's performance measurement system. Linkages with healthcare information systems will allow for longitudinal tracking of client health-related outcomes.

  19. Pharmacokinetic-pharmacodynamic modeling of antipsychotic drugs in patients with schizophrenia Part I : The use of PANSS total score and clinical utility

    NARCIS (Netherlands)

    Reddy, Venkatesh Pilla; Kozielska, Magdalena; Suleiman, Ahmed Abbas; Johnson, Martin; Vermeulen, An; Liu, Jing; de Greef, Rik; Groothuis, Geny M. M.; Danhof, Meindert; Proost, Johannes H.

    Background: To develop a pharmacokinetic-pharmacodynamic (PK-PD) model using individual-level data of Positive and Negative Syndrome Scale (PANSS) total score to characterize the antipsychotic drug effect taking into account the placebo effect and dropout rate. In addition, a clinical utility (CU)

  20. Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic)

    DEFF Research Database (Denmark)

    Birkeland, Kåre I.; Jørgensen, Marit E.; Carstensen, Bendix

    2017-01-01

    , and atrial fibrillation. We also assessed incidence of severe hypoglycaemia. Findings Matched SGLT2 inhibitor (n=22 830) and other glucose-lowering drug (n=68 490) groups were well balanced at baseline, with a mean follow-up of 0·9 (SD 4·1) years (80 669 patient-years) and mean age of 61 (12·0) years; 40...... with the results of clinical trials in patients at high cardiovascular risk. Funding AstraZeneca....

  1. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

    Science.gov (United States)

    Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

    2018-04-04

    Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

  2. Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers.

    Science.gov (United States)

    Chawla, Anita; Peeples, Miranda; Li, Nanxin; Anhorn, Rachel; Ryan, Jason; Signorovitch, James

    2018-06-01

    To assess the frequency of biopsies and molecular diagnostic testing (human DNA/RNA analysis), anti-cancer drug use (genomically-matched targeted therapy [GMTT], unmatched targeted therapy [UTT], endocrine therapy [ET], and chemotherapy [CT]), and medical service costs among adults with metastatic cancer. Adults diagnosed with metastatic breast, non-small cell lung (NSCLC), colorectal, head and neck, ovarian, and uterine cancer (2010Q1-2015Q1) were identified in the OptumHealth Care Solutions claims database and followed from first metastatic diagnosis for ≥1 month and until the end of data availability. Utilization was assessed for each cancer cohort (all and patients aged ≥65 years); per-patient-per-month (PPPM) medical service costs were assessed for all patients. Testing frequency estimates were applied to Surveillance, Epidemiology, and End Results Program data to estimate the number of untested patients (2010-2014). Patients with metastatic cancer (n = 8,193; breast [n = 3,414], NSCLC [n = 2,231], colorectal [n = 1,611], head and neck [n = 511], ovarian [n = 275], and uterine [n = 151]) were 63 years old (mean), with 11.1-22.2 months of observation. Biopsy and molecular diagnostic testing frequencies ranged from 7% (uterine) to 73% (ovarian), and from 34% (head and neck) to 52% (breast), respectively. Few were treated with GMTT (breast, 11%; NSCLC, 9%; colorectal, 6%). Treatment with UTT ranged from 0.7% (uterine) to 21% (colorectal). Biopsy, diagnostic testing, and anti-cancer drug therapy were less frequent for those ≥65 years. Medical service costs (PPPM, mean) ranged from $6,618 (head and neck) to $9,940 (ovarian). The estimated number of untested new patients with metastatic cancer was 636,369 (all) and 341,397 (≥65). In addition to the limitations of claims analyses, diagnostic testing frequency may be under-estimated if patients underwent testing prior to study inclusion. The low frequency of molecular diagnostic

  3. Cost-utility analysis comparing radioactive iodine, anti-thyroid drugs and total thyroidectomy for primary treatment of Graves' disease.

    Science.gov (United States)

    Donovan, Peter J; McLeod, Donald S A; Little, Richard; Gordon, Louisa

    2016-12-01

    Little data is in existence about the most cost-effective primary treatment for Graves' disease. We performed a cost-utility analysis comparing radioactive iodine (RAI), anti-thyroid drugs (ATD) and total thyroidectomy (TT) as first-line therapy for Graves' disease in England and Australia. We used a Markov model to compare lifetime costs and benefits (quality-adjusted life-years (QALYs)). The model included efficacy, rates of relapse and major complications associated with each treatment, and alternative second-line therapies. Model parameters were obtained from published literature. One-way sensitivity analyses were conducted. Costs were presented in 2015£ or Australian Dollars (AUD). RAI was the least expensive therapy in both England (£5425; QALYs 34.73) and Australia (AUD5601; 30.97 QALYs). In base case results, in both countries, ATD was a cost-effective alternative to RAI (£16 866; 35.17 QALYs; incremental cost-effectiveness ratio (ICER) £26 279 per QALY gained England; AUD8924; 31.37 QALYs; ICER AUD9687 per QALY gained Australia), while RAI dominated TT (£7115; QALYs 33.93 England; AUD15 668; 30.25 QALYs Australia). In sensitivity analysis, base case results were stable to changes in most cost, transition probabilities and health-relative quality-of-life (HRQoL) weights; however, in England, the results were sensitive to changes in the HRQoL weights of hypothyroidism and euthyroidism on ATD. In this analysis, RAI is the least expensive choice for first-line treatment strategy for Graves' disease. In England and Australia, ATD is likely to be a cost-effective alternative, while TT is unlikely to be cost-effective. Further research into HRQoL in Graves' disease could improve the quality of future studies. © 2016 European Society of Endocrinology.

  4. Drug-to-antibody determination for an antibody-drug-conjugate utilizing cathepsin B digestion coupled with reversed-phase high-pressure liquid chromatography analysis.

    Science.gov (United States)

    Adamo, Michael; Sun, Guoyong; Qiu, Difei; Valente, Joseph; Lan, Wenkui; Song, Hangtian; Bolgar, Mark; Katiyar, Amit; Krishnamurthy, Girija

    2017-01-20

    Antibody drug conjugates or ADCs are currently being evaluated for their effectiveness as targeted chemotherapeutic agents across the pharmaceutical industry. Due to the complexity arising from the choice of antibody, drug and linker; analytical methods for release and stability testing are required to provide a detailed understanding of both the antibody and the drug during manufacturing and storage. The ADC analyzed in this work consists of a tubulysin drug analogue that is randomly conjugated to lysine residues in a human IgG1 antibody. The drug is attached to the lysine residue through a peptidic, hydrolytically stable, cathepsin B cleavable linker. The random lysine conjugation produces a heterogeneous mixture of conjugated species with a variable drug-to-antibody ratio (DAR), therefore, the average amount of drug attached to the antibody is a critical parameter that needs to be monitored. In this work we have developed a universal method for determining DAR in ADCs that employ a cathepsin B cleavable linker. The ADC is first cleaved at the hinge region and then mildly reduced prior to treatment with the cathepsin B enzyme to release the drug from the antibody fragments. This pre-treatment allows the cathepsin B enzyme unrestricted access to the cleavage sites and ensures optimal conditions for the cathepsin B to cleave all the drug from the ADC molecule. The cleaved drug is then separated from the protein components by reversed phase high performance liquid chromatography (RP-HPLC) and quantitated using UV absorbance. This method affords superior cleavage efficiency to other methods that only employ a cathepsin digestion step as confirmed by mass spectrometry analysis. This method was shown to be accurate and precise for the quantitation of the DAR for two different random lysine conjugated ADC molecules. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. Effect of a therapeutic maximum allowable cost (MAC) program on the cost and utilization of proton pump inhibitors in an employer-sponsored drug plan in Canada.

    Science.gov (United States)

    Mabasa, Vincent H; Ma, Johnny

    2006-06-01

    Therapeutic maximum allowable cost (MAC) is a managed care intervention that uses reference pricing in a therapeutic class or category of drugs or an indication (e.g., heartburn). Therapeutic MAC has not been studied in Canada or the United States. The proton pump inhibitor (PPI) rabeprazole was used as the reference drug in this therapeutic MAC program based on prices for PPIs in the province of Ontario. No PPI is available over the counter in Canada. To evaluate the utilization and anticipated drug cost savings for PPIs in an employer-sponsored drug plan in Canada that implemented a therapeutic MAC program for PPIs. An employer group with an average of 6,300 covered members, which adopted the MAC program for PPIs in June 2003, was compared with a comparison group comprising the book of business throughout Canada (approximately 5 million lives) without a PPI MAC program (non-MAC group). Pharmacy claims for PPIs were identified using the first 6 characters of the generic product identifier (GPI 492700) for a 36-month period from June 1, 2002, through May 31, 2005. The primary comparison was the year prior to the intervention (from June 1, 2002, through May 31, 2003) and the first full year following the intervention (June 1, 2004, through May 31, 2005). Drug utilization was evaluated by comparing the market share of each of the PPIs for the 2 time periods and by the days of PPI therapy per patient per year (PPPY) and days of therapy per prescription (Rx). Drug cost was defined as the cost of the drug (ingredient cost), including allowable provincial pharmacy markup but excluding pharmacy dispense fee. Cost savings were calculated from the allowed drug cost per claim, allowed cost per day, and allowed cost PPPY. (All amounts are in Canadian dollars.) The MAC intervention group experienced an 11.7% reduction in the average cost per day of PPI drug therapy, from 2.14 US dollars in the preperiod to 1.89 US dollars in the postperiod, compared with a 3.7% reduction in

  6. Cardiovascular drugs in anaesthetic practice

    NARCIS (Netherlands)

    Schwarte, Lothar A.; Loer, S.A.; Wietasch, Johann; Scheeren, TWL

    This two-volume work of 91 chapters covers all aspects of practice in anaesthesia. Volume 1 addresses the underpinning sciences of anaesthesia including physiology, pharmacology, physics, anaesthetic equipment, statistics, and evidence-based anaesthesia. Volume 1 also outlines the fundamental

  7. Pharmacogenomics and cardiovascular disease

    DEFF Research Database (Denmark)

    Weeke, Peter; Roden, Dan M

    2013-01-01

    Variability in drug responsiveness is a sine qua non of modern therapeutics, and the contribution of genomic variation is increasingly recognized. Investigating the genomic basis for variable responses to cardiovascular therapies has been a model for pharmacogenomics in general and has established...... resulted in changes to the product labels but also have led to development of initial clinical guidelines that consider how to facilitate incorporating genetic information to the bedside. This review summarizes the state of knowledge in cardiovascular pharmacogenomics and considers how variants described...

  8. A Challenge for Diagnosing Acute Liver Injury with Concomitant/Sequential Exposure to Multiple Drugs: Can Causality Assessment Scales Be Utilized to Identify the Offending Drug?

    Directory of Open Access Journals (Sweden)

    Roxanne Lim

    2014-01-01

    Full Text Available Drug-induced hepatotoxicity most commonly manifests as an acute hepatitis syndrome and remains the leading cause of drug-induced death/mortality and the primary reason for withdrawal of drugs from the pharmaceutical market. We report a case of acute liver injury in a 12-year-old Hispanic boy, who received a series of five antibiotics (amoxicillin, ceftriaxone, vancomycin, ampicillin/sulbactam, and clindamycin for cervical lymphadenitis/retropharyngeal cellulitis. Histopathology of the liver biopsy specimen revealed acute cholestatic hepatitis. All known causes of acute liver injury were appropriately excluded and (only drug-induced liver injury was left as a cause of his cholestasis. Liver-specific causality assessment scales such as Council for the International Organization of Medical Sciences/Roussel Uclaf Causality Assessment Method scoring system (CIOMS/RUCAM, Maria and Victorino scale, and Digestive Disease Week-Japan were applied to seek the most likely offending drug. Although clindamycin is the most likely cause by clinical diagnosis, none of causality assessment scales aid in the diagnosis.

  9. FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

    Science.gov (United States)

    Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

    2018-02-01

    This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

  10. Temporal Changes in Prescription of Neuropharmacologic Drugs and Utilization of Resources Related to Neurologic Morbidity in Mechanically Ventilated Children With Bronchiolitis.

    Science.gov (United States)

    Shein, Steven L; Slain, Katherine; Wilson-Costello, Deanne; McKee, Bryan; Rotta, Alexandre T

    2017-12-01

    Critically ill children with bronchiolitis may require neuropharmacologic medications and support for neuro-functional sequelae, but current practices are not well described. We aimed to describe recent trends in neuropharmacology and utilization of neuro-rehabilitation resources in mechanically ventilated children with bronchiolitis. Analysis of the multicenter Pediatric Health Information System database. Forty-seven U.S. children's hospitals. PICU patients less than 2 years old with bronchiolitis undergoing mechanical ventilation between 2006 and 2015. None. Annual rates of utilization of neuropharmacologic medications (sedatives, analgesics, etc) and of neuro-rehabilitation services (physical therapy, neurologic consultation, etc) over the 10-year study period were compared. Neuropharmacologic medications prescribed on greater than or equal to 2 days were extracted. Utilization of MRI of the brain, neurologic consultation, swallow evaluation, occupational therapy, and physical therapy was also extracted. Among 12,508 subjects, the median age was 2.8 months, ~50% had comorbid conditions, and the median duration of mechanical ventilation was 7 days. The percentage of children prescribed greater than or equal to five drugs/drug classes increased over the study period from 36.5% to 55.8% (p use of greater than or equal to one service (36.3% in 2006 to 59.6% in 2015; p use of greater than or equal to two services (20.8% to 34.8%; p use of vasoactive medications and mortality did not. Prescription of neuropharmacologic agents increased over time using metrics of both overall drug burden and specific drug usage. Concurrently, the utilization of services that evaluate and/or treat neurologic morbidity was common and also increased over time.

  11. Utilización habitual de medicamentos en mujeres perimenopáusicas residentes en Jaca Routine drug utilization in perimenopausal women living in Jaca (Spain

    Directory of Open Access Journals (Sweden)

    María Silvia Sanclemente Pérez

    2009-08-01

    Full Text Available Objetivo: Describir la utilización habitual de medicamentos en mujeres perimenopáusicas y estudiar posibles factores relacionados. Métodos: Estudio observacional mediante entrevista directa en mujeres de 45 a 64años de edad adscritas a la zona de salud de Jaca. Resultados: El 69,4% de las mujeres consumían medicamentos de forma habitual, el 58,6% de las que tenían entre 45 y 54años, y el 81,6% de las de 55 a 64años (p=0,002. La probabilidad de consumir fármacos aumentaba con estar en la posmenopausia (p=0,011, referir alguna enfermedad crónica (pObjective: To describe routine drug utilization in perimenopausal women and to analyze related factors. Methods: We performed an observational study though face-to-face interviews with women aged 45-64 years old living in the health district of Jaca (Spain. Results: Among the women studied, 69.4% routinely used drugs: 58.6% of women aged 45-54 years old and 81.6% aged 55-64 (p=0.002. Factors associated with a greater probability of drug use were postmenopausal status (p=0.011, reported chronic diseases (p<0.001, poor or very poor self-perceived health (p=0.009, and having consulted a general physician at least once in the previous year (p=0.005. Conclusions: Routine drug utilization was frequent in the women studied. Drug utilization was associated with postmenopausal status, perceived health problems, and visits to general physicians.

  12. Endothelial Ca+-activated K+ channels in normal and impaired EDHF-dilator responses--relevance to cardiovascular pathologies and drug discovery.

    Science.gov (United States)

    Grgic, Ivica; Kaistha, Brajesh P; Hoyer, Joachim; Köhler, Ralf

    2009-06-01

    The arterial endothelium critically contributes to blood pressure control by releasing vasodilating autacoids such as nitric oxide, prostacyclin and a third factor or pathway termed 'endothelium-derived hyperpolarizing factor' (EDHF). The nature of EDHF and EDHF-signalling pathways is not fully understood yet. However, endothelial hyperpolarization mediated by the Ca(2+)-activated K(+) channels (K(Ca)) has been suggested to play a critical role in initializing EDHF-dilator responses in conduit and resistance-sized arteries of many species including humans. Endothelial K(Ca) currents are mediated by the two K(Ca) subtypes, intermediate-conductance K(Ca) (KCa3.1) (also known as, a.k.a. IK(Ca)) and small-conductance K(Ca) type 3 (KCa2.3) (a.k.a. SK(Ca)). In this review, we summarize current knowledge about endothelial KCa3.1 and KCa2.3 channels, their molecular and pharmacological properties and their specific roles in endothelial function and, particularly, in the EDHF-dilator response. In addition we focus on recent experimental evidences derived from KCa3.1- and/or KCa2.3-deficient mice that exhibit severe defects in EDHF signalling and elevated blood pressures, thus highlighting the importance of the KCa3.1/KCa2.3-EDHF-dilator system for blood pressure control. Moreover, we outline differential and overlapping roles of KCa3.1 and KCa2.3 for EDHF signalling as well as for nitric oxide synthesis and discuss recent evidence for a heterogeneous (sub) cellular distribution of KCa3.1 (at endothelial projections towards the smooth muscle) and KCa2.3 (at inter-endothelial borders and caveolae), which may explain their distinct roles for endothelial function. Finally, we summarize the interrelations of altered KCa3.1/KCa2.3 and EDHF system impairments with cardiovascular disease states such as hypertension, diabetes, dyslipidemia and atherosclerosis and discuss the therapeutic potential of KCa3.1/KCa2.3 openers as novel types of blood pressure-lowering drugs.

  13. 21 CFR 870.3375 - Cardiovascular intravascular filter.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiovascular intravascular filter. 870.3375... Cardiovascular intravascular filter. (a) Identification. A cardiovascular intravascular filter is an implant that... and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k...

  14. Cardiovascular radiology

    International Nuclear Information System (INIS)

    VanAman, M.; Mueller, C.F.

    1985-01-01

    Soon after Roentgen documented the uses of x-rays in 1895, fluoroscopic and film evaluation of the heart began. Even today the chest roentgenogram remains one of the first and most frequently used studies for the evaluation of the normal and abnormal heart and great vessels. This chapter gives an overview of plain film evaluation of the cardiovascular system and follow up with comments on the newer imaging modalities of computed tomography, and digital subtraction angiography, in the cardiovascular disease workup. The authors present an evaluation of plain films of the chest, which remains their most cost effective, available, simple, and reliable initial screening tool in the evaluation of cardiovascular disease

  15. The Utility of Impulsive Bias and Altered Decision Making as Predictors of Drug Efficacy and Target Selection: Rethinking Behavioral Screening for Antidepressant Drugs.

    Science.gov (United States)

    Marek, Gerard J; Day, Mark; Hudzik, Thomas J

    2016-03-01

    Cognitive dysfunction may be a core feature of major depressive disorder, including affective processing bias, abnormal response to negative feedback, changes in decision making, and increased impulsivity. Accordingly, a translational medicine paradigm predicts clinical action of novel antidepressants by examining drug-induced changes in affective processing bias. With some exceptions, these concepts have not been systematically applied to preclinical models to test new chemical entities. The purpose of this review is to examine whether an empirically derived behavioral screen for antidepressant drugs may screen for compounds, at least in part, by modulating an impulsive biasing of responding and altered decision making. The differential-reinforcement-of-low-rate (DRL) 72-second schedule is an operant schedule with a documented fidelity for discriminating antidepressant drugs from nonantidepressant drugs. However, a theoretical basis for this empirical relationship has been lacking. Therefore, this review will discuss whether response bias toward impulsive behavior may be a critical screening characteristic of DRL behavior requiring long inter-response times to obtain rewards. This review will compare and contrast DRL behavior with the five-choice serial reaction time task, a test specifically designed for assessing motoric impulsivity, with respect to psychopharmacological testing and the neural basis of distributed macrocircuits underlying these tasks. This comparison suggests that the existing empirical basis for the DRL 72-second schedule as a pharmacological screen for antidepressant drugs is complemented by a novel hypothesis that altering impulsive response bias for rodents trained on this operant schedule is a previously unrecognized theoretical cornerstone for this screening paradigm. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

  16. Skin too thin? The developing utility of zebrafish skin (neuro)pharmacology for CNS drug discovery research.

    Science.gov (United States)

    Nguyen, Michael; Poudel, Manoj K; Stewart, Adam Michael; Kalueff, Allan V

    2013-09-01

    Skin coloration can be affected by many genetic, environmental and pharmacological factors. Zebrafish (Danio rerio) are a useful and versatile model organism in biomedical research due to their genetic tractability, physiological homology to mammals, low cost, reproducibility and high throughput. Zebrafish coloration is mediated by chromatophores - the skin color pigment cells largely controlled by endocrine and neural mechanisms. The characteristic darkening of zebrafish skin is caused by the dispersion (and paling - by aggregation) of melanosomes (pigment-containing organelles), which show high homology to mammalian structures. Various pharmacological agents potently affect zebrafish coloration - the phenotype that often accompanies behavioral effects of the drugs, and may be used for drug discovery. Although zebrafish behavior and skin responses are usually not directly related, they share common regulatory (neural, endocrine) mechanisms, and therefore may be assessed in parallel during psychotropic drug screening. For example, some psychoactive drugs can potently affect zebrafish skin coloration. Can we use this knowledge to refine phenotype-driven psychotropic drug discovery? Here, we present current models using zebrafish skin coloration assays, and discuss how these models may be applied to enhance in vivo CNS drug discovery. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Cardiovascular safety of etoricoxib

    Directory of Open Access Journals (Sweden)

    Viktoriya Georgievna Barskova

    2011-01-01

    Full Text Available Meticulous attention is paid to the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs, the so-called selective cyclooxy-genase 2 (COX-2 inhibitors in particular. The author considers precisely this matter in case of Russia's recent NSAID etoricoxib that has been tested along with other most studied medications from this group, by applying one of the latest meta-analyses. The EULAR recommendations to use NSAIDs are given.

  18. Electrospun 4th-Generation Solid Dispersions of Poorly Water-Soluble Drug Utilizing Two Different Processes

    Directory of Open Access Journals (Sweden)

    Zhu Zhang

    2018-01-01

    Full Text Available Different from traditional solid dispersion (SD for improving the dissolution rates of poorly water-soluble drugs, the upgraded 4th SD was developed to furnish a drug sustained-release profile. In this work, two different kinds of 4th SDs were fabricated using two electrospinning processes. One is a ternary SD (nanofibers F2 that consisted of ethyl cellulose (EC, polyethylene glycol 1000 (PEG, and tamoxifen citrate (TAM from a modified coaxial process, and the other is a binary SD (nanofibers F1 which is comprised of EC and TAM from a single-fluid blending process. Scanning electronic microscopic observations demonstrated that F2 (330±50 nm showed a better quality than F1 (870±230 nm in terms of size and size distribution although both of them had a smooth surface morphology and a cross section. X-ray diffraction patterns verified that both SDs were amorphous nanocomposites owing to the favorable secondary interactions among these components, as suggested from the results of FTIR. In vitro dissolution experiments indicated that F2 could furnish an improved drug sustained-release characteristics compared to F1, exhausting all the contained TAM and having weaker leveling-off late release. The molecular behaviors of drug sustained-release from the binary 4th SD were suggested. The protocols reported here paved an alternative way for developing novel functional nanomaterials for effective delivery of poorly water-soluble drugs.

  19. Utility of Cardiovascular Magnetic Resonance-Derived Wave Intensity Analysis As a Marker of Ventricular Function in Children with Heart Failure and Normal Ejection Fraction.

    Science.gov (United States)

    Ntsinjana, Hopewell N; Chung, Robin; Ciliberti, Paolo; Muthurangu, Vivek; Schievano, Silvia; Marek, Jan; Parker, Kim H; Taylor, Andrew M; Biglino, Giovanni

    2017-01-01

    This study sought to explore the diagnostic insight of cardiovascular magnetic resonance (CMR)-derived wave intensity analysis to better study systolic dysfunction in young patients with chronic diastolic dysfunction and preserved ejection fraction (EF), comparing it against other echocardiographic and CMR parameters. Evaluating systolic and diastolic dysfunctions in children is challenging, and a gold standard method is currently lacking. Patients with presumed diastolic dysfunction [ n  = 18; nine aortic stenosis (AS), five hypertrophic, and four restrictive cardiomyopathies] were compared with age-matched control subjects ( n  = 18). All patients had no mitral or aortic incompetence, significant AS, or reduced systolic EF. E / A ratio, E / E ' ratio, deceleration time, and isovolumetric contraction time were assessed on echocardiography, and indexed left atrial volume (LAVi), acceleration time (AT), ejection time (ET), and wave intensity analyses were calculated from CMR. The latter was performed on CMR phase-contrast flow sequences, defining a ratio of the peaks of the early systolic forward compression wave (FCW) and the end-systolic forward expansion wave (FEW). Significant differences between patients and controls were seen in the E / E ' ratio (8.7 ± 4.0 vs. 5.1 ± 1.3, p  = 0.001) and FCW/FEW ratio (2.5 ± 1.6 vs. 7.2 ± 4.2 × 10 -5 m/s, p  wave intensity-derived ratio summarizing systolic and diastolic function could provide insight into ventricular function in children, on top of CMR and echocardiography, and it was here able to identify an element of ventricular dysfunction with preserved EF in a small group of young patients.

  20. Effect of Allopurinol on Cardiovascular Outcomes in Hyperuricemic Patients

    DEFF Research Database (Denmark)

    Larsen, Kasper Søltoft; Pottegård, Anton; Lindegaard, Hanne M

    2015-01-01

    BACKGROUND: Hyperuricemia and gout have been associated with increased cardiovascular risk. Allopurinol is an effective urate-lowering drug. Whether lowering of urate by allopurinol improves the cardiovascular risk in hyperuricemic patients remains to be established. OBJECTIVE: Our objective...

  1. Changes over time in risk factors for cardiovascular disease and use of lipid-lowering drugs in HIV-infected individuals and impact on myocardial infarction

    NARCIS (Netherlands)

    Sabin, C A; d'Arminio Monforte, A; Friis-Moller, N; Weber, R; El-Sadr, W M; Reiss, P; Kirk, O; Mercie, P; Law, M G; De Wit, S; Pradier, C; Phillips, A N; Lundgren, J D; Schölvinck, Elisabeth H.

    2008-01-01

    BACKGROUND: Because of the known relationship between exposure to combination antiretroviral therapy and cardiovascular disease (CVD), it has become increasingly important to intervene against risk of CVD in human immunodeficiency virus (HIV)-infected patients. We evaluated changes in risk factors

  2. EMERGING APPLICATIONS OF NANOMEDICINE FOR THERAPY AND DIAGNOSIS OF CARDIOVASCULAR DISEASES

    Science.gov (United States)

    Godin, Biana; Sakamoto, Jason H.; Serda, Rita E.; Grattoni, Alessandro; Bouamrani, Ali; Ferrari, Mauro

    2010-01-01

    Nanomedicine is an emerging field of medicine which utilizes nanotechnology concepts for advanced therapy and diagnostics. This convergent discipline, which merges research areas such as chemistry, biology, physics, mathematics and engineering thus bridging the gap between molecular and cellular interactions, has a potential to revolutionize current medical practice. This review presents recent developments in nanomedicine research, which are poised to have an important impact on cardiovascular disease and treatment by improving therapy and diagnosis of such cardiovascular disorders as atherosclerosis, restenosis and myocardial infarction. Specifically, we discuss the use of nanoparticles for molecular imaging and advanced therapeutics, specially designed drug eluting stents and in vivo/ex vivo early detection techniques. PMID:20172613

  3. Insulin and other antidiabetic drugs and hepatocellular carcinoma risk: a nested case-control study based on Italian healthcare utilization databases.

    Science.gov (United States)

    Bosetti, Cristina; Franchi, Matteo; Nicotra, Federica; Asciutto, Rosario; Merlino, Luca; La Vecchia, Carlo; Corrao, Giovanni

    2015-07-01

    Insulin and other antidiabetic drugs may modulate hepatocellular carcinoma (HCC) risk in diabetics. We have analyzed the role of various antidiabetic drugs on HCC in a nested case-control study using the healthcare utilization databases of the Lombardy Region in Italy. This included 190 diabetic subjects with a hospital discharge reporting a diagnosis of malignant HCC and 3772 diabetic control subjects matched to each case on sex, age, date at cohort entry, and duration of follow-up. Increased risks of HCC were found for use of insulin (odds ratio [OR] = 3.73, 95% confidence interval [CI] 2.52-5.51), sulfonylureas (OR = 1.39, 95%CI 0.98-1.99), and repaglinide (OR = 2.12, 95%CI 1.38-3.26), while a reduced risk was found for use of metformin (OR = 0.57, 95%CI 0.41-0.79). The risk of HCC increased with increasing duration of insulin use (OR = 2.52 for metformin. Our study supports the evidence that patients with diabetes using metformin, and possibly other antidiabetic drugs that increase insulin sensibility, have a reduced risk of HCC, while those using insulin or drugs that increase circulating insulin, such as insulin secretagogues, have an increased risk. Whether these associations are causal, or influenced by different severity of diabetes and/or possible residual bias or misclassification, is still open to discussion. Copyright © 2015 John Wiley & Sons, Ltd.

  4. Dynamics of vitamin K antagonist and new oral anticoagulants use in atrial fibrillation: a Danish drug utilization study

    DEFF Research Database (Denmark)

    Pottegård, Anton; Poulsen, B. K.; Larsen, Michael Due

    2014-01-01

    BackgroundDetailed data on real-life utilization of vitamin K antagonists (VKAs) and new oral anticoagulants (NOACs) in atrial fibrillation are sparse. ObjectivesTo describe the dynamics of VKA and NOAC use: that is, (i) how patients moved in and out of, as well as between, use of VKAs and NOACs...

  5. Utility of therapeutic drug monitoring in the management of HIV-infected pregnant women in receipt of lopinavir.

    LENUS (Irish Health Repository)

    Caswell, R J

    2011-01-01

    The pharmacokinetics of antiretroviral drugs in pregnancy is poorly understood. We reviewed the use of therapeutic drug monitoring (TDM) in clinical settings to document plasma concentrations of lopinavir during pregnancy and investigated how clinicians acted upon TDM results. A retrospective review was carried out of all HIV-infected pregnant women taking boosted lopinavir-based highly active antiretroviral therapy (HAART) at five National Health Service (NHS) centres in the UK between May 2004 and March 2007. Seventy-three women in receipt of lopinavir were identified, of whom 89% had plasma lopinavir concentrations above the suggested minimum recommended for wild-type HIV. Initial TDM results prompted dosage change in 10% and assessment of adherence and\\/or pharmacist review in 11%. TDM was repeated in 29%. TDM can play an important role in the clinical management of HIV-positive pregnant women, allowing informed dose modification and an alternative measure of adherence.

  6. Effective photodynamic therapy in drug-resistant prostate cancer cells utilizing a non-viral antitumor vector (a secondary publication).

    Science.gov (United States)

    Yamauchi, Masaya; Honda, Norihiro; Hazama, Hisanao; Tachikawa, Shoji; Nakamura, Hiroyuki; Kaneda, Yasufumi; Awazu, Kunio

    2016-03-31

    There is an urgent need to develop an efficient strategy for the treatment of drug-resistant prostate cancer. Photodynamic therapy (PDT), in which low incident levels of laser energy are used to activate a photosensitizer taken up by tumor cells, is expected as a novel therapy for the treatment of prostate cancer because of the minimal invasive nature of PDT. The present study was designed to assess the efficacy of a novel vector approach combined with a conventional porphyrin-based photosensitizer. Our group focused on a non-viral vector (hemagglutinating virus of Japan envelope; HVJ-E) combined with protoporphyrin IX (PpIX) lipid, termed the porphyrus envelope (PE). It has been previously confirmed that HVJ-E has drug-delivering properties and can induce cancer-specific cell death. The PE (HVJ-E contained in PpIX lipid) was developed as a novel photosensitizer. In this study, the antitumor and PDT efficacy of the PE against hormone-antagonistic human prostate cancer cells (PC-3) were evaluated. Our results demonstrated that, under specific circumstances, PDT using the PE was very effective against PC-3 cells. A novel therapy for drug-resistant prostate cancer based on this vector approach is eagerly anticipated.

  7. Use of multiattribute utility theory for formulary management in a health system.

    Science.gov (United States)

    Chung, Seonyoung; Kim, Sooyon; Kim, Jeongmee; Sohn, Kieho

    2010-01-15

    The application, utility, and flexibility of the multiattribute utility theory (MAUT) when used as a formulary decision methodology in a Korean medical center were evaluated. A drug analysis model using MAUT consisting of 10 steps was designed for two drug classes of dihydropyridine calcium channel blockers (CCBs) and angiotensin II receptor blockers (ARBs). These two drug classes contain the most diverse agents among cardiovascular drugs on Samsung Medical Center's drug formulary. The attributes identified for inclusion in the drug analysis model were effectiveness, safety, patient convenience, and cost, with relative weights of 50%, 30%, 10%, and 10%, respectively. The factors were incorporated into the model to quantify the contribution of each attribute. For each factor, a utility scale of 0-100 was established, and the total utility score for each alternative was calculated. An attempt was made to make the model adaptable to changing health care and regulatory circumstances. The analysis revealed amlodipine besylate to be an alternative agent, with the highest total utility score among the dihydropyridine CCBs, while barnidipine hydrochloride had the lowest score. For ARBs, losartan potassium had the greatest total utility score, while olmesartan medoxomil had the lowest. A drug analysis model based on the MAUT was successfully developed and used in making formulary decisions for dihydropyridine CCBs and ARBs for a Korean health system. The model incorporates sufficient utility and flexibility of a drug's attributes and can be used as an alternative decision-making tool for formulary management in health systems.

  8. Cardiovascular diseases

    International Nuclear Information System (INIS)

    Kodama, Kazunori

    1992-01-01

    This paper is aimed to discuss the involvement of delayed radiation effects of A-bomb exposure in cardiovascular diseases. First, the relationship between radiation and cardiovascular diseases is reviewed in the literature. Animal experiments have confirmed the relationship between ionizing radiation and vascular lesions. There are many reports which describe ischemic heart disease, cervical and cerebrovascular diseases, and peripheral disease occurring after radiation therapy. The previous A-bomb survivor cohort studies, i.e., the RERF Life Span Study and Adult Health Study, have dealt with the mortality rate from cardiovascular diseases, the prevalence or incidence of cardiovascular diseases, pathological findings, clinical observation of arteriosclerosis, ECG abnormality, blood pressure abnormality, and cardiac function. The following findings have been suggested: (1) A-bomb exposure is likely to be involved in the mortality rate and incidence of ischemic heart disease and cerebrovascular diseases; (2) similarly, the involvement of A-bomb exposure is considered in the prevalence of the arch of aorta; (3) ECG abnormality corresponding to ischemic heart disease may reflect the involvement of A-bomb exposure. To confirm the above findings, further studies are required on the basis of more accurate information and the appropriate number of cohort samples. Little evidence has been presented for the correlation between A-bomb exposure and both rheumatic heart disease and congenital heart disease. (N.K.) 88 refs

  9. Albumin binding of anti-inflammatory drugs. Utility of a site-oriented versus a stoichiometric analysis

    DEFF Research Database (Denmark)

    Honoré, B; Brodersen, R

    1984-01-01

    Binding equilibria of 12 nonsteroidal, anti-inflammatory substances, salicylic acid, diflunisal, phenylbutazone, azapropazone, fenbufen, biphenylacetic acid, naproxen, flurbiprofen, ibuprofin, diclofenac, indomethacin, and benoxaprofen, to defatted human serum albumin has been investigated at 37...... degrees, pH 7.4, in a sodium phosphate buffer, 66 mM, by means of equilibrium dialysis and, in case of salicylic acid, by dialysis rate determinations. Cobinding of each of these drugs with monoacetyl-4,4'-diaminodiphenyl sulfone, warfarin, and diazepam has been studied by measuring dialysis rates...

  10. Utilizing a dynamical description of IspH to aid in the development of novel antimicrobial drugs.

    Directory of Open Access Journals (Sweden)

    Patrick G Blachly

    Full Text Available The nonmevalonate pathway is responsible for isoprenoid production in microbes, including H. pylori, M. tuberculosis and P. falciparum, but is nonexistent in humans, thus providing a desirable route for antibacterial and antimalarial drug discovery. We coordinate a structural study of IspH, a [4Fe-4S] protein responsible for converting HMBPP to IPP and DMAPP in the ultimate step in the nonmevalonate pathway. By performing accelerated molecular dynamics simulations on both substrate-free and HMBPP-bound [Fe4S4](2+ IspH, we elucidate how substrate binding alters the dynamics of the protein. Using principal component analysis, we note that while substrate-free IspH samples various open and closed conformations, the closed conformation observed experimentally for HMBPP-bound IspH is inaccessible in the absence of HMBPP. In contrast, simulations with HMBPP bound are restricted from accessing the open states sampled by the substrate-free simulations. Further investigation of the substrate-free simulations reveals large fluctuations in the HMBPP binding pocket, as well as allosteric pocket openings - both of which are achieved through the hinge motions of the individual domains in IspH. Coupling these findings with solvent mapping and various structural analyses reveals alternative druggable sites that may be exploited in future drug design efforts.

  11. HIV and Cardiovascular Disease

    Science.gov (United States)

    ... Select a Language: Fact Sheet 652 HIV and Cardiovascular Disease HIV AND CARDIOVASCULAR DISEASE WHY SHOULD PEOPLE WITH HIV CARE ABOUT CVD? ... OF CVD? WHAT ABOUT CHANGING MEDICATIONS? HIV AND CARDIOVASCULAR DISEASE Cardiovascular disease (CVD) includes a group of problems ...

  12. Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies

    Science.gov (United States)

    Avery, Lindsay B.; Wang, Mengmeng; Kavosi, Mania S.; Joyce, Alison; Kurz, Jeffrey C.; Fan, Yao-Yun; Dowty, Martin E.; Zhang, Minlei; Zhang, Yiqun; Cheng, Aili; Hua, Fei; Jones, Hannah M.; Neubert, Hendrik; Polzer, Robert J.; O'Hara, Denise M.

    2016-01-01

    ABSTRACT Therapeutic antibodies continue to develop as an emerging drug class, with a need for preclinical tools to better predict in vivo characteristics. Transgenic mice expressing human neonatal Fc receptor (hFcRn) have potential as a preclinical pharmacokinetic (PK) model to project human PK of monoclonal antibodies (mAbs). Using a panel of 27 mAbs with a broad PK range, we sought to characterize and establish utility of this preclinical animal model and provide guidance for its application in drug development of mAbs. This set of mAbs was administered to both hemizygous and homozygous hFcRn transgenic mice (Tg32) at a single intravenous dose, and PK parameters were derived. Higher hFcRn protein tissue expression was confirmed by liquid chromatography-high resolution tandem mass spectrometry in Tg32 homozygous versus hemizygous mice. Clearance (CL) was calculated using non-compartmental analysis and correlations were assessed to historical data in wild-type mouse, non-human primate (NHP), and human. Results show that mAb CL in hFcRn Tg32 homozygous mouse correlate with human (r2 = 0.83, r = 0.91, p PK studies, enhancement of the early selection of lead molecules, and ultimately a decrease in the time for a drug candidate to reach the clinic. PMID:27232760

  13. Increasing the appeal and utilization of services for alcohol and drug problems: what consumers and their social networks prefer.

    Science.gov (United States)

    Tucker, Jalie A; Foushee, H Russell; Simpson, Cathy A

    2009-01-01

    A large gap exists in the United States between population need and the utilization of treatment services for substance-related problems. Surveying consumer preferences may provide valuable information for developing more attractive services with greater reach and impact on population health. A state-level telephone survey using random digit dialling sampling methods assessed preferences for available professional, mutual help, and lay resources, as well as innovative computerized and self-help resources that enhance anonymity (N=439 households in Alabama). Respondents preferred help that involved personal contact compared to computerized help or self-help, but were indifferent whether personalized help was dispensed by professional or lay providers. Attractive service features included lower cost, insurance coverage, confidentiality, rapid and convenient appointments, and addressing functional problems and risks of substance misuse. Respondents in households with a member who misused substances rated services more negatively, especially if services had been used. The findings highlight the utility of viewing substance misusers and their social networks as consumers, and the implications for improving the system of care and for designing and marketing services that are responsive to user preferences are discussed.

  14. Drug utilization review of potassium chloride injection formulations available in a private hospital in kuching, sarawak, malaysia.

    Science.gov (United States)

    Melissa, Mohammad Hirman; Azmi, Sarriff

    2013-07-01

    The concentrated potassium chloride injection is a high-alert medication and replacing it with a pre-mixed formulation can reduce the risks associated with its use. The aim of this study was to determine the clinical characteristics of patients receiving different potassium chloride formulations available at a private institution. The study also assessed the effectiveness and safety of pre-mixed formulations in the correction of hypokalaemia. This was a retrospective observational study consisting of 296 cases using concentrated and pre-mixed potassium chloride injections in 2011 in a private hospital in Kuching, Sarawak, Malaysia. There were 135 (45.6%) cases that received concentrated potassium chloride, and 161 (54.4%) cases that received pre-mixed formulations. The patients' clinical characteristics that were significantly related to the utilization of the different formulations were diagnosis (P < 0.001), potassium serum blood concentration (P < 0.05), and fluid overload risk (P < 0.05). The difference observed for the cases that achieved or maintained normokalaemia was statistically insignificant (P = 0.172). Infusion-related adverse effects were seen more in pre-mixes compared to concentrated formulations (6.8% versus 2.2%, P < 0.05). This study provides insight into the utilization of potassium chloride injections at this specific institution. The results support current recommendations to use pre-mixed formulations whenever possible.

  15. Assessment of function and clinical utility of alcohol and other drug web sites: An observational, qualitative study

    Directory of Open Access Journals (Sweden)

    Drennan Judy

    2011-05-01

    Full Text Available Abstract Background The increasing popularity and use of the internet makes it an attractive option for providing health information and treatment, including alcohol/other drug use. There is limited research examining how people identify and access information about alcohol or other drug (AOD use online, or how they assess the usefulness of the information presented. This study examined the strategies that individuals used to identify and navigate a range of AOD websites, along with the attitudes concerning presentation and content. Methods Members of the general community in Brisbane and Roma (Queensland, Australia were invited to participate in a 30-minute search of the internet for sites related to AOD use, followed by a focus group discussion. Fifty one subjects participated in the study across nine focus groups. Results Participants spent a maximum of 6.5 minutes on any one website, and less if the user was under 25 years of age. Time spent was as little as 2 minutes if the website was not the first accessed. Participants recommended that AOD-related websites should have an engaging home or index page, which quickly and accurately portrayed the site's objectives, and provided clear site navigation options. Website content should clearly match the title and description of the site that is used by internet search engines. Participants supported the development of a portal for AOD websites, suggesting that it would greatly facilitate access and navigation. Treatment programs delivered online were initially viewed with caution. This appeared to be due to limited understanding of what constituted online treatment, including its potential efficacy. Conclusions A range of recommendations arise from this study regarding the design and development of websites, particularly those related to AOD use. These include prudent use of text and information on any one webpage, the use of graphics and colours, and clear, uncluttered navigation options

  16. Trace Elements in Cardiovascular Diseases

    Energy Technology Data Exchange (ETDEWEB)

    Masironi, R. [Cardiovascular Diseases Unit, World Health Organization, Geneva (Switzerland)

    1970-07-01

    Cardiovascular diseases are the leading cause of death in industrialized countries. Their incidence increases, apparently, as a, function of technological progress so that in the future they may become a major public health problem in developing countries too. Early diagnosis and prevention are the tools best suited to curb such an alarming trend, but our knowledge of these topics is unsatisfactory, Valuable information would be obtained through a systematic investigation of trace elements in relation to cardiovascular function and to various types of cardiovascular diseases. Such studies would provide clues to the following questions: 1. Why does the incidence and type of cardiovascular disease differ from one country to another? May this be related to differences in tissue mineral concentrations among various population groups? 2. Which trace elements if any are beneficial to cardiovascular health, and which are harmful ones that may act as aetiological agents for some cardiovascular diseases? 3. Is it possible to utilize measurements of mineral element concentration for diagnostic purposes in cardiovascular disease? (author)

  17. Cardiovascular system

    International Nuclear Information System (INIS)

    Soulen, R.L.; Grosh, J.

    1984-01-01

    Invasive cardiovascular diagnostic procedures involve a finite risk and therefore can be recommended only when the benefit appears to exceed the risk by a substantial margin. The risk/benefit ratio varies not only with the procedure concerned but with the status of the vascular system, concomitant diseases, and the risks of both the suspected illness and its treatment. The risks inherent in the procedures per se are detailed in the sections to follow

  18. NKT cells in cardiovascular diseases

    NARCIS (Netherlands)

    Puijvelde, van G.H.M.; Kuiper, J.

    2017-01-01

    Despite life-style advice and the prescription of cholesterol-lowering and anti-thrombotic drugs, cardiovascular diseases are still the leading cause of death worldwide. Therefore, there is an urgent need for new therapeutic strategies focussing on atherosclerosis, the major underlying pathology of

  19. Big data analytics to improve cardiovascular care: promise and challenges.

    Science.gov (United States)

    Rumsfeld, John S; Joynt, Karen E; Maddox, Thomas M

    2016-06-01

    The potential for big data analytics to improve cardiovascular quality of care and patient outcomes is tremendous. However, the application of big data in health care is at a nascent stage, and the evidence to date demonstrating that big data analytics will improve care and outcomes is scant. This Review provides an overview of the data sources and methods that comprise big data analytics, and describes eight areas of application of big data analytics to improve cardiovascular care, including predictive modelling for risk and resource use, population management, drug and medical device safety surveillance, disease and treatment heterogeneity, precision medicine and clinical decision support, quality of care and performance measurement, and public health and research applications. We also delineate the important challenges for big data applications in cardiovascular care, including the need for evidence of effectiveness and safety, the methodological issues such as data quality and validation, and the critical importance of clinical integration and proof of clinical utility. If big data analytics are shown to improve quality of care and patient outcomes, and can be successfully implemented in cardiovascular practice, big data will fulfil its potential as an important component of a learning health-care system.

  20. Improving risk stratification for cardiovascular disease

    NARCIS (Netherlands)

    van Wijk, Diederik F.; Boekholdt, S. Matthijs

    2010-01-01

    Evaluation of: Heslop CL, Frohlich JJ, Hill JS. Myeloperoxidase and C-reactive protein have combined utility for long-term prediction of cardiovascular mortality after coronary angiography. J. Am. Coll. Cardiol. 55(11), 1102-1109 (2010). Identifying people at high risk of cardiovascular events is

  1. Relationship between healthy diet and risk of cardiovascular disease among patients on drug therapies for secondary prevention: a prospective cohort study of 31 546 high-risk individuals from 40 countries.

    Science.gov (United States)

    Dehghan, Mahshid; Mente, Andrew; Teo, Koon K; Gao, Peggy; Sleight, Peter; Dagenais, Gilles; Avezum, Alvaro; Probstfield, Jeffrey L; Dans, Tony; Yusuf, Salim

    2012-12-04

    Diet quality is strongly related to cardiovascular disease (CVD) incidence, but little is known about its impact on CVD events in older people at high risk of CVD and receiving effective drugs for secondary prevention. This study assessed the association between diet quality and CVD events in a large population of subjects from 40 countries with CVD or diabetes mellitus with end-organ damage receiving proven medications. Overall, 31 546 women and men 66.5±6.2 years of age enrolled in 2 randomized trials, the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial (ONTARGET) and the Telmisartan Randomized Assessment Study in ACEI Intolerant Subjects With Cardiovascular Disease (TRANSCEND), were studied. We used 2 dietary indexes: the modified Alternative Healthy Eating Index and the Diet Risk Score. The association between diet quality and the primary composite outcome of CV death, myocardial infarction, stroke, or congestive heart failure was assessed with Cox proportional hazard regression with adjustment for age, sex, trial enrollment allocation, region, and other known confounders. During the 56-month follow-up, there were 5190 events. Patients in the healthier quintiles of modified Alternative Healthy Eating Index scores had a significantly lower risk of CVD (hazard ratio, 0.78; 95% confidence interval, 0.71-0.87, top versus lowest quintile of modified Alternative Healthy Eating Index). The reductions in risk for CV death, myocardial infarction, and stroke were 35%, 14%, and 19%, respectively. The protective association was consistent regardless of whether patients were receiving proven drugs. A higher-quality diet was associated with a lower risk of recurrent CVD events among people ≥55 years of age with CVD or diabetes mellitus. Highlighting the importance of healthy eating by health professionals would substantially reduce CVD recurrence and save lives globally.

  2. Utilization of bio-degradable fermented tapioca to synthesized low toxicity of carbon nanotubes for drug delivery applications

    International Nuclear Information System (INIS)

    Nurulhuda, I.; Poh, R.; Mazatulikhma, M. Z.; Rusop, M.; Salman, A. H. A.; Haseeb, A. K.

    2016-01-01

    Carbon nanotubes (CNT) have potential biomedical applications, and investigations are shifting towards the production of such nanotubes using renewable natural sources. CNTs were synthesized at various temperatures of 700, 750, 800, 850 and 900 °C, respectively, using a local fermented food known as “tapai ubi” or fermented tapioca as a precursor. The liquid part of this fermented food was heated separately at 80°C and channeled directly into the furnace system that employs the thermal chemical vapor deposition (CVD) method. Ferrocene, which was the catalyst was placed in furnace 1 in the thermal CVD process. The resulting CNTs produced from the process were studied using field emission scanning electron microscopy (FESEM) and Raman spectroscopy. The FESEM images showed the growth morphology of the CNTs at the different temperatures employed. It was observed that the higher the synthesis temperature up to a point, the diameter of CNTs produced, after which the diameter increased. CNTs with helical structures were observed at 700 °C with a diameter range of 111 - 143 nm. A more straightened structure was observed at 750 °C with a diameter range of 59 - 121 nm. From 800 °C onwards, the diameters of the CNTs were less than 60 nm. Raman analysis revealed the present of D, G and G’ peak were observed at 1227-1358, 1565-1582, and 2678-2695 cm −1 , respectively. The highest degree of crystallity of the carbon nanotubes synthesized were obtained at 800 °C. The radial breathing mode (RBM) were in range between 212-220 and 279-292 cm −1 . Carbon nanotubes also being functionalized with Polyethylene bis(amine) Mw2000 (PEG 2000-NH2) and showed highly cells viability compared to non-functionalized CNT. The nanotubes synthesized will be applied as drug delivery in future study.

  3. Utilization of bio-degradable fermented tapioca to synthesized low toxicity of carbon nanotubes for drug delivery applications

    Energy Technology Data Exchange (ETDEWEB)

    Nurulhuda, I., E-mail: nurulnye@gmail.com [NANO-SciTech Centre, Institute of Science, Universiti Teknologi MARA, 40450 Shah Alam, Selangor (Malaysia); Poh, R. [Department of Molecular Medicine, University of Malaya, 50603 Kuala Lumpur (Malaysia); Mazatulikhma, M. Z. [Faculty of Applied Sciences, Universiti Teknologi MARA, 40450 Shah Alam, Selangor (Malaysia); Rusop, M., E-mail: nanouitm@gmail.com [NANO-Electronic Centre, Faculty of Electrical Engineering, Universiti Teknologi MARA, 40450 Shah Alam, Selangor (Malaysia); Salman, A. H. A.; Haseeb, A. K.

    2016-07-06

    Carbon nanotubes (CNT) have potential biomedical applications, and investigations are shifting towards the production of such nanotubes using renewable natural sources. CNTs were synthesized at various temperatures of 700, 750, 800, 850 and 900 °C, respectively, using a local fermented food known as “tapai ubi” or fermented tapioca as a precursor. The liquid part of this fermented food was heated separately at 80°C and channeled directly into the furnace system that employs the thermal chemical vapor deposition (CVD) method. Ferrocene, which was the catalyst was placed in furnace 1 in the thermal CVD process. The resulting CNTs produced from the process were studied using field emission scanning electron microscopy (FESEM) and Raman spectroscopy. The FESEM images showed the growth morphology of the CNTs at the different temperatures employed. It was observed that the higher the synthesis temperature up to a point, the diameter of CNTs produced, after which the diameter increased. CNTs with helical structures were observed at 700 °C with a diameter range of 111 - 143 nm. A more straightened structure was observed at 750 °C with a diameter range of 59 - 121 nm. From 800 °C onwards, the diameters of the CNTs were less than 60 nm. Raman analysis revealed the present of D, G and G’ peak were observed at 1227-1358, 1565-1582, and 2678-2695 cm{sup −1}, respectively. The highest degree of crystallity of the carbon nanotubes synthesized were obtained at 800 °C. The radial breathing mode (RBM) were in range between 212-220 and 279-292 cm{sup −1}. Carbon nanotubes also being functionalized with Polyethylene bis(amine) Mw2000 (PEG 2000-NH2) and showed highly cells viability compared to non-functionalized CNT. The nanotubes synthesized will be applied as drug delivery in future study.

  4. Cardiovascular death and manic-depressive psychosis

    DEFF Research Database (Denmark)

    Weeke, A; Juel, K; Vaeth, M

    2013-01-01

    In order to study if tricyclic antidepressant drugs (TCA) in therapeutic doses increase the risk of death due to cardiovascular causes, the relative mortality from cardiovascular diseases was studied in two large groups of first hospitalized manic-depressive patients, one from the TCA era...... to the general population. Among 1133 such cases admitted between 1950 and 1956, the rate was 1.87. Our findings do not support the hypothesis that TCA contribute to the cardiovascular mortality in manic-depressives and even support suggestions that TCA treatment may lower the risk of death by cardiovascular...

  5. Effect of cytochrome P450 2C19 polymorphism on adverse cardiovascular events after drug-eluting stent implantation in a large Hakka population with acute coronary syndrome receiving clopidogrel in southern China.

    Science.gov (United States)

    Zhong, Zhixiong; Hou, Jingyuan; Zhang, Qifeng; Li, Bin; Li, Cunren; Liu, Zhidong; Yang, Min; Zhong, Wei; He, Xuebo; Wu, Hesen; Zhong, Miaocai; Zhao, Pingsen

    2018-04-01

    The objective of this study is to evaluate the effects of cytochrome P450 2C19 (CYP2C19) polymorphism on adverse cardiovascular events (MACE) in Hakka patients with acute coronary syndrome (ACS) receiving clopidogrel who had undergone coronary drug-eluting stent placement after percutaneous coronary intervention (PCI) in southern China. Genotyping of CYP2C19 and MACE of 934 ACS patients with PCI on clopidogrel maintenance therapy were analyzed. Patients who carried loss-of-function CYP2C19 were treated with a 150-mg maintenance dose of clopidogrel or 90 mg of ticagrelor antiplatelet therapy, and patients who were non-carriers received clopidogrel therapy daily at a maintenance dose of 75 mg and the patients were followed-up for at least 12 months. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, and target vessel revascularization and stroke. The allelic frequency of CYP2C19*2 and CYP2C19*3 of Hakka patients in the current study was 31.64 and 5.19%, respectively. The CYP2C19 wild-type homozygotes (*1/*1) were the most predominant among the patients (40.36%), followed by the CYP2C19*2 heterozygotes (*1/*2) (40.26%). The distribution of CYP2C19 phenotypes was divided into extensive metabolizers (EM; 40.36%), intermediate metabolizers (IM; 45.61%), and poor metabolizers (PM; 14.03%). Based on the genotype-guided antiplatelet therapy, there was no significant association between the carrier status and the clinical outcome at 1, 6, and 12 months. In addition, no significant difference in the rates of bleeding was found among the three groups. After logistic regression analysis, hypertension was the only independent predictor of cardiovascular events (relative risk, 1.501; 95% CI, 1.011 to 2.229; P = 0.044). Our results shed new light on the important benefit of testing CYP2C19 polymorphisms before prescribing clopidogrel in patients treated with drug-eluting stent implantation after PCI. The testing may help to

  6. Cardiovascular risk prediction in HIV-infected patients: comparing the Framingham, atherosclerotic cardiovascular disease risk score (ASCVD), Systematic Coronary Risk Evaluation for the Netherlands (SCORE-NL) and Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) risk prediction models.

    Science.gov (United States)

    Krikke, M; Hoogeveen, R C; Hoepelman, A I M; Visseren, F L J; Arends, J E

    2016-04-01

    The aim of the study was to compare the predictions of five popular cardiovascular disease (CVD) risk prediction models, namely the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) model, the Framingham Heart Study (FHS) coronary heart disease (FHS-CHD) and general CVD (FHS-CVD) models, the American Heart Association (AHA) atherosclerotic cardiovascular disease risk score (ASCVD) model and the Systematic Coronary Risk Evaluation for the Netherlands (SCORE-NL) model. A cross-sectional design was used to compare the cumulative CVD risk predictions of the models. Furthermore, the predictions of the general CVD models were compared with those of the HIV-specific D:A:D model using three categories ( 20%) to categorize the risk and to determine the degree to which patients were categorized similarly or in a higher/lower category. A total of 997 HIV-infected patients were included in the study: 81% were male and they had a median age of 46 [interquartile range (IQR) 40-52] years, a known duration of HIV infection of 6.8 (IQR 3.7-10.9) years, and a median time on ART of 6.4 (IQR 3.0-11.5) years. The D:A:D, ASCVD and SCORE-NL models gave a lower cumulative CVD risk, compared with that of the FHS-CVD and FHS-CHD models. Comparing the general CVD models with the D:A:D model, the FHS-CVD and FHS-CHD models only classified 65% and 79% of patients, respectively, in the same category as did the D:A:D model. However, for the ASCVD and SCORE-NL models, this percentage was 89% and 87%, respectively. Furthermore, FHS-CVD and FHS-CHD attributed a higher CVD risk to 33% and 16% of patients, respectively, while this percentage was D:A:D, ASCVD and SCORE-NL models. This could have consequences regarding overtreatment, drug-related adverse events and drug-drug interactions. © 2015 British HIV Association.

  7. Cardiovascular Safety Pharmacology of Sibutramine.

    Science.gov (United States)

    Yun, Jaesuk; Chung, Eunyong; Choi, Ki Hwan; Cho, Dae Hyun; Song, Yun Jeong; Han, Kyoung Moon; Cha, Hey Jin; Shin, Ji Soon; Seong, Won-Keun; Kim, Young-Hoon; Kim, Hyung Soo

    2015-07-01

    Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an IC50 of 3.92 μM in patch clamp assay and increased the heart rate and blood pressure (76 Δbpm in heart rate and 51 ΔmmHg in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at 10 μM and 30 μM, resulted in 15% and 29% decreases in APD50, and 9% and 17% decreases in APD90, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.

  8. Utilização de medicamentos por indivíduos HIV positivos: abordagem qualitativa Utilization of prescribed drugs by HIV infected individuals: qualitative approach

    Directory of Open Access Journals (Sweden)

    Francisco A. Acurcio

    1999-02-01

    Full Text Available OBJETIVO: Analisar, em sua dimensão qualitativa, a utilização de medicamentos por indivíduos infectados pelo HIV, durante o processo de procura e atendimento em serviços de saúde. MÉTODOS: Foram realizadas 52 entrevistas semi-estruturadas com pacientes, trabalhadores da saúde e voluntários de organizações não-governamentais, e revistos 1.079 prontuários médicos para obtenção de informações sobre a utilização de medicamentos por portadores do HIV, cuja primeira visita a um dos serviços públicos de referência estudados ocorreu entre janeiro de 1989 e dezembro de 1992. RESULTADOS: Os problemas relacionados à utilização de anti-retrovirais foram: recusa ao uso, dificuldade de obtenção e de cumprimento da prescrição. Outros problemas foram a auto-medicação, dificuldade de obter medicamentos para patologias associadas e de cumprimento da prescrição de sulfas. CONCLUSÕES: Os resultados permitiram compreender melhor os principais obstáculos e dificuldades vivenciados pelo usuário dos serviços, desde o ato da prescrição até a continuidade do tratamento.OBJECTIVE: The assessment, in its qualitative dimension, of the utilization - by HIV infected individuals - of selected prescribed drugs during the process of the search for and the obtaining of care in public health services in Belo Horizonte, Brazil. METHOD: Fifty two semi-structured interviews with patients, health care workers and non- governamental organizations volunteers were carried out and 1,079 medical records were reviewed. Data were obtained on the utilization of prescribed drugs by HIV infected individuals, whose first visit to one of the public services studied occurred between January 1989 and December 1992. Problems related to the use of anti-retroviral and/or opportunistic infection medication were identified and a qualitative description of their possible causes and consequences was commented on. RESULTS: Refusal to use, difficulty in obtaining and

  9. Trends in statin consumption and cardiovascular mortality in Croatia 2004-2012.

    Science.gov (United States)

    Vojvodić, Zeljko; Stimac, Danijela

    2014-12-01

    Prescribing of statins showed an increasing trend in all developed countries, during the last two decades. The aim of this study was to research the trends in statin consumption in the period from 2004 to 2012 as well as trends of cardiovascular mortality during the 1990 to 2012 period, and to compare them between Croatia and several neighbouring countries. Data on statin expenditures and consumption expresed in defined daily doses per 1000 inhabitants per day (DDD/TID), were taken from annual reports of Croatian Agency for Medicinal Products and Medical Devices (HALMED). Data on crude mortality rates and standardized cardiovascular mortality rates, were taken from the Croatian Health Statistics Yearbooks. The utilization of statins increased by 196.7% during the observed period, with the highest consumption of atorvastatin and simvastatin. Financial expenditure of statins expanded at much faster rate in comparison with overall drug costs. Cardiovascular mortality rates decreased slightly, while maintaining higher level in comparison with some neighbouring countries.

  10. Etiologic features and utilization of antiepileptic drugs in people with chronic epilepsy in China: Report from the Epilepsy Cohort of Huashan Hospital (ECoH).

    Science.gov (United States)

    Ge, Yan; Yu, Peimin; Ding, Ding; Wang, Ping; Shi, Yunbo; Zhao, Ting; Tang, Xinghua; Hong, Zhen

    2015-10-01

    Chronic epilepsy is estimated to affect more than 2 million people in China. However, data of its clinical characteristics was rarely reported in China. In the present study, we summarized the etiologic features and utilization patterns of antiepileptic drugs (AEDs) in people with chronic epilepsy in a tertiary medical center in China. We prospectively recruited people with chronic epilepsy treated at the Epilepsy Outpatient Clinic of Huashan Hospital during October 2009 to August 2013. Demographic data, clinical characteristics, AED treatment, epilepsy-associated risk factors and medical history, and results of supplementary examinations of each participant were collected retrospectively via an interviewer-administered questionnaire and confirmed by the medical records. Among 554 people with chronic epilepsy, 58.0% of them were male, 66.8% had focal seizure, and 29.2% had symptomatic cause. Developmental anomalies of cerebral structure (16.7%) and cerebral trauma (16.7%) shared the leading cause of symptomatic epilepsy among children with epilepsy. While cerebral trauma (29.1%) and cerebrovascular disorder (36.4%) were the most common causes in groups of adults and elderly. Fifty percent of participants were taking AED monotherapy. Proportions of people with idiopathic, cryptogenic and symptomatic epilepsy treated by multitherapy were 35%, 46% and 45.6%, respectively. Valproic acid (VPA) was the most frequently utilized AED as monotherapy (32.7%) and within multitherapy (62.5%). This hospital-based study reported that etiologic features were diverse in different age groups of people with chronic epilepsy. VPA was widely utilized to treat chronic epilepsy in mainland China. Copyright © 2015 Elsevier B.V. All rights reserved.

  11. Changes over time in risk factors for cardiovascular disease and use of lipid-lowering drugs in HIV-infected individuals and impact on myocardial infarction

    DEFF Research Database (Denmark)

    Sabin, C A; d'Arminio Monforte, A; Friis-Moller, N

    2008-01-01

    for CVD and the use of lipid-lowering therapy in HIV-infected individuals and assessed the impact of any changes on the incidence of myocardial infarction. METHODS: The Data Collection on Adverse Events of Anti-HIV Drugs Study is a collaboration of 11 cohorts of HIV-infected patients that included follow...... was more common for those with abnormal lipid values and those with traditional risk factors for CVD (male sex, older age, higher body mass index [calculated as the weight in kilograms divided by the square of the height in meters], family and personal history of CVD, and diabetes mellitus). After...... controlling for these, use of lipid-lowering drugs became relatively less common over time. The incidence of myocardial infarction (0.32 cases per 100 person-years [PY]; 95% confidence interval [CI], 0.29-0.35 cases per 100 PY) appeared to remain stable. However, after controlling for changes in risk factors...

  12. Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular events

    NARCIS (Netherlands)

    Squizzato, Alessandro; Bellesini, Marta; Takeda, Andrea; Middeldorp, Saskia; Donadini, Marco Paolo

    2017-01-01

    Aspirin is the prophylactic antiplatelet drug of choice for people with cardiovascular disease. Adding a second antiplatelet drug to aspirin may produce additional benefit for people at high risk and people with established cardiovascular disease. This is an update to a previously published review

  13. Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular disease

    NARCIS (Netherlands)

    Squizzato, Alessandro; Keller, Tymen; Romualdi, Erica; Middeldorp, Saskia

    2011-01-01

    Aspirin is the prophylactic antiplatelet drug of choice for people with cardiovascular disease. Adding a second antiplatelet drug to aspirin may produce additional benefit for those at high risk and those with established cardiovascular disease. To quantify the benefit and harm of adding clopidogrel

  14. Towards predictive cardiovascular safety : a systems pharmacology approach

    NARCIS (Netherlands)

    Snelder, Nelleke

    2014-01-01

    Cardiovascular safety issues related to changes in blood pressure, arise frequently in drug development. In the thesis “Towards predictive cardiovascular safety – a systems pharmacology approach”, a system-specific model is described to quantify drug effects on the interrelationship between mean

  15. Five-year examination of utilization and drug cost outcomes associated with benefit design changes including reference pricing for proton pump inhibitors in a state employee health plan.

    Science.gov (United States)

    Johnson, Jill T; Neill, Kathryn K; Davis, Dwight A

    2011-04-01

    The Arkansas State Employee Benefits Division (EBD) is a self-insured program comprising public school and other state employees, their spouses, and dependents. Previous research published in JMCP (2006) showed drug cost savings of $2.20 per member per month (PMPM; 37.6%) or annualized savings of $3.4 million associated with a benefit design change and coverage of the proton pump inhibitor (PPI) omeprazole over-the-counter (OTC) beginning in March 2004. On May 1, 2005, brand esomeprazole was excluded from coverage, with current users grandfathered for 4 months until September 2005. Reference pricing for PPIs, including esomeprazole but excluding generic omeprazole, was implemented on September 1, 2005, and the beneficiary cost share for all PPIs except generic omeprazole was determined from comparison of the PPI actual price to the $0.90 omeprazole OTC reference price per unit. To examine PPI utilization and drug costs before and after (a) excluding esomeprazole from coverage (with grandfathering current users) and (b) implementing a therapeutic maximum allowable cost (TMAC), or reference-pricing benefit design, for the PPI class in a large state employee health plan with fairly stable enrollment of approximately 127,500 members in 2005 through 2008 and approximately 128,000 members in 2009 Q1. The pharmacy claims database for the EBD was used to examine utilization and cost data for PPIs in a longitudinal analysis for the 61-month period from March 1, 2004, through March 31, 2009. Pharmacy claims data were compared for the period 14 months prior to esomeprazole exclusion (preperiod), 4 months during the esomeprazole exclusion (postperiod 1), and the ensuing 43 months of PPI reference pricing (postperiod 2). PPI cost and utilization data for the intervention group of approximately 127,500 beneficiaries were compared with a group of 122 self-insured employers with a total of nearly 1 million beneficiaries whose pharmacy benefits did not include reference pricing for

  16. Assessment of some biochemical changes in blood and histological changes in heart of rats irradiated and/or treated with some cardiovascular drugs

    International Nuclear Information System (INIS)

    El-Sayed, H.I.; El-Batrawy, F.A.; ABDEL-GAWAD, E.I.; Sourour, D.A.

    2006-01-01

    The present study was designed to compare the effects of carvedilol, metaprolol and diltiazem on some serum enzyme levels and cardiac tissue in rats in irradiated with gamma rays and to detect any possible radioprotective effect offered by these drugs. Ninety six male rats were divided into 8 groups, 12 rats each. The first group served as control. The second, third and fourth groups were received carvedilol (5 mg/kg), metaprolol (20 mg/kg) and diltiazem hydrochloride (20 mg/kg), respectively, for two weeks. The fifth group was irradiated with a single dose (6 Gy) of gamma rays. The sixth, seventh and eighth groups were received the previous mentioned doses of drugs for two weeks before exposing the rats to gamma irradiation. The blood samples were collected at fixed time intervals of 24 hr, 72 hr and 1 week after stopping drug administration (treated groups) or after irradiation (irradiated and treated-irradiated groups).The results of the present study showed that a single dose (6 Gy) of whole body gamma radiation in rats induced cardiac damage which was manifested histopathologically and biochemically. Significant elevations in serum creatine kinase (CK) enzyme, creatine kinase MB (CK MB) isoenzyme and aspartate aminotransferase (AST) enzyme levels were observed in the irradiated group after 24 hour, 72 hour and one week post-irradiation as compared to the control group. Regarding the level of lactate dehydrogenase (LDH) enzyme, it showed significant increase on the first day (24 hour), while there was significant decrease on the third (72 hour) and seventh day (1 week) post-irradiation relative to the control value. Histopathological examination of gamma irradiated group revealed marked congestion and dilatation of the vessels between myocardial muscle fibres and lymphatic vessels. Regarding the myofibres, their changes varied from minimal changes in the form of separation of myofibrils to massive changes in the form of loss of striations. The nuclear changes

  17. Cardiovascular risk assessment in the treatment of nonalcoholic steatohepatitis: a secondary analysis of the MOZART trial.

    Science.gov (United States)

    Lin, Steven C; Ang, Brandon; Hernandez, Carolyn; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Richards, Lisa; Kono, Yuko; Bhatt, Archana; Aryafar, Hamed; Lin, Grace Y; Valasek, Mark A; Sirlin, Claude B; Brouha, Sharon; Loomba, Rohit

    2016-03-01

    Nonalcoholic steatohepatitis (NASH) is associated with increased cardiovascular risk and mortality. No US Food and Drug Administration (FDA) approved therapies for NASH are available; clinical trials to date have not yet systematically assessed for changes in cardiovascular risk. This study examines the prospective utility of cardiovascular risk assessments, the Framingham risk score (FRS) and coronary artery calcium (CAC) score, as endpoints in a NASH randomized clinical trial, and assesses whether histologic improvements lead to lower cardiovascular risk. Secondary analysis of a 24-week randomized, double-blind, placebo-controlled trial (MOZART) in which 50 biopsy-proven NASH patients received oral ezetimibe 10 mg daily (n = 25) versus placebo (n = 25). Biochemical profiling, FRS, CAC scores, liver biopsies were obtained at baseline and endpoint. Ezetimibe improved FRS whereas placebo did not (4.4 ± 6.2 to 2.9 ± 4.8, p = 0.038; 3.0 ± 4.4 to 2.9 ± 4.2, p = 0.794). CAC scores did not change with ezetimibe or placebo (180.4 ± 577.2 to 194.1 ± 623.9, p = 0.293; 151.4 ± 448.9 to 183.3 ± 555.7, p = 0.256). Ezetimibe improved FRS and CAC scores in more patients than placebo (48% versus 23%, p = 0.079, and 21% versus 0%, p = 0.090, respectively), though not significantly. No differences were noted in cardiovascular risk scores among histologic responders versus nonresponders. Ezetimibe improved FRS whereas placebo did not. FRS and CAC scores improved in a greater proportion of patients with ezetimibe; this trend did not reach significance. These findings indicate the utility and feasibility of monitoring cardiovascular risk in a NASH trial. The utility of CAC scores may be higher in trials of longer duration (⩾52 weeks) and with older patients (age ⩾45). ClinicalTrials.gov registration: NCT01766713.

  18. Cardiovascular considerations of attention deficit hyperactivity disorder medications: a report of the European Network on Hyperactivity Disorders work group, European Attention Deficit Hyperactivity Disorder Guidelines Group on attention deficit hyperactivity disorder drug safety meeting.

    Science.gov (United States)

    Hamilton, Robert M; Rosenthal, Eric; Hulpke-Wette, Martin; Graham, John G I; Sergeant, Joseph

    2012-02-01

    Regulatory decisions regarding attention deficit hyperactivity disorder drug licensing and labelling, along with recent statements from professional associations, raise questions of practice regarding the evaluation and treatment of patients with attention deficit hyperactivity disorder. To address these issues for the European community, the European Network for Hyperkinetic Disorders, through its European Attention Deficit Hyperactivity Disorder Guidelines Group, organised a meeting between attention deficit hyperactivity disorder specialists, paediatric cardiovascular specialists, and representatives of the major market authorisation holders for attention deficit hyperactivity disorder medications. This manuscript represents their consensus on cardiovascular aspects of attention deficit hyperactivity disorder medications. Although sudden death has been identified in multiple young individuals on attention deficit hyperactivity disorder medication causing regulatory concern, when analysed for exposure using currently available data, sudden death does not appear to exceed that of the general population. There is no current evidence to suggest an incremental benefit to electrocardiography assessment of the general attention deficit hyperactivity disorder patient. Congenital heart disease patients have an increased prevalence of attention deficit hyperactivity disorder, and can benefit from attention deficit hyperactivity disorder therapies, including medication. The attention deficit hyperactivity disorder specialist is the appropriate individual to evaluate benefit and risk and recommend therapy in all patients, although discussion with a heart specialist is reasonable for congenital heart disease patients. For attention deficit hyperactivity disorder patients with suspected heart disease or risk factor/s for sudden death, assessment by a heart specialist is recommended, as would also be the case for a non-attention deficit hyperactivity disorder patient. The

  19. Multi-constituent cardiovascular pills (MCCP)--challenges and promises of population-based prophylactic drug therapy for prevention of heart attack.

    Science.gov (United States)

    Jamieson, Michael J; Naghavi, Morteza

    2007-01-01

    Risk factors for atherosclerotic cardiovascular disease (CVD) are highly co-prevalent but poorly identified and treated. The Screening for Heart Attack Prevention and Education (SHAPE) Task Force from the Association for Eradication of Heart Attack (AEHA) has recently proposed a new strategy that recommends screening for subclinical atherosclerosis and implementing aggressive treatment of "vulnerable patients". The Task Force has also envisioned future developments that may shift mass screening strategies to mass prophylactic therapy. The "Polypill" concept, introduced by Wald and Law suggests a combination of statin, low-dose antihypertensives, aspirin and folic acid, in a single pill, taken prophylactically by high risk population can cut CVD event rates by as much as 80%. In this communication, we review the challenges and promises of such a strategy. "Polypill" is but one of an astronomical number of possible multiconstituent pills (MCCP). Attractive as the MCCP concept is, it lacks evidence from randomized controlled trials, and begs numerous questions about the credibility of the concept, the design and synthesis of such complex pills, pharmacokinetics, pharmacodynamics, bioequivalence, "class" vs. unique properties, interactions, evidence of clinical efficacy and safety, regulatory approval, post-marketing surveillance, prescription vs. over-the-counter use, responsibility for initiating and monitoring therapy, patient education, counterfeiting and importation, reimbursement, advertisement, patent protection, commercial viability, etc. If these issues are favorably addressed, MCCP stand to dramatically change the manner in which CVD is prevented particularly in developing societies. Notwithstanding, assuming low commercial interests, realizing the promises of MCCP will demand serious attention from national public health policymakers. The clinical and regulatory implications of population-based secondary prevention (which rely on a different evidence base

  20. QT interval correction for drug-induced changes in body temperature during integrated cardiovascular safety assessment in regulatory toxicology studies in dogs: A case study.

    Science.gov (United States)

    El Amrani, Abdel-Ilah; El Amrani-Callens, Francine; Loriot, Stéphane; Singh, Pramila; Forster, Roy

    2016-01-01

    Cardiovascular safety assessment requires accurate evaluation of QT interval, which depends on the length of the cardiac cycle and also on core body temperature (BT). Increases in QT interval duration have been shown to be associated with decreases in BT in dogs. An example of altered QT interval duration associated with changes in body temperature observed during a 4-week regulatory toxicology study in dogs is presented. Four groups of Beagle dogs received the vehicle or test item once on Day 1, followed by a 4-week observation period. Electrocardiogram (ECG) parameters were continuously recorded on Days 1 and 26 by jacketed external telemetry (JET). Core body temperature (BT) was measured with a conventional rectal thermometer at appropriate time-points during the Day 1 recording period. Decreased BT was observed approximately 2h after treatment on Day 1, along with increased QT interval duration corrected according to the Van de Water formula (QTcV), but the effect was no longer observed after correction for changes in BT [QTcVcT=QTcV-14(37.5-BT)] according to the Van der Linde formula. No significant changes in QTcV were reported at the end of the observation period, on Day 26. The present study demonstrates that core body (rectal) temperature can easily be monitored at appropriate time-points during JET recording in regulatory toxicology studies in dogs, in order to correct QT interval duration values for treatment-related changes in BT. The successful application of the Van der Linde formula to correct QTc prolongation for changes in BT was demonstrated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Potential of prescription registries to capture individual-level use of aspirin and other nonsteroidal anti-inflammatory drugs in Denmark: trends in utilization 1999–2012

    Directory of Open Access Journals (Sweden)

    Schmidt M

    2014-05-01

    Full Text Available Morten Schmidt,1 Jesper Hallas,2 Søren Friis1,31Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Clinical Pharmacology, University of Southern Denmark, Odense, Denmark; 3Danish Cancer Society Research Center, Danish Cancer Society, Copenhagen, DenmarkBackground: Due to over-the-counter availability, no consensus exists on whether adequate information on nonsteroidal anti-inflammatory drug (NSAID use can be obtained from prescription registries.Objectives: To examine utilization of aspirin and nonaspirin NSAIDs in Denmark between 1999 and 2012 and to quantify the proportion of total sales that was sold on prescription.Method: Based on nationwide data from the Danish Serum Institute and the Danish National Prescription Registry, we retrieved sales statistics for the Danish primary health care sector to calculate 1-year prevalences of prescription users of aspirin or nonaspirin NSAIDs, and to estimate the corresponding proportions of total sales dispensed on prescription.Results: Both low-dose aspirin and nonaspirin NSAIDs were commonly used in the Danish population between 1999 and 2012, particularly among elderly individuals. The 1-year prevalence of prescribed low-dose aspirin increased throughout the study period, notably among men. Nonaspirin NSAID use was frequent in all age groups above 15 years and showed a female preponderance. Overall, the prevalence of prescribed nonaspirin NSAIDs decreased moderately after 2004, but substantial variation according to NSAID subtype was observed; ibuprofen use increased, use of all newer selective cyclooxygenase-2 inhibitors nearly ceased after 2004, diclofenac use decreased by nearly 50% after 2008, and naproxen use remained stable. As of 2012, the prescribed proportion of individual-level NSAID sales was 92% for low-dose aspirin, 66% for ibuprofen, and 100% for all other NSAIDs.Conclusion: The potential for identifying NSAID use from prescription

  2. Description of anti-diabetic drug utilization pre- and post-formulary restriction of sitagliptin: findings from a national health plan.

    Science.gov (United States)

    Huang, Xingyue; Liu, Zhiwen; Shankar, Ravi R; Rajpathak, Swapnil

    2015-08-01

    Multi-tiered formularies are commonly used for controlling costs of prescription medications. Focused on type 2 diabetes mellitus (T2DM), this database study assessed drug utilization before and after a formulary restriction (2nd-3rd tier), and compared demographic and clinical characteristics of patients affected vs not by the restriction. Formulary restriction of sitagliptin (SITA) occurred July 1, 2012. The 'pre-period' was defined from January 1-June 30, 2012, the 'grace period' from July 1-September 30, 2012, and the 'post-period' from October 1, 2012-March 31, 2013. Patients from the OptumInsight database were included if diagnosed with T2DM, ≥18 years, had continuous enrollment, and had ≥2 prescriptions of SITA in the pre-period. Those who died or were aged ≥65 years in the post-period were excluded. Patients were grouped into SITA continuer and discontinuer cohorts based on SITA use in the post-period. Descriptive analyses assessed baseline patient characteristics and anti-hyperglycemic drug utilization in the pre- and post-periods. In total, 23,477 patients met inclusion criteria. In the post-period, 36.1% (n = 8480) of patients discontinued SITA. Among SITA discontinuers, 44.1% switched to a preferred DPP-4 inhibitor, 9.2% switched to glucagon-like peptides-1 (GLP-1) or insulin, and 2.4% switched to metformin or sulfonylurea. Of the SITA discontinuers, 21.6% dropped SITA without replacement and 8.4% discontinued all diabetes medications. In the post-period, a greater proportion of SITA discontinuers used GLP-1 (12.6% vs 5.8%) and insulin (29.1% vs 20.9%) than continuers, or had some change in anti-hyperglycemic treatment (67.5% vs 22.1%). Baseline demographic and clinical characteristics were similar between SITA continuers and discontinuers, indicating a lack of an association with SITA discontinuation. This descriptive study used a non-controlled observational approach. Following formulary change, 1/3 of patients discontinued SITA and 30% of

  3. Microscopic observation drug-susceptibility assay vs. Xpert® MTB/RIF for the diagnosis of tuberculosis in a rural African setting: a cost-utility analysis.

    Science.gov (United States)

    Wikman-Jorgensen, Philip E; Llenas-García, Jara; Pérez-Porcuna, Tomàs M; Hobbins, Michael; Ehmer, Jochen; Mussa, Manuel A; Ascaso, Carlos

    2017-06-01

    To compare the cost-utility of microscopic observation drug-susceptibility assay (MODS) and Xpert ® MTB/RIF implementation for tuberculosis (TB) diagnosis in rural northern Mozambique. Stochastic transmission compartmental TB model from the healthcare provider perspective with parameter input from direct measurements, systematic literature reviews and expert opinion. MODS and Xpert ® MTB/RIF were evaluated as replacement test of smear microscopy (SM) or as an add-on test after a negative SM. Costs were calculated in 2013 USD, effects in disability-adjusted life years (DALY). Willingness to pay threshold (WPT) was established at once the per capita Gross National Income of Mozambique. MODS as an add-on test to negative SM produced an incremental cost-effectiveness ratio (ICER) of 5647.89USD/DALY averted. MODS as a substitute for SM yielded an ICER of 5374.58USD/DALY averted. Xpert ® MTB/RIF as an add-on test to negative SM yielded ICER of 345.71USD/DALY averted. Xpert ® MTB/RIF as a substitute for SM obtained an ICER of 122.13USD/DALY averted. TB prevalence and risk of infection were the main factors impacting MODS and Xpert ® MTB/RIF ICER in the one-way sensitivity analysis. In the probabilistic sensitivity analysis, Xpert ® MTB/RIF was most likely to have an ICER below the WPT, whereas MODS was not. Our cost-utility analysis favours the implementation of Xpert ® MTB/RIF as a replacement of SM for all TB suspects in this rural high TB/HIV prevalence African setting. © 2017 John Wiley & Sons Ltd.

  4. Cost-utility and budget impact analysis of drug treatments in pulmonary arterial hypertension associated with congenital heart diseases in Thailand.

    Science.gov (United States)

    Thongsri, Watsamon; Bussabawalai, Thanaporn; Leelahavarong, Pattara; Wanitkun, Suthep; Durongpisitkul, Kritvikrom; Chaikledkaew, Usa; Teerawattananon, Yot

    2016-08-01

    This study aims to compare the lifetime costs and health outcomes of both first-line and sequential combination treatments with standard treatment for pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD) (PAH-CHD) patients. A cost-utility analysis was performed using a Markov model based on a societal perspective. One-way and probabilistic sensitivity analyses were performed to investigate the effect of parameter uncertainty. As first-line treatments, both beraprost (incremental cost-effectiveness ratio (ICER) = 192,752 and 201,308 Thai baht (THB) per quality-adjusted life year (QALY) gained) and sildenafil (ICER = 249,770 and 226,802 THB per QALY gained) seemed cost-effective for PAH-CHD patients aged ≤30 years in functional classes II and III, respectively, while no treatment was cost-effective for the sequential combination therapy. Sildenafil should be included in the National Drug List of Essential Medicines as the first-line treatment for PAH-CHD, and its price per dose should be negotiated to be reduced by 43-57%.

  5. The extraction of aromatic carboxylic acids by the copper complex with Curtis macrocyclic tetramine and its utilization for photometric determination of nonsteroidal anti-inflammatory drugs.

    Science.gov (United States)

    Zseltvay, Ivan; Zheltvay, Olga; Antonovich, Valerij

    2011-01-01

    Copper complex with Curtis macrocyclic tetramine is offered as reagent for extraction-photometric determination of nonsteroidal anti-inflammatory drugs (NSAIDs), belonging to the class of aromatic carboxylic acids. The studies indicate that this method is suitable for quantitative determination of NSAIDs, which have the constant distribution in the system chloroform/water (log P) no less than 3 and dissolubility in chloroform (S) no less than 10 mg/mL. Under optimum conditions, there are liner relationships between the absorption of chloroform extracts and concentration of NSAID in the range of 0.2-4 mg/mL for indometacin (Ind), 0.2-3 mg/mL for mefenamic acid (Mef) and 0.5-3 mg/mL for diclofenac (Dic). The detection limits (S/N = 3) of Ind, Mef and Dic are 0.2, 0.1 and 0.15 mg/mL, respectively. With the help of calculating method (SPARC V4.2) it was predicted the possibility of utilization of this method for extractive-photometric determination of its detached specimen NSAID.

  6. Cardiovascular diseases and periodontology.

    Science.gov (United States)

    Seymour, R A; Preshaw, P M; Thomason, J M; Ellis, J S; Steele, J G

    2003-04-01

    Cardiovascular diseases represent a widespread heterogeneous group of conditions that have significant morbidity and mortality. The various diseases and their treatments can have an impact upon the periodontium and the delivery of periodontal care. In this paper we consider three main topics and explore their relationship to the periodontist and the provision of periodontal treatment. The areas reviewed include the effect of cardiovascular drugs on the periodontium and management of patients with periodontal diseases; the risk of infective endocarditis arising from periodontal procedures; the inter-relationship between periodontal disease and coronary artery disease. Calcium-channel blockers and beta-adrenoceptor blockers cause gingival overgrowth and tooth demineralisation, respectively. Evidence suggests that stopping anticoagulant therapy prior to periodontal procedures is putting patients at a greater risk of thromboembolic disorders compared to the risk of prolonged bleeding. The relationship between dentistry and infective endocarditis remains a controversial issue. It would appear that spontaneous bacteraemia arising from a patient's oral hygiene practices is more likely to be the cause of endocarditis than one-off periodontal procedures. The efficacy of antibiotic prophylaxis is uncertain (and unlikely to be proven), and the risk of death from penicillin appears to be greater than the risk of death arising from infective endocarditis. Finally, the association between periodontal disease and coronary artery disease has been explored and there seem to be many issues with respect to data handling interpretation. Many putative mechanisms have been suggested; however, these only further highlight the need for intervention studies.

  7. The gut microbiome in atherosclerotic cardiovascular disease

    DEFF Research Database (Denmark)

    Jie, Zhuye; Xia, Huihua; Zhong, Shi-Long

    2017-01-01

    The gut microbiota has been linked to cardiovascular diseases. However, the composition and functional capacity of the gut microbiome in relation to cardiovascular diseases have not been systematically examined. Here, we perform a metagenome-wide association study on stools from 218 individuals...... with atherosclerotic cardiovascular disease (ACVD) and 187 healthy controls. The ACVD gut microbiome deviates from the healthy status by increased abundance of Enterobacteriaceae and Streptococcus spp. and, functionally, in the potential for metabolism or transport of several molecules important for cardiovascular...... health. Although drug treatment represents a confounding factor, ACVD status, and not current drug use, is the major distinguishing feature in this cohort. We identify common themes by comparison with gut microbiome data associated with other cardiometabolic diseases (obesity and type 2 diabetes...

  8. Risk of cardiovascular disease

    DEFF Research Database (Denmark)

    Gejl, Michael; Starup-Linde, Jakob; Scheel-Thomsen, Jan

    2014-01-01

    AIMS: Type 2 diabetes (DM) increases the risk of cardiovascular disease. We investigated the effects of antidiabetic drugs on the composite endpoint (CE) of ischemic heart disease, heart failure or stroke in DM patients. METHODS: We conducted a nested case-control study. Cases were DM patients who......% CI: 16.88-24.12), neuropathy (OR=1.39, 95% CI: 1.05-1.85) and peripheral artery disease (OR=1.31, 95% CI: 1.02-1.69) increased the risk of CE. Biguanides (OR=0.62 95% CI; 0.54-0.71) and liraglutide (OR=0.48 95% CI; 0.38-0.62) significantly decreased the risk of CE as did statin treatment (OR=0.63, 95...

  9. RIA in cardiovascular disease

    International Nuclear Information System (INIS)

    Hourani, M.H.

    1983-01-01

    When one discusses the management of chronic cardiac diseases, and in particular congestive heart failure (CHF), one cannot but think of digitalis and the important role it plays in the management of CHF. One also has to think about digitalis toxicity and the narrow margin between the therapeutic and toxic doses of digitalis and the important role that monitoring the serum level of the drug play in preventing and/or recognizing its toxic effects. Again, RIA has something to offer the clinician in this area. The purpose of this chapter is to discuss the radioassays for CPK-MB and digoxin mainly, as well as touch upon other assays of use in evaluating patients with cardiovascular disease

  10. Antiplatelet drug selection in PCI to vein grafts in patients with acute coronary syndrome and adverse clinical outcomes: Insights from the British Cardiovascular Intervention Society database.

    Science.gov (United States)

    Sirker, Alex; Kwok, Chun Shing; Kontopantelis, Evangelos; Johnson, Tom; Freeman, Philip; de Belder, Mark A; Ludman, Peter; Zaman, Azfar; Mamas, Mamas A

    2018-01-22

    This study aims to evaluate outcomes associated with different P2Y12 agents in Saphenous Vein graft (SVG) percutaneous coronary intervention (PCI). SVG PCI is associated with greater risks of ischemic complications, compared with native coronary PCI. Outcomes associated with the use of potent P2Y12 blocking drugs, Prasugrel and Ticagrelor, in SVG PCI are unknown. Patients included in the study underwent SVG PCI in the United Kingdom between 2007 and 2014 for acute coronary syndrome and were grouped by P2Y12 antiplatelet use. In-hospital major adverse cardiac events, major bleeding and 30-day and 1-year mortality were examined. Multiple imputations with chained equations to impute missing data were used. Adjustment for baseline imbalances was performed using (1) multiple logistic regression (MLR) and (separately) (2) propensity score matching (PSM). Data weres analyzed from 8,119 patients and most cases were treated with Clopidogrel (n = 7,401), followed by Ticagrelor (n = 497) and Prasugrel (n = 221). In both MLR and PSM models, there was no significant evidence to suggest that either Prasugrel or Ticagrelor was associated with significantly lower 30-day mortality compared with Clopidogrel. The odds ratios reported from the multivariable analysis were 1.22 (95% CI: 0.60-2.51) for Prasugrel vs. Clopidogrel and 0.48 (95% CI: 0.20-1.16) for Ticagrelor vs. Clopidogrel. No significant differences were seen for in-hospital ischemic or bleeding events. Our real world national study provides no clear evidence to indicate that use of potent P2Y12 blockers in SVG PCI is associated with improved clinical outcomes. © 2018 Wiley Periodicals, Inc.

  11. The Going Out In Sydney App: Evaluating the Utility of a Smartphone App for Monitoring Real-World Illicit Drug Use and Police Encounters Among Festival and Club Goers

    Directory of Open Access Journals (Sweden)

    Caitlin Elizabeth Hughes

    2017-06-01

    Full Text Available Gaining accurate information on illicit drug use and policing in real-world settings is a challenge. This study examines the utility of a smartphone app (‘Going Out In Sydney’ to prospectively follow up illicit drug use and policing encounters at music festivals and licensed entertainment precincts in Sydney, Australia. In all, 38 regular festival and licensed entertainment venue attendees used the app to log nights out over a 3-month period, including (1 where they went (eg, festival, nightclub, (2 the prevalence of illicit drug use, and (3 the incidence and nature of police encounters. A survey and interview were then conducted about the utility of the app. The app enabled rich data collection (n = 353 entries about illicit drug use and policing at both target settings. Follow-up surveys indicated that most participants were extremely satisfied with the ease of use of the app and privacy afforded, and compared with other data collection modes, such as paper-based logs and online surveys, rated the app the most desirable method of data collection. This suggests smartphone apps may be a viable option for future studies on illicit drug use and policing of drugs.

  12. Dental considerations in cardiovascular patients: A practical perspective

    OpenAIRE

    Chaudhry, Swantika; Jaiswal, Ritika; Sachdeva, Surender

    2016-01-01

    Cardiovascular disease trends, complications, and associated therapeutics impact the dental health and treatment. Such patients require special consideration with regard to when and which dental treatment is appropriate and what precautions are required. Alertness to potential oral adverse drug reactions enables referral of patient's to his physician or cardiologist. Cardiovascular drugs are also known to have mild to potentially fatal drug interactions. Dental professionals may be the first ...

  13. 76 FR 64223 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

    Science.gov (United States)

    2011-10-17

    ... Drug Administration 21 CFR Part 870 Cardiovascular Devices; Reclassification of External Pacemaker... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability; Proposed Rule and... [Docket No. FDA-2011-N-0650] Cardiovascular Devices; Reclassification of External Pacemaker Pulse...

  14. Patient-Centred Care of Older Adults With Cardiovascular Disease and Multiple Chronic Conditions.

    Science.gov (United States)

    Kim, Dae Hyun; Rich, Michael W

    2016-09-01

    Multimorbidity, defined as the presence of 2 or more chronic conditions, is common among older adults with cardiovascular disease. These individuals are at increased risk for poor health outcomes and account for a large proportion of health care utilization. Clinicians are challenged with the heterogeneity of this population, the complexity of the treatment regimen, limited high-quality evidence, and fragmented health care systems. Each treatment recommended by a clinical practice guideline for a single cardiovascular disease might be rational, but the combination of all evidence-based recommendations can be impractical or even harmful to individuals with multimorbidity. These challenges can be overcome with a patient-centred approach that incorporates the individual's preferences, relevant evidence, the overall and condition-specific prognosis, clinical feasibility of treatments, and interactions with other treatments and coexisting chronic conditions. The ultimate goal is to maximize benefits and minimize harms by optimizing adherence to the most essential treatments, while acknowledging trade-offs between treatments for different health conditions. It might be necessary to discontinue therapies that are not essential or potentially harmful to decrease the risk of drug-drug and drug-disease interactions from polypharmacy. A decision to initiate, withhold, or stop a treatment should be on the basis of the time horizon to benefits vs the individual's prognosis. In this review, we illustrate how cardiologists and general practitioners can adopt a patient-centred approach to focus on the aspects of cardiovascular and noncardiovascular health that have the greatest effect on functioning and quality of life in older adults with cardiovascular disease and multimorbidity. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  15. Continuous flow reduction of artemisinic acid utilizing multi-injection strategies-closing the gap towards a fully continuous synthesis of antimalarial drugs.

    Science.gov (United States)

    Pieber, Bartholomäus; Glasnov, Toma; Kappe, C Oliver

    2015-03-09

    One of the rare alternative reagents for the reduction of carbon-carbon double bonds is diimide (HN=NH), which can be generated in situ from hydrazine hydrate (N2H4⋅H2O) and O2. Although this selective method is extremely clean and powerful, it is rarely used, as the rate-determining oxidation of hydrazine in the absence of a catalyst is relatively slow using conventional batch protocols. A continuous high-temperature/high-pressure methodology dramatically enhances the initial oxidation step, at the same time allowing for a safe and scalable processing of the hazardous reaction mixture. Simple alkenes can be selectively reduced within 10-20 min at 100-120 °C and 20 bar O2 pressure. The development of a multi-injection reactor platform for the periodic addition of N2H4⋅H2O enables the reduction of less reactive olefins even at lower reaction temperatures. This concept was utilized for the highly selective reduction of artemisinic acid to dihydroartemisinic acid, the precursor molecule for the semisynthesis of the antimalarial drug artemisinin. The industrially relevant reduction was achieved by using four consecutive liquid feeds (of N2H4⋅H2O) and residence time units resulting in a highly selective reduction within approximately 40 min at 60 °C and 20 bar O2 pressure, providing dihydroartemisinic acid in ≥93% yield and ≥95% selectivity. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  16. Expected utility without utility

    OpenAIRE

    Castagnoli, E.; Licalzi, M.

    1996-01-01

    This paper advances an interpretation of Von Neumann–Morgenstern’s expected utility model for preferences over lotteries which does not require the notion of a cardinal utility over prizes and can be phrased entirely in the language of probability. According to it, the expected utility of a lottery can be read as the probability that this lottery outperforms another given independent lottery. The implications of this interpretation for some topics and models in decision theory are considered....

  17. Cardiovascular screening in Turner syndrome

    International Nuclear Information System (INIS)

    Dawson, K.L.; Wright, A.M.; Pitlick, P.T.

    1990-01-01

    This paper determines the utility of MR imaging as a cardiovascular screening method in patients with Turner syndrome and to compare its utility with that of echocardiography. Forty females with karytotypically proved Turner syndrome were prospectively evaluated with MR imaging and echocardiography. A 0.38-T resistive magnet was used to obtain ECG-gated axial and off-sagittal oblique images through the thorax with a spin-echo pulse sequence and TR 400--600 msec, TE 15--30 msec. Two-dimensional, M-mode, and Doppler echocardiography were performed and standard echocardiographic views were obtained

  18. Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial.

    Science.gov (United States)

    Luciano, Juan V; D'Amico, Francesco; Cerdà-Lafont, Marta; Peñarrubia-María, María T; Knapp, Martin; Cuesta-Vargas, Antonio I; Serrano-Blanco, Antoni; García-Campayo, Javier

    2014-10-01

    Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM. The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs). On average, the total costs per patient in the CBT group (1,847 €) were significantly lower than those in patients receiving RPT (3,664 €) or TAU (3,124 €). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for

  19. Cardio-Vascular Disease and Cancer

    OpenAIRE

    K. Mitchell-Fearon DrPh; D. Willie-Tyndale MSc; N. Waldron MPH; D. Holder-Nevins PhD; K. James MPH; H. Laws MPH; D. Eldemire-Shearer PhD

    2015-01-01

    Objective: To report the level of utilization of clinical preventive services by older adults in Jamaica and to identify independent factors associated with utilization. Method: A nationally representative, community-based survey of 2,943 older adults was undertaken. Utilization frequency for six preventive, cardiovascular or cancer-related services was calculated. Logistic regression models were used to determine the independent factors associated with each service. Results: A dichotomy in a...

  20. NKT cells in cardiovascular diseases.

    Science.gov (United States)

    van Puijvelde, Gijs H M; Kuiper, Johan

    2017-12-05

    Despite life-style advice and the prescription of cholesterol-lowering and anti-thrombotic drugs, cardiovascular diseases are still the leading cause of death worldwide. Therefore, there is an urgent need for new therapeutic strategies focussing on atherosclerosis, the major underlying pathology of cardiovascular diseases characterized by an accumulation of lipids in an inflamed arterial/vessel wall. CD1d-restricted lipid-sensing natural killer T (NKT) cells, bridging the innate and adaptive immunity, and CD1d-expressing antigen-presenting cells are detected in atherosclerotic lesions of mice and humans. In this review we will summarize studies that point to a critical role for NKT cells in the pathogenesis of atherosclerosis and other cardiovascular diseases by the secretion of pro-atherogenic cytokines and cytotoxins. These pro-atherogenic NKT cells are potential targets for new therapeutic strategies in the prevention and treatment of cardiovascular diseases. Additionally, proteins transferring lipids during atherosclerosis, which are also important in the loading of lipids onto CD1d and possible endogenous ligands responsible for the activation of NKT cells during atherosclerosis will be discussed. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Laser therapy in cardiovascular disease

    Science.gov (United States)

    Rindge, David

    2009-02-01

    Cardiovascular disease is the number one cause of death worldwide. It is broadly defined to include anything which adversely affects the heart or blood vessels. One-third of Americans have one or more forms of it. By one estimate, average human life expectancy would increase by seven years if it were eliminated. The mainstream medical model seeks mostly to "manage" cardiovascular disease with pharmaceuticals or to surgically bypass or reopen blocked vessels via angioplasty. These methods have proven highly useful and saved countless lives. Yet drug therapy may be costly and ongoing, and it carries the risk of side effects while often doing little or nothing to improve underlying health concerns. Similarly, angioplasty or surgery are invasive methods which entail risk. Laser therapy1 regenerates tissue, stimulates biological function, reduces inflammation and alleviates pain. Its efficacy and safety have been increasingly well documented in cardiovascular disease of many kinds. In this article we will explore the effects of laser therapy in angina, atherosclerosis, coronary artery disease, hypertension, hyperlipidemia, myocardial infarction, stroke and other conditions. The clinical application of various methods of laser therapy, including laserpuncture and transcutaneous, supravascular and intravenous irradiation of blood will be discussed. Implementing laser therapy in the treatment of cardiovascular disease offers the possibility of increasing the health and wellbeing of patients while reducing the costs and enhancing safety of medical care.

  2. Cardiovascular imaging

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    Nuclear cardiology has grown exponentially over the past decade. The introduction of the gamma camera, the development of new radionuclides, and the implementation of computers have transformed the field of nuclear cardiology from largely research in the 1970s to routine clinical applications in the 1980s. At first, noninvasive nuclear imaging techniques were used predominantly to aid disease detection. In the ensuing years, emphasis has shifted to the functional assessment of patients with known disease. Widely available noninvasive techniques now allow the quantitative assessment of left and right ventricular function, one of the most important predictors of survival in patients with cardiac disease. Exercise radionuclide ventriculography provides valuable information on the myocardial reserve in patients with normal resting function. The serial measurement of the ventricular ejection fraction assists in the timing of valvular replacement therapy. In patients receiving doxorubicin, serial ejection fraction follow-up helps prevent the development of irreversible, drug-induced cardiomyopathy. It is now generally acknowledged that the detection of latent coronary disease is improved by the addition of 201 T1 imaging to the standard exercise electrocardiogram. Thallium imaging and infarct avid imaging with /sup 99m/Tc-pyrophosphate have proven useful in quantifying myocardial infarction size, and in assessing the value of therapy aimed at limiting infarction extent. In the evaluation of coronary artery disease, scintigraphy provides physiologic data that complements angiography, which is more anatomic. An angiographic lesion, read as a 70 percent narrowing, may not necessarily be flow-limiting, whereas one read as 40 percent, may, in fact, have physiologic consequences, if it is of sufficient length or eccentricity, or is in series with another insignificant stenosis

  3. The year 2012 in the European Heart Journal-Cardiovascular Imaging: Part I.

    Science.gov (United States)

    Edvardsen, Thor; Plein, Sven; Saraste, Antti; Knuuti, Juhani; Maurer, Gerald; Lancellotti, Patrizio

    2013-06-01

    The new multi-modality cardiovascular imaging journal, European Heart Journal - Cardiovascular Imaging, was started in 2012. During its first year, the new Journal has published an impressive collection of cardiovascular studies utilizing all cardiovascular imaging modalities. We will summarize the most important studies from its first year in two articles. The present 'Part I' of the review will focus on studies in myocardial function, myocardial ischaemia, and emerging techniques in cardiovascular imaging.

  4. Understanding cardiovascular disease

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/patientinstructions/000759.htm Understanding cardiovascular disease To use the sharing features on this page, ... lead to heart attack or stroke. Types of Cardiovascular Disease Coronary heart disease (CHD) is the most common ...

  5. APOE Genotyping, Cardiovascular Disease

    Science.gov (United States)

    ... Resources For Health Professionals Subscribe Search APOE Genotyping, Cardiovascular Disease Send Us Your Feedback Choose Topic At a ... help understand the role of genetic factors in cardiovascular disease . However, the testing is sometimes used in clinical ...

  6. Cardiovascular Disease and Diabetes

    Science.gov (United States)

    ... Peripheral Artery Disease Venous Thromboembolism Aortic Aneurysm More Cardiovascular Disease & Diabetes Updated:Jan 29,2018 The following ... clear that there is a strong correlation between cardiovascular disease (CVD) and diabetes. At least 68 percent ...

  7. Retrospective analysis of drug utilization, health care resource use, and costs associated with IFN therapy for adjuvant treatment of malignant melanoma

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2015-07-01

    Full Text Available ≥Ying Zhang,1 Trong Kim Le,1 James W Shaw,2 Srividya Kotapati31Center for Observational Research and Data Sciences, Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Research and Development, Hopewell, NJ, USA; 2Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Research and Development, Princeton, NJ, USA; 3Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Research and Development, Wallingford Center, CT, USABackground: This study examines real-world drug utilization patterns, health care resource use, and costs among patients receiving adjuvant treatment with IFN versus patients receiving no treatment ("observation" for malignant melanoma following surgery.Methods: A retrospective cohort study was conducted using administrative claims from Truven Health Analytics (MarketScan® to identify all adjuvant melanoma patients (aged ≥18 years diagnosed between June 2007 and June 2011 who had a lymph node dissection (ie, index surgery and were treated with IFN or subsequently observed. Health care resource use and costs of services were converted to 2012 US dollars and were evaluated and compared using multivariable regression.Results: Of 1,999 eligible subjects with melanoma surgery claims, 179 (9.0% were treated with IFN and 1,820 (91.0% were observed. The median duration (days and number of doses of IFN therapy were 73 and 36, respectively. Among IFN-treated patients, only 10.6% completed ≥80% of maintenance therapy. The total average cost for patients treated with IFN was US$60,755±$3,972 (n=179; significantly higher than for patients undergoing observation ($31,641±$2,471; P<0.0001. Similar trends were observed when evaluating total cost components, including melanoma-related and non-melanoma–related medical costs. Among the melanoma-related medical costs, outpatient services, including office visits and laboratory testing, represented between 33% and 53% of total costs and

  8. Cardiovascular Consequences of Obesity and Targets for Treatment

    OpenAIRE

    Mittendorfer, Bettina; Peterson, Linda R.

    2008-01-01

    Obesity is a risk factor for cardiovascular disease, including coronary artery disease and heart failure, but the mechanisms by which it may cause them are not completely clear. Currently, therapies aimed at obesity-related cardiovascular disease include weight loss strategies and reduction of the other risk factors that are associated with obesity and cardiovascular disease. Other pathways with for potential drug development for obesity-related CVD are also discussed.

  9. [Screening for atherosclerosis to prevent cardiovascular risk : a pro-contra debate].

    Science.gov (United States)

    Nanchen, David; Genest, Jacques

    2018-02-28

    Detecting atherosclerosis using imaging techniques is the subject of intense debate in the scientific community. Among the arguments in favor of screening, a better identification or better stratification of cardiovascular risk is mentioned, compared to cardiovascular risk scores based solely on traditional risk factors, such as blood pressure or cholesterol levels. Imaging techniques are also used to monitor the progression of atherosclerosis among patients using lipid-lowering or antihypertensive drugs in primary prevention. However, several experts in recent years have challenged the clinical utility of these imaging techniques in asymptomatic adults. This article proposes a debate « for or against » to describe the main arguments for or against the use of imaging for screening for atherosclerosis.

  10. Efficacy of cardiovascular complications correction in patients with breast cancer

    International Nuclear Information System (INIS)

    Savchenko, A.S.

    2011-01-01

    The work was performed with the purpose to assess the efficacy of cardiovascular complications correction at combination treatment for breast cancer (BC). Timely diagnosis and correction of cardiovascular diseases in BC with the use of inhalation cardioactive drugs (nitrates and calcium antagonists) improved the efficacy of accompanying therapy, prevented progress of early and late RT complications, improved the quality of life.

  11. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2011-08-30

    ... Pacemaker Electrode; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction... preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect...

  12. Cardiovascular effects of phentermine and topiramate

    DEFF Research Database (Denmark)

    Jordan, Jens; Astrup, Arne; Engeli, Stefan

    2014-01-01

    Weight loss can reduce the increased cardiovascular risk associated with obesity. Pharmacotherapy is a recognized weight loss treatment option; however, cardiovascular safety issues with some previous weight loss drugs raise concerns for newly approved pharmacotherapies. Phentermine is approved...... for short-term obesity treatment in conjunction with lifestyle modifications, but is commonly used chronically. Topiramate, approved for treating epilepsy and preventing migraines, also induces weight loss. A single-dose combination of low-dose phentermine and topiramate extended-release was recently...... approved by the United States Food and Drug Administration as an adjunct to lifestyle intervention for the chronic treatment of overweight/obese adults. This review summarizes and evaluates the cardiovascular risk/benefit profile associated with phentermine and topiramate, individually and in combination...

  13. 76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585

  14. The Impact of NSAID Treatment on Cardiovascular Risk

    DEFF Research Database (Denmark)

    Olsen, A. M. S.; Fosbol, E. L.; Gislason, Gunnar H.

    2014-01-01

    This MiniReview describes the present evidence for the relationship between cardiovascular risk and use of non-steroidal anti-inflammatory drugs (NSAIDs) with special focus using Danish register-based data. NSAIDs are among the most widely used drugs worldwide and mainly used for management of pain...... and inflammatory conditions. Through the past decade, much attention has been given to the cardiovascular safety of these drugs, and several studies have shown increased risk of adverse cardiovascular effects associated with NSAID use. Current guidelines discourage any use of NSAIDs in patients with cardiovascular...... observational studies is accumulating, suggesting that NSAIDs are a major public health concern due to the widespread use of these drugs. Although it seems unlikely that we can completely avoid use of NSAIDs, even among high-risk patients, these results highlight the importance of balancing the benefit versus...

  15. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology

    NARCIS (Netherlands)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Günter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Jörg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J.; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-01-01

    Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures,

  16. Improving clinical trials for cardiovascular diseases : a position paper from the Cardiovascular Round Table of the European Society of Cardiology

    NARCIS (Netherlands)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Guenter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Joerg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J.; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-01-01

    Aims Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures,

  17. Validation and Clinical Utility of the hERG IC50:Cmax Ratio to Determine the Risk of Drug-Induced Torsades de Pointes: A Meta-Analysis.

    Science.gov (United States)

    Lehmann, David F; Eggleston, William D; Wang, Dongliang

    2018-03-01

    Use of the QT interval corrected for heart rate (QTc) on the electrocardiogram (ECG) to predict torsades de pointes (TdP) risk from culprit drugs is neither sensitive nor specific. The ratio of the half-maximum inhibitory concentration of the hERG channel (hERG IC50) to the peak serum concentration of unbound drug (C max ) is used during drug development to screen out chemical entities likely to cause TdP. To validate the use of the hERG IC50:C max ratio to predict TdP risk from a culprit drug by its correlation with TdP incidence. Medline (between 1966 and March 2017) was accessed for hERG IC50 and C max values from the antihistamine, fluoroquinolone, and antipsychotic classes to identify cases of drug-induced TdP. Exposure to a culprit drug was estimated from annual revenues reported by the manufacturer. Inclusion criteria for TdP cases were provision of an ECG tracing that demonstrated QTc prolongation with TdP and normal serum values of potassium, calcium, and magnesium. Cases reported in patients with a prior rhythm disturbance and those involving a drug interaction were excluded. The Meta-Analysis of Observational Studies in Epidemiology checklist was used for epidemiological data extraction by two authors. Negligible risk drugs were defined by an hERG IC50:C max ratio that correlated with less than a 5% chance of one TdP event for every 100 million exposures (relative risk [RR] 1.0). The hERG IC50:C max ratio correlated with TdP risk (0.312; 95% confidence interval 0.205-0.476, pratio of 80 (RR 1.0). The RR from olanzapine is on par with loratadine; ziprasidone is comparable with ciprofloxacin. Drugs with an RR greater than 50 include astemizole, risperidone, haloperidol, and thioridazine. The hERG IC50:C max ratio was correlated with TdP incidence for culprit drugs. This validation provides support for the potential use of the hERG IC50:C max ratio for clinical decision making in instances of drug selection where TdP risk is a concern. © 2018

  18. Cardiovascular-Active Venom Toxins: An Overview.

    Science.gov (United States)

    Rebello Horta, Carolina Campolina; Chatzaki, Maria; Rezende, Bruno Almeida; Magalhães, Bárbara de Freitas; Duarte, Clara Guerra; Felicori, Liza Figueiredo; Ribeiro Oliveira-Mendes, Bárbara Bruna; do Carmo, Anderson Oliveira; Chávez-Olórtegui, Carlos; Kalapothakis, Evanguedes

    2016-01-01

    Animal venoms are a mixture of bioactive compounds produced as weapons and used primarily to immobilize and kill preys. As a result of the high potency and specificity for various physiological targets, many toxins from animal venoms have emerged as possible drugs for the medication of diverse disorders, including cardiovascular diseases. Captopril, which inhibits the angiotensin-converting enzyme (ACE), was the first successful venom-based drug and a notable example of rational drug design. Since captopril was developed, many studies have discovered novel bradykinin-potentiating peptides (BPPs) with actions on the cardiovascular system. Natriuretic peptides (NPs) have also been found in animal venoms and used as template to design new drugs with applications in cardiovascular diseases. Among the anti-arrhythmic peptides, GsMTx-4 was discovered to be a toxin that selectively inhibits the stretch-activated cation channels (SACs), which are involved in atrial fibrillation. The present review describes the main components isolated from animal venoms that act on the cardiovascular system and presents a brief summary of venomous animals and their venom apparatuses.

  19. Cardiovascular risk prediction in the Netherlands

    NARCIS (Netherlands)

    Dis, van S.J.

    2011-01-01

    Background: In clinical practice, Systematic COronary Risk Evaluation (SCORE) risk prediction functions and charts are used to identify persons at high risk for cardiovascular diseases (CVD), who are considered eligible for drug treatment of elevated blood pressure and serum cholesterol. These

  20. Cardiovascular MRI with ferumoxytol

    International Nuclear Information System (INIS)

    Finn, J.P.; Nguyen, K.-L.; Han, F.; Zhou, Z.; Salusky, I.; Ayad, I.; Hu, P.

    2016-01-01

    The practice of contrast-enhanced magnetic resonance angiography (CEMRA) has changed significantly in the span of a decade. Concerns regarding gadolinium (Gd)-associated nephrogenic systemic fibrosis in those with severely impaired renal function spurred developments in low-dose CEMRA and non-contrast MRA as well as efforts to seek alternative MR contrast agents. Originally developed for MR imaging use, ferumoxytol (an ultra-small superparamagnetic iron oxide nanoparticle), is currently approved by the US Food and Drug Administration for the treatment of iron deficiency anaemia in adults with renal disease. Since its clinical availability in 2009, there has been rising interest in the scientific and clinical use of ferumoxytol as an MR contrast agent. The unique physicochemical and pharmacokinetic properties of ferumoxytol, including its long intravascular half-life and high r 1 relaxivity, support a spectrum of MRI applications beyond the scope of Gd-based contrast agents. Moreover, whereas Gd is not found in biological systems, iron is essential for normal metabolism, and nutritional iron deficiency poses major public health challenges worldwide. Once the carbohydrate shell of ferumoxytol is degraded, the elemental iron at its core is incorporated into the reticuloendothelial system. These considerations position ferumoxytol as a potential game changer in the field of CEMRA and MRI. In this paper, we aim to summarise our experience with the cardiovascular applications of ferumoxytol and provide a brief synopsis of ongoing investigations on ferumoxytol-enhanced MR applications.

  1. Cardiovascular disease among severe mental illness and psychiatric medication

    Directory of Open Access Journals (Sweden)

    Sileshi Demelash

    2017-01-01

    Full Text Available People with mental illness are more likely to have serious coexisting physical health problems than the general population. Although lifestyle and genetics may contribute independent risks of cardiovascular dysfunction in schizophrenia and other serious mental illness, antipsychotic treatment also represents an important contributor to risk of cardiovascular disorder, particularly for certain drugs and for vulnerable patients. Mental health professionals and other health care provider must give emphasis to recognize the clinical signposts indicating mental health related cardiovascular problems to forestall progression to type II diabetes, cardiovascular events and premature death.

  2. Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

    Science.gov (United States)

    Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

    2017-04-01

    Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

  3. 78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute...

    Science.gov (United States)

    2013-12-30

    .... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems... of these devices into class II. List of Subjects in 21 CFR Part 870 Medical devices, Cardiovascular... Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows: PART 870--CARDIOVASCULAR DEVICES 0 1...

  4. Impact of recent reforms in Austria on utilization and expenditure of PPIs and lipid-lowering drugs: implications for the future.

    Science.gov (United States)

    Godman, Brian; Burkhardt, Thomas; Bucsics, Anna; Wettermark, Björn; Wieninger, Peter

    2009-10-01

    To assess the impact of a plethora of reforms and initiatives introduced in Austria since 2002 on the actual utilization and expenditure of proton pump inhibitors and statins. Utilization of dispensed prescriptions in ambulatory care was captured from 2001 to 2007 using defined daily doses (DDD) as well as DDDs/1000 inhabitants/day for patients covered by the social health insurance system. The data were provided by the internal data warehouse of Hauptverband der Osterreichischen Sozialversicherungsträger. Total costs in Euros were used for the analysis from the payer's perspective. The reduction in the expenditure per DDD for both generic PPIs and statins was generally in line with expectations at over 60% of originator prices before multiple sources became available. There was also increased utilization of generics following the range of demand-side initiatives. This was 89.5% for generic omeprazole versus total omeprazole and 95.1% for generic simvastatin versus total simvastatin by the end of 2007. The utilization of atorvastatin fell substantially from 36.5% of all statins in 2002 to 10.7% by the end of 2007 following restrictions on its prescribing to patients not achieving target lipid levels with, for instance, generic simvastatin. The combined initiatives reduced expenditure per DDD for the PPIs and the statins by 41 and 60%, respectively, in 2007 versus 2001 levels. This reduction translated into lower expenditure for the statins in 2007 versus 2001 despite substantially increased utilization. The results provide examples to other European countries, especially the restrictions on atorvastatin utilization. Nevertheless, further initiatives will be needed to conserve resources as utilization rates grow in chronic disease areas. This includes potential lessons from other European countries.

  5. Research in cardiovascular care

    DEFF Research Database (Denmark)

    Jaarsma, Tiny; Deaton, Christi; Fitzsimmons, Donna

    2014-01-01

    with the increasing opportunities and challenges in multidisciplinary research, the Science Committee of the Council on Cardiovascular Nursing and Allied Professionals (CCNAP) recognised the need for a position statement to guide researchers, policymakers and funding bodies to contribute to the advancement...... of the body of knowledge that is needed to further improve cardiovascular care. In this paper, knowledge gaps in current research related to cardiovascular patient care are identified, upcoming challenges are explored and recommendations for future research are given....

  6. Apolipoprotein E and cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Adriana Moreno Valladares

    2006-01-01

    Full Text Available Apolipoprotein E is a polymorphic glycoprotein who interacts with the lipoprotein receptors (LRP-Receptor Related Protein and the receptors for low density lipoproteins of (LDL receptors. When lipoproteins bring up the receptors begins lipids captation and degradation which allows cholesterol utilization, taking place an intracellular auto regulation. The three isoforms of greater importance: Apo E2, E3 and E4 are product of three alleles e2, e3, e4 of one only gene. This factor is related with the amount of lipoproteins that contains ApoE for E/B receptors. A low concentration of lipoproteins with ApoE can increase the activity of LDL receptors and consequently downward the circulating LDL. In the other hand particles with Apo E3 or Apo E4, can cause a downward regulation of LDL and in this way produces a LDL plasma elevation. Many studies in human populations have concluded that this polymorphism of apoE and the plasma variation of lipoproteins are associated with cardiovascular risk. Cardiovascular disease is the result of different interaction between factors which are genetic factor specially ApoE polymorphism e4 allelic of ApoE can explain, in some degree, the greater frequency of cardiovascular disease in those who carries it.

  7. Utilization of an Automated Pipetting System in the Cell Line-Based Screening of the Activity of a DNA-Damaging Anti-Tumour Drug

    Czech Academy of Sciences Publication Activity Database

    Suchánková, Tereza; Ovesná, P.; Samadder, P.; Souček, Karel

    2014-01-01

    Roč. 60, č. 1 (2014), s. 50-55 ISSN 0015-5500 R&D Projects: GA MŠk(CZ) EE2.3.30.0030 Institutional support: RVO:68081707 Keywords : cell line screen * drug treatment * liquid handling station Subject RIV: BO - Biophysics Impact factor: 1.000, year: 2014

  8. Cardiovascular risk factors and collateral artery formation.

    Science.gov (United States)

    de Groot, D; Pasterkamp, G; Hoefer, I E

    2009-12-01

    Arterial lumen narrowing and vascular occlusion is the actual cause of morbidity and mortality in atherosclerotic disease. Collateral artery formation (arteriogenesis) refers to an active remodelling of non-functional vascular anastomoses to functional collateral arteries, capable to bypass the site of obstruction and preserve the tissue that is jeopardized by ischaemia. Hemodynamic forces such as shear stress and wall stress play a pivotal role in collateral artery formation, accompanied by the expression of various cytokines and invasion of circulating leucocytes. Arteriogenesis hence represents an important compensatory mechanism for atherosclerotic vessel occlusion. As arteriogenesis mostly occurs when lumen narrowing by atherosclerotic plaques takes place, presence of cardiovascular risk factors (e.g. hypertension, hypercholesterolaemia and diabetes) is highly likely. Risk factors for atherosclerotic disease affect collateral artery growth directly and indirectly by altering hemodynamic forces or influencing cellular function and proliferation. Adequate collateralization varies significantly among atherosclerotic patients, some profit from the presence of extensive collateral networks, whereas others do not. Cardiovascular risk factors could increase the risk of adverse cardiovascular events in certain patients because of the reduced protection through an alternative vascular network. Likewise, drugs primarily thought to control cardiovascular risk factors might contribute or counteract collateral artery growth. This review summarizes current knowledge on the influence of cardiovascular risk factors and the effects of cardiovascular medication on the development of collateral vessels in experimental and clinical studies.

  9. [Vitamina D. A wonderful drug?].

    Science.gov (United States)

    Casado de Frías, Enrique

    2011-01-01

    During the last years vitamina D receptors have been found in a vast number of tissues and cell types. In paralel, the therapeutic utility of vitamina D has expanded to the prophylaxis of muscular, oncologic, cardiovascular and autoinmmune disorders.

  10. Pareto utility

    NARCIS (Netherlands)

    Ikefuji, M.; Laeven, R.J.A.; Magnus, J.R.; Muris, C.H.M.

    2013-01-01

    In searching for an appropriate utility function in the expected utility framework, we formulate four properties that we want the utility function to satisfy. We conduct a search for such a function, and we identify Pareto utility as a function satisfying all four desired properties. Pareto utility

  11. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.

    Science.gov (United States)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Günter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Jörg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-03-01

    Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines. The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development. A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier

  12. Reducing post-surgical adhesions utilizing a drug-enhanced device: sodium carboxymethylcellulose aqueous gel/poly(p-dioxanone) and Tranilast

    International Nuclear Information System (INIS)

    Cui, Helen; Gensini, Michel; Kataria, Ram; Twaddle, Tricia; Zhang, John; Wadsworth, Scott; Cooper, Kevin; Petrilli, Janel; Rodgers, Kathleen; DiZerega, Gere

    2009-01-01

    Post-surgical adhesion formation has numerous deleterious side effects in a wide variety of surgical settings. Physical barriers used together with laparoscopy were developed to reduce tissue trauma seen with open procedures. However, despite surgeons' meticulous techniques and the use of such barriers, adhesion formation remains a serious clinical problem, creating complications that cost the health care system over $1 billion annually. Our laboratories have combined a previously marketed drug, Tranilast, with a sodium carboxymethylcellulose (NaCMC) gel in a sustained release formulation using poly(p-dioxanone) (PDO) to provide a locally delivered medicated device that significantly reduces adhesions. This paper describes the preparation of the gel and the sustained release formulation, its key physical properties, and its sustained release kinetics. Pre-clinical data on inhibition of adhesion formation by the sustained release poly(p-dioxanone)/sodium carboxymethylcellulose/Tranilast drug enhanced device are also presented.

  13. Drug utilization study from a government sponsored pharmacy in a tertiary care teaching hospital of rural West Bengal: A cross-sectional study

    OpenAIRE

    Tanmoy Gangopadhyay; Ananya Mandal; Sonai Mandal; Bishan Basu; Tamoghna Maiti; Abhijit Das; Soumitra Mandal; Sekhar Mandal

    2016-01-01

    Context: Newly started government sponsored pharmacies providing discounts have been available to the public at the medical college hospitals in West Bengal. Aims: The present study was undertaken to evaluate the drug prescribing trends from the prescriptions at such a pharmacy at a tertiary care hospital. Methods: The study was a prospective cross-sectional study that spanned for a period of 1-month from 1 to 31 August 2015. Prescriptions were reviewed and analyzed using the World Health Org...

  14. Postirradiation cardiovascular dysfunction

    International Nuclear Information System (INIS)

    Hawkins, R.N.; Cockerham, L.G.

    1987-01-01

    Cardiovascular dysfunction may be defined as the inability of any element of the cardiovascular system to perform adequately upon demand, leading to inadequate performance and nutritive insufficiency of various parts of the body. Exposure to supralethal doses of radiation (accidental and therapeutic) has been show to induce significant alterations in cardiovascular function in man. These findings indicate that, after irradiation, cardiovascular function is a major determinant of continued performance and even survival. For the two persons who received massive radiation doses (45 and 88 Gy, respectively) in criticality accidents, the inability to maintain systematic arterial blood pressure (AP) was the immediate cause of death. In a study of cancer patients given partial-body irradiation, two acute lethalities were attributed to myocardial infarction after an acute hypotensive episode during the first few hours postexposure. Although radiation-induced cardiovascular dysfunction has been observed in many species, its severity, duration, and even etiology may vary with the species, level of exposure, and dose rate. For this reason, our consideration of the effects of radiation on cardiovascular performance is limited to the circulatory derangements that occur in rat, dog, and monkey after supralethal doses and lead to radiation-induced cardiovascular dysfunction in these experimental models. The authors consider other recent data as they pertain to the etiology of cardiovascular dysfunction in irradiated animals

  15. Lifestyle in Cardiovascular Disease

    NARCIS (Netherlands)

    J.O. Younge (John)

    2015-01-01

    markdownabstract__Abstract__ Globally, the burden of cardiovascular disease (CVD) is still increasing. However, in recent decades, better treatment modalities have led to less cardiovascular related deaths. After years of research, we now generally accept that lifestyle factors are the most

  16. Examining the Feasibility and Utility of Estimating Partial Expected Value of Perfect Information (via a Nonparametric Approach) as Part of the Reimbursement Decision-Making Process in Ireland: Application to Drugs for Cancer.

    Science.gov (United States)

    McCullagh, Laura; Schmitz, Susanne; Barry, Michael; Walsh, Cathal

    2017-11-01

    In Ireland, all new drugs for which reimbursement by the healthcare payer is sought undergo a health technology assessment by the National Centre for Pharmacoeconomics. The National Centre for Pharmacoeconomics estimate expected value of perfect information but not partial expected value of perfect information (owing to computational expense associated with typical methodologies). The objective of this study was to examine the feasibility and utility of estimating partial expected value of perfect information via a computationally efficient, non-parametric regression approach. This was a retrospective analysis of evaluations on drugs for cancer that had been submitted to the National Centre for Pharmacoeconomics (January 2010 to December 2014 inclusive). Drugs were excluded if cost effective at the submitted price. Drugs were excluded if concerns existed regarding the validity of the applicants' submission or if cost-effectiveness model functionality did not allow required modifications to be made. For each included drug (n = 14), value of information was estimated at the final reimbursement price, at a threshold equivalent to the incremental cost-effectiveness ratio at that price. The expected value of perfect information was estimated from probabilistic analysis. Partial expected value of perfect information was estimated via a non-parametric approach. Input parameters with a population value at least €1 million were identified as potential targets for research. All partial estimates were determined within minutes. Thirty parameters (across nine models) each had a value of at least €1 million. These were categorised. Collectively, survival analysis parameters were valued at €19.32 million, health state utility parameters at €15.81 million and parameters associated with the cost of treating adverse effects at €6.64 million. Those associated with drug acquisition costs and with the cost of care were valued at €6.51 million and €5.71

  17. Utility of imaging mass spectrometry (IMS) by matrix-assisted laser desorption ionization (MALDI) on an ion trap mass spectrometer in the analysis of drugs and metabolites in biological tissues.

    Science.gov (United States)

    Drexler, Dieter M; Garrett, Timothy J; Cantone, Joseph L; Diters, Richard W; Mitroka, James G; Prieto Conaway, Maria C; Adams, Stephen P; Yost, Richard A; Sanders, Mark

    2007-01-01

    The properties and potential liabilities of drug candidate are investigated in detailed ADME assays and in toxicity studies, where findings are placed in context of exposure to dosed drug and metabolites. The complex nature of biological samples may necessitate work-up procedures prior to high performance liquid chromatography-mass spectrometric (HPLC-MS) analysis of endogenous or xenobiotic compounds. This concept can readily be applied to biological fluids such as blood or urine, but in localized samples such as organs and tissues potentially important spatial, thus anatomical, information is lost during sample preparation as the result of homogenization and extraction procedures. However, the localization of test article or spatial identification of metabolites may be critical to the understanding of the mechanism of target-organ toxicity and its relevance to clinical safety. Tissue imaging mass spectrometry (IMS) by matrix-assisted laser desorption ionization (MALDI) and ion trap mass spectrometry (MS) with higher order mass spectrometric scanning functions was utilized for localization of dosed drug or metabolite in tissue. Laser capture microscopy (LCM) was used to obtain related samples from tissue for analyses by standard MALDI-MS and HPLC-MS. In a toxicology study, rats were administered with a high dosage of a prodrug for 2 weeks. Birefringent microcrystalline material (10-25 microm) was observed in histopathologic formalin-fixed tissue samples. Direct analysis by IMS provided the identity of material in the microcrystals as circulating active drug while maintaining spatial orientation. Complementary data from visual cross-polarized light microscopy as well as standard MALDI-MS and HPLC-MS experiments on LCM samples validated the qualitative results obtained by IMS. Furthermore, the HPLC-MS analysis on the LCM samples afforded a semi-quantitative assessment of the crystalline material in the tissue samples. IMS by MALDI ion trap MS proved sensitive

  18. [Drugs in pregnancy].

    Science.gov (United States)

    Danchev, N; Astrug, A; Tsankova, V; Nikolova, I

    2006-01-01

    The use of drugs in pregnancy is being discussed. The influence of different factors, both physiological and drug related (physicochemical characteristics, dose, duration of pharmacotherapy) on the processes of absorption, distribution, protein binding, metabolism and excretion are reviewed. The up-to-date classification of the drugs in relation to their effects on the fetus is presented. Special emphasize is given to drugs (antibiotics, cardio-vascular, psychotropic etc.) used for the treatment of acute and chronic conditions in the course of pregnancy. Drugs used for symptoms like pain, high temperature and constipation are also reviewed. Recommendations for the use of safer drugs in pregnancy are given. Drugs with proven teratogenic effects are presented.

  19. Register-based studies of cardiovascular disease

    DEFF Research Database (Denmark)

    Abildstrøm, Steen Z; Torp-Pedersen, Christian; Madsen, Mette

    2011-01-01

    Introduction: The use of the unique personal identification number in the Nordic database systems enables the researchers to link the registers at the individual level. The registers can be used for both defining specific patient populations and to identify later events during follow-up. This rev...... the hospitalisation rate and treatment of cardiovascular disease. The risk of unmeasured factors affecting the results calls for cautious interpretation of the results.......-up. This review gives three examples within cardiovascular epidemiology to illustrate the use of the national administrative registers available to all researchers upon request. Research topics: The hospitalisation rate of acute myocardial infarction (AMI) was expected to be increased and case-fatality rate......-based treatment increased significantly over time and adherence to treatment was high. Finally, use of specific nonsteroidal antiinflammatory drugs by healthy subjects was associated with a dose-dependent increase in cardiovascular risk. CONCLUSION: The nationwide registers have proven very useful in monitoring...

  20. Simultaneous Voltammetric Determination of Acetaminophen and Isoniazid (Hepatotoxicity-Related Drugs) Utilizing Bismuth Oxide Nanorod Modified Screen-Printed Electrochemical Sensing Platforms.

    Science.gov (United States)

    Mahmoud, Bahaa G; Khairy, Mohamed; Rashwan, Farouk A; Banks, Craig E

    2017-02-07

    To overcome the recent outbreaks of hepatotoxicity-related drugs, a new analytical tool for the continuously determination of these drugs in human fluids is required. Electrochemical-based analytical methods offer an effective, rapid, and simple tool for on-site determination of various organic and inorganic species. However, the design of a sensitive, selective, stable, and reproducible sensor is still a major challenge. In the present manuscript, a facile, one-pot hydrothermal synthesis of bismuth oxide (Bi 2 O 2.33 ) nanostructures (nanorods) was developed. These BiO nanorods were cast onto mass disposable graphite screen-printed electrodes (BiO-SPEs), allowing the ultrasensitive determination of acetaminophen (APAP) in the presence of its common interference isoniazid (INH), which are both found in drug samples. The simultaneous electroanalytical sensing using BiO-SPEs exhibited strong electrocatalytic activity toward the sensing of APAP and INH with an enhanced analytical signal (voltammetric peak) over that achievable at unmodified (bare) SPEs. The electroanalytical sensing of APAP and INH are possible with accessible linear ranges from 0.5 to 1250 μM and 5 to 1760 μM with limits of detection (3σ) of 30 nM and 1.85 μM, respectively. The stability, reproducibility, and repeatability of BiO-SPE were also investigated. The BiO-SPEs were evaluated toward the sensing of APAP and INH in human serum, urine, saliva, and tablet samples. The results presented in this paper demonstrate that BiO-SPEs sensing platforms provide a potential candidate for the accurate determination of APAP and INH within human fluids and pharmaceutical formulations.

  1. Cardiovascular risk-benefit profile of sibutramine.

    Science.gov (United States)

    Scheen, A J

    2010-01-01

    Sibutramine is a combined norepinephrine and serotonin reuptake inhibitor used as an antiobesity agent to reduce appetite and promote weight loss in combination with diet and exercise. At a daily dose of 10-20 mg, it was initially considered to have a good safety profile, as it does not induce primary pulmonary hypertension or adverse effects on cardiac valves, in contrast to previous reports relating to some other antiobesity agents. However, it exerts disparate effects on cardiovascular risk factors. On the one hand, sibutramine may have antiatherogenic activities, as it improves insulin resistance, glucose metabolism, dyslipidemia, and inflammatory markers, with most of these effects resulting from weight loss rather than from an intrinsic effect of the drug. On the other hand, because of its specific mode of action, sibutramine exerts a peripheral sympathomimetic effect, which induces a moderate increase in heart rate and attenuates the reduction in BP attributable to weight loss or even slightly increases BP. It may also prolong the QT interval, an effect that could induce arrhythmias. Because of these complex effects, it is difficult to conclude what the final impact of sibutramine on cardiovascular outcomes might be. Sibutramine has been shown to exert favorable effects on some surrogate cardiovascular endpoints such as reduction of left ventricular hypertrophy and improvement of endothelial dysfunction. A good cardiovascular safety profile was demonstrated in numerous 1- to 2-year controlled trials, in both diabetic and nondiabetic well selected patients, as well as in several observational studies. However, since 2002, several cardiovascular adverse events (hypertension, tachycardia, arrhythmias, and myocardial infarction) have been reported in sibutramine-treated patients. This led to a contraindication of the use of this antiobesity agent in patients with established coronary heart disease, previous stroke, heart failure, or cardiac arrhythmias. SCOUT

  2. Cardiovascular safety of biologic therapies for the treatment of RA.

    Science.gov (United States)

    Greenberg, Jeffrey D; Furer, Victoria; Farkouh, Michael E

    2011-11-15

    Cardiovascular disease represents a major source of extra-articular comorbidity in patients with rheumatoid arthritis (RA). A combination of traditional cardiovascular risk factors and RA-related factors accounts for the excess risk in RA. Among RA-related factors, chronic systemic inflammation has been implicated in the pathogenesis and progression of atherosclerosis. A growing body of evidence--mainly derived from observational databases and registries--suggests that specific RA therapies, including methotrexate and anti-TNF biologic agents, can reduce the risk of future cardiovascular events in patients with RA. The cardiovascular profile of other biologic therapies for the treatment of RA has not been adequately studied, including of investigational drugs that improve systemic inflammation but alter traditional cardiovascular risk factors. In the absence of large clinical trials adequately powered to detect differences in cardiovascular events between biologic drugs in RA, deriving firm conclusions on cardiovascular safety is challenging. Nevertheless, observational research using large registries has emerged as a promising approach to study the cardiovascular risk of emerging RA biologic therapies.

  3. Dental considerations in cardiovascular patients: A practical perspective

    Directory of Open Access Journals (Sweden)

    Swantika Chaudhry

    2016-07-01

    Full Text Available Cardiovascular disease trends, complications, and associated therapeutics impact the dental health and treatment. Such patients require special consideration with regard to when and which dental treatment is appropriate and what precautions are required. Alertness to potential oral adverse drug reactions enables referral of patient's to his physician or cardiologist. Cardiovascular drugs are also known to have mild to potentially fatal drug interactions. Dental professionals may be the first line of defense in the detection and referral of a patient suspected of having cardiovascular disease, an uncontrolled disease status, or oral adverse drug reactions, and they have a key role to play in oral and systemic disease prevention and treatment, in partnership with the patient and his physician.

  4. Epileptogenic networks and drug-resistant epilepsy: Present and future perspectives of epilepsy research-Utility for the epileptologist and the epilepsy surgeon

    Directory of Open Access Journals (Sweden)

    Jyotirmoy Banerjee

    2014-01-01

    Full Text Available A multidisciplinary approach is required to understand the complex intricacies of drug-resistant epilepsy (DRE. A challenge that neurosurgeons across the world face is accurate localization of epileptogenic zone. A significant number of patients who have undergone resective brain surgery for epilepsy still continue to have seizures. The reason behind this therapy resistance still eludes us. Thus to develop a cure for the difficult to treat epilepsy, we need to comprehensively study epileptogenesis. Till date, most of the studies on DRE is focused on undermining the abnormal functioning of receptors involved in synaptic transmission and reduced levels of antiepileptic drugs around there targets. But recent advances in imaging and electrophysiological techniques have suggested the role epileptogenic networks in the process of epileptogenesis. According to this hypothesis, the local neurons recruit distant neurons through complex oscillatory circuits, which further recruit more distant neurons, thereby generating a hypersynchronus neuronal activity. The epileptogenic networks may be confined to the lesion or could propagate to distant focus. The success of surgery depends on the precision by which the epileptogenic network is determined while planning a surgical intervention. Here, we summarize various modalities of electrophysiological and imaging techniques to determine the functionally active epileptogenic networks. We also review evidence pertaining to the proposed role of epileptogenic network in abnormal synaptic transmission which is one of the major causes of epileptiform activity. Elucidation of current concepts in regulation of synaptic transmission by networks will help develop therapies for epilepsy cases that cannot be managed pharmacologically.

  5. The Utility of Infliximab Therapeutic Drug Monitoring among Patients with Inflammatory Bowel Disease and Concerns for Loss of Response: A Retrospective Analysis of a Real-World Experience

    Directory of Open Access Journals (Sweden)

    Robert A. Mitchell

    2016-01-01

    Full Text Available Background. Infliximab (IFX therapeutic drug monitoring (TDM allows for objective decision making in patients with inflammatory bowel disease (IBD and loss of response. Questions remain about whether IFX TDM improves outcomes. Methods. Patients with IBD who had IFX TDM due to concerns for loss of response were considered for inclusion. Serum IFX trough concentration and anti-drug antibody (ADA concentrations were measured. Patients were grouped by TDM results: group 1, low IFX/high ADA; group 2, low IFX/low ADA; group 3, therapeutic IFX. Changes in management were analyzed according to groupings; remission rates were assessed at 6 months. Results. 71 patients were included of whom 37% underwent an appropriate change in therapy. Groups 1 (67% and 2 (83% had high adherence compared to only 9% in group 3. At 6 months, 57% had achieved remission. More patients who underwent an appropriate change in therapy achieved remission, though this did not reach statistical significance (69% versus 49%; P=0.098. Conclusions. A trend towards increased remission rates was associated with appropriate changes in management following TDM results. Many patients with therapeutic IFX concentrations did not undergo an appropriate change in management, potentially reflecting a lack of available out-of-class options at the time of TDM or due to uncertainty of the meaning of the reported therapeutic range.

  6. Drug abuse: newly-emerging drugs and trends.

    Science.gov (United States)

    Davis, Gregory G

    2012-09-01

    Drug abusers have access to new, more potent compounds that evade existing laws by virtue of their novel chemical structures. These drugs are available for purchase at stores and over the internet. The drugs are not illegal because they are so new that laws have not yet been passed to ban them. These drugs are leading to emergency department visits for cardiovascular, neurologic, and psychiatric complications. Standard drug screens are not designed to detect these new substances. The internet provides access to drugs for substance abusers but also provides physicians speed of access to the habits of substance abusers.

  7. Caffeine and cardiovascular health.

    Science.gov (United States)

    Turnbull, Duncan; Rodricks, Joseph V; Mariano, Gregory F; Chowdhury, Farah

    2017-10-01

    This report evaluates the scientific literature on caffeine with respect to potential cardiovascular outcomes, specifically relative risks of total cardiovascular disease (CVD), coronary heart disease (CHD) and acute myocardial infarction (AMI), effects on arrhythmia, heart failure, sudden cardiac arrest, stroke, blood pressure, hypertension, and other biomarkers of effect, including heart rate, cerebral blood flow, cardiac output, plasma homocysteine levels, serum cholesterol levels, electrocardiogram (EKG) parameters, heart rate variability, endothelial/platelet function and plasma/urine catecholamine levels. Caffeine intake has been associated with a range of reversible and transient physiological effects broadly and cardiovascular effects specifically. This report attempts to understand where the delineations exist in caffeine intake and corresponding cardiovascular effects among various subpopulations. The available literature suggests that cardiovascular effects experienced by caffeine consumers at levels up to 600 mg/day are in most cases mild, transient, and reversible, with no lasting adverse effect. The point at which caffeine intake may cause harm to the cardiovascular system is not readily identifiable in part because data on the effects of daily intakes greater than 600 mg is limited. However, the evidence considered within this review suggests that typical moderate caffeine intake is not associated with increased risks of total cardiovascular disease; arrhythmia; heart failure; blood pressure changes among regular coffee drinkers; or hypertension in baseline populations. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care.

    Science.gov (United States)

    Östgren, C J; Sundström, J; Svennblad, B; Lohm, L; Nilsson, P M; Johansson, G

    2013-05-01

    To explore the association of HbA1c and educational level with risk of cardiovascular events and mortality in patients with Type 2 diabetes. A cohort of 32 871 patients with Type 2 diabetes aged 35 years and older identified by extracting data from electronic patient records for all patients who had a diagnosis of Type 2 diabetes and had glucose-lowering agents prescribed between 1999 and 2009 at 84 primary care centres in Sweden. Associations of mean HbA1c levels and educational level with risks of cardiovascular events and all-cause mortality were analysed. The associations of HbA1c with risk of all-cause and cardiovascular mortality were J-shaped, with the lowest risk observed for cardiovascular mortality at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. The lowest risk observed for all-cause mortality was at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. There was an increased risk for cardiovascular death [hazard ratio 1.6 (1.2-2.1), P = 0.0008] at the lowest HbA1c decile for subjects in the low education category. For subjects with higher education there was no evident J curve for cardiovascular death [hazard ratio 1.2 (0.8-1.6), P = 0.3873]. Our results lend support to the recent American Diabetes Association/ European Association for the Study of Diabetes position statement that emphasizes the importance of additional factors, including the propensity for hypoglycaemia, which should influence HbA1c targets and treatment choices for individual patients. (Clinical Trials Registry No; NCT 01121315). © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  9. Cardiovascular Update: Risk, Guidelines, and Recommendations.

    Science.gov (United States)

    Pearson, Tamera

    2015-09-01

    This article provides an update of the current status of cardiovascular disease (CVD) in the United States, including a brief review of the underlying pathophysiology and epidemiology. This article presents a discussion of the latest American Heart Association guidelines that introduce the concept of promoting ideal cardiovascular health, defined by seven identified metrics. Specific CVD risk factors and utilization of the 10-year CVD event prediction calculator are discussed. In addition, current management recommendations of health-related conditions that increase risk for CVD, such as hypertension and hypercholesterolemia, are provided. Finally, a discussion of detailed evidence-based lifestyle recommendations to promote cardiovascular health and reduce CVD risks concludes the update. © 2015 The Author(s).

  10. Cardiovascular involvement in myositis

    DEFF Research Database (Denmark)

    Diederichsen, Louise P

    2017-01-01

    PURPOSE OF REVIEW: The purpose of this review is to provide an update on cardiovascular involvement in idiopathic inflammatory myopathy (IIM). Studies from the past 18 months are identified and reviewed. Finally, the clinical impact of these findings is discussed. RECENT FINDINGS: Epidemiological...... on cardiac magnetic resonance (CMR) imaging suggests that CMR should be considered as a potentially viable diagnostic tool to evaluate the possibility of silent myocardial inflammation in IIM with normal routine noninvasive evaluation. SUMMARY: Updated literature on cardiovascular involvement in IIM has...... identified an increased risk for subclinical and clinical cardiovascular disease in these rare inflammatory muscle diseases....

  11. Cardiovascular complications of cirrhosis

    DEFF Research Database (Denmark)

    Møller, S; Henriksen, Jens Henrik Sahl

    2008-01-01

    Cardiovascular complications of cirrhosis include cardiac dysfunction and abnormalities in the central, splanchnic and peripheral circulation, and haemodynamic changes caused by humoral and nervous dysregulation. Cirrhotic cardiomyopathy implies systolic and diastolic dysfunction and electrophysi......Cardiovascular complications of cirrhosis include cardiac dysfunction and abnormalities in the central, splanchnic and peripheral circulation, and haemodynamic changes caused by humoral and nervous dysregulation. Cirrhotic cardiomyopathy implies systolic and diastolic dysfunction....... The clinical significance of cardiovascular complications and cirrhotic cardiomyopathy is an important topic for future research, and the initiation of new randomised studies of potential treatments for these complications is needed....

  12. Crowdfunding for cardiovascular research.

    Science.gov (United States)

    Krittanawong, Chayakrit; Zhang, HongJu Janet; Aydar, Mehmet; Wang, Zhen; Sun, Tao

    2018-01-01

    The competition for public cardiovascular research grants has recently increased. Independent researchers are facing increasing competition for public research grant support and ultimately may need to seek alternative funding sources. Crowdfunding, a financing method of raising funds online by pooling together small donations from the online community to support a specific initiative, seems to have significant potential. However, the feasibility of crowdfunding for cardiovascular research remains unknown. Here, we performed exploratory data analysis of the feasibility of online crowdfunding in cardiovascular research. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Molecular cardiovascular imaging

    International Nuclear Information System (INIS)

    Schaefers, M.

    2007-01-01

    Although huge and long-lasting research efforts have been spent on the development of new diagnostic techniques investigating cardiovascular diseases, still fundamental challenges exist; the main challenge being the diagnosis of a suspected or known coronary artery disease or its consequences (myocardial infarction, heart failure etc.). Beside morphological techniques, functional imaging modalities are available in clinical diagnostic algorithms, whereas molecular cardiovascular imaging techniques are still under development. This review summarizes clinical-diagnostical challenges of modern cardiovascular medicine as well as the potential of new molecular imaging techniques to face these. (orig.)

  14. Adult ADHD Medications and Their Cardiovascular Implications

    Directory of Open Access Journals (Sweden)

    A. Sinha

    2016-01-01

    Full Text Available Attention-deficit/hyperactivity disorder (ADHD is a chronic neurobiological disorder exhibited by difficulty maintaining attention, as well as hyperactivity and impulsive behavior. Central nervous system (CNS stimulants are the first line of treatment for ADHD. With the increase in number of adults on CNS stimulants, the question that arises is how well do we understand the long-term cardiovascular effects of these drugs. There has been increasing concern that adults with ADHD are at greater risk for developing adverse cardiovascular events such as sudden death, myocardial infarction, and stroke as compared to pediatric population. Cardiovascular response attributed to ADHD medication has mainly been observed in heart rate and blood pressure elevations, while less is known about the etiology of rare cardiovascular events like acute myocardial infarction (AMI, arrhythmia, and cardiomyopathy and its long-term sequelae. We present a unique case of AMI in an adult taking Adderall (mixed amphetamine salts and briefly discuss the literature relevant to the cardiovascular safety of CNS stimulants for adult ADHD.

  15. Hptlc-densitometry mass spectrometric utilization in the chemical finger printing of herbal drugs-a case study on commiphora mukul (abstract)

    International Nuclear Information System (INIS)

    Musharaf, S.G.; Iqbal, N.; Gulzar, U.; Ali, A.; Choudhary, M.I.; Rahman, A.

    2011-01-01

    In Asia, particularly in the Indo-Pak sub-continent, plants have been used as sources of indigenous drugs for thousands of years. However, at the global level the traditional herbal medicines couldn't achieve significance in medical and scientific communities due to the lack of quantitative standardization and consistency. The quantitative analysis of medical plants by using TLC and HPTLC methods is increasingly popular as manufacturers, researchers, and drug regulatory authorities are recognizing their versatility and cost effectiveness. It has been demonstrated that these techniques can analyze even a mixture of 15 plants in a single analytical run. We have recently developed a HPTLC-densitometric method based on ICH (International Conference on Harmonization) recommendations for the analysis of hypolipidemic agents, E- and Z-guggulsterones and capable to separate both isomers from their conger, 17, (20)-dihydroguggulsterone (non-hypolipidemic agent) and therefore quantify the biomarker compounds precisely and equally applicable for the varieties of guggulsterone samples including resins, guggulipid and marketed formulations, for the first time. E- and Z-guggulsterones are the constituents of guggul or guggulu (Sanskrit), sticky gum resin obtained from the Mukul myrrh tree (Commiphora mukul), widely used in the traditional medicines, particularly in Ayurveda for the treatment of gout, arthritis, rheumatism, obesity and inflammation. Pharmacological studies showed that guggul lipid (45% ethyl acetate extract of guggul) lowers the blood lipids in patients and possessed clinically proved hypolipidemic activity. Moreover, Guggul helps to reduce high cholesterol, because it lowers harmful low density lipoproteins (LDL-proteins) while elevating the beneficial high density lipoproteins. It is well documented that the E- and Z-isomers of guggulsterones are the biomarker compounds, responsible the hypolipidemic activity. (author)

  16. Morphine and clonidine combination therapy improves therapeutic window in mice: synergy in antinociceptive but not in sedative or cardiovascular effects.

    Directory of Open Access Journals (Sweden)

    Laura S Stone

    Full Text Available Opioids are used to manage all types of pain including acute, cancer, chronic neuropathic and inflammatory pain. Unfortunately, opioid-related adverse effects such as respiratory depression, tolerance, physical dependence and addiction have led to an underutilization of these compounds for adequate pain relief. One strategy to improve the therapeutic utility of opioids is to co-administer them with other analgesic agents such as agonists acting at α2-adrenergic receptors (α2ARs. Analgesics acting at α2ARs and opioid receptors (ORs frequently synergize when co-administered in vivo. Multimodal analgesic techniques offer advantages over single drug treatments as synergistic combination therapies produce analgesia at lower doses, thus reducing undesired side effects. This inference presumes, however, that the synergistic interaction is limited to the analgesic effects. In order to test this hypothesis, we examined the effects of α2AR/OR combination therapy in acute antinociception and in the often-undesired side effects of sedation and cardiovascular depression in awake unrestrained mice. Morphine, clonidine or their combination was administered by spinal or systemic injection in awake mice. Antinociception was determined using the warm water tail flick assay (52.5°C. Sedation/motor impairment was evaluated using the accelerating rotarod assay and cardiovascular function was monitored by pulse oximetry. Data were converted to percent maximum possible effect and isobolographic analysis was performed to determine if an interaction was subadditive, additive or synergistic. Synergistic interactions between morphine and clonidine were observed in the antinociceptive but not in the sedative/motor or cardiovascular effects. As a result, the therapeutic window was improved ∼200-fold and antinociception was achieved at non-sedating doses with little to no cardiovascular depression. In addition, combination therapy resulted in greater maximum analgesic

  17. How to utilize Ca²⁺ signals to rejuvenate the repairative phenotype of senescent endothelial progenitor cells in elderly patients affected by cardiovascular diseases: a useful therapeutic support of surgical approach?

    Science.gov (United States)

    Moccia, Francesco; Dragoni, Silvia; Cinelli, Mariapia; Montagnani, Stefania; Amato, Bruno; Rosti, Vittorio; Guerra, Germano; Tanzi, Franco

    2013-01-01

    Endothelial dysfunction or loss is the early event that leads to a host of severe cardiovascular diseases, such as atherosclerosis, hypertension, brain stroke, myocardial infarction, and peripheral artery disease. Ageing is regarded among the most detrimental risk factor for vascular endothelium and predisposes the subject to atheroscleorosis and inflammatory states even in absence of traditional comorbid conditions. Standard treatment to restore blood perfusion through stenotic arteries are surgical or endovascular revascularization. Unfortunately, ageing patients are not the most amenable candidates for such interventions, due to high operative risk or unfavourable vascular involvement. It has recently been suggested that the transplantation of autologous bone marrow-derived endothelial progenitor cells (EPCs) might constitute an alternative and viable therapeutic option for these individuals. Albeit pre-clinical studies demonstrated the feasibility of EPC-based therapy to recapitulate the diseased vasculature of young and healthy animals, clinical studies provided less impressive results in old ischemic human patients. One hurdle associated to this kind of approach is the senescence of autologous EPCs, which are less abundant in peripheral blood and display a reduced pro-angiogenic activity. Conversely, umbilical cord blood (UCB)-derived EPCs are more suitable for cellular therapeutics due to their higher frequency and sensitivity to growth factors, such as vascular endothelial growth factor (VEGF). An increase in intracellular Ca(2+) concentration is central to EPC activation by VEGF. We have recently demonstrated that the Ca(2+) signalling machinery driving the oscillatory Ca(2+) response to this important growth factor is different in UCB-derived EPCs as compared to their peripheral counterparts. In particular, we focussed on the so-called endothelial colony forming cells (ECFCs), which are the only EPC population belonging to the endothelial lineage and able

  18. Cardiovascular Disease in Acromegaly.

    Science.gov (United States)

    Sharma, Morali D; Nguyen, Anh V; Brown, Spandana; Robbins, Richard J

    2017-01-01

    In patients with acromegaly, chronic excess of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) leads to the development of acromegalic cardiomyopathy. Its main features are biventricular hypertrophy, diastolic dysfunction, and in later stages, systolic dysfunction and congestive heart failure. Surgical and/or pharmacological treatment of acromegaly and control of cardiovascular risk factors help reverse some of these pathophysiologic changes and decrease the high risk of cardiovascular complications.

  19. Current practices in corrosion, surface characterization, and nickel leach testing of cardiovascular metallic implants.

    Science.gov (United States)

    Nagaraja, Srinidhi; Di Prima, Matthew; Saylor, David; Takai, Erica

    2017-08-01

    In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In addition to the above topics, best practices for these various tests were discussed, and knowledge gaps were identified. Prior to the workshop, discussants had the option to provide feedback and information on issues relating to each of the topics via a voluntary preworkshop assignment. During the workshop, the pooled responses were presented and a panel of experts discussed the results. This article summarizes the proceedings of this workshop and background information provided by workshop participants. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. J Biomed Mater Res Part B: Appl Biomater, 105B: 1330-1341, 2017. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

  20. Sortilin and Its Multiple Roles in Cardiovascular and Metabolic Diseases

    DEFF Research Database (Denmark)

    Goettsch, Claudia; Kjølby, Mads Fuglsang; Aikawa, Elena

    2018-01-01

    Cardiovascular disease is a leading cause of morbidity and mortality in the Western world. Studies of sortilin's influence on cardiovascular and metabolic diseases goes far beyond the genome-wide association studies that have revealed an association between cardiovascular diseases and the 1p13...... locus that encodes sortilin. Emerging evidence suggests a significant role of sortilin in the pathogenesis of vascular and metabolic diseases; this includes type II diabetes mellitus via regulation of insulin resistance, atherosclerosis through arterial wall inflammation and calcification...... of sortilin's contributions to cardiovascular and metabolic diseases but focuses particularly on atherosclerosis. We summarize recent clinical findings that suggest that sortilin may be a cardiovascular risk biomarker and also discuss sortilin as a potential drug target....

  1. YKL-40: a new biomarker in cardiovascular disease?

    DEFF Research Database (Denmark)

    Mathiasen, Anders Bruun; Henningsen, Kristoffer Mads Aaris; Harutyunyan, Marina Jurjevna

    2010-01-01

    Cardiovascular disease in the form of coronary artery disease is the most common cause of death in western countries. Early treatment with stabilizing drugs and mechanical revascularization by percutaneous coronary intervention or coronary bypass surgery has reduced the mortality significantly....... But in spite of improved treatments, many patients are still plagued by a high frequency of angina symptoms, hospitalizations and a poor prognosis. There is a need for new independent or supplementary biomarkers that can help to predict cardiovascular disease and cardiovascular events earlier and more...... precisely, and thus accompany existing biomarkers in both primary and secondary cardiovascular prevention. One such potential new biomarker is the protein YKL-40. As an independent biomarker in both cardiovascular diseases and noncardiovascular diseases, current evidence suggests YKL-40 to be most useful...

  2. Cardiovascular morbidity and the use of inhaled bronchodilators

    Directory of Open Access Journals (Sweden)

    Christine Macie

    2008-03-01

    Full Text Available Christine Macie, Kate Wooldrage, Jure Manfreda, Nicholas AnthonisenDepartment of Medicine, University of Manitoba, Winnipeg, Manitoba, CanadaAbstract: We used the Manitoba Health database to examine the relationship between use of inhaled respiratory drugs in people with chronic obstructive respiratory diseases and cardiovascular hospitalizations from 1996 through 2000. The drugs examined were beta agonists [BA], ipratropium bromide IB, and inhaled steroids (ICS. End points were first hospitalizations for supraventricular tachycardia, myocardial infarction, heart failure or stroke. A nested case control analysis was employed comparing people with and without cardiovascular events. Cases and controls were matched for gender and age, and conditional logistic regression was used in multivariate analysis considering other respiratory drugs, respiratory diagnosis and visit frequency, non-respiratory, non-cardiac comorbidities, and receipt of drugs for cardiovascular disease. In univariate analyses, BA, IB and ICS were all associated with hospitalizations for cardiovascular disease, but in multivariate analyses ICS did not increase risk while both BA and IB did. There were interactions between respiratory and cardiac drugs receipt in that bronchodilator associated risks were higher in people not taking cardiac drugs; this was especially true for stroke. There were strong interactions with specific cardiac drugs; for example, both BA and IB substantially increased the risk of supraventricular tachycardia in patients not anti-arryhthmic agents, but not in the presence of such agents. We conclude that bronchodilator therapy for chronic obstructive diseases is associated with increased cardiovascular risk, especially in patients without previous cardiovascular diagnoses, and that this is unlikely due to the severity of the respiratory disease, since risk was not increased with ICS.Keywords: bronchodilator therapy, inhaled corticosteroids, nested case

  3. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  4. Impact of Urate Level on Cardiovascular Risk in Allopurinol Treated Patients. A Nested Case-Control Study

    DEFF Research Database (Denmark)

    Søltoft Larsen, Kasper; Pottegård, Anton; Lindegaard, Hanne M

    2016-01-01

    BACKGROUND: Gout gives rise to increased risk of cardiovascular events. Gout attacks can be effectively prevented with urate lowering drugs, and allopurinol potentially reduces cardiovascular risk. What target level of urate is required to reduce cardiovascular risk is not known. OBJECTIVES...

  5. A pilot randomised controlled trial to assess the utility of an e-learning package that trains users in adverse drug reaction causality.

    Science.gov (United States)

    Conroy, Elizabeth J; Kirkham, Jamie J; Bellis, Jennifer R; Peak, Matthew; Smyth, Rosalind L; Williamson, Paula R; Pirmohamed, Munir

    2015-12-01

    Causality assessment of adverse drug reactions (ADRs) by healthcare professionals is often informal which can lead to inconsistencies in practice. The Liverpool Causality Assessment Tool (LCAT) offers a systematic approach. An interactive, web-based, e-learning package, the Liverpool ADR Causality Assessment e-learning Package (LACAeP), was designed to improve causality assessment using the LCAT. This study aimed to (1) get feedback on usability and usefulness on the LACAeP, identify areas for improvement and development, and generate data on effect size to inform a larger scale study; and (2) test the usability and usefulness of the LCAT. A pilot, single-blind, parallel-group, randomised controlled trial hosted by the University of Liverpool was undertaken. Participants were paediatric medical trainees at specialty training level 1+ within the Mersey and North-West England Deaneries. Participants were randomised (1 : 1) access to the LACAeP or no training. The primary efficacy outcome was score by correct classification, predefined by a multidisciplinary panel of experts. Following participation, feedback on both the LCAT and the LACAeP was obtained, via a built in survey, from participants. Of 57 randomised, 35 completed the study. Feedback was mainly positive although areas for improvement were identified. Seventy-four per cent of participants found the LCAT easy to use and 78% found the LACAeP training useful. Sixty-one per cent would be unlikely to recommend the training. Scores ranged from 4 to 13 out of 20. The LACAeP increased scores by 1.3, but this was not significant. Improving the LACAeP before testing it in an appropriately powered trial, informed by the differences observed, is required. Rigorous evaluation will enable a quality resource that will be of value in healthcare professional training. © 2015 The Authors. International Journal of Pharmacy Practice published by John Wiley & Sons Ltd on behalf of Royal Pharmaceutical Society.

  6. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Science.gov (United States)

    Urushihara, Hisashi; Doi, Yuko; Arai, Masaru; Matsunaga, Toshiyuki; Fujii, Yosuke; Iino, Naoko; Kawamura, Takashi; Kawakami, Koji

    2011-01-01

    In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases); this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases). The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases). The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the current discrimination by age and

  7. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Directory of Open Access Journals (Sweden)

    Hisashi Urushihara

    Full Text Available BACKGROUND: In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases; this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases. The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases. CONCLUSIONS/SIGNIFICANCE: The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question

  8. Quantitative analysis of cellular glutathione by flow cytometry utilizing monochlorobimane: some applications to radiation and drug resistance in vitro and in vivo.

    Science.gov (United States)

    Rice, G C; Bump, E A; Shrieve, D C; Lee, W; Kovacs, M

    1986-12-01

    An assay using a bimane derivative has been developed to detect free glutathione (GSH) in individual viable cells by flow cytometry. Monochlorobimane [syn-(ClCH2CH3)-1,5-diazabicycla[3.30]acta-3,6-diene-2,8-dio ne], itself nonfluorescent, reacts with GSH to form a highly fluorescent derivative. High pressure liquid chromatography analysis showed that, using specific staining conditions, the only low molecular weight fluorescent derivative formed in Chinese hamster ovary cells was that formed with GSH. Very little reaction with protein sulfhydryls was observed. Rates of GSH depletion in Chinese hamster ovary cells exposed to diethylmaleate were essentially the same, whether measured by relative fluorescence intensity, by flow cytometry or by enzymatic assay on cellular extracts. This method was shown to be useful for measurement of GSH resynthesis, uptake, and depletion by prolonged hypoxia and misonidazole treatment. Since measurements are made on individual cells, cell-to-cell variation and populational heterogeneity in GSH content are revealed by flow cytometry. Although under most conditions in vitro GSH content is relatively homogeneous, under certain circumstances, such as release from hypoxia, heterogeneity in populational GSH levels was observed. The significance of this heterogeneity is discussed in regard to the induction of gene amplification and drug resistance by transient hypoxia. Numerous subclones of Chinese hamster ovary cells selected by growth in Adriamycin or methotrexate-containing medium express elevated levels of GSH per cell. The method was extended to quantitate the GSH content of cells excised from EMT-6/SF mouse tumors that had been treated in vivo with L-buthionine-S-R-sulfoximine, an inhibitor of GSH synthesis. The bivariate analysis (forward angle light scatter versus monochlorobimane fluorescence) of cells derived from these tumors gave excellent resolution of normal and tumor cells and demonstrated extensive heterogeneity in the tumor

  9. Envejecimiento del sistema cardiovascular Cardiovascular system aging

    Directory of Open Access Journals (Sweden)

    José M Ocampo

    2005-08-01

    Full Text Available El envejecimiento del sistema cardiovascular está asociado con un número característico de cambios a nivel bioquímico, histológico y morfológico. Sin embargo, no todas las modificaciones presentadas se asocian con deterioro en la función. Entre los cambios a nivel cardiaco se tienen: disminución en el número de miocitos y en las células del sistema de conducción cardiaca, desarrollo de fibrosis, cambios en el transporte de calcio a través de las membranas y disminución del cronotropismo, inotropismo y lusitropismo mediados por estímulo b-adrenérgico. A nivel vascular, hay incremento en la rigidez de la pared de las arterias, con aumento en la velocidad de la onda de pulso, disfunción endotelial y disminución de la vasodilatación mediada por estímulo b-adrenérgico. Durante el reposo el sistema cardiovascular es capaz de desarrollar mecanismos adaptativos eficientes, pero en situaciones de estrés como el ejercicio, los cambios asociados con el envejecimiento se hacen evidentes ya que está disminuida la capacidad para obtener la frecuencia cardiaca máxima, está incrementada la postcarga y hay disminución de la contractilidad intrínseca. Por lo anterior, los ancianos deben utilizar al máximo el mecanismo de Frank-Starling para mantener el gasto cardiaco. Los cambios estructurales y funcionales asociados con el envejecimiento cardiovascular, disminuyen de forma significativa el umbral en el cual las enfermedades cardiacas llegan a ser evidentes, y deben ser conocidos por el personal de salud encargado de cuidar a los ancianos.Cardiovascular aging is associated with characteristic biochemical, histological and morphological changes. Nevertheless, these changes are not necessarily associated to a deterioration in its function. Among the cardiac changes found, there is a reduction in the number of myocytes and of the cardiac conduction system cells, development of fibrosis, changes in the trans-membrane calcium transport and a

  10. Associations of HbA1c and educational level with risk of cardiovascular events in 32 871 drug-treated patients with Type 2 diabetes: a cohort study in primary care

    OpenAIRE

    ?stgren, C J; Sundstr?m, J; Svennblad, B; Lohm, L; Nilsson, P M; Johansson, G

    2013-01-01

    Aims To explore the association of HbA1c and educational level with risk of cardiovascular events and mortality in patients with Type 2 diabetes. Methods A cohort of 32 871 patients with Type 2 diabetes aged 35 years and older identified by extracting data from electronic patient records for all patients who had a diagnosis of Type 2 diabetes and had glucose-lowering agents prescribed between 1999 and 2009 at 84 primary care centres in Sweden. Associations of mean HbA1c levels and educational...

  11. Drug-related acute renal failure in hospitalised patients

    Directory of Open Access Journals (Sweden)

    Lujan Iavecchia

    2015-11-01

    Conclusions: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality.

  12. Cardio-Vascular Disease and Cancer

    Directory of Open Access Journals (Sweden)

    K. Mitchell-Fearon DrPh

    2015-11-01

    Full Text Available Objective: To report the level of utilization of clinical preventive services by older adults in Jamaica and to identify independent factors associated with utilization. Method: A nationally representative, community-based survey of 2,943 older adults was undertaken. Utilization frequency for six preventive, cardiovascular or cancer-related services was calculated. Logistic regression models were used to determine the independent factors associated with each service. Results: A dichotomy in annual utilization rates exists with cardiovascular services having much higher uptake than those for cancer (83.1% for blood pressure, 76.7% blood glucose, 68.1% cholesterol, 35.1% prostate, 11.3% mammograms, and 9.6% papanicolaou smears. Age, source of routine care, and having a chronic disease were most frequently associated with uptake. Discussion: Education of providers and patients on the need for utilizing preventive services in older adults is important. Improved access to services in the public sector may also help increase uptake of services.

  13. Major adverse cardiovascular event reduction with GLP-1 and SGLT2 agents: evidence and clinical potential

    Science.gov (United States)

    Røder, Michael E.

    2017-01-01

    Treatment of patients with type 2 diabetes is directed against treating symptoms of hyperglycemia, minimizing the risk of hypoglycemia, and the risk of microvascular and macrovascular complications. The majority of patients with type 2 diabetes die from cardiovascular or cerebrovascular disease. Future therapies should therefore focus on reducing cardiovascular morbidity in this high-risk population. Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are two drug classes with proven antihyperglycemic effect in type 2 diabetes. However, these drugs seem to have other effects such as weight reduction, low risk of hypoglycemia, and blood pressure reduction. Emerging evidence suggests pleiotropic effects, which potentially could be important in reducing cardiovascular risk. Prompted by regulatory authorities demanding cardiovascular outcome trials (CVOTs) assessing the cardiovascular safety of new antihyperglycemic drug candidates, many CVOTs are ongoing and a few of these are finalized. Somewhat surprising recent CVOTs in both drug classes have shown promising data on cardiovascular morbidity and mortality in patients with a very high risk of cardiovascular events. It is uncertain whether this is a class effect of the two drug classes, and it is yet unproven whether long-term cardiovascular benefits of these drugs can be extrapolated to populations at lower risk of cardiovascular disease. The aim of the present review is to give an overview of our current knowledge of the GLP-1RA and SGLT2-i classes, with specific focus on mechanisms of action, effects on cardiovascular risk factors and cardiovascular morbidity and mortality from the CVOTs presently available. The clinical potential of these data is discussed. PMID:29344329

  14. Tea and Cardiovascular Disease

    Science.gov (United States)

    Deka, Apranta; Vita, Joseph A.

    2011-01-01

    There is increasing evidence for a protective effect of tea consumption against cardiovascular disease. This review summarizes the available epidemiological data providing evidence for and against such an effect. We also review observational and intervention studies that investigated an effect of tea and tea extracts on cardiovascular risk factors, including blood pressure, serum lipids, diabetes mellitus, and obesity. Finally, we review potential mechanisms of benefit, including anti-inflammatory, anti-oxidant, and anti-proliferative effects, as well as favorable effects on endothelial function. Overall, the observational data suggest a benefit, but results are mixed and likely confounded by lifestyle and background dietary factors. The weight of evidence indicates favorable effects on risk factors and a number of plausible mechanisms have been elucidated in experimental and translational human studies. Despite the growing body evidence, it remains uncertain whether tea consumption should be recommended to the general population or to patients as a strategy to reduce cardiovascular risk. PMID:21477653

  15. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care : a randomised controlled trial

    NARCIS (Netherlands)

    Hellemans, Irene M; van Tulder, Maurits W; Heymans, Martijn W; Rauwerda, Jan A; van Rossum, Albert C; Seidell, Jaap C; IJzelenberg, W.

    2012-01-01

    BACKGROUND: The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention

  16. Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL).

    Science.gov (United States)

    Hjelmesæth, Jøran; Åsberg, Anders; Andersson, Shalini; Sandbu, Rune; Robertsen, Ida; Johnson, Line Kristin; Angeles, Philip Carlo; Hertel, Jens Kristoffer; Skovlund, Eva; Heijer, Maria; Ek, Anna-Lena; Krogstad, Veronica; Karlsen, Tor-Ivar; Christensen, Hege; Andersson, Tommy B; Karlsson, Cecilia

    2018-05-29

    Roux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6 weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups. This open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6 weeks) and long-term (2 years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24 hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUC oral /AUC iv ) of midazolam (CYP3A4 probe), systemic exposure (AUC oral ) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers. The COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants. NCT02386917. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Quantitative characterization of myocardial infarction by cardiovascular magnetic resonance predicts future cardiovascular events in patients with ischemic cardiomyopathy

    Directory of Open Access Journals (Sweden)

    Pauly John M

    2008-04-01

    Full Text Available Abstract Background Cardiovascular magnetic resonance (CMR can provide quantitative data of the myocardial tissue utilizing high spatial and temporal resolution along with exquisite tissue contrast. Previous studies have correlated myocardial scar tissue with the occurrence of ventricular arrhythmia. This study was conducted to evaluate whether characterization of myocardial infarction by CMR can predict cardiovascular events in patients with ischemic cardiomyopathy (ICM. Results We consecutively studied 86 patients with ICM (LVEF Conclusion Quantification of the scar volume and scar percentage by CMR is superior to LVEDV, LVESV, and LVEF in prognosticating the future likelihood of the development of cardiovascular events in patients with ICM.

  18. Cardiovascular diseases and diabetes

    DEFF Research Database (Denmark)

    Green, A.; Sortso, C.; Jensen, Peter Bjødstrup

    2016-01-01

    We present an investigation of the occurrence of cardiovascular disease in patients with diabetes in Denmark 2000 through 2011. The Diabetes Impact Study 2013 is based on all registrants in the Danish National Diabetes Register as of July 3rd 2013 (n=497,232). Record linkage with the Danish...... National Patient Register was used to defining the first date of experiencing a cardiovascular event by means of a discharge diagnosis and/or having performed a coronary bypass operation or revascularization of the coronary arteries. The proportion of patients with already established CVD at the diagnosis...

  19. Drug Facts

    Medline Plus

    Full Text Available ... Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use and Other People Drug Use and Families Drug Use and Kids Drug Use and Unborn ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, ... Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug Use and Kids ...

  1. Drug Facts

    Medline Plus

    Full Text Available ... People Drug Use and Families Drug Use and Kids Drug Use and Unborn Children Drug Use and ... Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used ...

  2. Neurobehavioral and Cardiovascular Effects of Potassium Cyanide Administered Orally to Mice.

    Science.gov (United States)

    Hawk, Michael A; Ritchie, Glenn D; Henderson, Kim A; Knostman, Katherine A B; Roche, Brian M; Ma, Zhenxu J; Matthews, Claire M; Sabourin, Carol L; Wakayama, Edward J; Sabourin, Patrick J

    2016-09-01

    The Food and Drug Administration Animal Rule requires evaluation of cardiovascular and central nervous system (CNS) effects of new therapeutics. To characterize an adult and juvenile mouse model, neurobehavioral and cardiovascular effects and pathology of a single sublethal but toxic, 8 mg/kg, oral dose of potassium cyanide (KCN) for up to 41 days postdosing were investigated. This study describes the short- and long-term sensory, motor, cognitive, and behavioral changes associated with oral dosing of a sublethal but toxic dose of KCN utilizing functional observation battery and Tier II CNS testing in adult and juvenile mice of both sexes. Selected tissues (histopathology) were evaluated for changes associated with KCN exposure with special attention to brain regions. Telemetry (adult mice only) was used to evaluate cardiovascular and temperature changes. Neurobehavioral capacity, sensorimotor responsivity or spontaneous locomotor activity, and rectal temperature were significantly reduced in adult and juvenile mice at 30 minutes post-8 mg/kg KCN dose. Immediate effects of cyanide included bradycardia, adverse electrocardiogram arrhythmic events, hypotension, and hypothermia with recovery by approximately 1 hour for blood pressure and heart rate effects and by 2 hours for body temperature. Lesions consistent with hypoxia, such as mild acute tubular necrosis in the kidneys corticomedullary junction, were the only histopathological findings and occurred at a very low incidence. The mouse KCN intoxication model indicates rapid and completely reversible effects in adult and juvenile mice following a single oral 8 mg/kg dose. Neurobehavioral and cardiovascular measurements can be used in this animal model as a trigger for treatment. © The Author(s) 2016.

  3. Perceptions of risk: understanding cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Ruth Webster

    2010-09-01

    Full Text Available Ruth Webster1, Emma Heeley21Cardiovascular Division, 2Neurological and Mental Health Division, The George Institute for International Health, Camperdown, NSW, AustraliaAbstract: Cardiovascular disease (CVD is still the leading cause of death and disability worldwide despite the availability of well-established and effective preventive options. Accurate perception of a patient’s risk by both the patient and the doctors is important as this is one of the components that determine health-related behavior. Doctors tend to not use cardiovascular (CV risk calculators and underestimate the absolute CV risk of their patients. Patients show optimistic bias when considering their own risk and consistently underestimate it. Poor patient health literacy and numeracy must be considered when thinking about this problem. Patients must possess a reasonably high level of understanding of numerical processes when doctors discuss risk, a level that is not possessed by large numbers of the population. In order to overcome this barrier, doctors need to utilize various tools including the appropriate use of visual aids to accurately communicate risk with their patients. Any intervention has been shown to be better than nothing in improving health understanding. The simple process of repeatedly conveying risk information to a patient has been shown to improve accuracy of risk perception. Doctors need to take responsibility for the accurate assessment and effective communication of CV risk in their patients in order to improve patient uptake of cardioprotective lifestyle choices and preventive medications.Keywords: risk perception, cardiovascular disease, cardioprotective lifestyle

  4. Cardiovascular effects of monoterpenes: a review

    Directory of Open Access Journals (Sweden)

    Márcio R. V. Santos

    2011-07-01

    Full Text Available The monoterpenes are secondary metabolites of plants. They have various pharmacological properties including antifungal, antibacterial, antioxidant, anticancer, anti-spasmodic, hypotensive, and vasorelaxant. The purpose of this research was to review the cardiovascular effects of monoterpenes. The data in this resarch were collected using the Internet portals Pubmed, Scopus, and ISI Web of Knowledge between the years 1987 and 2010. In the study 33 monoterpenes were included, which were related to each of the thirteen individual words: artery, cardiovascular, heart, myocyte, vasorelaxant, vessel, hypotension, hypotensive, cardiomyocyte, ventricular, vasodilatory, aorta, and aortic. The research utilized 22 articles published mainly in the journals Phytomedicine, Fundamental Clinical Pharmacology, Planta Medica, Life Science, European Journal of Pharmacology, and Brazilian Journal of Medical and Biological Research. Of the 33 monoterpenes studied surveyed, sixteen of them had already been studied for their effects on the cardiovascular system: carvacrol, citronellol, p-cymene, eucalyptol (1,8-cineole, linalool, menthol, myrtenal, myrtenol, α-pinene, rotundifolone (piperitenone oxide, sobrerol, thymol, α-limonene, α-terpinen-4-ol, α-terpineol, and perillyl alcohol. The main effects observed were vasorelaxation, decreased heart rate and blood pressure. This review showed that the monoterpenes may be considered promising agents for prevention or treatment of diseases of the cardiovascular system.

  5. Cardiovascular effects of monoterpenes: a review

    Directory of Open Access Journals (Sweden)

    Márcio R. V. Santos

    2011-08-01

    Full Text Available The monoterpenes are secondary metabolites of plants. They have various pharmacological properties including antifungal, antibacterial, antioxidant, anticancer, anti-spasmodic, hypotensive, and vasorelaxant. The purpose of this research was to review the cardiovascular effects of monoterpenes. The data in this resarch were collected using the Internet portals Pubmed, Scopus, and ISI Web of Knowledge between the years 1987 and 2010. In the study 33 monoterpenes were included, which were related to each of the thirteen individual words: artery, cardiovascular, heart, myocyte, vasorelaxant, vessel, hypotension, hypotensive, cardiomyocyte, ventricular, vasodilatory, aorta, and aortic. The research utilized 22 articles published mainly in the journals Phytomedicine, Fundamental Clinical Pharmacology, Planta Medica, Life Science, European Journal of Pharmacology, and Brazilian Journal of Medical and Biological Research. Of the 33 monoterpenes studied surveyed, sixteen of them had already been studied for their effects on the cardiovascular system: carvacrol, citronellol, p-cymene, eucalyptol (1,8-cineole, linalool, menthol, myrtenal, myrtenol, α-pinene, rotundifolone (piperitenone oxide, sobrerol, thymol, α-limonene, α-terpinen-4-ol, α-terpineol, and perillyl alcohol. The main effects observed were vasorelaxation, decreased heart rate and blood pressure. This review showed that the monoterpenes may be considered promising agents for prevention or treatment of diseases of the cardiovascular system.

  6. Cardiovascular risk calculation

    African Journals Online (AJOL)

    James A. Ker

    2014-08-20

    Aug 20, 2014 ... smoking and elevated blood sugar levels (diabetes mellitus). These risk ... These are risk charts, e.g. FRS, a non-laboratory-based risk calculation, and ... for hard cardiovascular end-points, such as coronary death, myocardial ...

  7. Gender and Cardiovascular Disease

    NARCIS (Netherlands)

    Den Ruijter, Hester M.; Pasterkamp, Gerard

    2015-01-01

    More women than men die of cardiovascular disease (CVD) each year in every major developed country and most emerging economies. Nonetheless, CVD has often been considered as men’s disease due to the higher rates of coronary artery disease (CAD) of men at younger age. This has led to the

  8. Cardiovascular risk prediction

    DEFF Research Database (Denmark)

    Graversen, Peter; Abildstrøm, Steen Z.; Jespersen, Lasse

    2016-01-01

    Aim European society of cardiology (ESC) guidelines recommend that cardiovascular disease (CVD) risk stratification in asymptomatic individuals is based on the Systematic Coronary Risk Evaluation (SCORE) algorithm, which estimates individual 10-year risk of death from CVD. We assessed the potential...

  9. Epigenetics and cardiovascular disease

    Science.gov (United States)

    Despite advances in the prevention and management of cardiovascular disease (CVD), this group of multifactorial disorders remains a leading cause of mortality worldwide. CVD is associated with multiple genetic and modifiable risk factors; however, known environmental and genetic influences can only...

  10. The Cardiovascular Research Grid (CVRG)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CardioVascular Research Grid (CVRG) project is creating an infrastructure for sharing cardiovascular data and data analysis tools. CVRG tools are developed using...

  11. Cold Weather and Cardiovascular Disease

    Science.gov (United States)

    ... Venous Thromboembolism Aortic Aneurysm More Cold Weather and Cardiovascular Disease Updated:Sep 16,2015 Th is winter ... and procedures related to heart disease and stroke. Cardiovascular Conditions • Conditions Home • Arrhythmia and Atrial Fibrillation • Cardiac ...

  12. Nutrition and cardiovascular health.

    Science.gov (United States)

    Berciano, Silvia; Ordovás, José M

    2014-09-01

    A multitude of studies have been published on the relationship between cardiovascular disease risk and a variety of nutrients, foods, and dietary patterns. Despite the well-accepted notion that diet has a significant influence on the development and prevention of cardiovascular disease, the foods considered healthy and harmful have varied over the years. This review aims to summarize the current scientific evidence on the cardioprotective effect of those foods and nutrients that have been considered healthy as well as those that have been deemed unhealthy at any given time in history. For this purpose, we reviewed the most recent literature using as keywords foods and nutrients (ie, meat, omega-3) and cardiovascular disease-related terms (ie, cardiovascular diseases, stroke). Emphasis has been placed on meta-analyses and Cochrane reviews. In general, there is a paucity of intervention studies with a high level of evidence supporting the benefits of healthy foods (ie, fruits and vegetables), whereas the evidence supporting the case against those foods considered less healthy (ie, saturated fat) seems to be weakened by most recent evidence. In summary, most of the evidence supporting the benefits and harms of specific foods and nutrients is based on observational epidemiological studies. The outcome of randomized clinical trials reveals a more confusing picture with most studies providing very small effects in one direction or another; the strongest evidence comes from dietary patterns. The current status of the relationship between diet and cardiovascular disease risk calls for more tailored recommendations based on genomic technologies. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  13. Increasing incidence of statin prescribing for the elderly without previous cardiovascular conditions:  A nation wide register study

    DEFF Research Database (Denmark)

    Kildemoes, Helle Wallach; Andersen, Morten

    Supported by the growing evidence of the beneficial effects of statins in a range of conditions, statin utilization has increased considerably in most Western countries over the last decade. Objectives To estimate to what extent a widening of indication scope for statins accounts for the increasing...... Danish statin utilization during 1996-2005, applying treatment incidence as a measure of changing prescribing behaviour Methods From three nationwide registers, we retrieved individual records on demographics, dispensed prescription drugs and hospital discharges. Danish inhabitants were followed...... for seven cardiovascular conditions, corresponding to a hierarchy of statin indications. Poisson regression analyses were applied to quantify the incidence growth, according to age and indication.  Results Treatment incidence increased from 4/1000 person years in 2000 to 17/1000 in 2005, the increase being...

  14. Nonfasting hyperlipidemia and cardiovascular disease

    DEFF Research Database (Denmark)

    Nordestgaard, B G; Langsted, A; Freiberg, J J

    2009-01-01

    , total cholesterol/HDL cholesterol, and apolipoprotein B/apolipoprotein A1 all associate with increased risk of cardiovascular disease. These new data open the possibility that nonfasting rather than fasting lipid profiles can be used for cardiovascular risk prediction. If implemented, this would...... of cardiovascular disease and early death....

  15. Asian & Pacific Islanders and Cardiovascular Diseases

    Science.gov (United States)

    ... Fact Sheet 2016 Update Asian & Pacific Islanders and Cardiovascular Diseases Cardiovascular Disease (CVD) (ICD 10 codes I00-I99, Q20- ... of na- tive Hawaiians or oth- A indicates cardiovascular disease plus congenital cardiovascular disease (ICD-10 I00- ...

  16. Impact of urate level on cardiovascular risk in allopurinol treated patients. A nested case control study

    DEFF Research Database (Denmark)

    Larsen, Kasper Søltoft; Pottegård, Anton; Lindegaard, H. M.

    2015-01-01

    Background: Gout gives rise to increased risk of adverse cardiovascular outcomes. Gout attacks can be effectively prevented with urate lowering drugs such as allopurinol, and allopurinol further potentially reduces the cardiovascular risk. Whether treatment to a target level of uric acid is requi...

  17. 21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiovascular permanent or temporary pacemaker... § 870.3680 Cardiovascular permanent or temporary pacemaker electrode. (a) Temporary pacemaker electrode—(1) Identification. A temporary pacemaker electrode is a device consisting of flexible insulated...

  18. Cardiovascular risk factors and diseases precede oral hypoglycaemic therapy in patients with type 2 diabetes mellitus

    NARCIS (Netherlands)

    Erkens, JA; Herings, RMC; Stolk, RP; Spoelstra, JA; Grobbee, DE; Leufkens, HGM

    Although patients with type 2 diabetes mellitus and cardiovascular disease share common risk factors, the link between these diseases remains largely unexplained. In this case-control study, the earlier use of cardiovascular drugs (before the diagnosis of diabetes) was investigated among cases with

  19. 75 FR 54493 - Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary...

    Science.gov (United States)

    2010-09-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2000-P-0924] (formerly Docket No. FDA-2000-P-1533) Cardiovascular Devices; Reclassification of... follows: PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to...

  20. 78 FR 79304 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

    Science.gov (United States)

    2013-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2013-N-0487] Cardiovascular Devices; Reclassification of External Counter- Pulsating Devices for...--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority...