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Sample records for adverse cardiovascular events

  1. Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review

    OpenAIRE

    Atkinson, Hartley C.; Potts, Amanda L.; Anderson, Brian J

    2015-01-01

    Background Increased bioavailability of phenylephrine is reported when combined with paracetamol in over-the-counter formulations for the symptomatic treatment of the common cold and influenza. Such formulations could increase phenylephrine-related cardiovascular adverse events particularly in susceptible individuals. Quantification of the effect of phenylephrine concentration on blood pressure allows simulation of potential adverse combination therapy effects. Methods MEDLINE and EMBASE data...

  2. Cardiovascular magnetic resonance parameters of atherosclerotic plaque burden improve discrimination of prior major adverse cardiovascular events

    Directory of Open Access Journals (Sweden)

    Bansilal Sameer

    2009-04-01

    Full Text Available Abstract Aims Patients with prior major cardiovascular or cerebrovascular events (MACE are more likely to have future recurrent events independent of traditional cardiovascular disease risk factors. The purpose of this study was to determine if patients with traditional risk factors and prior MACE had increased cardiovascular magnetic resonance (CMR plaque burden measures compared to patients with risk factors but no prior events. Methods and Results Black blood carotid and thoracic aorta images were obtained from 195 patients using a rapid extended coverage turbo spin echo sequence. CMR measures of plaque burden were obtained by tracing lumen and outer vessel wall contours. Patients with prior MACE had significantly higher MR plaque burden (wall thickness, wall area and normalized wall index in carotids and thoracic aorta compared to those without prior MACE (Wall thickness carotids: 1.03 ± 0.03 vs. 0.93± 0.03, p = 0.001; SD wall thickness carotids: 0.137 ± 0.0008 vs. 0.102 ± 0.0004, p Conclusion A greater plaque burden and plaque eccentricity is prevalent among patients with prior MACE.

  3. Association of atherosclerotic renal artery stenosis with major adverse cardiovascular events after acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    Zheng Bin; Liu Jinghua; Ma Qin; Zhao Donghui; Wang Xin; Zheng Ze

    2014-01-01

    Background Patients with atherosclerotic renal artery stenosis (ARAS) are in substantial risk of cardiovascular adverse events.We investigated whether myocardial infarction patients with ARAS are in additional risk of cardiovascular events.Methods In this retrospective study,257 patients with type 1 myocardial infarction were enrolled.Median follow-up was 42 months.Composite endpoint events are analyzed by definitions of ARAS as ≥50% or ≥70% diameter stenosis.Results Defining ARAS as ≥70% diameter stenosis,ARAS was a significant predictor for composite endpoint events including death,non-fatal myocardial infarction,ischaemic stroke and intracranial haemorrhage,rehospitalisation for cardiac failure (HR:4.381; 95% Cl:1.770-10.842) by Cox regression analysis,but not for death.Diabetes mellitus was also a significant predictor for composite endpoint events (HR:2.756; 95% Cl:1.295-5.863).However,defining ARAS ≥50% diameter stenosis,ARAS was no longer a significant predictor for composite endpoint events or death.Conclusions Although not associated with mortality,ARAS ≥70% is associated with major adverse cardiac events after acute myocardial infarction.For prognosis,≥70% diameter stenosis is a more appropriate criteria for ARAS definition than ≥50% diameter stenosis.

  4. Association of Selected Antipsychotic Agents With Major Adverse Cardiovascular Events and Noncardiovascular Mortality in Elderly Persons

    DEFF Research Database (Denmark)

    Sahlberg, Marie; Holm, Ellen; Gislason, Gunnar H; Køber, Lars; Torp-Pedersen, Christian; Andersson, Charlotte

    2015-01-01

    events and noncardiovascular mortality associated with individual APs (ziprasidone, olanzapine, risperidone, quetiapine, levomepromazine, chlorprothixen, flupentixol, and haloperidol) in Danish treatment-naïve patients aged ≥70 years. METHODS AND RESULTS: We followed all treatment-naïve Danish citizens...... treatment, compared with risperidone, incidence rate ratios of major adverse cardiovascular events were higher with use of levomepromazine (3.80, 95% CI 3.43 to 4.21) and haloperidol (1.85, 95% CI 1.67 to 2.05) and lower for treatment with flupentixol (0.54, 95% CI 0.45 to 0.66), ziprasidone (0.31, 95% CI 0...

  5. Association of Selected Antipsychotic Agents With Major Adverse Cardiovascular Events and Noncardiovascular Mortality in Elderly Persons

    DEFF Research Database (Denmark)

    Sahlberg, Marie; Holm, Ellen; Gislason, Gunnar H; Køber, Lars; Torp-Pedersen, Christian; Andersson, Charlotte

    2015-01-01

    BACKGROUND: Data from observational studies have raised concerns about the safety of treatment with antipsychotic agents (APs) in elderly patients with dementia, but this area has been insufficiently investigated. We performed a head-to-head comparison of the risk of major adverse cardiovascular...... treatment, compared with risperidone, incidence rate ratios of major adverse cardiovascular events were higher with use of levomepromazine (3.80, 95% CI 3.43 to 4.21) and haloperidol (1.85, 95% CI 1.67 to 2.05) and lower for treatment with flupentixol (0.54, 95% CI 0.45 to 0.66), ziprasidone (0.31, 95% CI 0.......10 to 0.97), chlorprothixen (0.76, 95% CI 0.61 to 0.95), and quetiapine (0.68, 95% CI 0.58 to 0.80). Relationships were generally similar for long-term treatment. The majority of agents were associated with higher risks among patients with cardiovascular disease compared with patients without...

  6. Endothelial Dysfunction Is Associated With Major Adverse Cardiovascular Events in Peritoneal Dialysis Patients

    OpenAIRE

    Lee, Mi Jung; Han, Seung Hyeok; Lee, Jung Eun; Choi, Hoon Young; Yoon, Chang-Yun; Kim, Eun Jin; Han, Jae Hyun; Han, Ji Suk; Oh, Hyung Jung; Park, Jung Tak; Kang, Shin-Wook; Yoo, Tae-Hyun

    2014-01-01

    Abstract Endothelial dysfunction is implicated in increased cardiovascular risk in nondialyzed population. However, the prognostic impact of endothelial dysfunction on cardiovascular outcome has not been investigated in peritoneal dialysis (PD) patients. We prospectively determined endothelial function by brachial artery endothelium-dependent vasodilation (flow-mediated dilation [FMD]) in 143 nondiabetic PD patients and 32 controls. Primary outcome was a major adverse cardiac and cerebrovascu...

  7. Metabolic syndrome definitions and components in predicting major adverse cardiovascular events after kidney transplantation.

    Science.gov (United States)

    Prasad, G V Ramesh; Huang, Michael; Silver, Samuel A; Al-Lawati, Ali I; Rapi, Lindita; Nash, Michelle M; Zaltzman, Jeffrey S

    2015-01-01

    Metabolic syndrome (MetS) associates with cardiovascular risk post-kidney transplantation, but its ambiguity impairs understanding of its diagnostic utility relative to components. We compared five MetS definitions and the predictive value of constituent components of significant definitions for major adverse cardiovascular events (MACE) in a cohort of 1182 kidney transplant recipients. MetS definitions were adjusted for noncomponent traditional Framingham risk factors and relevant transplant-related variables. Kaplan-Meier, logistic regression, and Cox proportional hazards analysis were utilized. There were 143 MACE over 7447 patient-years of follow-up. Only the World Health Organization (WHO) 1998 definition predicted MACE (25.3 vs 15.5 events/1000 patient-years, P = 0.019). Time-to-MACE was 5.5 ± 3.5 years with MetS and 6.8 ± 3.9 years without MetS (P hazard ratio (HR) for MACE (1.814 [95% confidence interval 1.26-2.60]), increased successively by microalbuminuria (HR 1.946 [1.37-2.75]), dyslipidemia (3.284 [1.72-6.26]), hypertension (4.127 [2.16-7.86]), and central obesity (4.282 [2.09-8.76]). MetS did not affect graft survival. In summary, although the WHO 1998 definition provides greatest predictive value for post-transplant MACE, most of this is conferred by dysglycemia and is overshadowed by age and previous cardiac disease. PMID:25207680

  8. Family history predicts major adverse cardiovascular events (MACE) in young adults with psoriasis

    DEFF Research Database (Denmark)

    Egeberg, Alexander; Bruun, Louise E; Mallbris, Lotus;

    2016-01-01

    history of CVD. METHODS: Between January 1, 1997, and December 31, 2011, we identified 2,722,375 individuals, including 25,774 and 4504 patients with mild and severe psoriasis, through administrative registers. Incidence rate ratios were estimated by Poisson regression. RESULTS: Mean baseline age was 26......BACKGROUND: Patients with psoriasis may have increased risk of major adverse cardiovascular (CV) events (MACE), and a family history of CV disease (CVD) is an independent risk factor for MACE. OBJECTIVE: We investigated the risk of first-time MACE in patients with psoriasis with or without a family.......6 (SD 8.6) years. A family history of CVD was found among 16,080 (62.4%) and 3009 (66.8%) patients with mild and severe psoriasis, respectively. In patients with psoriasis and a family history of CVD, the adjusted incidence rate ratios (95% CI) of MACE were 1.28 (1.12-1.46) and 1.62 (1.14-2.30) for mild...

  9. Major adverse maternal cardiovascular-related events in those with aortopathies. What should we expect?

    Science.gov (United States)

    Bradley, Elisa A; Zaidi, Ali N; Goldsmith, Pamela; Sisk, Tracey; Colombo, David; Roble, Sharon; Bradley, David; Daniels, Curt

    2014-11-15

    Major adverse maternal cardiovascular-related events (MAMCRE) in aortopathy patients undergoing pregnancy are poorly defined. The aim was to assess for MAMCRE in pregnant patients with aortopathy or aortic enlargement in conotruncal defects (CTD), and determine if there are differences between groups. We conducted a single-center retrospective review of pregnant women (2000-2013) with hereditary vascular disease (HVD: BAV, COA), heritable fibrillinopathies (HF: MFS, EDS, LDS, FTAAS), and CTD with aortic dilatation (TOF, d-TGA, DORV). MAMCRE included: aortic dissection/surgery, therapeutic abortion, change in mode of delivery, and aortic growth > 0.5 cm within 1 year. We identified 73 patients/97 pregnancies (39/50 HVD, 15/20 HF, and 19/27 CTD). There were 14 MAMCRE (14%); 85% (n = 12) occurred in HV and HF patients and was associated with higher baseline cross-sectional-to-height (CSA/Ht) ratio (6.6 [Symbol: see text] 2.5 vs. 5.1 [Symbol: see text] 1.3, p = 0.005). There was more aortic surgery in the HF (vs. HV) (RR 3.9, p = 0.12). Only 2 MAMCRE (aortic growth) occurred in CTD. Overall and emergent C-section was higher than the general population (52% vs. 29%, p < 0.001 and 16% vs. 3%, p < 0.001) as was postpartum hemorrhage (PPH) (6% vs. 1.5%, p < 0.001). We describe the largest series of pregnant women with aortopathy and found a substantial incidence of MAMCRE, which was associated with higher pre-pregnancy CSA/Ht ratio. Rates of C-section and PPH were higher than the general population. Our data suggest that larger, multi-center studies are needed to define risks that predict MAMCRE/obstetric events in women with aortopathies, allowing optimal medical care during pregnancy. PMID:25499384

  10. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, Morten; Johansen, Martin B; Mæng, Michael; Kaltoft, Anne; Jensen, Lisette O; Hansen, Hans-Henrik Tilsted; Bøtker, Hans E; Baron, John A; Sørensen, Henrik Toft

    2012-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The CYP3A4 inhibition by lipophilic statins may attenuate the effectiveness of clopidogrel. • No studies have measured drug exposure in a time-varying manner that detects discontinuation and restart of clopidogrel and statin therapy, allowing clinical...... quantification of the interaction effect. WHAT THIS STUDY ADDS • Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of major adverse cardiovascular events within 12 months after coronary stent implantation. • Although we observed an interaction between use of...... clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of major adverse cardiovascular events in patients using clopidogrel after coronary stent implantation. AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major...

  11. The influence of a triclosan toothpaste on adverse events in patients with cardiovascular disease over 5-years.

    Science.gov (United States)

    Cullinan, Mary P; Palmer, Janet E; Carle, Anne D; West, Malcolm J; Westerman, Bill; Seymour, Gregory J

    2015-03-01

    Adverse effects of long-term usage of triclosan-containing toothpaste in humans are currently unknown. We assessed the effect of long-term use of 0.3% triclosan-toothpaste on serious adverse events (SAEs) in patients with cardiovascular disease (CVD). 438 patients with a history of stable CVD were entered into the 5-year longitudinal Cardiovascular and Periodontal Study at Prince Charles Hospital, Brisbane, Australia and randomised into test (triclosan) or placebo groups. There were no significant differences in demographics or clinical features between the groups. Patients were examined at baseline, and annually for 5-years. SAEs were classified according to the System Organ Classes defined by MedDRA (Medical Dictionary for Regulatory Activities). Results were analysed using chi square and Kaplan Meier analysis. Overall, 232 patients (123 in the triclosan group; 109 in the placebo group) experienced 569 SAEs (288 in the triclosan group and 281 in the placebo group). There was no significant difference between the groups in numbers of patients experiencing SAEs (p=0.35) or specific cardiovascular SAEs (p=0.82), nor in time to the first SAE or first cardiovascular SAE, irrespective of gender, age or BMI after adjusting for multiple comparisons (p>0.05). The adjusted odds of experiencing an SAE were estimated to increase by 2.7% for each year of age (p=0.02) and the adjusted odds of experiencing a cardiovascular SAE were estimated to increase by 5.1% for each unit increase in BMI (p=0.02). Most cardiovascular events were related to unstable angina or myocardial infarcts, 21 were associated with arrhythmia and 41 were vascular events such as aortic aneurysm and cerebrovascular accident. Within the limitations of the present study the data suggest that the use of triclosan-toothpaste may not be associated with any increase in SAEs in this CVD population. The long-term impact of triclosan on hormone-related disease, such as cancer, in humans remains to be determined

  12. CHADS2 Scores in the Prediction of Major Adverse Cardiovascular Events in Patients with Cushing’s Syndrome

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    Yuh-Feng Wang

    2014-01-01

    Full Text Available Vascular events are one of the major causes of death in case of Cushing’s syndrome (CS. However, due to the relative low frequency of CS, it is hard to perform a risk assessment for these events. As represented congestive heart failure (C, hypertension (H, age (A, diabetes (D, and stroke (S, the CHADS2 score is now accepted to classify the risk of major adverse cardiovascular events (MACEs in patients with atrial fibrillation. In this study, participants were enrolled from the National Health Research Institute Database (NHIRD of Taiwan, and we reviewed 551 patients with their sequential clinically diagnosed CS data between 2002 and 2009 in relation to MACEs risk using CHADS2 score. Good correlation could be identified between the CS and CHADS2 score (AUC=0.795. Our results show that patients with CS show significantly higher risk of vascular events and the CHADS2 score could be applied for MACEs evaluation. Adequate lifestyle modifications and aggressive cardiovascular risks treatment are suggested for CS patients with higher CHADS2 score.

  13. Body mass index and risk of perioperative cardiovascular adverse events and mortality in 34,744 Danish patients undergoing hip or knee replacement

    DEFF Research Database (Denmark)

    Thornqvist, Catharina; Gislason, Gunnar H.; Køber, Lars; Jensen, Per Føge; Torp-Pedersen, Christian; Andersson, Charlotte

    2014-01-01

    BACKGROUND AND PURPOSE: Obesity is a risk factor for osteoarthritis in the lower limb, yet the cardiovascular risks associated with obesity in hip or knee replacement surgery are unknown. We examined associations between body mass index (BMI) and the risk of a major adverse cardiovascular event (...

  14. Body mass index and risk of perioperative cardiovascular adverse events and mortality in 34,744 Danish patients undergoing hip or knee replacement

    OpenAIRE

    Thornqvist, Catharina; Gislason, Gunnar H.; Køber, Lars; Jensen, Per Føge; Torp-Pedersen, Christian; Andersson, Charlotte

    2014-01-01

    Background and purpose Obesity is a risk factor for osteoarthritis in the lower limb, yet the cardiovascular risks associated with obesity in hip or knee replacement surgery are unknown. We examined associations between body mass index (BMI) and the risk of a major adverse cardiovascular event (MACE: ischemic stroke, acute myocardial infarction, or cardiovascular death) or the risk of all-cause mortality in a nationwide Danish cohort of patients who underwent primary hip or knee replacement s...

  15. Depression, anxiety and major adverse cardiovascular and cerebrovascular events in patients following coronary artery bypass graft surgery

    DEFF Research Database (Denmark)

    Tully, Phillip J; Winefield, Helen R; Baker, Robert A;

    2015-01-01

    BACKGROUND: Although depression and anxiety have been implicated in risk for major adverse cardiovascular and cerebrovascular events (MACCE), a theoretical approach to identifying such putative links is lacking. The objective of this study was to examine the association between theoretical...... conceptualisations of depression and anxiety with MACCE at the diagnostic and symptom dimension level. METHODS: Before coronary artery bypass graft (CABG) surgery, patients (N = 158; 20.9 % female) underwent a structured clinical interview to determine caseness for depression and anxiety disorders. Depression and...... anxiety disorders were arranged into the distress cluster (major depression, dysthymia, generalized anxiety disorder, post-traumatic stress disorder) and fear cluster (panic disorder, agoraphobia, social phobia). Patients also completed the self-report Mood and Anxiety Symptom Questionnaire, measuring...

  16. Use of clopidogrel and calcium channel blockers and risk of major adverse cardiovascular events

    DEFF Research Database (Denmark)

    Schmidt, Morten; Johansen, Martin B; Robertson, Douglas J;

    2012-01-01

    Eur J Clin Invest 2011 ABSTRACT: Background  The CYP3A4 inhibition by calcium channel blockers (CCBs) may attenuate the effectiveness of clopidogrel. Using time-varying drug exposure ascertainment, we examined whether CCB use modified the association between clopidogrel use and major adverse...

  17. Elevated ratio of urinary metabolites of thromboxane and prostacyclin is associated with adverse cardiovascular events in ADAPT.

    Directory of Open Access Journals (Sweden)

    Thomas J Montine

    Full Text Available Results from prevention trials, including the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT, have fueled discussion about the cardiovascular (CV risks associated with non-steroidal anti-inflammatory drugs (NSAIDs. We tested the hypotheses that (i adverse CV events reported among ADAPT participants (aged 70 years and older are associated with increased ratio of urine 11-dehydrothromboxane B(2 (Tx-M to 2'3-donor-6-keto-PGF1 (PGI-M attributable to NSAID treatments; (ii coincident use of aspirin (ASA would attenuate NSAID-induced changes in Tx-M/PGI-M ratio; and (iii use of NSAIDs and/or ASA would not alter urine or plasma concentrations of F(2-isoprostanes (IsoPs, in vivo biomarkers of free radical damage. We quantified urine Tx-M and PGI-M, and urine and plasma F(2-IsoPs from 315 ADAPT participants using stable isotope dilution assays with gas chromatography/mass spectrometry, and analyzed these data by randomized drug assignment and self-report compliance as well as ASA use. Adverse CV events were significantly associated with higher urine Tx-M/PGI-M ratio, which seemed to derive mainly from lowered PGI-M. Participants taking ASA alone had reduced urine Tx-M/PGI-M compared to no ASA or NSAID; however, participants taking NSAIDs plus ASA did not have reduced urine Tx-M/PGI-M ratio compared to NSAIDs alone. Neither NSAID nor ASA use altered plasma or urine F(2-IsoPs. These data suggest a possible mechanism for the increased risk of CV events reported in ADAPT participants assigned to NSAIDs, and suggest that the changes in the Tx-M/PGI-M ratio was not substantively mitigated by coincident use of ASA in individuals 70 years or older.

  18. The GPIIIA PlA2 polymorphism is associated with an increased risk of cardiovascular adverse events

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    Iaccarino Guido

    2010-09-01

    Full Text Available Abstract Background The clinical impact of PlA2 polymorphism has been investigated in several diseases, but the definition of its specific role on thrombotic cardiovascular complications has been challenging. We aimed to explore the effect of PlA2 polymorphism on outcome in patients with atherosclerosis. Methods We studied 400 consecutive patients with coronary artery disease (CAD undergoing percutaneous coronary intervention. A replication study was conducted in 74 hypertensive patients with cerebrovascular events while a group of 100 healthy subjects was included as control population. PlA genotype was determined by PCR-RFLP on genomic DNA from peripheral blood cells. Major adverse cardiac events (MACE, were considered as end points, and recorded at a mean follow up of 24 ± 4.3 months. Results The frequencies of PlA2 polymorphism was similar between groups and genotype distribution was in Hardy-Weinberg equilibrium. In patients with CAD, the presence of PlA2 allele was associated with higher incidence of cardiac death (13.1% vs. 1.5%, p = 0.0001, myocardial infarction (10.7% vs. 2.6%, p = 0.004 and needs of new revascularization (34.8% vs. 17.7%, p = 0.010. Accordingly, the Kaplan-Meier analysis for event free survival in patients harboring the PlA2 allele showed worse long-term outcome for these patients (p = 0.015. Cox regression analysis identified the presence of PlA2 as an independent predictor of cardiac death (OR: 9.594, 95% CI: 2.6 to 35.3, p = 0.002 and overall MACE (OR: 1.829, 95% CI: 1.054 to 3.176, p = 0.032. In the replication study, the PlA2 polymorphism increased the risk of stroke (OR: 4.1, 95% CI: 1.63-12.4, p = 0.02 over TIA and was identified as an independent risk factor for stroke (B:-1.39; Wald: 7.15; p = 0.001. Conclusions Our study demonstrates that in patients with severe atherosclerosis the presence of PlA2 allele is associated with thrombotic cardiovascular complications.

  19. Cardiovascular adverse effects of phenytoin.

    Science.gov (United States)

    Guldiken, B; Rémi, J; Noachtar, Soheyl

    2016-05-01

    Phenytoin is an established drug in the treatment of acute repetitive seizures and status epilepticus. One of its main advantages over benzodiazepines is the less sedative effect. However, the possibility of cardiovascular adverse effects with the intravenous use of phenytoin cause a reluctance to its usage, and this has lead to a search for safer anticonvulsant drugs. In this study, we aimed to review the studies which evaluated the safety of phenytoin with respect to cardiovascular adverse effects. The original clinical trials and case reports listed in PUBMED in English language between the years of 1946-2014 were evaluated. As the key words, "phenytoin, diphenylhydantoin, epilepsy, seizure, cardiac toxicity, asystole, arrhythmia, respiratory arrest, hypotension, death" were used. Thirty-two clinical trials and ten case reports were identified. In the case reports, a rapid infusion rate (>50 mg/min) of phenytoin appeared as the major cause of increased mortality. In contrast, no serious cardiovascular adverse effects leading to death were met in the clinical trials which applied the recommended infusion rate and dosages. An infusion rate of 50 mg/min was reported to be safe for young patients. For old patients and patients with a cardiovascular co-morbidity, a slower infusion rate was recommended with a careful follow-up of heart rhythm and blood pressure. No cardiovascular adverse effect was reported in oral phenytoin overdoses except one case with a very high serum phenytoin level and hypoalbuminemia. Phenytoin is an effective and well tolerated drug in the treatment of epilepsy. Intravenous phenytoin is safe when given at recommended infusion rates and doses. PMID:26645393

  20. Stable angina pectoris with no obstructive coronary artery disease is associated with increased risks of major adverse cardiovascular events

    DEFF Research Database (Denmark)

    Jespersen, Lasse; Hvelplund, Anders; Abildstrøm, Steen Z;

    2012-01-01

    (MACE), defined as cardiovascular death, myocardial infarction, stroke or heart failure, and all-cause mortality. Significantly more women (65%) than men (32%) had no obstructive CAD (P<0.001). In Cox's models adjusted for age, body mass index, diabetes, smoking, and use of lipid-lowering or...... stable angina and normal coronary arteries or diffuse non-obstructive CAD have elevated risks of MACE and all-cause mortality compared with a reference population without ischaemic heart disease.......AimsPatients with chest pain and no obstructive coronary artery disease (CAD) are considered at low risk for cardiovascular events but evidence supporting this is scarce. We investigated the prognostic implications of stable angina pectoris in relation to the presence and degree of CAD with no...

  1. Association of beta-Blocker Therapy With Risks of Adverse Cardiovascular Events and Deaths in Patients With Ischemic Heart Disease Undergoing Noncardiac Surgery A Danish Nationwide Cohort Study

    DEFF Research Database (Denmark)

    Andersson, C.; Merie, C.; Jorgensen, M.;

    2014-01-01

    IMPORTANCE Clinical guidelines have been criticized for encouraging the use of beta-blockers in noncardiac surgery despite weak evidence. Relevant clinical trials have been small and have not convincingly demonstrated an effect of beta-blockers on hard end points (ie, perioperative myocardial...... infarction, ischemic stroke, cardiovascular death, and all-cause death). OBJECTIVE To assess the association of beta-blocker treatment with major cardiovascular adverse events (MACE) and all-cause mortality in patients with ischemic heart disease undergoing noncardiac surgery. DESIGN, SETTING. PARTICIPANTS...... models were used to calculate the 30-day risks of MACE (ischemic stroke, myocardial infarction, or cardiovascular death) and all-cause mortality associated with beta-blocker therapy. MAIN OUTCOMES AND MEASURES Thirty-day risk of MACE and all-cause mortality. RESULTS Of 28 263 patients with ischemic heart...

  2. Relation of Serum Adiponectin Levels to Number of Traditional Atherosclerotic Risk Factors and All-Cause Mortality and Major Adverse Cardiovascular Events (from the Copenhagen City Heart Study)

    DEFF Research Database (Denmark)

    Lindberg, Soren; Mogelvang, Rasmus; Pedersen, Sune H;

    2013-01-01

    Adiponectin exerts anti-inflammatory and antiatherogenic effects and appears to protect against arteriosclerosis. Accordingly, an association between low concentrations of plasma adiponectin and cardiovascular (CV) disease has been demonstrated in several studies. In contrast, elevated plasma adi...... nonfatal myocardial infarction or ischemic stroke (n = 502). High adiponectin was inversely associated with an increasing number of traditional CV risk factors (p...... adiponectin has been associated with increased mortality and an increasing number of major adverse CV events (MACE). Because of these conflicting results, the true role of adiponectin remains to be elucidated. In the Copenhagen City Heart Study, we prospectively followed up 5,624 randomly selected men and...

  3. The Personality and Psychological Stress Predict Major Adverse Cardiovascular Events in Patients With Coronary Heart Disease After Percutaneous Coronary Intervention for Five Years.

    Science.gov (United States)

    Du, Jinling; Zhang, Danyang; Yin, Yue; Zhang, Xiaofei; Li, Jifu; Liu, Dexiang; Pan, Fang; Chen, Wenqiang

    2016-04-01

    To investigate the effects of personality type and psychological stress on the occurrence of major adverse cardiovascular events (MACEs) at 5 years in patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Two hundred twenty patients with stable angina (SA) or non-ST segment elevation acute coronary syndrome (NSTE-ACS) treated with PCI completed type A behavioral questionnaire, type D personality questionnaire, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Trait Coping Style Questionnaire (TCSQ), and Symptom Checklist 90 (SCL-90) at 3 days after PCI operation. Meanwhile, biomedical markers (cTnI, CK-MB, LDH, LDH1) were assayed. MACEs were monitored over a 5-year follow-up. NSTE-ACS group had higher ratio of type A behavior, type A/D behavior, and higher single factor scores of type A personality and type D personality than control group and SAP group. NSTE-ACS patients had more anxiety, depression, lower level of mental health (P depression, and lower level of mental health. Type D patients were at a cumulative increased risk of adverse outcome compared with non-type D patients (P obvious anxiety, depression emotion, and lower level of mental health, which were related to personality and coping style. Type D personality was an independent predictor of adverse events. PMID:27082597

  4. Short- and long-term major cardiovascular adverse events in carotid artery interventions: a nationwide population-based cohort study in Taiwan.

    Directory of Open Access Journals (Sweden)

    Ming-Lung Tsai

    Full Text Available Carotid artery stenosis is one of the leading causes of ischemic stroke. Carotid artery stenting has become well-established as an effective treatment option for carotid artery stenosis. For this study, we aimed to determine the efficacy and safety of carotid stenting in a population-based large cohort of patients by analyzing the Taiwan National Healthcare Insurance (NHI database.2,849 patients who received carotid artery stents in the NHI database from 2004 to 2010 were identified. We analyzed the risk factors of outcomes including major adverse cardiovascular events including death, acute myocardial infarction, and cerebral vascular accidents at 30 days, 1 year, and overall period and further evaluated cause of death after carotid artery stenting.The periprocedural stroke rate was 2.7% and the recurrent stroke rate for the overall follow-up period was 20.3%. Male, diabetes mellitus, and heart failure were significant risk factors for overall recurrent stroke (Hazard Ratio (HR = 1.35, p = 0.006; HR = 1.23, p = 0.014; HR = 1.61, p < 0.001, respectively. The periprocedural acute myocardial infarction rate was 0.3%. Age and Diabetes mellitus were the significant factors to predict periprocedural myocardial infarction (HR = 3.06, p = 0.019; HR = 1.68, p < 0.001, respectively. Periprocedural and overall mortality rates were 1.9% and 17.3%, respectively. The most significant periprocedural mortality risk factor was acute renal failure. Age, diabetes mellitus, acute or chronic renal failure, heart failure, liver disease, and malignancy were factors correlated to the overall period mortality.Periprocedural acute renal failure significantly increased the mortality rate and the number of major adverse cardiovascular events, and the predict power persisted more than one year after the procedure. Age and diabetes mellitus were significant risk factors to predict acute myocardial infarction after carotid artery stenting.

  5. The Personality and Psychological Stress Predict Major Adverse Cardiovascular Events in Patients With Coronary Heart Disease After Percutaneous Coronary Intervention for Five Years

    Science.gov (United States)

    Du, Jinling; Zhang, Danyang; Yin, Yue; Zhang, Xiaofei; Li, Jifu; Liu, Dexiang; Pan, Fang; Chen, Wenqiang

    2016-01-01

    Abstract To investigate the effects of personality type and psychological stress on the occurrence of major adverse cardiovascular events (MACEs) at 5 years in patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Two hundred twenty patients with stable angina (SA) or non-ST segment elevation acute coronary syndrome (NSTE-ACS) treated with PCI completed type A behavioral questionnaire, type D personality questionnaire, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Trait Coping Style Questionnaire (TCSQ), and Symptom Checklist 90 (SCL-90) at 3 days after PCI operation. Meanwhile, biomedical markers (cTnI, CK-MB, LDH, LDH1) were assayed. MACEs were monitored over a 5-year follow-up. NSTE-ACS group had higher ratio of type A behavior, type A/D behavior, and higher single factor scores of type A personality and type D personality than control group and SAP group. NSTE-ACS patients had more anxiety, depression, lower level of mental health (P < 0.05; P < 0.01), more negative coping styles and less positive coping styles. The plasma levels of biomedical predictors had positive relation with anxiety, depression, and lower level of mental health. Type D patients were at a cumulative increased risk of adverse outcome compared with non-type D patients (P < 0.05). Patients treated with PCI were more likely to have type A and type D personality and this tendency was associated with myocardial injury. They also had obvious anxiety, depression emotion, and lower level of mental health, which were related to personality and coping style. Type D personality was an independent predictor of adverse events. PMID:27082597

  6. Adverse Event Reporting System (AERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

  7. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination,...

  8. Adverse events in healthcare: learning from mistakes.

    Science.gov (United States)

    Rafter, N; Hickey, A; Condell, S; Conroy, R; O'Connor, P; Vaughan, D; Williams, D

    2015-04-01

    Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety. PMID:25078411

  9. Hospital deaths and adverse events in Brazil

    Directory of Open Access Journals (Sweden)

    Pavão Ana Luiza B

    2011-09-01

    Full Text Available Abstract Background Adverse events are considered a major international problem related to the performance of health systems. Evaluating the occurrence of adverse events involves, as any other outcome measure, determining the extent to which the observed differences can be attributed to the patient's risk factors or to variations in the treatment process, and this in turn highlights the importance of measuring differences in the severity of the cases. The current study aims to evaluate the association between deaths and adverse events, adjusted according to patient risk factors. Methods The study is based on a random sample of 1103 patient charts from hospitalizations in the year 2003 in 3 teaching hospitals in the state of Rio de Janeiro, Brazil. The methodology involved a retrospective review of patient charts in two stages - screening phase and evaluation phase. Logistic regression was used to evaluate the relationship between hospital deaths and adverse events. Results The overall mortality rate was 8.5%, while the rate related to the occurrence of an adverse event was 2.9% (32/1103 and that related to preventable adverse events was 2.3% (25/1103. Among the 94 deaths analyzed, 34% were related to cases involving adverse events, and 26.6% of deaths occurred in cases whose adverse events were considered preventable. The models tested showed good discriminatory capacity. The unadjusted odds ratio (OR 11.43 and the odds ratio adjusted for patient risk factors (OR 8.23 between death and preventable adverse event were high. Conclusions Despite discussions in the literature regarding the limitations of evaluating preventable adverse events based on peer review, the results presented here emphasize that adverse events are not only prevalent, but are associated with serious harm and even death. These results also highlight the importance of risk adjustment and multivariate models in the study of adverse events.

  10. Hyperglycemic adverse events following antipsychotic drug administration in spontaneous adverse event reports

    OpenAIRE

    Kato, Yamato; Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; NAKAYAMA, Yoko; Kinosada, Yasutomi; NAKAMURA, MITSUHIRO

    2015-01-01

    Background Antipsychotics are potent dopamine antagonists used to treat schizophrenia and bipolar disorder. The aim of this study was to evaluate the relationship between antipsychotic drugs and adverse hyperglycemic events using the FDA Adverse Event Reporting System (FAERS) database. In particular, we focused on adverse hyperglycemic events associated with atypical antipsychotic use, which are major concerns. Findings We analyzed reports of adverse hyperglycemic events associated with 26 an...

  11. Perindopril for improving cardiovascular events

    OpenAIRE

    DiNicolantonio JJ; O’Keefe JH

    2014-01-01

    James J DiNicolantonio, James H O'Keefe Department of Preventive Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO, USAIn a recent review in Vascular Health and Risk Management Wang et al state that “In mainly placebo-controlled cardiovascular (CV)-outcome studies in patients with hypertension, CV benefits with perindopril were associated with large reductions in BP.”1 However, perindopril in the European Trial on Reduction of Cardiac Events With Perind...

  12. Perindopril for improving cardiovascular events

    Directory of Open Access Journals (Sweden)

    DiNicolantonio JJ

    2014-08-01

    Full Text Available James J DiNicolantonio, James H O'Keefe Department of Preventive Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO, USAIn a recent review in Vascular Health and Risk Management Wang et al state that “In mainly placebo-controlled cardiovascular (CV-outcome studies in patients with hypertension, CV benefits with perindopril were associated with large reductions in BP.”1 However, perindopril in the European Trial on Reduction of Cardiac Events With Perindopril in Stable Coronary Artery Disease (EUROPA study significantly reduced major cardiovascular events despite a small reduction (approximately 4 mmHg in systolic blood pressure from baseline.2,3 Additionally, the average baseline blood pressure in the EUROPA was just 137/82 mmHg, and in those without hypertension, perindopril still provided a 20% reduction in the combined endpoint of cardiovascular death, myocardial infarction, and cardiac arrest.4,5 In fact, patients receiving perindopril with a baseline systolic blood pressure of <120 mmHg had the greatest reduction in the primary event.6 View original paper by Wang and colleagues. 

  13. [Treatments with immunoglobulin and thrombotic adverse events].

    Science.gov (United States)

    Darnige, L; Lillo-Le Louët, A

    2014-01-01

    Treatments with intravenous or subcutaneous immunoglobulin (Ig) are used in a broad variety of disorders. Tolerance of Ig is usually good but adverse events, including some serious ones, have been reported and may differ among different Ig preparations. Thrombotic complications occur in 0.6 to 13% of cases and can involve arterial or venous circulation, rarely both. Deep venous thrombosis with or without pulmonary embolism, stroke or myocardial infarction remained the most frequent thrombotic complications. Some risk factors have been identified, mainly old age, multiple cardiovascular risk factors, and past history of thrombo-embolic manifestations. Several mechanisms are suggested to explain this increased risk of thrombotic complications. Indeed, Ig treatments increase the plasma viscosity, increase and activate platelets, can trigger the coagulation cascade through the presence of activated factor XI in some Ig preparations, and release vasoactive molecules responsible for vasospasm. Patients have to be carefully monitored and risk factors to be identified as soon as possible. The role of antiplatelets or anticoagulation is not well determined but should probably be proposed to patients with high risk. PMID:24011913

  14. Standardizing adverse drug event reporting data

    OpenAIRE

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a sta...

  15. Adverse events in spine surgery in Sweden

    OpenAIRE

    Öhrn, Annica; Olai, Anders; Rutberg, Hans; Nilsen, Per; Tropp, Hans

    2011-01-01

    Background and purpose Our knowledge of complications and adverse events in spinal surgery is limited, especially concerning incidence and consequences. We therefore investigated adverse events in spine surgery in Sweden by comparing patient claims data from the County Councils' Mutual Insurance Company register with data from the National Swedish Spine Register (Swespine). Methods We analyzed patient claims (n = 182) to the insurance company after spine surgery performed between 2003 and 200...

  16. Adverse pregnancy outcomes and subsequent risk of cardiovascular disease in women with systemic lupus erythematosus

    OpenAIRE

    Lin, Pin; Rhew, Elisa; Ness, Roberta B.; PEACEMAN, Alan; Dyer, Alan; McPherson, David; Kondos, George T.; Edmundowicz, Daniel; Sutton-Tyrrell, Kim; Thompson, Trina; Ramsey-Goldman, Rosalind

    2014-01-01

    Background/objective Patients with systemic lupus erythematosus (SLE) are at increased risk for adverse pregnancy outcomes and cardiovascular disease (CVD). The objective of this exploratory study was to investigate the association between a history of adverse pregnancy outcomes and subsequent risk of subclinical CVD assessed by imaging studies and verified clinical CVD events in 129 women with SLE. Methods The occurrence of adverse pregnancy outcomes, specifically pre-eclampsia, preterm birt...

  17. 经皮冠状动脉介入术后再发不良心血管事件的影响因素分析%Analysis of influential factors for recurrent adverse cardiovascular events after percutaneous coronary intervention

    Institute of Scientific and Technical Information of China (English)

    张爱玲; 刘瑶; 杨莉萍; 胡欣

    2014-01-01

    Objective To analyze the influential factors for recurrent adverse cardiovascular events within one year and 15 years after percutaneous coronary intervention( PCI)in patients with coronary atherosclerotic heart disease(CHD). Methods The patients with CHD,who underwent PCI or bypass operation of coronary artery meanwhile in Department of Cardiology,Beijing Hospital from january 1998 to March 2013,had complete medical records and received dual antiplatelet therapy with clopidogrel and aspirin for one year,were enrolled in the study. Patients' specimens of blood were collected and cytochrome P450 (CYP)2C19 genotype associated with metabolism of clopidogrel were detected. The patients were divided into the reference metabolizers group( *1 / *1),intermediate metabolizers group( *1 / *2 and *1 / *3)and slow metabolizers group( *2 / *2,*2 / *3 and *3 / *3)by the results of genotype detection. The situation of recurrent adverse cardiovascular events within one year and 15 years after the first PCI and the correlative factors were analyzed retrospectively. Results A total of 210 patients were enrolled in the study. They comprised of 148 males and 62 females with age 49-84(67 ± 10)years. There were 163 and 47 patients undergoing PCI for the first and second times,respectively. There were 185 and 25 patients undergoing PCI only and bypass operation of coronary artery meanwhile,respectively. There were 158,156,and 91 cases complicated with hypertension,hyperlipoidemia,and diabetes,respectively. The incidence of adverse cardiovascular events in the reference metabolizers group,the intermediate metabolizers group,and the slow metabolizers group within one year after PCI were 13. 3%(13 / 98),24. 7%(23 / 93),and 31. 6%(6 /19),respectively. The incidence of adverse cardiovascular events in the slow metabolizers group and the intermediate metabolizers group were 2. 37 and 1. 86 times of those in the reference metabolizers group, respectively. Carrying CYP2C19*2 or *3 genotype was

  18. Seamless prevention of adverse events from tattooing

    DEFF Research Database (Denmark)

    Serup, Jørgen

    2015-01-01

    The boom in tattooing has been paralleled by more frequent adverse events, which may be localised in the skin or systemic and manifested clinically or latent. Infections, allergic reactions from red-coloured tattoos and papulo-nodular reactions from black tattoos dominate. Mild complaints are very...... to hygienic security. Records and documentation of tattoo cases with complications and the culprit inks as well as the establishment of national or European-based surveillance systems that are properly equipped to deliver efficient clarification and handling of adverse events and hazards of tattooing and inks...

  19. Cardiovascular events in patients with COPD: TORCH study results

    DEFF Research Database (Denmark)

    Calverley, Peter M A; Anderson, Julie A; Celli, Bartolome; Ferguson, Gary T; Jenkins, Christine; Jones, Paul W; Crim, Courtney; Willits, Lisa R; Yates, Julie C; Vestbo, Jørgen; NN, NN

    2010-01-01

    BACKGROUND: Previous studies have suggested that long-term use of beta agonists to treat chronic obstructive pulmonary disease (COPD) may increase the risk of cardiovascular adverse events. In this post hoc analysis, data from the TOwards a Revolution in COPD Health (TORCH) study were used to...... investigate whether use of the long-acting beta(2) agonist salmeterol over 3 years increased the risk of cardiovascular adverse events in patients with moderate to severe COPD. METHODS: TORCH was a randomised, double-blind, placebo controlled study conducted at 444 centres in 42 countries. Patients (n=6184...... showed that salmeterol alone or in combination (SFC) did not increase the risk of cardiovascular events in patients with moderate to severe COPD....

  20. Orthokeratology vs. spectacles: Adverse events and discontinuations

    OpenAIRE

    Santodomingo Rubido, Jacinto; Villa Collar, César; Gilmartin, Bernard; Gutiérrez Ortega, Ángel Ramón

    2012-01-01

    Purpose. To assess the relative clinical success of orthokeratology contact lenses (OK) and distance single-vision spectacles (SV) in children in terms of incidences of adverse events and discontinuations over a 2-year period. Methods. Sixty-one subjects 6 to 12 years of age with myopia of - 0.75 to - 4.00DS and astigmatism

  1. [Analysis of Spontaneously Reported Adverse Events].

    Science.gov (United States)

    Nakamura, Mitsuhiro

    2016-01-01

    Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues. PMID:27040337

  2. Reporting vaccine-associated adverse events.

    OpenAIRE

    Duclos, P.; Hockin, J; Pless, R; Lawlor, B.

    1997-01-01

    OBJECTIVE: To determine family physicians' awareness of the need to monitor and report vaccine-associated adverse events (VAAE) in Canada and to identify mechanisms that could facilitate reporting. DESIGN: Mailed survey. SETTING: Canadian family practices. PARTICIPANTS: Random sample of 747 family physicians. Overall response rate was 32% (226 of 717 eligible physicians). MAIN OUTCOME MEASURES: Access to education on VAAE; knowledge about VAAE monitoring systems, reporting criteria, and repor...

  3. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    OpenAIRE

    Ali AK; Hartzema AG

    2012-01-01

    Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database...

  4. Adverse Pregnancy Outcomes and Cardiovascular Risk Factor Management

    OpenAIRE

    Mehta, Puja K.; Minissian, Margo; Merz, C. Noel Bairey

    2015-01-01

    Cardiovascular disease (CVD) is the leading health threat to American women. In addition to established risk factors for hypertension, hyperlipidemia, diabetes, smoking, and obesity, adverse pregnancy outcomes (APOs) including pre-eclampsia, eclampsia, and gestational diabetes are now recognized as factors that increase a woman’s risk for future CVD. CVD risk factor burden is disproportionately higher in those of low socioeconomic status and in ethnic/racial minority women. Since younger wome...

  5. Methylmercury Exposure and Adverse Cardiovascular Effects in Faroese Whaling Men

    OpenAIRE

    Choi, Anna Lai; Weihe, Pal; Budtz-Jørgensen, Esben; Jørgensen, Poul J.; Jukka T Salonen; Tuomainen, Tomi-Pekka; Murata, Katsuyuki; Nielsen, Hans Petur; Petersen, Maria Skaalum; Askham, Jórun; Grandjean, Philippe

    2008-01-01

    Background: Methylmercury (MeHg), a worldwide contaminant found in fish and seafood, has been linked to an increased risk of cardiovascular mortality. Objective: We examined 42 Faroese whaling men (30–70 years of age) to assess possible adverse effects within a wide range of MeHg exposures from consumption of pilot whale meat. Methods: We assessed exposure levels from mercury analysis of toenails and whole blood (obtained at the time of clinical examination), and a hair sample collected 7 yea...

  6. Perindopril for improving cardiovascular events

    OpenAIRE

    DiNicolantonio, James; O'Keefe, James

    2014-01-01

    James J DiNicolantonio, James H O'Keefe Department of Preventive Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO, USAIn a recent review in Vascular Health and Risk Management Wang et al state that “In mainly placebo-controlled cardiovascular (CV)-outcome studies in patients with hypertension, CV benefits with perindopril were associated with large reductions in BP.”1 However, perindopril in the European Trial on Reduction of Cardiac Ev...

  7. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  8. CDC WONDER: Vaccine Adverse Event Reporting System (VAERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by...

  9. Overview and Management of Cardiac Adverse Events Associated With Tyrosine Kinase Inhibitors

    OpenAIRE

    Lenihan, Daniel J.; Kowey, Peter R.

    2013-01-01

    Regular monitoring, early recognition, and appropriate interventions for cardiovascular (CV) adverse events (AEs) can help more patients derive the benefit of long-term tyrosine kinase inhibitor (TKI) therapy. This review examines what is known about the mechanism of action of CV AEs associated with TKI use and discusses therapeutic interventions that may prevent and manage these events in clinical practice.

  10. Managing Adverse Events With Immune Checkpoint Agents.

    Science.gov (United States)

    Dadu, Ramona; Zobniw, Chrystia; Diab, Adi

    2016-01-01

    Immune checkpoint inhibitors (anti-cytotoxic T-lymphocyte antigen 4 and anti programmed cell death 1/programmed cell death 1 ligand antibodies) have shown impressive clinical activity in multiple cancer types. Despite achieving great clinical success, challenges and limitations of these drugs as monotherapy or various combinational strategies include the development of a unique set of immune-related adverse events (irAEs) that can be severe and even fatal. Therefore, identification of patients at risk, prevention, consistent communication between patients and medical team, rapid recognition, and treatment of irAEs are critical in optimizing treatment outcomes. This review focuses on the description of more common irAEs and provides a suggested approach for management of specific irAEs. PMID:27111908

  11. Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

    DEFF Research Database (Denmark)

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse...

  12. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

    Full Text Available Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US.Methods and materials: Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction.Results: In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports, corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4. Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316 and 1.09 (0.95–1.24, respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA.Conclusion: Omalizumab is

  13. Text mining electronic health records to identify hospital adverse events

    DEFF Research Database (Denmark)

    Gerdes, Lars Ulrik; Hardahl, Christian

    2013-01-01

    Manual reviews of health records to identify possible adverse events are time consuming. We are developing a method based on natural language processing to quickly search electronic health records for common triggers and adverse events. Our results agree fairly well with those obtained using manu...

  14. CYTOKINE PROFILE IN VISCERAL OBESITY AND ADVERSE CARDIOVASCULAR PROGNOSIS OF MYOCARDIAL INFARCTION

    Directory of Open Access Journals (Sweden)

    O. V. Gruzdeva

    2015-06-01

    Full Text Available Presence of myocardial infarction in patients with obesity can lead to an uncontrolled increase in proinflammatory cytokines and unfavorable course of the pathological process. Objective: to study the relationship of key inflammatory factors and the development of complications at different terms after myocardial infarction in patients with visceral obesity. The study involved 94 men with myocardial infarction. Visceral obesity was diagnosed by multi-slice computed tomography (LightspeedVCT 64 ,General Electric,USA. On the 1st and 12th day of hospitalization, we determined serum concentrations of interleukins (TNFα, IL-1β, IL-6, IL-8 IL-10 and IL-12, and C-reactive protein. Adverse cardiovascular events were documented during the next year. The most informative indicators were identified by a stepwise logistic regression analysis. In patients with myocardial infarction an imbalance of cytokine profile revealed, i.e., an increase in proinflammatory markers (TNFα, IL-1β, IL-6, IL-8, IL-12, CRP, along with decrease in IL-10, being more pronounced in cases of visceral obesity. Among the studied markers, closest relationship was observed between visceral obesity and serum concentrations of IL-6 and CRP. Over the year, adverse cardiovascular events proved to be more frequent in patients with visceral obesity. Post-infarction complication risk was associated with higher concentrations of IL-6, IL-12 and IL-10 deficiency. Hence, development of adverse cardiovascular events within a year after myocardial infarction is more typical to the patients with visceral obesity, and is accompanied by activation of proinflammatory cytokines and IL-10 deficiency.

  15. Data mining for signal detection of adverse event safety data.

    Science.gov (United States)

    Chen, Hung-Chia; Tsong, Yi; Chen, James J

    2013-01-01

    The Adverse Event Reporting System (AERS) is the primary database designed to support the Food and Drug Administration (FDA) postmarketing safety surveillance program for all approved drugs and therapeutic biologic products. Most current disproportionality analysis focuses on the detection of potential adverse events (AE) involving a single drug and a single AE only. In this paper, we present a data mining biclustering technique based on the singular value decomposition to extract local regions of association for a safety study. The analysis consists of collection of biclusters, each representing an association between a set of drugs with the corresponding set of adverse events. Significance of each bicluster can be tested using disproportionality analysis. Individual drug-event combination can be further tested. A safety data set consisting of 193 drugs with 8453 adverse events is analyzed as an illustration. PMID:23331228

  16. Depressive Symptoms and Risk of New Cardiovascular Events or Death in Patients with Myocardial Infarction

    DEFF Research Database (Denmark)

    Larsen, Karen Kjær; Christensen, Bo; Søndergaard, Jens; Vestergaard, Mogens

    2013-01-01

    Depressive symptoms is associated with adverse cardiovascular outcomes in patients with myocardial infarction (MI), but the underlying mechanisms are unclear and it remains unknown whether subgroups of patients are at a particularly high relative risk of adverse outcomes. We examined the risk of...... new cardiovascular events and/or death in patients with depressive symptoms following first-time MI taking into account other secondary preventive factors. We further explored whether we could identify subgroups of patients with a particularly high relative risk of adverse outcomes....

  17. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C

    2012-01-01

    Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation...

  18. Incidence and preventability of adverse events requiring intensive care admission

    OpenAIRE

    Vlayen, Annemie; Verelst, Sandra; Bekkering, Geertruida E; Schrooten, Ward; Hellings, Johan; Claes, Neree

    2011-01-01

    Rationale, aims and objectives: Adverse events are unintended patient injuries or complications that arise from health care management resulting in death, disability or prolonged hospital stay. Adverse events that require critical care are a considerable financial burden to the health care system, but also their global impact on patients and society is probably underestimated. The objectives of this systematic review were to synthesize the best available evidence regarding the estimates of th...

  19. RADARx: Recognizing, Assessing, and Documenting Adverse Rx events.

    OpenAIRE

    Brown, S; Black, K.; Mrochek, S.; Wood, A.; Bess, T.; Cobb, J; Francis, J.

    2000-01-01

    BACKGROUND: Adverse events are a leading cause of morbidity and mortality. Adverse Drug Events (ADEs) are frequent, under-reported, costly, and largely preventable. Computerized tools expose effectively ADEs and can reduce their impact. METHODS: RADARx is a Veterans Administration (VA) VistA-compatible M software program that integrates computerized ADE screening, probability assessment, documentation, and reporting capabilities. Data dictionary mapping tools have enabled RADARx implementatio...

  20. Medical adverse events in elderly hospitalized patients: a prospective study

    Directory of Open Access Journals (Sweden)

    Claudia Szlejf

    2012-11-01

    Full Text Available OBJECTIVES: To determine the frequency of medical adverse events in elderly patients admitted to an acute care geriatric unit, the predictive factors of occurrence, and the correlation between adverse events and hospital mortality rates. METHODS: This prospective study included 171 admissions of patients aged 60 years and older in the acute care geriatric unit in a teaching hospital in Brazil between 2007 and 2008. The following variables were assessed at admission: the patient age, gender, number of prescription drugs, geriatric syndromes (e.g., immobility, postural instability, dementia, depression, delirium, and incontinence, comorbidities, functional status (evaluated with the Katz Index of Independence in Activities of Daily Living, and severity of illness (evaluated with the Simplified Acute Physiology Score Il. The incidence of delirium, infection, mortality, and the prescription of potentially inappropriate medications (based on the Beers criteria were assessed during hospitalization. An observer who was uninvolved in patient care reported the adverse events. RESULTS: The mean age of the sample was 78.12 years. A total of 187 medical adverse events occurred in 94 admissions (55%. The predictors of medical adverse events were undetermined. Compared with the patients with no adverse events, the patients with medical adverse events had a significantly longer hospital stay (21.41 ± 15.08 days versus 10.91 ± 7.21 days and a higher mortality rate (39 deaths [41.5%] versus 17 deaths [22.1%]. Mortality was significantly predicted by the Simplified Acute Physiology Score II score (odds ratio [OR] = 1.13, confidence interval [CI] 95%, 1.07 to 1.20, the Katz score (OR=1.47, CI 95%, 1.18 to 1.83, and medical adverse events (OR = 3.59, CI 95%, 1.55 to 8.30. CONCLUSION: Medical adverse events should be monitored in every elderly hospitalized patient because there is no risk profile for susceptible patients, and the consequences of adverse events are

  1. A database in ACCESS for assessing vaccine serious adverse events

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas,1 Dave Jackson2,3 1Department of Family Medicine, G012 Health Sciences Centre, University of Calgary Medical School, Calgary, AB, Canada; 2Independent Research Consultant, Calgary, AB, Canada; 3Database Consultant, University of Calgary, Calgary, AB, Canada Purpose: To provide a free flexible database for use by any researcher for assessing reports of adverse events after vaccination. Results: A database was developed in Microsoft ACCESS to assess reports of serious adverse events after yellow fever vaccination using Brighton Collaboration criteria. The database is partly automated (if data panels contain identical data fields the data are automatically also entered into those fields. The purpose is to provide the database free for developers to add additional panels to assess other vaccines. Keywords: serious adverse events after vaccination, database, process to assess vaccine-associated events 

  2. A database in ACCESS for assessing vaccine serious adverse events

    OpenAIRE

    Thomas RE; Jackson D

    2015-01-01

    Roger E Thomas,1 Dave Jackson2,3 1Department of Family Medicine, G012 Health Sciences Centre, University of Calgary Medical School, Calgary, AB, Canada; 2Independent Research Consultant, Calgary, AB, Canada; 3Database Consultant, University of Calgary, Calgary, AB, Canada Purpose: To provide a free flexible database for use by any researcher for assessing reports of adverse events after vaccination. Results: A database was developed in Microsoft ACCESS to assess reports of serious adverse ev...

  3. A review of Perindopril in the reduction of cardiovascular events

    Directory of Open Access Journals (Sweden)

    Duncan J Campbell

    2006-06-01

    Full Text Available Duncan J CampbellSt. Vincent’s Institute of Medical Research and the Department of Medicine, University of Melbourne, St. Vincent’s Hospital, Fitzroy, Victoria, AustraliaBackground: Angiotensin-converting enzyme inhibitors (ACEI have a well-established role in the prevention of cardiovascular events in hypertension, left ventricular dysfunction, and heart failure. More recently, ACEI have been shown to prevent cardiovascular events in individuals with increased cardiovascular risk, where hypertension, left ventricular dysfunction, or heart failure was not the primary indication for ACEI therapy.Objective: To review studies of the effects of the ACEI perindopril on cardiovascular events.Method: The EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease Study, PROGRESS (Perindopril Protection Against Recurrent Stroke Study, and ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial – Blood Pressure Lowering Arm trials are reviewed.Results: Perindopril alone reduced cardiovascular events in subjects with stable coronary heart disease. Perindopril in combination with indapamide reduced cardiovascular events in subjects with cerebrovascular disease. Perindopril in combination with amlodipine reduced cardiovascular events in subjects with hypertension.Conclusion: Perindopril reduced cardiovascular events. The reduction of cardiovascular events by perindopril was in large part associated with reduction of blood pressure, and greater reduction in cardiovascular events was associated with greater reduction of blood pressure. Perindopril may need to be combined with other antihypertensive agents to maximize reduction of cardiovascular events.Keywords: Angiotensin-converting enzyme inhibitor, hypertension, coronary heart disease, stroke, myocardial infarction, heart failure

  4. Adverse events due to the immunization: Case report

    Directory of Open Access Journals (Sweden)

    Medić Snežana

    2012-01-01

    Full Text Available Introduction. An adverse event after immunization is a medical incident following the administration of vaccine, which can be connected with vaccine usage. This event could be a reaction to a vaccine component or lapse in vaccine handling, transport and storage or coincidental event. The assessment of severity of this reaction and the decision about prospective permanent contraindications for futher immunization are to be made by the regional expert team for permanent contraindications. This is regulated by low. Case report. A series of adverse events after immunization in three children of a single family is reported. As regulated by law, all three children were vaccinated with different vaccines, from 2007. to 2010. Although the recorded events were diverse by their nature, way of clinical manifestation and severity they all required hospitalization. In addition to being siblings, the three children had the same atopic diseases in their personal and family anamnesis. All adverse events were explored including allergological/immunological tests. Thanks to the good cooperation of involved general practicioners, pediatricians, members of expert team for permanent contraindications and clinicians, two of three children received the full series of vaccines in optimal time. Discussion. Decision making about futher immunization of children with adverse event after vaccine administration depends on the nature and severity of developed medical condition, results of medical exploration, existing immunity and personal risk of getting disease and subsequent complications. Conclusion. Bearing in mind the significance of immunization for personal and collective immunity, good cooperation of all physicians and experts involved in each single case of adverse event is required.

  5. No association between anxiety and depression and adverse clinical outcome among patients with cardiovascular disease

    DEFF Research Database (Denmark)

    Kornerup, Henriette; Zwisler, Ann-Dorthe Olsen; Prescott, Eva

    2011-01-01

    Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far.......Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far....

  6. A Review of Perindopril in the Reduction of Cardiovascular Events

    OpenAIRE

    Campbell, Duncan J.

    2006-01-01

    Background Angiotensin-converting enzyme inhibitors (ACEI) have a well-established role in the prevention of cardiovascular events in hypertension, left ventricular dysfunction, and heart failure. More recently, ACEI have been shown to prevent cardiovascular events in individuals with increased cardiovascular risk, where hypertension, left ventricular dysfunction, or heart failure was not the primary indication for ACEI therapy. Objective To review studies of the effects of the ACEI perindopr...

  7. Adverse Cardiovascular Effects of Nitrous Oxide: It is not all about Hyperhomocysteinaemia

    Directory of Open Access Journals (Sweden)

    Ata Mahmoodpoor

    2015-04-01

    Full Text Available Once admired for its supposed safety, nitrous oxide is presently blamed to increase adverse cardiovascular effects through augmenting plasma homocysteine concentrations (1, 2. Hemodynamic alterations following the administration of nitrous oxide are extremely complicated and sometimes contradictory. Enhanced venous return, arterial pressure, pulmonary and systemic vascular resistance, cardiac output, pupillary dilation and diaphoresis occur under nitrous oxide administration consistent with sympathomimetic properties of nitrous oxide (3. Conversely, reductions in arterial pressure are also probable, especially in patients with coronary artery disease. Nitrous oxide can also depress myocardial contractility due to decreased availability of Ca2+ for contractile activation; yet, myocardial relaxation kinetics remains intact (4. In the presence of a volatile anesthetic, nitrous oxide decreases MVO2 (Myocardial oxygen consumption and myocardial O2 extraction which may exacerbate myocardial ischemia during concomitant reductions in arterial pressure in patients with coronary artery disease. Consequently, it could be conjectured that probable adverse cardiovascular effects following nitrous oxide administration are variable and consequent of a multi-variable phenomenon rather than a single variable such as increased levels of homocysteine. Studied purely focusing on the effects of nitrous oxide are difficult to conduct due to the numerous confounding factors.In a study by Myles et al., hyperhomocysteinemia has been introduced as the source of the adverse cardiovascular effects of nitrous oxide. However, in this study, increased inspired oxygen concentrations were used to overcome arterial desaturation (1. Given the fact that a constant volume and flow rates are used throughout the anesthesia in a particular patient, increasing the concentrations of oxygen would be associated with decreased delivered nitrous oxide and volatile anesthetic concentrations

  8. Predictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: Pooled analysis from the SPIRIT II, III, IV and COMPARE trials

    NARCIS (Netherlands)

    D.J. Kereiakes (Dean); P.C. Smits (Pieter); E. Kedhi (Elvin); H. Parise (Helen); M. Fahy (Martin); P.W.J.C. Serruys (Patrick); G.W. Stone (Gregg)

    2011-01-01

    textabstractAims: Although clinical trials have demonstrated superior clinical efficacy and improved safety of the everolimus-eluting stent (EES) compared with paclitaxel-eluting stents (PES) the clinical, angiographic and procedural factors associated with adverse clinical outcomes following drug-e

  9. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  10. Genomic architecture of pharmacological efficacy and adverse events

    OpenAIRE

    Chhibber, Aparna; Kroetz, Deanna L.; Tantisira, Kelan G.; McGeachie, Michael; Cheng, Cheng; Plenge, Robert; Stahl, Eli; Sadee, Wolfgang; RITCHIE, MARYLYN D.; Pendergrass, Sarah A.

    2014-01-01

    The pharmacokinetic and pharmacodynamic disciplines address pharmacological traits, including efficacy and adverse events. Pharmacogenomics studies have identified pervasive genetic effects on treatment outcomes, resulting in the development of genetic biomarkers for optimization of drug therapy. Pharmacogenomics-based tests are already being applied in clinical decision making. However, despite substantial progress in identifying the genetic etiology of pharmacological response, current biom...

  11. Population-based investigations to study the association of cardiovascular polymorphisms and adverse pregnancy outcome

    DEFF Research Database (Denmark)

    Lykke, Jacob Alexander; Langhoff-Roos, Jens; Young, Bradford;

    2007-01-01

    Adverse pregnancy outcome refers to placenta-mediated complications that may share a common etiopathogenesis in some cases. Unraveling associations between prothrombotic genetic predispositions and these pregnancy disorders, namely recurrent fetal loss, stillbirth, severe preeclampsia, intrauteri...... pro-thrombotic and cardiovascular genetic polymorphisms. These studies are urgently needed to accurately assess the linkage between family history, presence of adverse pregnancy outcome, and long-term cardiovascular risk....... growth restriction, and placental abruption, requires rigorous epidemiological studies involving large cohorts of patients with sufficient numbers of the adverse pregnancy outcomes in question. Such is the case with the Denmark National Birth Cohort, which was initiated in 1996 and followed pregnant...

  12. Population-based investigations to study the association of cardiovascular polymorphisms and adverse pregnancy outcome

    DEFF Research Database (Denmark)

    Lykke, Jacob Alexander; Langhoff-Roos, Jens; Young, Bradford;

    2007-01-01

    Adverse pregnancy outcome refers to placenta-mediated complications that may share a common etiopathogenesis in some cases. Unraveling associations between prothrombotic genetic predispositions and these pregnancy disorders, namely recurrent fetal loss, stillbirth, severe preeclampsia, intrauterine...... study focuses on pro-thrombotic and cardiovascular genetic polymorphisms in a nested-case control study comparing pregnancies with and without an adverse pregnancy outcome in the index pregnancy. This study will be adequately powered to determine the relationship between adverse pregnancy outcome and...

  13. Vigilancia de eventos adversos a vacunas: Adverse events surveillance Vaccines

    Directory of Open Access Journals (Sweden)

    Katia Abarca V

    2007-02-01

    Full Text Available El propósito de los sistemas de vigilancia de eventos adversos a vacunas es monitorizar aquellos temporalmente relacionados con las vacunaciones, para evaluar su causalidad y para describir eventos acaecidos luego de la introducción de nuevas vacunas. El fin último de estos sistemas es proporcionar a la población el mejor estándar de seguridad relativo a vacunas. El sistema de vigilancia puede ser pasivo (reportes espontáneos o activo (seguimiento activo de los vacunados; la mayoría en ejercicio es pasiva. Este artículo presenta un resumen abreviado de los sistemas de vigilancia de eventos adversos a vacunas más conocidos, incluyendo los sistema empleados en los Estados Unidos de América (Vaccine Adverse Events Report System-VAERS, Canadá y Europa, como así también una referencia al sistema chileno, destacando las principales ventajas y limitaciones en cada casoThe objective of the surveillance systems of vaccine adverse events is monitoring events temporally related to vaccination, to evaluate their causality with the vaccine and to detect events after the introduction of new vaccines. The ultimate goal of these systems is to provide the population with the best safety standard of the vaccines. The surveillance system can be passive (spontaneous reports or active (active follow up of vaccinees; the majority of them are passive. The article gives a brief review of the most known vaccine adverse events surveillance systems, including the American Vaccine Adverse Events Report System (VAERS, the Canadian and European systems, a commentary about the Chilean one, highlighting its main advantages and also its limitations

  14. Physical distress is associated with cardiovascular events in a high

    OpenAIRE

    Klemsdal Tor O; Ekeberg Øivind; Einvik Gunnar; Sandvik Leiv; Hjerkinn Elsa M

    2016-01-01

    Background Self-reported health perceptions such as physical distress and quality of life are suggested independent predictors of mortality and morbidity in patients with established cardiovascular disease. This study examined the associations between these factors and three years incidence of cardiovascular events in a population of elderly men with long term hyperlipidemia. Methods We studied observ...

  15. Vitex agnus castus: a systematic review of adverse events.

    Science.gov (United States)

    Daniele, Claudia; Thompson Coon, Joanna; Pittler, Max H; Ernst, Edzard

    2005-01-01

    Vitex agnus castus L. (VAC) [Verbenaceae] is a deciduous shrub that is native to Mediterranean Europe and Central Asia. Traditionally, VAC fruit extract has been used in the treatment of many female conditions, including menstrual disorders (amenorrhoea, dysmenorrhoea), premenstrual syndrome (PMS), corpus luteum insufficiency, hyperprolactinaemia, infertility, acne, menopause and disrupted lactation. The German Commission E has approved the use of VAC for irregularities of the menstrual cycle, premenstrual disturbances and mastodynia. Clinical reviews are available for the efficacy of VAC in PMS, cycle disorders, hyperprolactinaemia and mastalgia, but so far no systematic review has been published on adverse events or drug interactions associated with VAC. Therefore, this review was conducted to evaluate all the available human safety data of VAC monopreparations. Literature searches were conducted in six electronic databases, in references lists of all identified papers and in departmental files. Data from spontaneous reporting schemes of the WHO and national drug safety bodies were also included. Twelve manufacturers of VAC-containing preparations and five herbalist organisations were contacted for additional information. No language restrictions were imposed. Combination preparations including VAC or homeopathic preparations of VAC were excluded. Data extraction of key data from all articles reporting adverse events or interactions was performed independently by at least two reviewers, regardless of study design. Data from clinical trials, postmarketing surveillance studies, surveys, spontaneous reporting schemes, manufacturers and herbalist organisations indicate that the adverse events following VAC treatment are mild and reversible. The most frequent adverse events are nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or

  16. Management of egfr tki–induced dermatologic adverse events

    OpenAIRE

    Melosky, B.; Leighl, N.B.; Rothenstein, J; Sangha, R.; Stewart, D; Papp, K.

    2015-01-01

    Targeting the epidermal growth factor receptor (egfr) pathway has become standard practice for the treatment of advanced non-small-cell lung cancer. Compared with chemotherapy, egfr tyrosine kinase inhibitors (tkis) have been associated with improved efficacy in patients with an EGFR mutation. Together with the increase in efficacy comes an adverse event (ae) profile different from that of chemotherapy. That profile includes three of the most commonly occurring dermatologic aes: acneiform ras...

  17. Serious adverse events associated with yellow fever vaccine

    OpenAIRE

    de Menezes Martins, Reinaldo; da Luz Fernandes Leal, Maria; Homma, Akira

    2015-01-01

    Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease in some otherwise healthy individuals, with high lethality. After extensive studies, although some risk factors have been identified, the real cause of causes of this serious adverse event are largely unknown, but findings point to individual host factors. Meningoencephalitis, once considered to happen only in children less than 6 months...

  18. Framingham risk score with cardiovascular events in chronic kidney disease.

    Directory of Open Access Journals (Sweden)

    Szu-Chia Chen

    Full Text Available The Framingham Risk Score (FRS was developed to predict coronary heart disease in various populations, and it tended to under-estimate the risk in chronic kidney disease (CKD patients. Our objectives were to determine whether FRS was associated with cardiovascular events, and to evaluate the role of new risk markers and echocardiographic parameters when they were added to a FRS model. This study enrolled 439 CKD patients. The FRS is used to identify individuals categorically as "low" (4.7 cm, left ventricular hypertrophy or left ventricular ejection fraction<50% to the FRS model significantly improves the predictive values for cardiovascular events. In CKD patients, "high" risk categorized by FRS predicts cardiovascular events. Novel biomarkers and echocardiographic parameters provide additional predictive values for cardiovascular events. Future study is needed to assess whether risk assessment enhanced by using these biomarkers and echocardiographic parameters might contribute to more effective prediction and better care for patients.

  19. Covert hypothyroidism presenting as a cardiovascular event.

    Science.gov (United States)

    LeMar, H J; West, S G; Garrett, C R; Hofeldt, F D

    1991-11-01

    Hypothyroidism presenting with classic signs and symptoms is generally easily recognized. Less often, patients with hypothyroidism may present with symptoms and laboratory abnormalities suggestive of cardiovascular disease. In this article, we describe six such patients. Hypothyroidism was suspected when creatine phosphokinase (CPK) levels were persistently elevated. The diagnosis was confirmed by thyroid function tests, and thyroid hormone therapy resulted in resolution of symptoms and CPK elevations. Persistently elevated CPK levels associated with cardiovascular symptoms but without demonstrable myocardial damage should prompt consideration of covert hypothyroidism. PMID:1951418

  20. Dyspnea assessment and adverse events during sputum induction in COPD

    Directory of Open Access Journals (Sweden)

    Moschandreas Joanna

    2006-06-01

    Full Text Available Abstract Background The inhalation of normal or hypertonic saline during sputum induction (SI may act as an indirect bronchoconstrictive stimulus leading to dyspnea and lung function deterioration. Our aim was to assess dyspnea and adverse events in COPD patients who undergo SI following a safety protocol. Methods Sputum was induced by normal and hypertonic (4.5% saline solution in 65 patients with COPD of varying severity. In order to minimize saline-induced bronchoconstriction a protocol based on the European Respiratory Society sputum induction Task group report was followed. Dyspnea change was scored using the Borg scale and lung function was assessed by spirometry and oximetry. Results Borg score changes [median(IQR 1.5(0–2] were observed during SI in 40 subjects; 16 patients required temporary discontinuation of the procedure due to dyspnea-general discomfort and 2 did not complete the session due to dyspnea-wheezing. The change in Borg dyspnea score was significantly correlated with oxygen saturation and heart rate changes and with discontinuation of the procedure due to undesired symptoms. 19 subjects presented an hyperresponsive reaction (decline>20% from baseline FEV1. No significant correlation between Borg changes and FEV1decline was found. Patients with advanced COPD presented significantly greater Borg and oxygen saturation changes than patients with less severe disease (p = 0.02 and p = 0.001, respectively. Baseline FEV1, oxygen saturation and 6MWT demonstrated significant diagnostic values in distinguishing subjects who develop an adverse physiologic reaction during the procedure. Conclusion COPD patients undergoing SI following a safety protocol do not experience major adverse events. Dyspnea and oxygen desaturation is more likely to occur in patients with disease in advanced stages, leading to short discontinuation or less frequently to termination of the procedure. Baseline FEV1, oxygen saturation and 6MWT may have a

  1. Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

    Directory of Open Access Journals (Sweden)

    Eckstrand Julie

    2010-02-01

    Full Text Available Abstract Background Despite the high frequency with which adverse drug events (ADEs occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA. Methods A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described. Results A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1% were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157, 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note. Conclusions Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist

  2. Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol

    Directory of Open Access Journals (Sweden)

    Lorenzo-Aguiar Dolores

    2011-01-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients. The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, Regicor, SCORE, and DORICA to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation. Methods/Design Observational prospective cohort study of all kidney transplant recipients in the A Coruña Hospital (Spain in the period 1981-2008 (2059 transplants corresponding to 1794 patients. The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease. Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE equation, and the REGICOR (Registre Gironí del COR (Gerona Heart Registry, and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk functions. The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk

  3. Better Adherence to the Mediterranean Diet Could Mitigate the Adverse Consequences of Obesity on Cardiovascular Disease: The SUN Prospective Cohort

    Directory of Open Access Journals (Sweden)

    Sonia Eguaras

    2015-11-01

    Full Text Available Strong observational evidence supports the association between obesity and cardiovascular events. In elderly high-risk subjects, the Mediterranean diet (MedDiet was reported to counteract the adverse cardiovascular effects of adiposity. Whether this same attenuation is also present in younger subjects is not known. We prospectively examined the association between obesity and cardiovascular clinical events (myocardial infarction, stroke or cardiovascular death after 10.9 years follow-up in 19,065 middle-aged men and women (average age 38 year according to their adherence to the MedDiet (<6 points or ≥6 points in the Trichopoulou’s Mediterranean Diet Score. We observed 152 incident cases of cardiovascular disease (CVD. An increased risk of CVD across categories of body mass index (BMI was apparent if adherence to the MedDiet was low, with multivariable-adjusted hazard ratios (HRs: 1.44 (95% confidence interval: 0.93–2.25 for ≥25 – <30 kg/m2 of BMI and 2.00 (1.04–3.83 for ≥30 kg/m2 of BMI, compared to a BMI < 25 kg/m2. In contrast, these estimates were 0.77 (0.35–1.67 and 1.15 (0.39–3.43 with good adherence to MedDiet. Better adherence to the MedDiet was associated with reduced CVD events (p for trend = 0.029. Our results suggest that the MedDiet could mitigate the harmful cardiovascular effect of overweight/obesity.

  4. Better Adherence to the Mediterranean Diet Could Mitigate the Adverse Consequences of Obesity on Cardiovascular Disease: The SUN Prospective Cohort

    Science.gov (United States)

    Eguaras, Sonia; Toledo, Estefanía; Hernández-Hernández, Aitor; Cervantes, Sebastián; Martínez-González, Miguel A.

    2015-01-01

    Strong observational evidence supports the association between obesity and cardiovascular events. In elderly high-risk subjects, the Mediterranean diet (MedDiet) was reported to counteract the adverse cardiovascular effects of adiposity. Whether this same attenuation is also present in younger subjects is not known. We prospectively examined the association between obesity and cardiovascular clinical events (myocardial infarction, stroke or cardiovascular death) after 10.9 years follow-up in 19,065 middle-aged men and women (average age 38 year) according to their adherence to the MedDiet (<6 points or ≥6 points in the Trichopoulou’s Mediterranean Diet Score). We observed 152 incident cases of cardiovascular disease (CVD). An increased risk of CVD across categories of body mass index (BMI) was apparent if adherence to the MedDiet was low, with multivariable-adjusted hazard ratios (HRs): 1.44 (95% confidence interval: 0.93–2.25) for ≥25 – <30 kg/m2 of BMI and 2.00 (1.04–3.83) for ≥30 kg/m2 of BMI, compared to a BMI < 25 kg/m2. In contrast, these estimates were 0.77 (0.35–1.67) and 1.15 (0.39–3.43) with good adherence to MedDiet. Better adherence to the MedDiet was associated with reduced CVD events (p for trend = 0.029). Our results suggest that the MedDiet could mitigate the harmful cardiovascular effect of overweight/obesity. PMID:26556370

  5. Circulating fibrocytes as predictors of adverse events in unstable angina.

    Science.gov (United States)

    Keeley, Ellen C; Schutt, Robert C; Marinescu, Mark A; Burdick, Marie D; Strieter, Robert M; Mehrad, Borna

    2016-06-01

    Half of the patients who present with unstable angina (UA) develop recurrent symptoms over the subsequent year. Identification of patients destined to develop such adverse events would be clinically valuable, but current tools do not allow for this discrimination. Fibrocytes are bone marrow-derived progenitor cells that co-express markers of leukocytes and fibroblasts and are released into the circulation in the context of tissue injury. We hypothesized that, in patients with UA, the number of circulating fibrocytes predicts subsequent adverse events. We enrolled 55 subjects with UA, 18 with chronic stable angina, and 22 controls and correlated their concentration of circulating fibrocytes to clinical events (recurrent angina, myocardial infarction, revascularization, or death) over the subsequent year. Subjects with UA had a >2-fold higher median concentration of both total and activated fibrocytes compared with subjects with chronic stable angina and controls. In UA subjects, the concentration of total fibrocytes identified those who developed recurrent angina requiring revascularization (time-dependent area under the curve 0.85) and was superior to risk stratification using thrombolysis in myocardial infarction risk score and N-terminal pro B-type natriuretic peptide levels (area under the curve, 0.53 and 0.56, respectively, P fibrocyte level was associated with recurrent angina (hazard ratio, 1.016 per 10,000 cells/mL increase; 95% confidence interval, 1.007-1.024; P fibrocytes are elevated in patients with UA and successfully risk stratify them for adverse clinical outcomes. Fibrocytes may represent a novel biomarker of outcome in this population. PMID:27012475

  6. Analysis of Adverse Events in Identifying GPS Human Factors Issues

    Science.gov (United States)

    Adams, Catherine A.; Hwoschinsky, Peter V.; Adams, Richard J.

    2004-01-01

    The purpose of this study was to analyze GPS related adverse events such as accidents and incidents (A/I), Aviation Safety Reporting System (ASRS) reports and Pilots Deviations (PDs) to create a framework for developing a human factors risk awareness program. Although the occurrence of directly related GPS accidents is small the frequency of PDs and ASRS reports indicated there is a growing problem with situational awareness in terminal airspace related to different types of GPs operational issues. This paper addresses the findings of the preliminary research and a brief discussion of some of the literature on related GPS and automation issues.

  7. Xerosis and pruritus as major EGFRI-associated adverse events

    OpenAIRE

    Clabbers, Julia M. K.; Boers–Doets, Christine B.; Gelderblom, Hans; Stijnen, Theo; Lacouture, Mario E.; van der Hoeven, Koos J. M.; Kaptein, Adrian A.

    2015-01-01

    Purpose The objective of this sub-analysis of the BeCet study (NCT01136005) was to examine health-related quality of life (HRQoL) of patients experiencing dermatological adverse events (AEs) during the first 6 weeks of epidermal growth factor receptor inhibitor (EGFRI) treatment. Methods Patients (n = 85) treated with EGFRI completed five questionnaires during the first 6 weeks of treatment. 77 patients provided enough data for the sub-analysis. Experienced AEs were reported in the Dermatolog...

  8. Are Residents' Extended Shifts Associated With Adverse Events?

    OpenAIRE

    Ayas, Najib T.; Brian E Cade; Barger, Laura; Cronin, John W.; Rosner, Bernard Alfred; Speizer, Frank Erwin; Czeisler, Charles Andrew

    2006-01-01

    Editors' Summary Background. In the United States, medical students who are doing their internship (first year of postgraduate clinical training) regularly work in the clinic for longer than 24 h at a time. It is already known that doctors or students who work for long shifts make more medical errors and are less able to pay attention to what they are doing. Many thousands of adverse medical events per year including, in the extreme, deaths of patients, are thought to result from medical erro...

  9. Adverse events with continuous doxapram infusion against late postoperative hypoxaemia

    DEFF Research Database (Denmark)

    Rosenberg, J; Kristensen, P A; Pedersen, M H;

    1996-01-01

    OBJECTIVE: A randomized double-blind controlled trial of doxapram versus placebo against late postoperative hypoxaemia was planned to include 40 patients (2 x 20). RESULTS: After inclusion of 18 patients a serious adverse event was encountered with development of a brain stem infarction in a 90-y...... promising, further studies on the effect of continuous nocturnal postoperative doxapram infusion on levels of arterial oxygen saturation should be postponed until more knowledge about the pharmacokinetics of doxapram in this particular clinical situation has been gathered....

  10. Incidence of Major Cardiovascular Events in Immigrants to Ontario, Canada

    OpenAIRE

    Tu, Jack V.; Chu, Anna; Rezai, Mohammad R.; Guo, Helen; Maclagan, Laura C.; Austin, Peter C; Booth, Gillian L.; Manuel, Douglas G.; Chiu, Maria; Ko, Dennis T.; Lee, Douglas S; Shah, Baiju R; Donovan, Linda R; Sohail, Qazi Zain; Alter, David A.

    2015-01-01

    Background— Immigrants from ethnic minority groups represent an increasing proportion of the population in many high-income countries, but little is known about the causes and amount of variation between various immigrant groups in the incidence of major cardiovascular events. Methods and Results— We conducted the Cardiovascular Health in Ambulatory Care Research Team (CANHEART) Immigrant Study, a big data initiative, linking information from Citizenship and Immigration Canada’s Permanent Res...

  11. Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database.

    Science.gov (United States)

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

      Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women. PMID:26935093

  12. An approach to death as an adverse event following immunization.

    Science.gov (United States)

    Gold, Michael S; Balakrishnan, Madhava Ram; Amarasinghe, Ananda; MacDonald, Noni E

    2016-01-01

    Co-incidental death occurring proximate to vaccination may be reported as an adverse event following immunization. Such events are particularly concerning because they may raise community and health provider concerns about the safety of the specific vaccine and often the immunization programme in general. Coincidental events need to be differentiated from vaccine reactions, such as anaphylaxis, which may very rarely result in death. In 2013, the World Health Organization (WHO) released an updated manual for the Causality Assessment of an AEFI. The purpose of this review is to apply the WHO causality methodology to death when this is reported as an AEFI. The causality assessment scheme recommends a four step process to enable classification of the AEFI and to differentiate events which are causally consistent from those that are inconsistent with immunization. However, for some events causality maybe indeterminate. Consistent causal reactions that may result in death are very rare and maybe related to the vaccine product (e.g. anaphylaxis, viscerotrophic disease), vaccine quality defect (e.g. an incompletely attenuated live vaccine agent) or an immunization error (e.g. vaccine vial contamination). Events that are inconsistent with immunizations are due to co-incidental conditions that may account for infant and childhood mortality. In countries with a high infant mortality rate the coincidental occurrence of death and immunization may occur not infrequently and a robust mechanism to obtain information from autopsy and perform an AEFI investigation and causality assessment is essential. Communication with the community and all stakeholders to maintain confidence in the immunization programme is critical. PMID:26608326

  13. Adverse events related to emergency department care: a systematic review.

    Directory of Open Access Journals (Sweden)

    Antonia S Stang

    Full Text Available OBJECTIVE: To systematically review the literature regarding the prevalence, preventability, severity and types of adverse events (AE in the Emergency Department (ED. METHODS: We systematically searched major bibliographic databases, relevant journals and conference proceedings, and completed reference reviews of primary articles. Observational studies (cohort and case-control, quasi-experimental (e.g. before/after studies and randomized controlled trials, were considered for inclusion if they examined a broad demographic group reflecting a significant proportion of ED patients and described the proportion of AE. Studies conducted outside of the ED setting, those examining only a subpopulation of patients (e.g. a specific entrance complaint or receiving a specific intervention, or examining only adverse drug events, were excluded. Two independent reviewers assessed study eligibility, completed data extraction, and assessed study quality with the Newcastle Ottawa Scale. RESULTS: Our search identified 11,624 citations. Ten articles, representing eight observational studies, were included. Methodological quality was low to moderate with weaknesses in study group comparability, follow-up, and outcome ascertainment and reporting. There was substantial variation in the proportion of patients with AE related to ED care, ranging from 0.16% (n = 9308 to 6.0% (n = 399. Similarly, the reported preventability of AE ranged from 36% (n = 250 to 71% (n = 24. The most common types of events were related to management (3 studies, diagnosis (2 studies and medication (2 studies. CONCLUSIONS: The variability in findings and lack of high quality studies on AE in the high risk ED setting highlights the need for research in this area. Further studies with rigorous, standardized outcome assessment and reporting are required.

  14. Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention

    Institute of Scientific and Technical Information of China (English)

    Guo-Shuang Feng; Harry HX Xia; Ji-You Li; Shiu Kum Lam; Wei-Cheng You; Jun-Ling Ma; Benjamin CY Wong; Lian Zhang; Wei-Dong Liu; Kai-Feng Pan; Lin Shen; Xiao-Dong Zhang; Jie Li

    2008-01-01

    AIM: To evaluate the long-term risk of gastroduodenal ulcer and cardiovascular events induced by celecoxib in a population-based, randomized, double-blind,placebo-controlled study.METHODS: From 2004 to 2006, a total of 1024 Chinese patients (aged 35 to 64 years) with severe chronic atrophic gastritis, intestinal metaplasia or dysplasia were randomly assigned to receive 200 mg of celecoxib twice daily or placebo in Linqu County (Shandong Province, China), a high-risk area of gastric cancer. All gastroduodenal ulcer and cardiovascular events occurred were recorded and the patients were followed up for 1.5 years after treatment. At the end of the trial, a systematic interview survey about other adverse events was conducted.RESULTS: Gastroduodenal ulcer was detected in 19 of 463 (3.72%) patients who Received: celecoxib and 17 of 473 (3.31%) patients who Received placebo,respectively (odds ratio = 1.13, 95% CI = 0.58-2.19).Cardiovascular (CV) events occurred in 4 patients who received celecoxib and in 5 patients who received placebo,respectively.Compared with those who received placebo,patients who received celecoxib had no significant increase in occurrence of Cvevents (hazard ratio = 0.84,95% CI =0.23-3.15).Among the adverse events acquired by interview survey,only the frequency of bloating was significantly higher in patients treated with celecoxib than in those treated with placebo.CONCLUSION:Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.

  15. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis

    DEFF Research Database (Denmark)

    Fellström, Bengt C; Jardine, Alan G; Schmieder, Roland E; Holdaas, Hallvard; Bannister, Kym; Beutler, Jaap; Chae, Dong-Wan; Chevaile, Alejandro; Cobbe, Stuart M; Grönhagen-Riska, Carola; De Lima, José J; Lins, Robert; Mayer, Gert; McMahon, Alan W; Parving, Hans-Henrik; Remuzzi, Giuseppe; Samuelsson, Ola; Sonkodi, Sandor; Sci, D; Süleymanlar, Gultekin; Tsakiris, Dimitrios; Tesar, Vladimir; Todorov, Vasil; Wiecek, Andrzej; Wüthrich, Rudolf P; Gottlow, Mattis; Johnsson, Eva; Zannad, Faiez

    2009-01-01

    BACKGROUND: Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. METHODS: We conducted an international, multicenter, randomized, double-blind, prospective...... trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke......: In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number...

  16. Evaluating imbalances of adverse events during biosimilar development.

    Science.gov (United States)

    Vana, Alicia M; Freyman, Amy W; Reich, Steven D; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A; Zacharchuk, Charles M; Ewesuedo, Reginald

    2016-07-01

    Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

  17. Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting.

    Science.gov (United States)

    Hatoun, Jonathan; Suen, Winnie; Liu, Constance; Shea, Sandy; Patts, Gregory; Weinberg, Janice; Eng, Jessica

    2016-07-01

    Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P systems were unlikely to change after reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P system effectiveness, and educational preferences. PMID:25753451

  18. Late Adverse Events after Enhanced and Unenhanced MRI and CT

    DEFF Research Database (Denmark)

    Azzouz, Manal; Rømsing, Janne; Thomsen, Henrik S.

    2014-01-01

    Prospective evaluation of frequency of late and very late adverse events in patients undergoing enhanced or unenhanced magnetic resonance imaging (MRI) or computed tomography (CT). The imaging procedure was performed according to the protocols of the department. All patients were contacted three...... of LAEs was significantly higher in the enhanced MRI (38%) and CT (27%) groups than unenhanced MRI (20%) and CT (16%) groups. The frequency of nausea, dizziness, abdominal pain and diarrhoea was significantly higher in the enhanced MRI group than in the MRI control group, while taste sensation...... was reported more frequent in the enhanced CT group than in the CT control group. The incidence of VLAEs was significantly higher in the enhanced CT (21%) than unenhanced CT group (13%). The same LAEs and VLAEs were reported in all four groups. LAEs and VLAEs were reported more often in patients with allergy...

  19. Mining for adverse drug events with formal concept analysis

    CERN Document Server

    Estacio-Moreno, Alexander; Bousquet, Cédric

    2009-01-01

    The pharmacovigilance databases consist of several case reports involving drugs and adverse events (AEs). Some methods are applied consistently to highlight all signals, i.e. all statistically significant associations between a drug and an AE. These methods are appropriate for verification of more complex relationships involving one or several drug(s) and AE(s) (e.g; syndromes or interactions) but do not address the identification of them. We propose a method for the extraction of these relationships based on Formal Concept Analysis (FCA) associated with disproportionality measures. This method identifies all sets of drugs and AEs which are potential signals, syndromes or interactions. Compared to a previous experience of disproportionality analysis without FCA, the addition of FCA was more efficient for identifying false positives related to concomitant drugs.

  20. Genomic architecture of pharmacological efficacy and adverse events.

    Science.gov (United States)

    Chhibber, Aparna; Kroetz, Deanna L; Tantisira, Kelan G; McGeachie, Michael; Cheng, Cheng; Plenge, Robert; Stahl, Eli; Sadee, Wolfgang; Ritchie, Marylyn D; Pendergrass, Sarah A

    2014-12-01

    The pharmacokinetic and pharmacodynamic disciplines address pharmacological traits, including efficacy and adverse events. Pharmacogenomics studies have identified pervasive genetic effects on treatment outcomes, resulting in the development of genetic biomarkers for optimization of drug therapy. Pharmacogenomics-based tests are already being applied in clinical decision making. However, despite substantial progress in identifying the genetic etiology of pharmacological response, current biomarker panels still largely rely on single gene tests with a large portion of the genetic effects remaining to be discovered. Future research must account for the combined effects of multiple genetic variants, incorporate pathway-based approaches, explore gene-gene interactions and nonprotein coding functional genetic variants, extend studies across ancestral populations, and prioritize laboratory characterization of molecular mechanisms. Because genetic factors can play a key role in drug response, accurate biomarker tests capturing the main genetic factors determining treatment outcomes have substantial potential for improving individual clinical care. PMID:25521360

  1. Serious adverse events reported for anti-obesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, Ebba Holme

    2016-01-01

    BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti...... to 2014 and located in EV were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex...... to share and seriousness of AEs, type of AEs (SOC) and medicines (ATC level 5). CONCLUSIONS: Many serious AEs were found for anti-obesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines...

  2. Circadian clock and the onset of cardiovascular events.

    Science.gov (United States)

    Takeda, Norihiko; Maemura, Koji

    2016-06-01

    The onset of cardiovascular diseases often shows time-of-day variation. Acute myocardial infarction or ventricular arrhythmia such as ventricular tachycardia occurs mainly in the early morning. Multiple biochemical and physiological parameters show circadian rhythm, which may account for the diurnal variation of cardiovascular events. These include the variations in blood pressure, activity of the autonomic nervous system and renin-angiotensin axis, coagulation cascade, vascular tone and the intracellular metabolism of cardiomyocytes. Importantly, the molecular clock system seems to underlie the circadian variation of these parameters. The center of the biological clock, also known as the central clock, exists in the suprachiasmatic nucleus. In contrast, the molecular clock system is also activated in each cell of the peripheral organs and constitute the peripheral clock. The biological clock system is currently considered to have a beneficial role in maintaining the homeostasis of each organ. Discoordination, however, between the peripheral clock and external environment could potentially underlie the development of cardiovascular events. Therefore, understanding the molecular and cellular pathways by which cardiovascular events occur in a diurnal oscillatory pattern will help the establishment of a novel therapeutic approach to the management of cardiovascular disorders. PMID:26888119

  3. Inappropriate prescribing and adverse drug events in older people.

    LENUS (Irish Health Repository)

    Hamilton, Hilary J

    2009-01-01

    Inappropriate prescribing (IP) in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs), morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  4. Inappropriate prescribing and adverse drug events in older people

    Directory of Open Access Journals (Sweden)

    Gallagher Paul F

    2009-01-01

    Full Text Available Abstract Inappropriate prescribing (IP in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs, morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  5. Telmisartan to prevent recurrent stroke and cardiovascular events

    DEFF Research Database (Denmark)

    Yusuf, Salim; Diener, Hans-Christoph; Sacco, Ralph L; Cotton, Daniel; Ounpuu, Stephanie; Lawton, William A; Palesch, Yuko; Martin, Reneé H; Albers, Gregory W; Bath, Philip; Bornstein, Natan; Chan, Bernard P L; Chen, Sien-Tsong; Cunha, Luis; Dahlöf, Björn; De Keyser, Jacques; Donnan, Geoffrey A; Estol, Conrado; Gorelick, Philip; Gu, Vivian; Hermansson, Karin; Hilbrich, Lutz; Kaste, Markku; Lu, Chuanzhen; Machnig, Thomas; Pais, Prem; Roberts, Robin; Skvortsova, Veronika; Teal, Philip; Toni, Danilo; VanderMaelen, Cam; Voigt, Thor; Weber, Michael; Yoon, Byung-Woo; Iversen, Helle Klingenberg

    2008-01-01

    BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood...... pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke. METHODS: In a multicenter trial involving 20,332 patients who recently had an...... ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening...

  6. Late gadolinium enhancement by magnetic resonance explains adverse cardiac events in individuals with ventricular arrhythmia

    International Nuclear Information System (INIS)

    Objective: To determine whether the presence of late gadolinium enhancement (LGE) by cardiovascular magnetic resonance (CMR) predict adverse cardiac events in patients with ventricular arrhythmia. Methods: We selected 74 consecutive patients with symptomatic ventricular arrhythmia (premature ventricular contractions and ventricular tachycardia) and left ventricular ejection fraction (LVEF) >55% sent to CMR for evaluation of structural heart disease previously undetected by other complementary methods. LGE, systolic function and volumes of both ventricles were analyzed. At follow-up was assessed a combined end point: hospitalization for ventricular arrhythmia, appropriate implantable cardioverter-defibrillator therapy and cardiac death. Results: During a median follow up of 575 days (interquartile range 24-1120 days) and by analyzing the population according to the presence (n=9, 12%) or not (n=65, 88%) LGE was observed that the group with positive Gd had lower LVEF (58% vs. 66% respectively, p=0.01) and larger volumes (EDV: 185 ml vs. 123 ml respectively, p=0.01 and ESV: 81 ml vs. 42 ml respectively, p=0.01) than the other group. Two (22%) patients in the LGE + group vs. one (4%) of those without LGE showed the combined endpoint (p=0.01) and when performing a logistic regression analysis it was found that the LGE is a predictor of adverse cardiac events analyzed (p=0.029). Conclusions: In this consecutive series of patients with ventricular arrhythmia we demonstrate a strong association between myocardial LGE and adverse cardiac events; this supports the hypothesis that myocardial fibrosis is an important arrhythmogenic substrate. In addition, almost all individuals without LGE were free of events during follow-up suggesting that it is possible to identify through the CMR low-risk individuals who can be treated conservatively. (authors)

  7. Lower 1,5-anhydroglucitol is associated with adverse clinical events after percutaneous coronary intervention.

    Science.gov (United States)

    Fujiwara, Takayuki; Yoshida, Masashi; Akashi, Naoyuki; Yamada, Hodaka; Tsukui, Takunori; Nakamura, Tomohiro; Sakakura, Kenichi; Wada, Hiroshi; Arao, Kenshiro; Katayama, Takuji; Umemoto, Tomio; Funayama, Hiroshi; Sugawara, Yoshitaka; Mitsuhashi, Takeshi; Kakei, Masafumi; Momomura, Shin-Ichi; Ako, Junya

    2016-06-01

    Diabetes mellitus and impaired glucose tolerance are well-known risk factors for coronary artery disease (CAD) and adverse clinical events after percutaneous coronary intervention (PCI). Postprandial hyperglycemia is an important risk factor for CAD and serum 1,5-anhydroglucitol (1,5-AG) reflects postprandial hyperglycemia more robustly than hemoglobin (Hb)A1c. We aimed to clarify the relationship between serum 1,5-AG level and adverse clinical events after PCI. We enrolled 141 patients after PCI with follow-up coronary angiography. We evaluated associations between glycemic biomarkers including HbA1c and 1,5-AG and cardiovascular events during follow-up. Median serum 1,5-AG level was significantly lower in patients with any coronary revascularization and target lesion revascularization (TLR) [13.4 µg/ml (first quartile, third quartile 9.80, 18.3) vs. 18.7 (12.8, 24.2), p = 0.005; 13.4 µg/ml (10.2, 16.4) vs. 18.7 (12.9, 24.2), p = 0.001, respectively]. Multivariate logistic analysis showed lower 1,5-AG was independently associated with any coronary revascularization and TLR (odds ratio 0.93, 95 % confidence interval 0.86-0.99, p = 0.04; 0.90, 0.81-0.99, p = 0.044, respectively), whereas higher HbA1c was not. Postprandial hyperglycemia and lower 1,5-AG are important risk factors for adverse clinical events after PCI. PMID:25921916

  8. Plasma levels of resistin predict cardiovascular events

    Directory of Open Access Journals (Sweden)

    Vida-Simiti Luminița

    2014-03-01

    .0616, p=0.0299 au fost independent asociate cu noi evenimente cardiovasculare. Concluzii: La pacienţi cu ateroscleroză clinic manifestă nivelele plasmatice ale resistinei pot prezice noi evenimente ischemice.

  9. Serious adverse event reporting in investigator-initiated clinical trials.

    Science.gov (United States)

    Wallace, Sophie; Myles, Paul S; Zeps, Nikolajs; Zalcberg, John R

    2016-04-01

    Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). PMID:27031396

  10. Iatrogenic or adverse event: perception of nursing staff

    Directory of Open Access Journals (Sweden)

    Fátima Helena Cecchetto, Tais Souza Fachinelli, Emiliane Nogueira Souza

    2010-07-01

    Full Text Available Objective: to identify the professionals' perception of the active nursing in units of intensive care (intensive care unit in face to the lived iatrogenic occurrences. Method: this is about a descriptive-exploratory study from qualitative approach, accomplished with Intensive care unit 12 nursing professionals of a region hospital. The data were collected through a semi-structured interview, recorded and analyzed according to the presuppositions of Bardin content analysis. The reaearch project has been approved by the Ethics committee of the Institution Nossa Senhora de Fatima (protocol number 021/08. Results: after the description and analysis of the data, six categories emerged: The professionals' understanding on iatrogenic occurrences; Occurrences frequent iatrogenic; Factors related to iatrogenic occurrences; The professionals' feelings; Professional position before an iatrogenic occurrence; Importance of the communication. Conclusion: the results evidenced that the nursing professional notices the gravity of the fact and worries about the results of the event with the patient, trying to communicate the team and taking the responsibility. In that context, accomplish permanent education, provide psychological support for the caretakers and ideal conditions of work can contribute to the patient's safety. Descriptors: unit of intensive therapy; iatrogenic; adverse event; nursing.

  11. Uric Acid and Cardiovascular Events: A Mendelian Randomization Study.

    Science.gov (United States)

    Kleber, Marcus E; Delgado, Graciela; Grammer, Tanja B; Silbernagel, Günther; Huang, Jie; Krämer, Bernhard K; Ritz, Eberhard; März, Winfried

    2015-11-01

    Obesity and diets rich in uric acid-raising components appear to account for the increased prevalence of hyperuricemia in Westernized populations. Prevalence rates of hypertension, diabetes mellitus, CKD, and cardiovascular disease are also increasing. We used Mendelian randomization to examine whether uric acid is an independent and causal cardiovascular risk factor. Serum uric acid was measured in 3315 patients of the Ludwigshafen Risk and Cardiovascular Health Study. We calculated a weighted genetic risk score (GRS) for uric acid concentration based on eight uric acid-regulating single nucleotide polymorphisms. Causal odds ratios and causal hazard ratios (HRs) were calculated using a two-stage regression estimate with the GRS as the instrumental variable to examine associations with cardiometabolic phenotypes (cross-sectional) and mortality (prospectively) by logistic regression and Cox regression, respectively. Our GRS was not consistently associated with any biochemical marker except for uric acid, arguing against pleiotropy. Uric acid was associated with a range of prevalent diseases, including coronary artery disease. Uric acid and the GRS were both associated with cardiovascular death and sudden cardiac death. In a multivariate model adjusted for factors including medication, causal HRs corresponding to each 1-mg/dl increase in genetically predicted uric acid concentration were significant for cardiovascular death (HR, 1.77; 95% confidence interval, 1.12 to 2.81) and sudden cardiac death (HR, 2.41; 95% confidence interval, 1.16 to 5.00). These results suggest that high uric acid is causally related to adverse cardiovascular outcomes, especially sudden cardiac death. PMID:25788527

  12. Self-reported physical activity and major adverse events in patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Proietti, Marco; Boriani, Giuseppe; Laroche, Cécile;

    2016-01-01

    ', 'regular', and 'intense', based on patient self-reporting. Data on physical activity were available for 2442 patients: 38.9% reported none, 34.7% occasional, 21.7% regular, and 4.7% intense physical activity. Prevalence of the principal CV risk factors progressively decreased from none to intense physical......AIMS: Physical activity is protective against cardiovascular (CV) events, both in general population and in high-risk CV cohorts. However, the relationship between physical activity with major adverse outcomes in atrial fibrillation (AF) is not well-established. Our aim was to analyse this...... relationship in a 'real-world' AF population. Second, we investigated the influence of physical activity on arrhythmia progression. METHODS AND RESULTS: We studied all patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Pilot Survey. Physical activity was defined as 'none', 'occasional...

  13. A large-scale survey of adverse events experienced in yoga classes

    OpenAIRE

    Matsushita, Tomoko; Oka, Takakazu

    2015-01-01

    Background Yoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events. Methods The subjects were ...

  14. Statin safety: an appraisal from the adverse event reporting system.

    Science.gov (United States)

    Davidson, Michael H; Clark, John A; Glass, Lucas M; Kanumalla, Anju

    2006-04-17

    The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin. PMID:16581327

  15. Preventing cardiovascular events with empagliflozin: at what cost?

    OpenAIRE

    Naci, Huseyin; Basu, Sanjay; Yudkin, John S.

    2015-01-01

    The EMPA-REG OUTCOME study,1 as the first randomised trial to show that a glucose-lowering intervention was associated with reduced cardiovascular events,2 raises important questions for policy makers. Chief among these questions is whether the detected effect size produces a cost-effective risk reduction from the studied pharmacological approach. The study has undoubtedly brought good news for the trial funders: analysts predict that its findings will propel empagliflozin ahead of other gluc...

  16. Rate of Atherosclerotic Plaque Formation Predicts Cardiovascular Events in ESRD

    OpenAIRE

    Benedetto, Francesco Antonio; Tripepi, Giovanni; Mallamaci, Francesca; Zoccali, Carmine

    2008-01-01

    Carotid intima media thickness (IMT) is a strong, independent predictor of cardiovascular events in both the general population and among those with end-stage renal disease (ESRD), but it is unknown whether changes in IMT or other ultrasound-measured indicators of atherosclerosis over time provide additional prognostic information. The progression of atherosclerosis with carotid ultrasound was followed in a cohort of 135 ESRD patients, 103 of whom had a repeat ultrasound after 15 mo of follow...

  17. Prenatal influenza exposure and cardiovascular events in adulthood

    DEFF Research Database (Denmark)

    Cocoros, Noelle M; Lash, Timothy L; Ozonoff, Al;

    2014-01-01

    Objectives This study examined the association between prenatal exposure to pandemic influenza and cardiovascular events in adulthood. Design Using Danish surveillance data to identify months when influenza activity was highest during three previous pandemics (1918, 1957, and 1968), persons were...... for the 1918 pandemic are possible, and the current young ages of persons included in the analyses for the 1957 and 1968 pandemics may warrant later re-evaluation....

  18. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2011-03-01

    Full Text Available Abstract Background In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. Methods This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Results Among the 1968 patients, 74 patients (3.76% suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Conclusions Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs were related to the patients' gender and age and the local

  19. Calcific aortic valve damage as a risk factor for cardiovascular events

    International Nuclear Information System (INIS)

    Aortic valve calcification (AVC) is a common disease of the elderly. It is a progressive disease ranging from mild valve thickening to severe calcification with aortic valve stenosis. Risk factors for AVC are similar to those for atherosclerosis: age, gender, hypercholesterolemia, diabetes, hypertension, smoking and renal failure. AVC shares many similarities to atherosclerosis, including inflammatory cells and calcium deposits, and correlates with coronary plaque burden. Presence of AVC is associated with increased risk of adverse cardiovascular events. The objective for this review is to discuss the clinical features, natural history and prognostic significance of aortic valve calcifications, including mechanical and hemodynamic factors of flow distribution

  20. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    OpenAIRE

    Courtot, Mélanie; Brinkman, Ryan R; Ruttenberg, Alan

    2014-01-01

    Background When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processi...

  1. The incidence of adverse events in Swedish hospitals: a retrospective medical record review study

    OpenAIRE

    Soop, Michael; Fryksmark, Ulla; Köster, Max; Haglund, Bengt

    2009-01-01

    Objectives To estimate the incidence, nature and consequences of adverse events and preventable adverse events in Swedish hospitals. Design A three-stage structured retrospective medical record review based on the use of 18 screening criteria. Setting Twenty-eight Swedish hospitals. Population A representative sample (n = 1967) of the 1.2 million Swedish hospital admissions between October 2003 and September 2004. Main Outcome Measures Proportion of admissions with adverse events, the proport...

  2. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    OpenAIRE

    Brown, S.L.; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to ...

  3. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    OpenAIRE

    Fabiana Rossi Varallo; Helaine Carneiro Capucho; Cleópatra da Silva Planeta; Patrícia de Carvalho Mastroianni

    2014-01-01

    OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to Decemb...

  4. Self-immolation and its adverse life-events risk factors: results from an Iranian population

    OpenAIRE

    Alireza Ahmadi; Schwebel, David C.; Shahrzad Bazargan-Hejazi

    2015-01-01

    Abstract: Background: Despite considerable loss of life by deliberate self-burning in low and middle-income countries, few scholars have examined psychiatric factors such as adverse life events that may be related to self-immolation. Methods: This case-control study investigated adverse life-events as risk factors for self-immolation patients admitted to a burn center serving the western region of Iran. Variables inves-tigated included the following adverse life-events: unplanned pregna...

  5. A case–control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events

    OpenAIRE

    Geier, David A.; Geier, Mark R

    2014-01-01

    GARDASIL (Merck & Co., Inc., Whitehouse Station, NJ, USA) is a quadrivalent human papillomavirus (HPV4) vaccine. An epidemiological study was undertaken to evaluate concerns about the potential for HPV4 vaccination to induce serious autoimmune adverse events (SAAEs). The vaccine adverse event reporting system (VAERS) database was examined for adverse event reports associated with vaccines administered from January 2006 through December 2012 to recipients between 18 and 39 years old with a lis...

  6. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    OpenAIRE

    Mélanie Courtot; Brinkman, Ryan R.; Alan Ruttenberg

    2014-01-01

    BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated process...

  7. Evaluation and registration of adverse events in clinical drug trials in migraine

    DEFF Research Database (Denmark)

    Tfelt-Hansen, P.; Bjarnason, N.H.; Dahlof, C.; Derry, S.; Loder, E.; Massiou, H.

    2008-01-01

    Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be...... indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given Udgivelsesdato: 2008/7...

  8. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

    Full Text Available OBJECTIVE: Adverse event reports (AERs submitted to the US Food and Drug Administration (FDA were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase inhibitors (statins and to attempt to determine the rank-order of the association. METHODS: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. RESULTS: Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. CONCLUSIONS: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.

  9. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    Science.gov (United States)

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  10. Depressive Symptoms and Risk of New Cardiovascular Events or Death in Patients with Myocardial Infarction: A Population-Based Longitudinal Study Examining Health Behaviors and Health Care Interventions

    DEFF Research Database (Denmark)

    Larsen, Karen Kjær; Christensen, Bo; Søndergaard, Jens; Vestergaard, Mogens

    bruges til at skærpe opmærksomheden over for denne patientgruppe hos de praktiserende læger, hvor op mod 90 % af alle patienter med depression bliver diagnosticeret og behandlet. Background: Depressive symptoms is associated with adverse cardiovascular outcomes in patients with myocardial infarction (MI......), but the underlying mechanisms are unclear and it remains unknown whether subgroups of patients are at a particularly high relative risk of adverse outcomes. We examined the risk of new cardiovascular events and/or death in patients with depressive symptoms following first-time MI taking into account...... 2009 and 31 December 2009, and followed up until 31 July 2012. Depressive symptoms were found in 18.6% using the Hospital Anxiety and Depression Scale (HADS-D$8). A total of 239 new cardiovascular events, 95 deaths, and 288 composite events (239 new cardiovascular events and 49 deaths) occurred during...

  11. A Critical Approach to Evaluating Clinical Efficacy, Adverse Events and Drug Interactions of Herbal Remedies.

    Science.gov (United States)

    Izzo, Angelo A; Hoon-Kim, Sung; Radhakrishnan, Rajan; Williamson, Elizabeth M

    2016-05-01

    Systematic reviews and meta-analyses represent the uppermost ladders in the hierarchy of evidence. Systematic reviews/meta-analyses suggest preliminary or satisfactory clinical evidence for agnus castus (Vitex agnus castus) for premenstrual complaints, flaxseed (Linum usitatissimum) for hypertension, feverfew (Tanacetum partenium) for migraine prevention, ginger (Zingiber officinalis) for pregnancy-induced nausea, ginseng (Panax ginseng) for improving fasting glucose levels as well as phytoestrogens and St John's wort (Hypericum perforatum) for the relief of some symptoms in menopause. However, firm conclusions of efficacy cannot be generally drawn. On the other hand, inconclusive evidence of efficacy or contradictory results have been reported for Aloe vera in the treatment of psoriasis, cranberry (Vaccinium macrocarpon) in cystitis prevention, ginkgo (Ginkgo biloba) for tinnitus and intermittent claudication, echinacea (Echinacea spp.) for the prevention of common cold and pomegranate (Punica granatum) for the prevention/treatment of cardiovascular diseases. A critical evaluation of the clinical data regarding the adverse effects has shown that herbal remedies are generally better tolerated than synthetic medications. Nevertheless, potentially serious adverse events, including herb-drug interactions, have been described. This suggests the need to be vigilant when using herbal remedies, particularly in specific conditions, such as during pregnancy and in the paediatric population. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26887532

  12. Transcranial Doppler ultrasonography predicts cardiovascular events after TIA

    International Nuclear Information System (INIS)

    Transient ischemic attack (TIA) patients are at high vascular risk. We assessed the value of extracranial (ECD) and transcranial (TCD) Doppler and duplex ultrasonography to predict clinical outcome after TIA. 176 consecutive TIA patients admitted to the Stroke Unit were recruited in the study. All patients received diffusion-weighted imaging, standardized ECD and TCD. At a median follow-up of 27 months, new vascular events were recorded. 22 (13.8%) patients experienced an ischemic stroke or TIA, 5 (3.1%) a myocardial infarction or acute coronary syndrome, and 5 (3.1%) underwent arterial revascularization. ECD revealed extracranial ≥ 50% stenosis or occlusions in 34 (19.3%) patients, TCD showed intracranial stenosis in 15 (9.2%) and collateral flow patterns due to extracranial stenosis in 5 (3.1%) cases. Multivariate analysis identified these abnormal ECD and TCD findings as predictors of new cerebral ischemic events (ECD: hazard ratio (HR) 4.30, 95% confidence interval (CI) 1.75 to 10.57, P = 0.01; TCD: HR 4.73, 95% CI 1.86 to 12.04, P = 0.01). Abnormal TCD findings were also predictive of cardiovascular ischemic events (HR 18.51, 95% CI 3.49 to 98.24, P = 0.001). TIA patients with abnormal TCD findings are at high risk to develop further cerebral and cardiovascular ischemic events

  13. Compliance with and short-term adverse events from clarithromycin versus placebo in patients with stable coronary heart disease: the CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, C M; Kolmos, H J; Frydendall, N;

    2009-01-01

    BACKGROUND: The randomized placebo-controlled double-blind CLARICOR trial investigated the influence of clarithromycin versus placebo on cardiovascular events and mortality in patients with chronic coronary artery disease (ClinicalTrials.gov NCT 00121550). The trial randomized 2172 patients to 500...... mg of clarithromycin daily versus 2200 patients to matching placebo for 14 days. This paper presents protocol-specified analysis of the patient-reported information regarding their compliance and non-serious adverse events during the 14 days of treatment as well as serious adverse events (mortality...... 100% tablet intake was reported by 90% of the clarithromycin group and by 93.7% of the placebo group. Of the clarithromycin patients, 39.5% reported at least one non-serious adverse event versus 25.1% of the placebo patients (P < 0.001). Gastrointestinal adverse reactions were reported 950 times by...

  14. Development and validation of a taxonomy of adverse handover events in hospital settings

    DEFF Research Database (Denmark)

    Andersen, Henning Boje; Siemsen, Inger Margrete D.; Petersen, Lene Funck; Nielsen, Jacob; Østergaard, Doris

    2015-01-01

    Patient Safety Database, 200 events) and 47 interviews with staff conducted at a large hospital in the Capital Region (232 events). The most prevalent causes of adverse events are inadequate competence (30 %), inadequate infrastructure (22 %) and busy ward (18 %). Inter-rater reliability (kappa) was 0...... tool for analyzing adverse handover events to identify frequent causes among reported handover failures. In turn, this provides a basis for selecting safety measures including handover protocols and training programmes....

  15. Family history of vascular disease and the risk of cardiovascular events

    NARCIS (Netherlands)

    Weijmans, M.

    2015-01-01

    A positive family history of cardiovascular disease is an established risk factor for the development of cardiovascular disease. In clinical practice, this evident relation between the presence of cardiovascular disease in families and first cardiovascular events has resulted in family history being

  16. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-03-01

    Full Text Available OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%, fatigue (12.3%, and chest pain (9.0%. Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

  17. Adverse events of modern antifungal drugs during treatment of invasive fungal infections

    Directory of Open Access Journals (Sweden)

    N. V. Dmitrieva

    2014-07-01

    Full Text Available Characteristics of adverse events of modern antimycotics by organ systems and comparative frequency between different medicines and their groups are presented. The examples of incompatibility of antifungal drugs with other pharmacological groups are discussed. Records of adverse events and drug compatibility will allow the practitioner to prevent and timely cure possible complications, should they arise.

  18. Narrative Perspectives in Psychosocial Intervention Following Adverse Life Events.

    Science.gov (United States)

    Borden, William

    1992-01-01

    Demonstrates how narrative perspectives provide means of conceptualizing brief psychotherapy following negative life outcomes. Representative case studies illustrate three types of narrative construction following adverse experiences and show how narrative perspectives shift focus from disability and dysfunction to concern for client strengths,…

  19. Early adverse events, HPA activity and rostral anterior cingulate volume in MDD.

    Directory of Open Access Journals (Sweden)

    Michael T Treadway

    Full Text Available BACKGROUND: Prior studies have independently reported associations between major depressive disorder (MDD, elevated cortisol concentrations, early adverse events and region-specific decreases in grey matter volume, but the relationships among these variables are unclear. In the present study, we sought to evaluate the relationships between grey matter volume, early adverse events and cortisol levels in MDD. METHODS/RESULTS: Grey matter volume was compared between 19 controls and 19 individuals with MDD using voxel-based morphometry. A history of early adverse events was assessed using the Childhood Trauma Questionnaire. Subjects also provided salivary cortisol samples. Depressed patients showed decreased grey matter volume in the rostral ACC as compared to controls. Rostral ACC volume was inversely correlated with both cortisol and early adverse events. CONCLUSIONS: These findings suggest a key relationship between ACC morphology, a history of early adverse events and circulating cortisol in the pathophysiology of MDD.

  20. TYPES OF TREMOR IN PATIENTS WITH CEREBROVASCULAR DISEASES AND CARDIOVASCULAR EVENTS

    OpenAIRE

    Petrov Igor; Mulic Mersudin; Antonio Georgiev

    2016-01-01

    Introduction: Tremor can occur as a part of the clinical feature of cerebrovascular diseases. Many patients with cerebral stroke have cardiovascular diseases as a comorbidity or complication of stroke; sometimes cardiovascular events can lead to embolic stroke. Aim: To present types of tremor in patients with cerebrovascular diseases and cardiovascular events and diabetes mellitus type 2, clinical characteristics of tremor and investigations used. Materia...

  1. Reliability of the peer-review process for adverse event rating.

    Directory of Open Access Journals (Sweden)

    Alan J Forster

    Full Text Available BACKGROUND: Adverse events are poor patient outcomes caused by medical care. Their identification requires the peer-review of poor outcomes, which may be unreliable. Combining physician ratings might improve the accuracy of adverse event classification. OBJECTIVE: To evaluate the variation in peer-reviewer ratings of adverse outcomes; determine the impact of this variation on estimates of reviewer accuracy; and determine the number of reviewers who judge an adverse event occurred that is required to ensure that the true probability of an adverse event exceeded 50%, 75% or 95%. METHODS: Thirty physicians rated 319 case reports giving details of poor patient outcomes following hospital discharge. They rated whether medical management caused the outcome using a six-point ordinal scale. We conducted latent class analyses to estimate the prevalence of adverse events as well as the sensitivity and specificity of each reviewer. We used this model and Bayesian calculations to determine the probability that an adverse event truly occurred to each patient as function of their number of positive ratings. RESULTS: The overall median score on the 6-point ordinal scale was 3 (IQR 2,4 but the individual rater median score ranged from a minimum of 1 (in four reviewers to a maximum median score of 5. The overall percentage of cases rated as an adverse event was 39.7% (3798/9570. The median kappa for all pair-wise combinations of the 30 reviewers was 0.26 (IQR 0.16, 0.42; Min = -0.07, Max = 0.62. Reviewer sensitivity and specificity for adverse event classification ranged from 0.06 to 0.93 and 0.50 to 0.98, respectively. The estimated prevalence of adverse events using a latent class model with a common sensitivity and specificity for all reviewers (0.64 and 0.83 respectively was 47.6%. For patients to have a 95% chance of truly having an adverse event, at least 3 of 3 reviewers are required to deem the outcome an adverse event. CONCLUSION: Adverse event

  2. G-CSF Predicts Cardiovascular Events in Patients with Stable Coronary Artery Disease.

    Directory of Open Access Journals (Sweden)

    Katharina M Katsaros

    Full Text Available Granulocyte-colony-stimulating-factor (G-CSF induces mobilization of progenitor cells but may also exert pro-inflammatory and pro-thrombotic effects. Treatment with recombinant G-CSF after acute myocardial infarction is currently under examination and has been associated with in-stent restenosis. However, it is not known whether plasma levels of endogenous G-CSF are also associated with an increased cardiovascular risk. Therefore we included 280 patients with angiographically proven stable coronary artery disease. G-CSF was measured by specific ELISA and patients were followed for a median of 30 months for the occurrence of major adverse cardiovascular events (MACE: death, myocardial infarction, re-hospitalization. Those with cardiac events during follow-up showed significant higher G-CSF levels (32.3 pg/mL IQR 21.4-40.5 pg/mL vs. 24.6 pg/mL IQR 16.4-34.9 pg/mL; p<0.05 at baseline. Patients with G-CSF plasma levels above the median had a 2-fold increased risk for MACE (p<0.05. This was independent from established cardiovascular risk factors. In addition, G-CSF above the median was a predictor of clinical in-stent restenosis after implantation of bare-metal stents (6.6% vs. 19.4%; p<0.05 but not of drug-eluting stents (7.7% vs. 7.6%; p = 0.98. This data suggests that endogenous plasma levels of G-CSF predict cardiovascular events independently from established cardiac risk factors and are associated with increased in-stent restenosis rates after implantation of bare metal stents.

  3. Vaccine-related adverse events in cuban children, 1999-2008

    Directory of Open Access Journals (Sweden)

    Belkys M. Galindo

    2012-01-01

    Full Text Available INTRODUCTION Cuba has implemented an effective National Immunization Program since 1962. The schedule, administered primarily to children, comprises 11 vaccines (8 domestically produced protecting against 13 diseases. In 1999 Cuba launched a national vaccine adverse event surveillance system to monitor and assess the safety of the immunization program, its vaccination procedures and the products administered. OBJECTIVES Describe adverse events following vaccination reported in children aged <16 years in Cuba from 1999 through 2008. METHODS A retrospective descriptive study was conducted of adverse events following vaccination reported from January 1999 through December 2008. Variables used: year, number of adverse events, province, type of vaccine, type and severity of adverse events (common minor, rare, severe, vaccination program errors, number of deaths, and final results of investigations of severe events. Percentages and rates per dose administered were calculated. Adverse event rates were calculated per 100,000 doses administered and by percentages of individual effects among events reported. RESULTS A total of 45,237,532 vaccine doses were administered, and 26,159 vaccine-associated adverse events were reported (overall rate: 57.8 per 100,000 doses. The group aged 0-5 years reported the highest rate of vaccine-associated adverse events (82/100,000 doses. The DTwP vaccine exhibited the highest rate of adverse events. Common minor events were: fever (17,538, reactions at injection site (4470 and systemic side effects (2422. Rare events (by WHO definition reported were: persistent crying (2666, hypotonic-hyporesponsive episodes (3, encephalopathy (2 and febrile seizures (112. Severe events included: anaphylaxis (2, respiratory distress (1, multiple organ failure (1, sudden death (1, vaccine-associated paralytic poliomyelitis (2, toxic shock syndrome (3, and sepsis (1. The 10 deaths and 3 cases of disability were investigated by an expert

  4. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    Directory of Open Access Journals (Sweden)

    Bero Lisa

    2010-11-01

    Full Text Available Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62% reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  5. Type 2 diabetes mellitus and atherogenic dyslipidemia: Which statin is most effective in the primary prevention of cardiovascular events?

    OpenAIRE

    Figg, Gemma

    2012-01-01

    Background: Type 2 diabetics are at high risk of atherosclerosis and cardiovascular (CV) events due to their associated dyslipidemic profile. Adverse levels of the lipid triad: low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TGs), have been shown to be major contributing factors. Statins (HMG-CoA reductase inhibitors) are recommended as first-line lipid therapy as evidence has shown their effectiveness in primary and secondary preve...

  6. Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

    OpenAIRE

    Reriani, Martin K.; Flammer, Andreas J.; Jama, Abdi; Lerman, Lilach O.; Lerman, Amir

    2012-01-01

    Over the years there has been considerable improvement in the clinical outcomes of patients treated for acute coronary syndrome (ACS). Despite a significant reduction in acute mortality, a large percentage of patients post ACS continue to experience adverse cardiovascular (CV) events, with high long-term mortality rates and overall suboptimal medical management. Long-term risk prediction tools rely on traditional CV risk factors and are developed and validated in specific populations. Establi...

  7. Fish oil and olive oil supplements attenuate the adverse cardiovascular effects of concentrated ambient air pollution particles exposure in healthy middle-aged adult human volunteers

    Science.gov (United States)

    Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality. Advanced age is among the factors associated with susceptibility to the adverse effects of air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular ris...

  8. Left atrial enlargement increases the risk of major adverse cardiac events independent of coronary vasodilator capacity

    Energy Technology Data Exchange (ETDEWEB)

    Koh, Angela S. [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); National Heart Centre Singapore, Singapore (Singapore); Murthy, Venkatesh L.; Sitek, Arkadiusz; Gayed, Peter; Bruyere, John; Di Carli, Marcelo F. [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); Wu, Justina [Brigham and Women' s Hospital, Division of Cardiology, Department of Medicine, and the Noninvasive Cardiovascular Imaging Program, Departments of Medicine (Cardiology) and Radiology, Boston, MA (United States); Dorbala, Sharmila [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); Brigham and Women' s Hospital, Department of Radiology and the Division of Cardiology, Noninvasive Cardiovascular Imaging Section, Boston, MA (United States)

    2015-09-15

    Longstanding uncontrolled atherogenic risk factors may contribute to left atrial (LA) hypertension, LA enlargement (LAE) and coronary vascular dysfunction. Together they may better identify risk of major adverse cardiac events (MACE). The aim of this study was to test the hypothesis that chronic LA hypertension as assessed by LAE modifies the relationship between coronary vascular function and MACE. In 508 unselected subjects with a normal clinical {sup 82}Rb PET/CT, ejection fraction ≥40 %, no prior coronary artery disease, valve disease or atrial fibrillation, LAE was determined based on LA volumes estimated from the hybrid perfusion and CT transmission scan images and indexed to body surface area. Absolute myocardial blood flow and global coronary flow reserve (CFR) were calculated. Subjects were systematically followed-up for the primary end-point - MACE - a composite of all-cause death, myocardial infarction, hospitalization for heart failure, stroke, coronary artery disease progression or revascularization. During a median follow-up of 862 days, 65 of the subjects experienced a composite event. Compared with subjects with normal LA size, subjects with LAE showed significantly lower CFR (2.25 ± 0.83 vs. 1.95 ± 0.80, p = 0.01). LAE independently and incrementally predicted MACE even after accounting for clinical risk factors, medication use, stress left ventricular ejection fraction, stress left ventricular end-diastolic volume index and CFR (chi-squared statistic increased from 30.9 to 48.3; p = 0.001). Among subjects with normal CFR, those with LAE had significantly worse event-free survival (risk adjusted HR 5.4, 95 % CI 2.3 - 12.8, p < 0.0001). LAE and reduced CFR are related but distinct cardiovascular adaptations to atherogenic risk factors. LAE is a risk marker for MACE independent of clinical factors and left ventricular volumes; individuals with LAE may be at risk of MACE despite normal coronary vascular function. (orig.)

  9. Left atrial enlargement increases the risk of major adverse cardiac events independent of coronary vasodilator capacity

    International Nuclear Information System (INIS)

    Longstanding uncontrolled atherogenic risk factors may contribute to left atrial (LA) hypertension, LA enlargement (LAE) and coronary vascular dysfunction. Together they may better identify risk of major adverse cardiac events (MACE). The aim of this study was to test the hypothesis that chronic LA hypertension as assessed by LAE modifies the relationship between coronary vascular function and MACE. In 508 unselected subjects with a normal clinical 82Rb PET/CT, ejection fraction ≥40 %, no prior coronary artery disease, valve disease or atrial fibrillation, LAE was determined based on LA volumes estimated from the hybrid perfusion and CT transmission scan images and indexed to body surface area. Absolute myocardial blood flow and global coronary flow reserve (CFR) were calculated. Subjects were systematically followed-up for the primary end-point - MACE - a composite of all-cause death, myocardial infarction, hospitalization for heart failure, stroke, coronary artery disease progression or revascularization. During a median follow-up of 862 days, 65 of the subjects experienced a composite event. Compared with subjects with normal LA size, subjects with LAE showed significantly lower CFR (2.25 ± 0.83 vs. 1.95 ± 0.80, p = 0.01). LAE independently and incrementally predicted MACE even after accounting for clinical risk factors, medication use, stress left ventricular ejection fraction, stress left ventricular end-diastolic volume index and CFR (chi-squared statistic increased from 30.9 to 48.3; p = 0.001). Among subjects with normal CFR, those with LAE had significantly worse event-free survival (risk adjusted HR 5.4, 95 % CI 2.3 - 12.8, p < 0.0001). LAE and reduced CFR are related but distinct cardiovascular adaptations to atherogenic risk factors. LAE is a risk marker for MACE independent of clinical factors and left ventricular volumes; individuals with LAE may be at risk of MACE despite normal coronary vascular function. (orig.)

  10. Validating administrative data for the detection of adverse events in older hospitalized patients

    Directory of Open Access Journals (Sweden)

    Ackroyd-Stolarz S

    2014-08-01

    Full Text Available Stacy Ackroyd-Stolarz,1,2 Susan K Bowles,3–5 Lorri Giffin6 1Performance Excellence Portfolio, Capital District Health Authority, Halifax, Nova Scotia, Canada; 2Department of Emergency Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 3Geriatric Medicine, Capital District Health Authority, Halifax, Nova Scotia, Canada; 4College of Pharmacy and Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 5Department of Pharmacy at Capital District Health Authority, Halifax, Nova Scotia, Canada; 6South Shore Family Health, Bridgewater, Nova Scotia, Canada Abstract: Older hospitalized patients are at risk of experiencing adverse events including, but not limited to, hospital-acquired pressure ulcers, fall-related injuries, and adverse drug events. A significant challenge in monitoring and managing adverse events is lack of readily accessible information on their occurrence. Purpose: The objective of this retrospective cross-sectional study was to validate diagnostic codes for pressure ulcers, fall-related injuries, and adverse drug events found in routinely collected administrative hospitalization data. Methods: All patients 65 years of age or older discharged between April 1, 2009 and March 31, 2011 from a provincial academic health sciences center in Canada were eligible for inclusion in the validation study. For each of the three types of adverse events, a random sample of 50 patients whose records were positive and 50 patients whose records were not positive for an adverse event was sought for review in the validation study (n=300 records in total. A structured health record review was performed independently by two health care providers with experience in geriatrics, both of whom were unaware of the patient's status with respect to adverse event coding. A physician reviewed 40 records (20 reviewed by each health care provider to establish interrater agreement. Results: A total of 39 pressure ulcers, 56 fall

  11. ACCEPT: Introduction of the Adverse Condition and Critical Event Prediction Toolbox

    Science.gov (United States)

    Martin, Rodney A.; Santanu, Das; Janakiraman, Vijay Manikandan; Hosein, Stefan

    2015-01-01

    The prediction of anomalies or adverse events is a challenging task, and there are a variety of methods which can be used to address the problem. In this paper, we introduce a generic framework developed in MATLAB (sup registered mark) called ACCEPT (Adverse Condition and Critical Event Prediction Toolbox). ACCEPT is an architectural framework designed to compare and contrast the performance of a variety of machine learning and early warning algorithms, and tests the capability of these algorithms to robustly predict the onset of adverse events in any time-series data generating systems or processes.

  12. Hypertension in Pregnancy and Future Cardiovascular Event Risk in Siblings.

    Science.gov (United States)

    Weissgerber, Tracey L; Turner, Stephen T; Mosley, Thomas H; Kardia, Sharon L R; Hanis, Craig L; Milic, Natasa M; Garovic, Vesna D

    2016-03-01

    Hypertension in pregnancy is a risk factor for future hypertension and cardiovascular disease. This may reflect an underlying familial predisposition or persistent damage caused by the hypertensive pregnancy. We sought to isolate the effect of hypertension in pregnancy by comparing the risk of hypertension and cardiovascular disease in women who had hypertension in pregnancy and their sisters who did not using the dataset from the Genetic Epidemiology Network of Arteriopathy study, which examined the genetics of hypertension in white, black, and Hispanic siblings. This analysis included all sibships with at least one parous woman and at least one other sibling. After gathering demographic and pregnancy data, BP and serum analytes were measured. Disease-free survival was examined using Kaplan-Meier curves and Cox proportional hazards regression. Compared with their sisters who did not have hypertension in pregnancy, women who had hypertension in pregnancy were more likely to develop new onset hypertension later in life, after adjusting for body mass index and diabetes (hazard ratio 1.75, 95% confidence interval 1.27-2.42). A sibling history of hypertension in pregnancy was also associated with an increased risk of hypertension in brothers and unaffected sisters, whereas an increased risk of cardiovascular events was observed in brothers only. These results suggest familial factors contribute to the increased risk of future hypertension in women who had hypertension in pregnancy. Further studies are needed to clarify the potential role of nonfamilial factors. Furthermore, a sibling history of hypertension in pregnancy may be a novel familial risk factor for future hypertension. PMID:26315531

  13. Renal function interferes with copeptin in prediction of major adverse cardiac events in patients undergoing vascular surgery.

    Directory of Open Access Journals (Sweden)

    Claudia Schrimpf

    Full Text Available Precise perioperative risk stratification is important in vascular surgery patients who are at high risk for major adverse cardiovascular events (MACE peri- and postoperatively. In clinical practice, the patient's perioperative risk is predicted by various indicators, e.g. revised cardiac index (RCRI or modifications thereof. Patients suffering from chronic kidney disease (CKD are stratified into a higher risk category. We hypothesized that Copeptin as a novel biomarker for hemodynamic stress could help to improve the prediction of perioperative cardiovascular events in patients undergoing vascular surgery including patients with chronic kidney disease.477 consecutive patients undergoing abdominal aortic, peripheral arterial or carotid surgery from June 2007 to October 2012 were prospectively enrolled. Primary endpoint was 30-day postoperative major adverse cardiovascular events (MACE.41 patients reached the primary endpoint, including 63.4% aortic, 26.8% carotid, and 9.8% peripheral surgeries. Linear regression analysis showed that RCRI (P< .001, pre- (P< .001, postoperative Copeptin (P< .001 and Copeptin level change (P= .001 were associated with perioperative MACE, but CKD remained independently associated with MACE and Copeptin levels. Multivariate regression showed that increased Copeptin levels added risk predictive information to the RCRI (P= .003. Especially in the intermediate RCRI categories was Copeptin significantly associated with the occurrence of MACE. (P< .05 Kruskal Wallis test. Subdivision of the study cohort into CKD stages revealed that preoperative Copeptin was significantly associated with CKD stages (P< .0001 and preoperative Copeptin measurements could not predict MACE in patients with more severe CKD stages.Preoperative Copeptin loses its risk predictive potential for perioperative MACE in patients with chronic kidney disease undergoing vascular surgery.

  14. Aspirin in Cardiovascular and Cerebrovascular Events: Does Market Failure Matter?

    Directory of Open Access Journals (Sweden)

    Roger L. Mendoza

    2011-01-01

    Full Text Available Problem statement: Two interrelated questions were raised for investigation in this study: (1 why may government intervene in an otherwise private transaction between physician and patient and between drug manufacturer and buyer? (2 Does government intervention make a difference in what these transacting parties would otherwise have decided or chosen in its absence? Approach: An internet literature search was performed, using query term combinations, to identify aspirin-related studies. The search yielded 51 juried publications that met our predetermined criteria for inclusion and thematic analysis. Results: Some variance exists within the surveyed literature concerning government intervention in aspirin prophylaxis for cardiovascular and cerebrovascular events, particularly heart attacks, strokes and cardiovascular death. This study identified 4 instances of market failure that offer some of the strongest theoretical and practical considerations for public policy intervention in aspirin’s pharmacological information. However, there is also indication that the sense of increased protection arising from safety regulations could stimulate risky behavior that nullifies their net protective effects or benefits. Conclusion: It is not clear either from the surveyed literature or existing economic theory if, ceteris paribus, mandatory safety information is necessary to alter or modify the marginal propensity of a physician to recommend and a patient to purchase, aspirin. The study suggested the need for policy reinforcements to any safety information regulation, if market failures are to be effectively addressed and risk compensating behavior reduced.

  15. Prolonged PR interval, first-degree heart block and adverse cardiovascular outcomes: a systematic review and meta-analysis

    OpenAIRE

    Kwok, Chun Shing; Muhammad RASHID; Beynon, Rhys; Barker, Diane; Patwala, Ashish; Morley-Davies, Adrian; Satchithananda, Duwarakan; Nolan, James; Myint, Phyo K; Buchan, Iain; Loke, Yoon K.; Mamas, Mamas A.

    2016-01-01

    Objective: First-degree atrioventricular block is frequently encountered in clinical practice and is generally considered a benign process. However, there is emerging evidence that prolonged PR interval may be associated with adverse outcomes. This study aims to determine if prolonged PR interval is associated with adverse cardiovascular outcomes and mortality. Methods: We searched MEDLINE and EMBASE for studies that evaluated clinical outcomes associated with prolonged and normal PR interval...

  16. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations

    Directory of Open Access Journals (Sweden)

    Kaori Kadoyama, Ikuya Miki, Takao Tamura, JB Brown, Toshiyuki Sakaeda, Yasushi Okuno

    2012-01-01

    Full Text Available Objective: The safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU using adverse event reports (AERs submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA.Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving 5-FU and oral fluoropyrimidines were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean.Results: Based on 22,017,956 co-occurrences, i.e., drug-adverse event pairs, found in 1,644,220 AERs from 2004 to 2009, it was suggested that leukopenia, neutropenia, and thrombocytopenia were more frequently accompanied by the use of 5-FU than capecitabine, whereas diarrhea, nausea, vomiting, and hand-foot syndrome were more frequently associated with capecitabine. The total number of co-occurrences was not large enough to compare tegafur, tegafur-uracil (UFT, tegafur-gimeracil-oteracil potassium (S-1, or doxifluridine to 5-FU.Conclusion: The results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's AERS database and data mining methods used, but the number of co-occurrences is an important factor in signal detection.

  17. Adverse Events in the Netherlands Vaccination Programme : Reports in 2010 and Review 1994-2010

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Moorer-Lanser N; PHaff TAJ; Oostvogels B; Wesselo C; van der Maas NAT; LCI; cib

    2012-01-01

    In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events followin

  18. Adverse events in cancer genetic testing: the third case series.

    Science.gov (United States)

    Bonadies, Danielle C; Brierley, Karina L; Barnett, Rachel E; Baxter, Melanie D; Donenberg, Talia; Ducaine, Whitney L; Ernst, Michelle E; Ernstx, Michelle E; Homer, Jeanne; Judkins, Megan; Lovick, Niki M; Powers, Jacquelyn M; Stanislaw, Christine; Stark, Elizabeth; Stenner, Rio C; Matloff, Ellen T

    2014-01-01

    After repeated media attention in 2013 due to the Angelina Jolie disclosure and the Supreme Court decision to ban gene patents, the demand for cancer genetic counseling and testing services has never been greater. Debate has arisen regarding who should provide such services and the quality of genetics services being offered. In this ongoing case series, we document 35 new cases from 7 states (California, Connecticut, Florida, Georgia, Missouri, Pennsylvania, and Utah) and the District of Columbia of adverse outcomes in cancer genetic testing when performed without the involvement of a certified genetic counselor. We identified 3 major themes of errors: wrong genetic tests ordered, genetic test results misinterpreted, and inadequate genetic counseling. Patient morbidity and mortality were an issue in several of these cases. The complexity of cancer genetic testing and counseling has grown exponentially with the advent of multigene panels that include rare genes and the potential for more variants of uncertain significance. We conclude that genetic counseling and testing should be offered by certified genetics providers to minimize the risks, maximize the benefits, and utilize health care dollars most efficiently. PMID:25098283

  19. Road traffic noise, air pollution components and cardiovascular events

    Directory of Open Access Journals (Sweden)

    Yvonne de Kluizenaar

    2013-01-01

    Full Text Available Traffic noise and air pollution have been associated with cardiovascular health effects. Until date, only a limited amount of prospective epidemiological studies is available on long-term effects of road traffic noise and combustion related air pollution. This study investigates the relationship between road traffic noise and air pollution and hospital admissions for ischemic heart disease (IHD: International Classification of Diseases (ICD9 410-414 or cerebrovascular disease (cerebrovascular event [CVE]: ICD9 430-438. We linked baseline questionnaire data to 13 years of follow-up on hospital admissions and road traffic noise and air pollution exposure, for a large random sample (N = 18,213 of inhabitants of the Eindhoven region, Netherlands. Subjects with cardiovascular event during follow-up on average had higher road traffic noise day, evening, night level (L den and air pollution exposure at the home. After adjustment for confounders (age, sex, body mass index, smoking, education, exercise, marital status, alcohol use, work situation, financial difficulties, increased exposure did not exert a significant increased risk of hospital admission for IHD or cerebrovascular disease. Relative risks (RRs for a 5 th to 95 th percentile interval increase were 1.03 (0.88-1.20 for L den; 1.04 (0.90-1.21 for particulate matter (PM 10 ; 1.05 (0.91-1.20 for elemental carbon (EC; and 1.12 (096-1.32 for nitrogen dioxide (NO 2 in the full model. While the risk estimate seemed highest for NO 2 , for a 5 th to 95 th percentile interval increase, expressed as RRs per 1 μg/m 3 increases, hazard ratios seemed highest for EC (RR 1.04 [0.92-1.18]. In the subgroup of study participants with a history of cardiovascular disease, RR estimates seemed highest for noise exposure (1.19 [0.87-1.64] for L den; in the subgroup of elderly RR seemed highest for air pollution exposure (RR 1.24 [0.93-1.66] for NO 2 .

  20. Active assessment of adverse events following yellow fever vaccination of persons aged 60 years and more

    OpenAIRE

    Miyaji, Karina Takesaki; Luiz, André Machado; Lara, Amanda Nazareth; do Socorro Souza Chaves, Tania; Piorelli, Roberta de Oliveira; Lopes, Marta Heloisa; Sartori, Ana Marli Christovam

    2013-01-01

    Introduction: Older age has been associated to serious adverse events (AE) following yellow fever (YF) vaccination in passive surveillance studies, but few prospective studies involving seniors have been published.

  1. Quality indicators of preventable adverse drug events in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    need quality improvement. One study concerned the four indicators on inadequate preventive treatment after acute myocardial infarction (AMI) (Article 4), and another study concerned the four indicators on inadequate monitoring of HbA1c resulting in admission with hyper- or iii hypoglycemia (Article 5...... preventable adverse drug events in the primary care setting (Article 1). Construction of the preventable adverse drug events assessment model required four steps. The first step consisted of the development, validation, and feasibility of preventable adverse drug event indicators for type 2 diabetes (Articles...... 10% of the Danish population receiving oral antihyperglycaemic treatment (9,791 persons) was set up, and indicator positives identified (Articles no. 2 and 3). The third step in the model consisted of a risk assessment of preventable adverse drug events, including an assessment of clinical areas that...

  2. Association of common genetic variants with risperidone adverse events in a Spanish schizophrenic population.

    Science.gov (United States)

    Almoguera, B; Riveiro-Alvarez, R; Lopez-Castroman, J; Dorado, P; Vaquero-Lorenzo, C; Fernandez-Piqueras, J; Llerena, A; Abad-Santos, F; Baca-García, E; Dal-Ré, R; Ayuso, C

    2013-04-01

    Risperidone non-compliance is often high due to undesirable side effects, whose development is in part genetically determined. Studies with genetic variants involved in the pharmacokinetics and pharmacodynamics of risperidone have yielded inconsistent results. Thus, the aim of this study was to investigate the putative association of genetic markers with the occurrence of four frequently observed adverse events secondary to risperidone treatment: sleepiness, weight gain, extrapyramidal symptoms and sexual adverse events. A series of 111 schizophrenia inpatients were genotyped for genetic variants previously associated with or potentially involved in risperidone response. Presence of adverse events was the main variable and potential confounding factors were considered. Allele 16Gly of ADRB2 was significantly associated with a higher risk of sexual adverse events. There were other non-significant trends for DRD3 9Gly and SLC6A4 S alleles. Our results, although preliminary, provide new candidate variants of potential use in risperidone safety prediction. PMID:22212732

  3. 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.

  4. Cox-2 inhibitors and the risk of cardiovascular thrombotic events.

    LENUS (Irish Health Repository)

    Khan, M

    2012-04-01

    In 1971, Vane showed that the analgesic action of traditional NSAIDs relies on inhibition of the cyclo-oxygenase (COX) enzyme, which in turn results in reduced synthesis of proalgesic prostaglandins. Two decades later COX was shown to exist as two distinct isoforms. The constitutive isoform COX-1, supports the beneficial homeostatic functions whereas the inducible isoform, COX-2 becomes up regulated by inflammatory mediators and its products cause many of the symptoms of inflammatory diseases such as rheumatoid and osteoarthritis. Despite the benefits of NSAIDs for acute and chronic pain one of the most clinically significant and well characterized adverse effect is on GI mucosa. The search for NSAIDs with less gastrointestinal toxicity led to the introduction of the selective cyclo-oxygenase-2 (COX-2) inhibitors. The COX-2 selective (COX-1 sparing) inhibitors are associated with reduced GI mucosal damage as demonstrated in several trials. In light of the overwhelming and sometimes contradictory information for patients and physicians regarding the safety of COX-2 agents this article will summarize the available evidence regarding cardiovascular (CV) safety data and contemporary recommendations for prescribing of COX-2-selective NSAIDs.

  5. Occurrence of Early Adverse Events After Vaccination Against Influenza at a Brazilian Reference Center

    OpenAIRE

    Marta Heloísa Lopes; Melissa Mascheretti; Marilia Miranda Franco; Ricardo Vasconcelos; Eliana Battaggia Gutierrez

    2008-01-01

    INTRODUCTION: Since 1999, the Ministry of Health in Brazil has conducted campaigns of vaccination against influenza targeted towards the elderly, chronically-diseased people and health care workers. The vaccine against influenza is associated with adverse events of minor importance. OBJECTIVE: To investigate the early adverse events related to the vaccine against influenza. CASUISTICS AND METHODS: One hundred and ninety seven elderly individuals and health care workers vaccinated against infl...

  6. Incidence and preventability of adverse events requiring intensive care admission: a systematic review

    OpenAIRE

    Vlayen, Annemie; Verelst, Sandra; Bekkering, Geertruida E; Schrooten, Ward; Hellings, Johan; Claes, Neree

    2012-01-01

    Rationale, aims and objectives Adverse events are unintended patient injuries or complications that arise from health care management resulting in death, disability or prolonged hospital stay. Adverse events that require critical care are a considerable financial burden to the health care system, but also their global impact on patients and society is probably underestimated. The objectives of this systematic review were to synthesize the best available evidence regarding the estimates of the...

  7. An Overview of Vascular Adverse Events Associated With Facial Soft Tissue Fillers: Recognition, Prevention, and Treatment.

    Science.gov (United States)

    Ferneini, Elie M; Ferneini, Antoine M

    2016-08-01

    Minimally invasive facial cosmetic surgery procedures have seen an exponential increase in numbers over the past decade. The most commonly performed procedures are neuromodulator and soft tissue filler procedures. Although soft tissue fillers have a high safety and predictability profile, these procedures recently have been associated with serious and dire adverse events. This article will discuss some of the vascular complications associated with facial soft tissue fillers. Management and prevention of these adverse events also will be discussed. PMID:27067061

  8. Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text

    OpenAIRE

    Eriksson, Robert; Jensen, Peter Bjødstrup; Pletscher-Frankild, Sune; Jensen, Lars Juhl; Brunak, Søren

    2013-01-01

    Objective Drugs have tremendous potential to cure and relieve disease, but the risk of unintended effects is always present. Healthcare providers increasingly record data in electronic patient records (EPRs), in which we aim to identify possible adverse events (AEs) and, specifically, possible adverse drug events (ADEs). Materials and methods Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Startin...

  9. Reasons for the persistence of adverse events in the era of safer surgery - a qualitative approach

    OpenAIRE

    Kaderli, Reto; Seelandt, Julia C.; Umer, Melika; Tschan, Franziska; Adrian P. Businger

    2013-01-01

    OBJECTIVE We sought to evaluate potential reasons given by board-certified doctors for the persistence of adverse events despite efforts to improve patient safety in Switzerland. SUMMARY BACKGROUND DATA In recent years, substantial efforts have been made to improve patient safety by introducing surgical safety checklists to standardise surgeries and team procedures. Still, a high number of adverse events remain. METHODS Clinic directors in operative medicine in Switzerland...

  10. A Simple Test of Adverse Events and Strategic Timing Theories of Consumer Bankruptcy

    OpenAIRE

    Li Gan; Tarun Sabarwal

    2005-01-01

    A test of adverse events and strategic timing theories can be conducted by determining whether some relevant financial decision variables, such as financial benefit from filing for bankruptcy, or debt discharged in bankruptcy are endogenous with the bankruptcy decision or not. For the strategic timing theory such decisions are endogenous, while for the adverse events theory they are not. Hausman tests for endogeneity show that financial benefit, unsecured debt, and non-exempt assets are exoge...

  11. Occurrence of early adverse events after vaccination against influenza at a brazilian reference center

    Directory of Open Access Journals (Sweden)

    Marta Heloísa Lopes

    2008-01-01

    Full Text Available INTRODUCTION: Since 1999, the Ministry of Health in Brazil has conducted campaigns of vaccination against influenza targeted towards the elderly, chronically-diseased people and health care workers. The vaccine against influenza is associated with adverse events of minor importance. OBJECTIVE: To investigate the early adverse events related to the vaccine against influenza. CASUISTICS AND METHODS: One hundred and ninety seven elderly individuals and health care workers vaccinated against influenza were included. An inquiry regarding adverse events related to the vaccine was applied seven days after the vaccination. RESULTS: Local adverse events were reported by 32.5% and systemic effects by 26.4% of the vaccinated subjects. Pain in the region of the injection, headache, myalgia, malaise, and coryza were more frequent in the workers than in the elderly (p<0.05. There was no statistically significant difference in the occurrence of fever. CONCLUSIONS: The belief of part of the population that credits frequent and uncomfortable adverse events to the vaccine was not confirmed. The subjective adverse events were more frequent in the health care workers, which can influence, in a negative way, the disclosure of the benefits of this vaccine due to their role as opinion makers.

  12. Adverse events with bismuth salts for Helicobacter pylori eradication:Systematic review and meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Alexander C Ford; Peter Malfertheiner; Monique Giguére; José Santana; Mostafizur Khan; Paul Moayyedi

    2008-01-01

    AIM:To assess the safety of bismuth used in Helicobacter pylori (H pylori) eradication therapy regimens.METHODS:We conducted a systematic review and meta-analysis.MEDLINE and EMBASE were searched (up to October 2007) to identify randomised controlled trials comparing bismuth with placebo or no treatment,or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or,in combination,with acid suppression.Total numbers of adverse events were recorded.Data were pooled and expressed as relative risks with 95% confidence intervals (CI).RESULTS:We identified 35 randomised controlled trials containing 4763 patients.There were no serious adverse events occurring with bismuth therapy.There was no statistically significant difference detected in total adverse events with bismuth [relative risk (RR)=1.01;95% CI:0.87-1.16],specific individual adverse events,with the exception of dark stools (RR = 5.06;95% CI:1.59-16.12),or adverse events leading to withdrawal of therapy (RR = 0.86;95% CI:0.54-1.37).CONCLUSION:Bismuth for the treatment of H pylori is safe and well-tolerated.The only adverse event occurring significantly more commonly was dark stools.

  13.  Psychosocial working environment for patients with ischaemic heart disease and association to adverse cardiac events

    DEFF Research Database (Denmark)

    Biering, Karin; Lund, Thomas; Hviid Andersen, Johan;

    2014-01-01

    OBJECTIVES: During the last decades a possible association between the psychosocial working environment and increased risk of Ischaemic heart disease (IHD) has been debated. A systematic review from 2009 found moderate evidence that high psychological demands, lack of social support and iso......-strain was associated with IHD. Whether the psychosocial working environment plays a role for patients with existing cardiovascular disease on the risk of new cardiac events and readmissions is unknown METHOD: A cohort of patients under 65 years and treated with Percutaneous Coronary Intervention was...... terms of quantitative and cognitive demands, workload, involvement, influence, tolerance, social support, the combinations of effort-reward and demand-control and the risk of adverse events. CONCLUSIONS: Reporting of problems in the psychosocial working environment are not associated with risk of...

  14. Hospitalized cardiovascular events in patients with diabetic macular edema

    Directory of Open Access Journals (Sweden)

    Nguyen-Khoa Bao-Anh

    2012-07-01

    Full Text Available Abstract Background Microvascular and macrovascular complications in diabetes stem from chronic hyperglycemia and are thought to have overlapping pathophysiology. The aim of this study was to investigate the incidence rate of hospitalized myocardial infarctions (MI and cerebrovascular accidents (CVA in patients with diabetic macular edema (DME compared with diabetic patients without retinal diseases. Methods This was a retrospective cohort study of a commercially insured population in an administrative claims database. DME subjects (n = 3519 and diabetes controls without retinal disease (n = 10557 were matched by age and gender. Healthcare claims were analyzed for the study period from 1 January 2002 to 31 December 2005. Incidence and adjusted rate ratios of hospitalized MI and CVA events were then calculated. Results The adjusted rate ratio for MI was 2.50 (95% CI: 1.83-3.41, p  Conclusion Event rates of MI or CVA were higher in patients with DME than in diabetes controls. This study is one of few with sufficient sample size to accurately estimate the relationship between DME and cardiovascular outcomes.

  15. The logic of surveillance guidelines: an analysis of vaccine adverse event reports from an ontological perspective.

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

    Full Text Available BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. METHODS AND FINDINGS: Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. CONCLUSIONS: By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. AVAILABILITY: Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero.

  16. Report of adverse events related to treatments to Institute de Veille sanitaire

    International Nuclear Information System (INIS)

    The 'code de sante publique' imposes to all health professionals an obligation to declare serious and undesirable events following cares applied during treatment investigations or prevention actions. An experimentation has been installed under the responsibility of the Institut de Veille sanitaire further to the 9 August 2004 bill. It aims to define how to declare undesirable adverse events to test its feasibility, its efficiency and to identify the necessary conditions to widespread its modalities. The field of these experimentations concerns all health professionals, working in public hospital or in private practice. The definition of undesirable adverse events should be clarified. Different ways to declare these events will be discussed with S.F.R.O. (Societe francaise de radiotherapie oncologique) to improve the current management of incidents and adverse events. (authors)

  17. Carotid flow velocity/diameter ratio is a predictor of cardiovascular events in hypertensive patients

    DEFF Research Database (Denmark)

    Bellinazzi, Vera R; Cipolli, José A; Pimenta, Marcio V; Guimarães, Paula V; Pio-Magalhães, José A; Coelho-Filho, Otavio R; Biering-Sørensen, Tor; Matos-Souza, José R; Sposito, Andrei C; Nadruz, Wilson

    2015-01-01

    with sFV/sAD ratio less than 85.7/s (optimal cut-off point obtained by receiver-operating characteristic analysis) compared to those with higher sFV/sAD values (log-rank test: P < 0.0001). In stepwise multivariable Cox-regression analyses, sFV/sAD was significantly associated with MACEs (P < 0......OBJECTIVE: The aim of this study was to evaluate the performance of common carotid artery diameter, flow velocity and flow velocity/artery diameter ratio as predictors of major adverse cardiovascular events (MACEs) in a sample of hypertensive patients. METHODS: A cohort of 403 hypertensive patients...... was followed up for a median of 1260 (714) days, and 27 suffered MACEs. At baseline, participants were evaluated by clinical, laboratory, echocardiographic and carotid ultrasound analysis. RESULTS: Patients with peak-systolic flow velocity (sFV) less than the median value and systolic artery diameter...

  18. Aspirin in Cardiovascular and Cerebrovascular Events: Does Market Failure Matter?

    Directory of Open Access Journals (Sweden)

    Roger Lee Mendoza

    2010-01-01

    Full Text Available Problem statement: Against the backdrop of the 2009 scientific studies qualifying the cardiovascular and cerebrovascular benefits of aspirin, two interrelated questions are raised for investigation in this study. First, why may the government intervene in an otherwise private transaction between physician and patient and between drug manufacturer and buyer, when it involves contentious pharmacological information? Second, does government intervention make a difference in what these transacting parties would otherwise have chosen to do in its absence? Approach: An Internet literature search was performed, using query term combinations, to identify relevant aspirin studies. The search yielded 61 juried publications that met our predetermined criteria for inclusion and thematic analysis. Results: Variance exists within the mix of economic and non-economic literature on aspirin information regulation. The study identified 4 instances of market failure that offer some of the most compelling theoretical and practical considerations for public policy intervention in the context of the 2009 findings. However, there is also indication that the sense of increased protection arising from safety regulations could stimulate risky behavior that nullifies their net protective effects or benefits. Conclusion: It is not clear either from the surveyed literature or existing economic theory if, ceteris paribus, regulated information alters or modifies the marginal propensity of a physician to recommend, and a patient to consume, aspirin to prevent cardiovascular and cerebrovascular events, particularly heart attacks, strokes and vascular death. The study suggests the need for policy reinforcements to safety information, if market failures are to be efficiently addressed and risk compensating behavior reduced.

  19. Combined Value of Red Blood Cell Distribution Width and Global Registry of Acute Coronary Events Risk Score for Predicting Cardiovascular Events in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

    OpenAIRE

    Zhao, Na; Mi, Lan; Liu, Xiaojun; Pan, Shuo; Xu, Jiaojiao; Xia, Dongyu; Liu, Zhongwei; Zhang, Yong; Xiang, Yu; Yuan, Zuyi; Guan, Gongchang; Wang, Junkui

    2015-01-01

    Global Registry of Acute Coronary Events (GRACE) risk score and red blood cell distribution width (RDW) content can both independently predict major adverse cardiac events (MACEs) in patients with acute coronary syndrome (ACS). We investigated the combined predictive value of RDW and GRACE risk score for cardiovascular events in patients with ACS undergoing percutaneous coronary intervention (PCI) for the first time. We enrolled 480 ACS patients. During a median follow-up time of 37.2 months,...

  20. Signal detection to identify serious adverse events (neuropsychiatric events in travelers taking mefloquine for chemoprophylaxis of malaria

    Directory of Open Access Journals (Sweden)

    Naing C

    2012-08-01

    Full Text Available Cho Naing,1,3 Kyan Aung,1 Syed Imran Ahmed,2 Joon Wah Mak31School of Medical Sciences, 2School of Pharmacy and Health Sciences, 3School of Postgraduate Studies and Research, International Medical University, Kuala Lumpur, MalaysiaBackground: For all medications, there is a trade-off between benefits and potential for harm. It is important for patient safety to detect drug-event combinations and analyze by appropriate statistical methods. Mefloquine is used as chemoprophylaxis for travelers going to regions with known chloroquine-resistant Plasmodium falciparum malaria. As such, there is a concern about serious adverse events associated with mefloquine chemoprophylaxis. The objective of the present study was to assess whether any signal would be detected for the serious adverse events of mefloquine, based on data in clinicoepidemiological studies.Materials and methods: We extracted data on adverse events related to mefloquine chemoprophylaxis from the two published datasets. Disproportionality reporting of adverse events such as neuropsychiatric events and other adverse events was presented in the 2 × 2 contingency table. Reporting odds ratio and corresponding 95% confidence interval [CI] data-mining algorithm was applied for the signal detection. The safety signals are considered significant when the ROR estimates and the lower limits of the corresponding 95% CI are ≥2.Results: Two datasets addressing adverse events of mefloquine chemoprophylaxis (one from a published article and one from a Cochrane systematic review were included for analyses. Reporting odds ratio 1.58, 95% CI: 1.49–1.68 based on published data in the selected article, and 1.195, 95% CI: 0.94–1.44 based on data in the selected Cochrane review. Overall, in both datasets, the reporting odds ratio values of lower 95% CI were less than 2.Conclusion: Based on available data, findings suggested that signals for serious adverse events pertinent to neuropsychiatric event were

  1. Higher risk of offspring schizophrenia following antenatal maternal exposure to severe adverse life events

    DEFF Research Database (Denmark)

    Khashan, Ali; Abel, Kathryn; McNamee, R.; Pedersen, Marianne Giørtz; Webb, Roger; Baker, P.N.; Kenny, L.C.; Mortensen, Preben Bo

    2008-01-01

    CONTEXT: Most societies believe that a mother's psychological state can influence her unborn baby. Severe adverse life events during pregnancy have been consistently associated with an elevated risk of low birth weight and prematurity. Such events during the first trimester have also been...

  2. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011

    Directory of Open Access Journals (Sweden)

    Dag Ø. Nordanger

    2014-05-01

    Full Text Available Background: Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective: To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method: We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results: All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions: Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care.

  3. Adverse events with use of antiepileptic drugs: a prescription and event symmetry analysis

    DEFF Research Database (Denmark)

    Tsiropoulos, Ioannis; Andersen, Morten; Hallas, Jesper

    2009-01-01

    gabapentin with glaucoma (ASR 8.0; 95%CI 1.1-355) and of valproic acid with hypothyroidism (ASR 8.0; 95%CI 1.1-355). CONCLUSIONS: Few unsuspected adverse AED effects were recognized in our study. Sequence symmetry analysis is a feasible method of monitoring for adverse AED effects. Copyright (c) 2009 John...

  4. Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    NARCIS (Netherlands)

    Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao-Yin; Cooper, Mark E.; de Zeeuw, Dick; Eckardt, Kai-Uwe; Ivanovich, Peter; Kewalramani, Reshma; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet; McMurray, John J. V.; Parfrey, Patrick; Parving, Hans-Henrik; Remuzzi, Giuseppe; Singh, Ajay K.; Solomon, Scott D.; Toto, Robert; Uno, Hajime

    2009-01-01

    Background: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and ther

  5. Adverse events of extracorporeal ultrasound-guided high intensity focused ultrasound therapy.

    Directory of Open Access Journals (Sweden)

    Tinghe Yu

    Full Text Available BACKGROUND: High-intensity focused ultrasound (HIFU is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy. METHODS AND FINDINGS: Clinical data were searched in 2 Chinese databases. Adverse events of USgFU were summarized and compared with those of magnetic resonance-guided HIFU (MRgFU; for uterine, bone or breast tumor and transrectal ultrasound-guided HIFU (for prostate cancer or benign prostate hyperplasia. USgFU treatment was performed using 7 types of device. Side effects were evaluated in 13262 cases. There were fewer adverse events in benign lesions than in malignant lesions (11.81% vs. 21.65%, p<0.0001. Rates of adverse events greatly varied between the disease types (0-280%, p<0.0001 and between the applied HIFU devices in both malignant (10.58-44.38%, p<0.0001 and benign lesions (1.67-17.57%, p<0.0001. Chronological analysis did not demonstrate a decrease in the rate of adverse events. Based upon evaluable adverse events, incidences in USgFU were consistent with those in MRgFU or transrectal HIFU. Some side effects frequently occurred following transrectal HIFU were not reported in USgFU. Several events including intrahepatic metastasis, intraoperative high fever, and occlusions of the superior mesenteric artery should be of particular concern because they have not been previously noted. The types of adverse events suggested that they were ultrasonic lesions. CONCLUSION: The frequency of adverse events depended on the location of the lesion and the type of HIFU device; however, side effects of USgFU were not yet understood. USgFU did not decrease the incidence of adverse events

  6. Attitudes toward metabolic adverse events among patients with schizophrenia in Japan

    Science.gov (United States)

    Sugawara, Norio; Yasui-Furukori, Norio; Yamazaki, Manabu; Shimoda, Kazutaka; Mori, Takao; Sugai, Takuro; Matsuda, Hiroshi; Suzuki, Yutaro; Minami, Yoshitake; Ozeki, Yuji; Okamoto, Kurefu; Sagae, Toyoaki; Someya, Toshiyuki

    2016-01-01

    Background Metabolic syndrome is a growing concern among patients with schizophrenia because metabolic abnormalities are widely regarded as a major risk factor for cardiovascular disease and premature death. The current study assessed attitudes toward metabolic adverse events among patients with schizophrenia. Methods A brief questionnaire was constructed to investigate patient recognition of the following broad areas: dietary habits, lifestyle, self-monitoring, knowledge, and medical practice. Between January 2012 and June 2013, questionnaires were sent to patients associated with 520 outpatient facilities and 247 inpatient facilities belonging to the Japan Psychiatric Hospital Association. All of the participants (n=22,072; inpatients =15,170, outpatients =6,902) were diagnosed with schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, or the International Classification of Diseases, tenth revision. Results Approximately 55.0% (8,069/14,669) of inpatients and 44.8% of outpatients (2,978/6,649) reported that they did not exercise at all. Although 60.9% (4,116/6,760) of outpatients reported that they felt obese, only 35.6% (5,261/14,794) of inpatients felt obese. More than half of the inpatients (51.2%; 7,514/14,690) and outpatients (60.8%; 4,086/6,721) hoped to receive regular blood tests to prevent weight gain and diseases such as diabetes. Conclusion Although more than half of patients hoped to prevent weight gain and diabetes, only a minority of patients were mindful of eating balanced meals and having physical exercise. Educational efforts and the promotion of the best pharmacotherapy and monitoring practices are needed for patients with schizophrenia. PMID:26966364

  7. Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

    Science.gov (United States)

    Bender, Ralf; Beckmann, Lars; Lange, Stefan

    2016-07-01

    The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd. PMID:26928768

  8. Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.

    Science.gov (United States)

    Suzuki, Yukiya; Suzuki, Honami; Umetsu, Ryogo; Uranishi, Hiroaki; Abe, Junko; Nishibata, Yuri; Sekiya, Yasuaki; Miyamura, Nobuteru; Hara, Hideaki; Tsuchiya, Teruo; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Clopidogrel is an antiplatelet agent widely used in combination with aspirin to limit the occurrence of cardiovascular (embolic/thrombotic) events. Consensus guidelines recommend proton pump inhibitors (PPIs) as a gastrointestinal (GI) prophylactic measure for all patients receiving dual antiplatelet therapy with clopidogrel and aspirin. The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 4.40 (95% confidence interval [CI], 4.02-4.81) and 3.40 (95% CI, 2.84-4.06), respectively. For embolic/thrombotic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 2.37 (95% CI, 2.16-2.59) and 2.38 (95% CI, 2.00-2.84), respectively. Among patients included in the FAERS database, the concurrent use of aspirin and clopidogrel with PPIs reduced the adjusted ROR of GI hemorrhagic events. PPIs had little influence on the adjusted ROR of embolic/thrombotic events. These results support the use of PPIs as a preventive measure against GI hemorrhagic events for patients receiving clopidogrel and aspirin. PMID:25947914

  9. Incidence and Management of Life-Threatening Adverse Events During Cardiac Catheterization for Congenital Heart Disease

    OpenAIRE

    Lin, C. Huie; Hegde, Sanjeet; Marshall, Audrey C.; Porras, Diego; Gauvreau, Kimberlee; Balzer, David T.; Beekman, Robert H.; Torres, Alejandro; Vincent, Julie A.; Moore, John W.; Holzer, Ralf; Armsby, Laurie; Bergersen, Lisa

    2013-01-01

    Continued advancements in congenital cardiac catheterization and interventions have resulted in increased patient and procedural complexity. Anticipation of life-threatening events and required rescue measures is a critical component to preprocedural preparation. We sought to determine the incidence and nature of life-threatening adverse events in congenital and pediatric cardiac catheterization, risk factors, and resources necessary to anticipate and manage events. Data from 8905 cases perfo...

  10. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children.

    Science.gov (United States)

    Cashman, Patrick; Moberley, Sarah; Dalton, Craig; Stephenson, Jody; Elvidge, Elissa; Butler, Michelle; Durrheim, David N

    2014-09-22

    Vaxtracker is a web based survey for active post marketing surveillance of Adverse Events Following Immunisation. It is designed to efficiently monitor vaccine safety of new vaccines by early signal detection of serious adverse events. The Vaxtracker system automates contact with the parents or carers of immunised children by email and/or sms message to their smart phone. A hyperlink on the email and text messages links to a web based survey exploring adverse events following the immunisation. The Vaxtracker concept was developed during 2011 (n=21), and piloted during the 2012 (n=200) and 2013 (n=477) influenza seasons for children receiving inactivated influenza vaccine (IIV) in the Hunter New England Local Health District, New South Wales, Australia. Survey results were reviewed by surveillance staff to detect any safety signals and compare adverse event frequencies among the different influenza vaccines administered. In 2012, 57% (n=113) of the 200 participants responded to the online survey and 61% (290/477) in 2013. Vaxtracker appears to be an effective method for actively monitoring adverse events following influenza vaccination in children. PMID:25077424

  11. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

  12. Traditional Cardiovascular Risk Factors as Predictors of Cardiovascular Events in the U.S. Astronaut Corps

    Science.gov (United States)

    Halm, M. K.; Clark, A.; Wear, M. L.; Murray, J. D.; Polk, J. D.; Amirian, E.

    2009-01-01

    Risk prediction equations from the Framingham Heart Study are commonly used to predict the absolute risk of myocardial infarction (MI) and coronary heart disease (CHD) related death. Predicting CHD-related events in the U.S. astronaut corps presents a monumental challenge, both because astronauts tend to live healthier lifestyles and because of the unique cardiovascular stressors associated with being trained for and participating in space flight. Traditional risk factors may not hold enough predictive power to provide a useful indicator of CHD risk in this unique population. It is important to be able to identify individuals who are at higher risk for CHD-related events so that appropriate preventive care can be provided. This is of special importance when planning long duration missions since the ability to provide advanced cardiac care and perform medical evacuation is limited. The medical regimen of the astronauts follows a strict set of clinical practice guidelines in an effort to ensure the best care. The purpose of this study was to evaluate the utility of the Framingham risk score (FRS), low-density lipoprotein (LDL) and high-density lipoprotein levels, blood pressure, and resting pulse as predictors of CHD-related death and MI in the astronaut corps, using Cox regression. Of these factors, only two, LDL and pulse at selection, were predictive of CHD events (HR(95% CI)=1.12 (1.00-1.25) and HR(95% CI)=1.70 (1.05-2.75) for every 5-unit increase in LDL and pulse, respectively). Since traditional CHD risk factors may lack the specificity to predict such outcomes in astronauts, the development of a new predictive model, using additional measures such as electron-beam computed tomography and carotid intima-media thickness ultrasound, is planned for the future.

  13. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole

    DEFF Research Database (Denmark)

    Jakobsen, Klaus Damgaard; Bruhn, Christina Hedegaard; Pagsberg, Anne-Katrine;

    2016-01-01

    insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as...... neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients....

  14. The Effects of Pharmaceutical Marketing and Promotion on Adverse Drug Events and Regulation

    OpenAIRE

    Guy David; Sara Markowitz; Seth Richards

    2009-01-01

    This paper analyzes the relationship between postmarketing promotional activity and reporting of adverse drug events by modeling the interaction between a welfare maximizing regulator (the FDA) and a profit maximizing firm. In our analysis demand is sensitive to both promotion and regulatory interventions. Promotion-driven market expansions enhance profitability yet may involve the risk that the drug would be prescribed inappropriately, leading to adverse regulatory actions against the firm. ...

  15. Systemic adverse events following rituximab therapy in patients with Graves' disease

    DEFF Research Database (Denmark)

    El Fassi, D; Nielsen, Claus Henrik; Junker, Michael Peter;

    2011-01-01

    methimazole only. Adverse events were recorded, and the presence of circulating immune complexes (CICs) was measured as IgG, IgM and complement component 3 (C3) depositing on normal monocytes following incubation with patient plasma. Results: Five patients had benign infusion-related adverse events at first...... infusion. Two patients developed a serum sickness-like reaction 11 days after the first RTX-infusion. One of these patients developed diarrhoea, raised orosomucoid levels, low-grade inflammation in colonoscopic biopsies, and iridocyclitis a year later. At day 14, the most pronounced immunoglobulin/C3...

  16. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian;

    2014-01-01

    to explore and improve team processes in the clinical environment. Though research on in situ simulation in healthcare is in its infancy, literature is abundant on patient safety, medical simulation, team training and human factors1. Patient safety reporting systems that identify risks to patients can...... and used for debriefing6 focusing on team communication and team adaptation7 after in situ simulation training. Perspective and relevance First, this study might help taking reported critical incidents and adverse events back to the clinic. Second, reported critical incidents and adverse events coupled...

  17. Serious adverse events in a hospital using early warning score - what went wrong?

    DEFF Research Database (Denmark)

    Petersen, John Asger; Mackel, Rebecca; Antonsen, Kristian;

    2014-01-01

    AIM: To evaluate the performance of a new early warning score (EWS) system by reviewing all serious adverse events in our hospital over a 6-month time period. METHOD: All incidents of unexpected death (UD), cardiac arrest (CA) and unanticipated intensive care unit admission(UICU) of adult patients......%. On call physicians provided adequate care in 49% of cases of UICU and 29% of cases of the CO. Senior staff was involved according to protocol in 53% and 36% of cases of UICU and CO, respectively. CONCLUSION: Poor compliance with the escalation protocol was commonly found when serious adverse events...

  18. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ... of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food... Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse...

  19. Analysis of the communication of adverse events from the perspective of the nurses directly involved in patient care

    Directory of Open Access Journals (Sweden)

    Ilse Maria Tigre de Arruda Leitão

    2014-01-01

    Full Text Available This descriptive study aimed to analyze the process of communicating adverse events in the hospital context, from the nurses’ perspective. Data was collected in January 2013 in a public hospital in Fortaleza, Ceará, Brazil. A semi-structured interview was held with 37 nurses, covering guiding questions regarding the communication/recording of adverse events. It was found that communication of adverse events exists in the service, but that cases are under-reported and inadequately analyzed; the nurses were not unanimous in identifying the documents indicated for recording events; and a punitive culture predominates in the situations which generate adverse events, evidenced by reports of practices of reprimanding and punishment of the professionals. It is concluded that encouraging appropriate communication of adverse events in the service is necessary, considering recording as indispensable in the organizational communication process, as this is the source of data for analyzing the occurrence of adverse events and ensures patient safety.

  20. Pharmaco-epidemiology of Sumatriptan : cardiovascular adverse reactions to a new antimigrainous drug

    NARCIS (Netherlands)

    J.P. Ottervanger (Jan Paul)

    1996-01-01

    textabstractThe rationale to study a potential adverse reaction of a specific drug mainly depends on three questions: 1) how serious is the adverse reaction? 2) what is the incidence of the adverse reaction among users of the dlUg?, and 3) what is the frequency of consumption of the specific dlUg in

  1. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard; Winterstein, Almut G; Søndergaard, Birthe;

    2007-01-01

    (1993-March 2007), EMBASE (1980-February 2007), and Web of Science (1945-March 2007). Key words included medication error, adverse drug reaction, iatrogenic disease, outpatient, ambulatory care, primary health care, general practice, patient admission, hospitalization, observational study, retrospective.......5 per 1000 person-months. Cardiovascular drugs, analgesics, and hypoglycemic agents together accounted for 86.5% of pADEs, and 77.2% of pADEs resulted in symptoms of the central nervous system, electrolyte/renal system, and gastrointestinal tract. Medication errors resulting in pADEs occurred in the...

  2. Prevalence of Negative Life Events and Chronic Adversities in European Pre- and Primary-School Children

    DEFF Research Database (Denmark)

    Vanaelst, Barbara; Huybrechts, Inge; Bourdeaudhuij, Ilse;

    2012-01-01

    lifestyle-induced health EFfects In Children and infantS’). Results The following findings were observed: (1) Certain adversities occur only rarely, while others are very regular (i.e. parental divorce); (2) A large percentage of children is shielded from stressors, while a small group of children is......Background Children are not always recognized as being susceptible to stress, although childhood stressors may originate from multiple events in their everyday surroundings with negative effects on children’s health. Methods As there is a lack of large-scale, European prevalence data on childhood...... adversities, this study presents the prevalence of (1) negative life events and (2) familial and social adversities in 4637 European pre- and primary-school children (4–11 years old), using a parentally-reported questionnaire embedded in the IDEFICS project (‘Identification and prevention of Dietary- and...

  3. Predicting adverse obstetric outcome after early pregnancy events and complications: a review

    DEFF Research Database (Denmark)

    van Oppenraaij, R H F; Jauniaux, E; Christiansen, O B;

    2009-01-01

    BACKGROUND The aim was to evaluate the impact of early pregnancy events and complications as predictors of adverse obstetric outcome. METHODS We conducted a literature review on the impact of first trimester complications in previous and index pregnancies using Medline and Cochrane databases......) after two or more miscarriages, the risk of placenta praevia, premature preterm rupture of membranes, VPTD and low birthweight (LBW) after recurrent miscarriage and the risk of VPTD after two or more termination of pregnancy. Clinically relevant associations of adverse obstetric outcome in the ongoing...... hyperemesis gravidarum. CONCLUSIONS Data from our literature review indicate, by finding significant associations, that specific early pregnancy events and complications are predictors for subsequent adverse obstetric and perinatal outcome. Though, some of these associations are based on limited or small...

  4. Ethnic differences in adverse events in Dutch hospital care? A record review study.

    NARCIS (Netherlands)

    Rosse, F. van; Bruijne, M.C. de; Essink-Bot, M.L.; Wagner, C.

    2013-01-01

    Objectives: US studies showed an increased risk of adverse events (AEs) in hospital care among ethnic minorities, but in Europe ethnic inequities in patient safety have never been analysed. In the Netherlands, approx.12% of the population is of non-Western ethnic origin. Because ethnic inequities

  5. Developmental Regression and Autism Reported to the Vaccine Adverse Event Reporting System

    Science.gov (United States)

    Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W.; Braun, M. Miles

    2007-01-01

    We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the…

  6. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Science.gov (United States)

    2011-09-15

    ...Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams......

  7. General practitioners′ attitudes toward reporting and learning from adverse events: results from a survey

    DEFF Research Database (Denmark)

    Mikkelsen, Thorbjørn H.; Sokolowski, Ineta; Olesen, Frede

    2006-01-01

    OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others...

  8. Adverse events during a placebo phase for inpatients with chronic schizophrenia

    NARCIS (Netherlands)

    van de Laar, N; Henter, L; Bartko, JJ; Wyatt, RJ

    2001-01-01

    Background: This report builds on a previous analysis examining the long-term effects of a placebo period on a group of inpatients with chronic schizophrenia. In the present analysis, outcome was evaluated through the use of the Psychiatric Adverse Events Rating Scale. Methods: This retrospective an

  9. Exploring the causes of adverse events in hospitals and potential prevention strategies.

    NARCIS (Netherlands)

    Smits, M.; Zegers, M.; Groenewegen, P.P.; Timmermans, D.R.M.; Zwaan, L.; Wal, G. van der; Wagner, C.

    2010-01-01

    Objectives: To examine the causes of adverse events (AEs) and potential prevention strategies to minimise the occurrence of AEs in hospitalised patients. Methods For the 744 AEs identified in the patient record review study in 21 Dutch hospitals, trained reviewers were asked to select all causal fac

  10. Exploring the causes of adverse events in hospitals and potential prevention strategies

    NARCIS (Netherlands)

    Smits, M.; Zegers, M.; Groenewegen, P.P.; Zwaan, L.; Wal, G. van der; Wagner, C.; Timmermans, D.

    2010-01-01

    Objectives To examine the causes of adverse events (AEs) and potential prevention strategies to minimise the occurrence of AEs in hospitalised patients. Methods For the 744 AEs identified in the patient record review study in 21 Dutch hospitals, trained reviewers were asked to select all causal fact

  11. From big data to bedside decision-making: the case for AdverseEvents

    Directory of Open Access Journals (Sweden)

    Giuseppe Biondi Zoccai

    2013-07-01

    Full Text Available Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA venue for such task, the FDA Adverse Event Reporting System (FAERS has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.

  12. The Adverse Events and Hemodynamic Effects of Adenosine-Based Cardiac MRI

    International Nuclear Information System (INIS)

    We wanted to prospectively assess the adverse events and hemodynamic effects associated with an intravenous adenosine infusion in patients with suspected or known coronary artery disease and who were undergoing cardiac MRI. One hundred and sixty-eight patients (64 ± 9 years) received adenosine (140 μg/kg/min) during cardiac MRI. Before and during the administration, the heart rate, systemic blood pressure, and oxygen saturation were monitored using a MRI-compatible system. We documented any signs and symptoms of potential adverse events. In total, 47 out of 168 patients (28%) experienced adverse effects, which were mostly mild or moderate. In 13 patients (8%), the adenosine infusion was discontinued due to intolerable dyspnea or chest pain. No high grade atrioventricular block, bronchospasm or other life-threatening adverse events occurred. The hemodynamic measurements showed a significant increase in the heart rate during adenosine infusion (69.3 ± 11.7 versus 82.4 ± 13.0 beats/min, respectively; p < 0.001). A significant but clinically irrelevant increase in oxygen saturation occurred during adenosine infusion (96 ± 1.9% versus 97 ± 1.3%, respectively; p < 0.001). The blood pressure did not significantly change during adenosine infusion (systolic: 142.8 ± 24.0 versus 140.9 ± 25.7 mmHg; diastolic: 80.2 ± 12.5 mmHg versus 78.9 ± 15.6, respectively). This study confirms the safety of adenosine infusion during cardiac MRI. A considerable proportion of all patients will experience minor adverse effects and some patients will not tolerate adenosine infusion. However, all adverse events can be successfully managed by a radiologist. The increased heart rate during adenosine infusion highlights the need to individually adjust the settings according to the patient, e.g., the number of slices of myocardial perfusion imaging.

  13. Impact of adverse events of antiretroviral treatment on regimen change and mortality in Ugandan children

    Directory of Open Access Journals (Sweden)

    Ntambwe Malangu

    2010-03-01

    Full Text Available Background: Outcomes of antiretroviral treatment have been documented in both developed and developing countries. It has been reported consistently that the treatment is associated with many adverse events. However, little is known about their impact on the quality of life, clinical management, and survival in children aged less than 6 years in Uganda.Objectives: The purpose of this study was to determine the prevalence of the adverse events of antiretroviral treatment, their impact on mortality and the change in regimens prescribed to children treated at Mildway Centre in Uganda.Method: A retrospective chart review was performed for children younger than 6 years, treated since the Mildway Centre was opened in 1999. In order to achieve a larger sample, the records of children treated from January 2000 to July 2005 were included in the study. A pre-tested data collection form was used to collate socio-demographic and clinical data of the patients. These included the documented adverse events, causes of death, stage of infection, duration of treatment, regimen prescribed, year of enrolment into the treatment program, as well as whether or not they were still alive. Descriptive statistics were used in the analysis of data.Results: Of the 179 children, the majority were males and had a median age of 4 years. The majority (58.8% of children had suffered from severe immune depression since they met the WHO clinical stage III and IV, 73.8% had a baseline CD4T of less than 15%. Four regimens were prescribed to the children. The most common was a regimen containing zidovudine, lamivudine, and nevirapine (34.6%, followed by a regimen containing stavudine, lamivudine, and nevirapine (27.9%. Eleven children (6.1% had their regimen changed, of which six (54.5% were due to adverse events. The prevalence of adverse events was 8%; of the 14 documented adverse events, the most common were severe anaemia (3, vomiting (3, and skin rashes (3. After 12 months on

  14. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

    Directory of Open Access Journals (Sweden)

    Deyo Richard A

    2006-06-01

    Full Text Available Abstract Background Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1 specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2 quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. Methods We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. Results During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%. Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35, but agreement was substantial (kappa ≥ 0.61 for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted

  15. Attitudes toward metabolic adverse events among patients with schizophrenia in Japan

    Directory of Open Access Journals (Sweden)

    Sugawara N

    2016-02-01

    Full Text Available Norio Sugawara,1–3 Norio Yasui-Furukori,2,3 Manabu Yamazaki,4 Kazutaka Shimoda,3,5 Takao Mori,4 Takuro Sugai,3,6 Hiroshi Matsuda,4 Yutaro Suzuki,3,6 Yoshitake Minami,4 Yuji Ozeki,3,5 Kurefu Okamoto,4 Toyoaki Sagae,7 Toshiyuki Someya3,6 1Aomori Prefectural Center for Mental Health and Welfare, Aomori, 2Department of Neuropsychiatry, Hirosaki University School of Medicine, Hirosaki, 3Japanese Society of Clinical Neuropsychopharmacology, 4Japan Psychiatric Hospital Association, Tokyo, 5Department of Psychiatry, Dokkyo Medical University School of Medicine, Mibu, 6Department of Psychiatry, Niigata University Graduate School of Medical and Dental Sciences, Niigata, 7Department of Health and Nutrition, Yamagata Prefectural Yonezawa University of Nutrition Sciences, Yonezawa, Japan Background: Metabolic syndrome is a growing concern among patients with schizophrenia because metabolic abnormalities are widely regarded as a major risk factor for cardiovascular disease and premature death. The current study assessed attitudes toward metabolic adverse events among patients with schizophrenia. Methods: A brief questionnaire was constructed to investigate patient recognition of the following broad areas: dietary habits, lifestyle, self-monitoring, knowledge, and medical practice. Between January 2012 and June 2013, questionnaires were sent to patients associated with 520 outpatient facilities and 247 inpatient facilities belonging to the Japan Psychiatric Hospital Association. All of the participants (n=22,072; inpatients =15,170, outpatients =6,902 were diagnosed with schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, or the International Classification of Diseases, tenth revision. Results: Approximately 55.0% (8,069/14,669 of inpatients and 44.8% of outpatients (2,978/6,649 reported that they did not exercise at all. Although 60.9% (4,116/6,760 of outpatients reported that they felt obese, only 35.6% (5

  16. High cardiovascular event rates in patients with asymptomatic carotid stenosis: the REACH Registry

    DEFF Research Database (Denmark)

    Aichner, F T; Topakian, R; Alberts, M J; Bhatt, D L; Haring, H-P; Hill, M D; Montalescot, G; Goto, S; Touzé, E; Mas, J-L; Steg, P G; Röther, J; Iversen, Helle Klingenberg

    2009-01-01

    BACKGROUND AND PURPOSE: Data on current cardiovascular event rates in patients with asymptomatic carotid artery stenosis (ACAS) are sparse. We compared the 1-year outcomes of patients with ACAS > or =70% versus patients without ACAS in an international, prospective cohort of outpatients with or at....... 0.26%, P = 0.04), cardiovascular death (2.29% vs. 1.52%, P = 0.002), the composite end-point cardiovascular death/myocardial infarction/stroke (6.03% vs. 4.29%, P <0.0001) and bleeding events (1.41% vs. 0.81%, P = 0.002). In patients with ACAS, Cox regression analyses identified history of...... cerebrovascular ischaemic events as most important predictor of future stroke (HR 3.21, 95% CI 1.82-5.65, P <0.0001). CONCLUSION: Asymptomatic carotid artery stenosis was associated with high 1-year rates of cardiovascular and cerebrovascular ischaemic events. Stroke was powerfully predicted by prior...

  17. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.

    Science.gov (United States)

    Jakobsen, Klaus Damgaard; Bruhn, Christina Hedegaard; Pagsberg, Anne-Katrine; Fink-Jensen, Anders; Nielsen, Jimmi

    2016-10-01

    Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients. PMID:27504593

  18. Patients at high risk of adverse events from intravenous contrast media after computed tomography examination

    Energy Technology Data Exchange (ETDEWEB)

    Reddan, Donal [University College Galway Hospitals, Unit 7, Merlin Park Hospital, Galway (Ireland)]. E-mail: donal.reddan@mailn.hse.ie

    2007-05-15

    Adverse reactions to iodinated contrast media (CM) may occur and require prompt recognition and treatment. Although adverse reactions to radiocontrast agents cannot be eliminated, an important first step toward reducing their incidence is to identify patients at greatest risk. Prior to examinations using CM, patients should be adequately assessed by obtaining thorough medical histories and using simple screening tests. Studies have demonstrated that patients with a history of asthma, allergy, hyperthyroidism, and previous reaction to CM are at risk for severe reactions to iodinated CM. Renal adverse reactions reportedly occur more frequently in patients with pre-existing chronic kidney disease, especially those with diabetic nephropathy. Patients with congestive heart failure, dehydration, older age, and those who use nephrotoxic medications are also at risk for developing contrast-associated nephropathy. The occurrence of adverse events may be further increased in patients with multiple risk factors. As the number of patients undergoing computed tomography procedures continues to increase, it is essential for physicians to be able to identify patients at risk for adverse events of CM. Patient-related risk factors are discussed and simple tools for risk stratification presented.

  19. Patients at high risk of adverse events from intravenous contrast media after computed tomography examination

    International Nuclear Information System (INIS)

    Adverse reactions to iodinated contrast media (CM) may occur and require prompt recognition and treatment. Although adverse reactions to radiocontrast agents cannot be eliminated, an important first step toward reducing their incidence is to identify patients at greatest risk. Prior to examinations using CM, patients should be adequately assessed by obtaining thorough medical histories and using simple screening tests. Studies have demonstrated that patients with a history of asthma, allergy, hyperthyroidism, and previous reaction to CM are at risk for severe reactions to iodinated CM. Renal adverse reactions reportedly occur more frequently in patients with pre-existing chronic kidney disease, especially those with diabetic nephropathy. Patients with congestive heart failure, dehydration, older age, and those who use nephrotoxic medications are also at risk for developing contrast-associated nephropathy. The occurrence of adverse events may be further increased in patients with multiple risk factors. As the number of patients undergoing computed tomography procedures continues to increase, it is essential for physicians to be able to identify patients at risk for adverse events of CM. Patient-related risk factors are discussed and simple tools for risk stratification presented

  20. Risk Factors and Adverse Events Poorly Predict Infections and Hypogammaglobulinemia in Granulomatosis with Polyangiitis Patients Receiving Rituximab

    Directory of Open Access Journals (Sweden)

    Emilio Besada

    2016-01-01

    Full Text Available Background. 29 GPA patients from the Northern Norway vasculitis disease registry received rituximab (RTX induction and maintenance. 24% and 31% had, respectively, severe and chronic infections while 45% had hypogammaglobulinemia and 28% discontinued RTX due to hypogammaglobulinemia. The aim of the study was to examine how known predictors and adverse events interacted with adverse events using structural statistical methods. Methods. Five predictors (age, cyclophosphamide, total Ig and CD4/CD8 ratio prior RTX, and type of RTX maintenance regimen and 4 adverse events (severe and chronic infections, hypogammaglobulinemia, and RTX discontinuation were modeled in principal component and redundancy analyses. Results. The 5 predictors explained 51% of the variance of the GPA cohort. Models including cyclophosphamide exposure and total Ig level predicted best adverse events. However total Ig level has low R squared. The 2 best combinations of adverse events explained 13% of the variance of the predictors and adverse events. Only chronic infections were associated with combination of all adverse events (P=0.014. Hypogammaglobulinemia did not seem associated with the other adverse events. Conclusions. Traditional risk factors for infections and hypogammaglobulinemia seemed to poorly predict adverse events in our GPA cohort.

  1. Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.

    Science.gov (United States)

    Gibbons, Robert D; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K; Bhaumik, Dulal K; Brown, C Hendricks; Kapur, Kush; Marcus, Sue M; Hur, Kwan; Mann, J John

    2008-05-20

    A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Administration (FDA)'s Adverse Event Reporting System (AERS) on the relationship between antidepressants and suicide. We obtain point estimates and 95 per cent confidence (posterior) intervals for the rate multiplier for each drug (e.g. antidepressants), which can be used to determine whether a particular drug has an increased risk of association with a particular AE (e.g. suicide). Confidence (posterior) intervals that do not include 1.0 provide evidence for either significant protective or harmful associations of the drug and the adverse effect. We also examine EB, parametric Bayes, and semiparametric Bayes estimators of the rate multipliers and associated confidence (posterior) intervals. Results of our analysis of the FDA AERS data revealed that newer antidepressants are associated with lower rates of suicide adverse event reports compared with older antidepressants. We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system. PMID:18404622

  2. n-3 Fatty Acids and Cardiovascular Events after Myocardial Infarction

    NARCIS (Netherlands)

    Kromhout, D.; Giltay, E.J.; Geleijnse, J.M.

    2010-01-01

    Background - Results from prospective cohort studies and randomized, controlled trials have provided evidence of a protective effect of n-3 fatty acids against cardiovascular diseases. We examined the effect of the marine n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and

  3. Empagliflozin reduces cardiovascular events and mortality in type 2 diabetes.

    Science.gov (United States)

    Guthrie, Robert

    2016-05-01

    Review of: Zinnam, B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine. 2015; 373: 2117-2128. Patients were required to have a history of established cardiovascular disease, along with Type 2 Diabetes but were either not on antidiabetic therapy for the preceding 12 weeks, with a glycated hemoglobin level between 7% and 9%, or were on stable antidiabetic therapy for the preceding 12 weeks, with a glycated hemoglobin between 7.0% and 10.0%. Patients were randomized in a 1:1:1 ratio to either empagliflozin 10 mg or 25 mg or matching placebo. Antidiabetic therapy was not to be changed for the first 12 weeks after randomization, with intensification of antidiabetic therapy allowed if the patient had a confirmed glucose of >240 mg/dl (>13.3 mmol/l). Physicians were encouraged to treat other cardiac risk factors like hyperlipidemia according to local guidelines. The primary outcome was a composite of death from cardiovascular causes, non-fatal myocardial infarction, or nonfatal stroke. Results showed a significant reduction in the rates of death from cardiovascular causes, overall mortality, and in hospital admissions for heart failure, while there was no reduction in the rates of non-fatal myocardial infarction or stroke. PMID:27043258

  4. Road traffic noise, air pollution components and cardiovascular events

    NARCIS (Netherlands)

    Kluizenaar, Y. de; Lenthe, F.J. van; Visschedijk, A.J.H.; Zandveld, P.Y.J; Miedema, H.M.E.; Mackenbach, J.P.

    2013-01-01

    Traffic noise and air pollution have been associated with cardiovascular health effects. Until date, only a limited amount of prospective epidemiological studies is available on long-term effects of road traffic noise and combustion related air pollution. This study investigates the relationship bet

  5. Associations between immune depression and cardiovascular events in HIV infection

    DEFF Research Database (Denmark)

    Sabin, Caroline A.; Nielsen, Lene Ryom; De Wit, Stephane; Mocroft, Amanda; Phillips, Andrew N; Worm, Signe W; Weber, Rainer; D'Arminio Monforte, Antonella; Reiss, Peter; Kamara, David; El-Sadr, Wafaa; Pradier, Christian; Dabis, Francois; Law, Matthew; Lundgren, Jens

    2013-01-01

    To consider associations between the latest/nadir CD4 cell count, and time spent with CD4 cell count less than 200 cells/μl (duration of immune depression), and myocardial infarction (MI), coronary heart disease (CHD), stroke, or cardiovascular disease (CVD) (CHD or stroke) in 33 301 HIV...

  6. Patient-reported health as a prognostic factor for adverse events following percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Biering K

    2014-01-01

    Full Text Available Karin Biering,1 Hans Erik Bøtker,2 Troels Niemann,3 Niels Henrik Hjollund4,51Department of Occupational Medicine, Regional Hospital West Jutland, Herning, 2Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, 3Department of Cardiology, Regional Hospital West Jutland, Herning, 4WestChronic, Regional Hospital West Jutland, Herning, 5Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, DenmarkObjective: A relation may exist between self-reported health and adverse events in coronary heart disease. Previous studies have been vulnerable to possible selection bias. In the study reported here, we examined the association between self-rated health and adverse events in terms of cardiac events, cardiac readmissions, and all-cause mortality in a complete cohort of patients treated with percutaneous coronary intervention (PCI.Study design and setting: A cohort of patients with coronary heart disease treated with PCI was followed up with questionnaires 4 weeks after PCI to measure self-rated health and in registers to identify adverse events. Of 1,752 eligible patients under 67 years, 26 died during the first 4 weeks. A total of 224 patients were excluded from the analysis because they were readmitted with a cardiac diagnosis before answering the first questionnaire. We received complete SF-12 Health Survey component summaries from 984 of the remaining 1,502 patients. We used multiple imputation to establish a complete cohort, including nonrespondents.Results: During follow-up, 83 patients died, 220 patients experienced a new cardiac event, and 526 patients experienced a hospital readmission related to coronary heart disease. Poor self-rated health was related to cardiac events, cardiac readmission, and all-cause mortality. The associations were stronger for all-cause mortality than for events and readmissions. Physical health was more important than mental health, but both revealed an exposure–response pattern

  7. ADVERSE EVENT REPORTING FOR A DERMATOPHARMACOKINETIC STUDY OF DICLOFENAC SODIUM TOPICAL FORMULATIONS

    Directory of Open Access Journals (Sweden)

    Mayee Rahul

    2011-09-01

    Full Text Available In this single-dose-one arm, open label three way parallel design, pharmacokinetic study of three marketed formulations of Diclofenac Sodium using 12 healthy Indian male subjects, the pharmacokinetic parameters of three marketed Diclofenac Sodium topical formulations were compared. Marketed Diclofenac Sodium topical formulations (A, B & C were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample C was used as a reference sample. Subjects received treatment A, treatment B & treatment C on both the arms simultaneously, following open label three way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. Diclofenac Sodium was estimated in Stratum Corneum using a validated Spectroscopic method and the treatments were claimed to be bio-equivalent.The aim of this article was to report the occurrence of adverse events during this study. It was observed that only a single incidence of mild adverse event was reported in two volunteers, and it involved mild laceration on the right forearm. But, the event was found to be self resolving & with the relationship of the adverse event to study medication was “unlikely” but it could be due to the ‘tape stripping method’ employed for DPK analysis.

  8. Ontology-based time information representation of vaccine adverse events in VAERS for temporal analysis

    Directory of Open Access Journals (Sweden)

    Tao Cui

    2012-12-01

    Full Text Available Abstract Background The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS provides a valuable data source for post-vaccination adverse event analyses. The structured data in the system has been widely used, but the information in the write-up narratives is rarely included in these kinds of analyses. In fact, the unstructured nature of the narratives makes the data embedded in them difficult to be used for any further studies. Results We developed an ontology-based approach to represent the data in the narratives in a “machine-understandable” way, so that it can be easily queried and further analyzed. Our focus is the time aspect in the data for time trending analysis. The Time Event Ontology (TEO, Ontology of Adverse Events (OAE, and Vaccine Ontology (VO are leveraged for the semantic representation of this purpose. A VAERS case report is presented as a use case for the ontological representations. The advantages of using our ontology-based Semantic web representation and data analysis are emphasized. Conclusions We believe that representing both the structured data and the data from write-up narratives in an integrated, unified, and “machine-understandable” way can improve research for vaccine safety analyses, causality assessments, and retrospective studies.

  9. Management of adverse events in the treatment of patients with immunoglobulin therapy: A review of evidence.

    Science.gov (United States)

    Cherin, Patrick; Marie, Isabelle; Michallet, Mauricette; Pelus, Eric; Dantal, Jacques; Crave, Jean-Charles; Delain, Jean-Christophe; Viallard, Jean-François

    2016-01-01

    Immunoglobulin (IG) therapy is actually used for a broad range of diseases including primary and secondary immunodeficiency disorders, and autoimmune diseases. This therapy is available for intravenous (IV) and subcutaneous (SC) administration. The efficacy of the IG therapy has been demonstrated in numerous studies and across different diseases. Generally, IG infusions are well tolerated; however some well-known adverse reactions, ranging from mild to severe, are associated with the therapy. The most common adverse reactions including headache, nausea, myalgia, fever, chills, chest discomfort, skin and anaphylactic reactions, could arise immediately during or after the infusion. Delayed events could be more severe and include migraine headaches, aseptic meningitis, haemolysis renal impairment and thrombotic events. This paper reviews all the potential adverse events related to IG therapy and establishes a comprehensive guideline for the management of these events. Moreover it resumes the opinions and clinical experience of expert endorsers on the utilization of the treatment. Published data were classified into levels of evidence and the strength of the recommendation was given for each intervention according to the GRADE system. PMID:26384525

  10. Adverse events in families with hypertrophic or dilated cardiomyopathy and mutations in the MYBPC3 gene

    Directory of Open Access Journals (Sweden)

    Lehrke Stephanie

    2008-10-01

    Full Text Available Abstract Background Mutations in MYBPC3 encoding myosin binding protein C belong to the most frequent causes of hypertrophic cardiomyopathy (HCM and may also lead to dilated cardiomyopathy (DCM. MYBPC3 mutations initially were considered to cause a benign form of HCM. The aim of this study was to examine the clinical outcome of patients and their relatives with 18 different MYBPC3 mutations. Methods 87 patients with HCM and 71 patients with DCM were screened for MYBPC3 mutations by denaturing gradient gel electrophoresis and sequencing. Close relatives of mutation carriers were genotyped for the respective mutation. Relatives with mutation were then evaluated by echocardiography and magnetic resonance imaging. A detailed family history regarding adverse clinical events was recorded. Results In 16 HCM (18.4% and two DCM (2.8% index patients a mutation was detected. Seven mutations were novel. Mutation carriers exhibited no additional mutations in genes MYH7, TNNT2, TNNI3, ACTC and TPM1. Including relatives of twelve families, a total number of 42 mutation carriers was identified of which eleven (26.2% had at least one adverse event. Considering the twelve families and six single patients with mutations, 45 individuals with cardiomyopathy and nine with borderline phenotype were identified. Among the 45 patients, 23 (51.1% suffered from an adverse event. In eleven patients of seven families an unexplained sudden death was reported at the age between 13 and 67 years. Stroke or a transient ischemic attack occurred in six patients of five families. At least one adverse event occurred in eleven of twelve families. Conclusion MYBPC3 mutations can be associated with cardiac events such as progressive heart failure, stroke and sudden death even at younger age. Therefore, patients with MYBPC3 mutations require thorough clinical risk assessment.

  11. Physical distress is associated with cardiovascular events in a high risk population of elderly men

    Directory of Open Access Journals (Sweden)

    Klemsdal Tor O

    2009-03-01

    Full Text Available Abstract Background Self-reported health perceptions such as physical distress and quality of life are suggested independent predictors of mortality and morbidity in patients with established cardiovascular disease. This study examined the associations between these factors and three years incidence of cardiovascular events in a population of elderly men with long term hyperlipidemia. Methods We studied observational data in a cohort of 433 men aged 64–76 years from a prospective, 2 × 2 factorial designed, three-year interventional trial. Information of classical risk factors was obtained and the following questionnaires were administered at baseline: Hospital Anxiety and Depression Scale, Physical Symptom Distress Index and Life Satisfaction Index. The occurrence of cardiovascular death, myocardial infarction, cerebrovascular incidences and peripheral arterial disease were registered throughout the study period. Continuous data with skewed distribution was split into tertiles. Hazard ratios (HR were calculated from Cox regression analyses to assess the associations between physical distress, quality of life and cardiovascular events. Results After three years, 49 cardiovascular events were registered, with similar incidence among subjects with and without established cardiovascular disease. In multivariate analyses adjusted for age, smoking, systolic blood pressure, serum glucose, HADS-anxiety and treatment-intervention, physical distress was positively associated (HR 3.1, 95% CI 1.2 – 7.9 for 3rd versus 1st tertile and quality of life negatively associated (HR 2.6, 95% CI 1.1–5.8 for 3rd versus 1st tertile with cardiovascular events. The association remained statistically significant only for physical distress (hazard ratio 2.8 95% CI 1.2 – 6.8, p Conclusion Physical distress, but not quality of life, was independently associated with increased risk of cardiovascular events in an observational study of elderly men predominantly

  12. Cardiovascular disease event rates in patients with severe psoriasis treated with systemic anti-inflammatory drugs

    DEFF Research Database (Denmark)

    Ahlehoff, O; Skov, L; Gislason, G;

    2013-01-01

    OBJECTIVES: Psoriasis is a chronic inflammatory disorder associated with cardiovascular morbidity and mortality. Systemic anti-inflammatory drugs, including biological agents, are widely used in the treatment of patients with moderate to severe psoriasis and may attenuate the risk of cardiovascular...... disease events. We therefore examined the rate of cardiovascular disease events in patients with severe psoriasis treated with systemic anti-inflammatory drugs. DESIGN, SETTING AND PARTICIPANTS: Individual-level linkage of nationwide administrative databases was used to assess the event rates associated...... endpoint of cardiovascular death, myocardial infarction and stroke were 0.48 (95% CI 0.17-1.38) and 0.50 (95% CI 0.26-0.97). CONCLUSION: In this nationwide study of patients with severe psoriasis, systemic anti-inflammatory treatment with biological agents or methotrexate was associated with lower...

  13. Cardiovascular event-free survival after adjuvant radiation therapy in breast cancer patients stratified by cardiovascular risk

    International Nuclear Information System (INIS)

    The objective of this study was to estimate the risk of a cardiovascular event or death associated with modern radiation in a population of elderly female breast cancer patients with varying baseline cardiovascular risk. The data used for this analysis are from the linked Surveillance, Epidemiology, and End-Results (SEER)-Medicare database. The retrospective cohort study included women aged 66 years and older with stage 0–III breast cancer diagnosed between 2000 and 2005. Women were grouped as low, intermediate, or high cardiovascular risk based on the presence of certain clinical diagnoses. The risk for the combined outcome of a hospitalization for a cardiovascular event or death within 6 months and 24 months of diagnosis was estimated using a multivariable Cox model. The median follow-up time was 24 months. Among the 91,612 women with American Joint Committee on Cancer (AJCC) stage 0–III breast cancer: 39,555 (43.2%) were treated with radiation therapy and 52,057 (56.8%) were not. The receipt of radiation therapy in the first 6 months was associated with a statistically significant increased risk for the combined outcome in women categorized as high risk (HR = 1.510; 95% CI, 1.396–1.634) or intermediate risk (HR = 1.415; 95% CI, 1.188–1.686) but not low risk (HR = 1.027; 95% CI, 0.798–1.321). Women with a prior medical history of cardiovascular disease treated with radiation therapy are at increased risk for an event and should be monitored for at least 6 months following treatment with radiation therapy

  14. Aspirin in Cardiovascular and Cerebrovascular Events: Does Market Failure Matter?

    OpenAIRE

    Roger Lee Mendoza

    2010-01-01

    Problem statement: Against the backdrop of the 2009 scientific studies qualifying the cardiovascular and cerebrovascular benefits of aspirin, two interrelated questions are raised for investigation in this study. First, why may the government intervene in an otherwise private transaction between physician and patient and between drug manufacturer and buyer, when it involves contentious pharmacological information? Second, does government intervention make a difference in what these transactin...

  15. Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008.

    Science.gov (United States)

    Ben-Hamou, Monsif; Marshall, Nathaniel S; Grunstein, Ronald R; Saini, Bandana; Fois, Romano A

    2011-12-01

    A prominent media publicity cluster during 2007-2008 in Australia linked the common hypnotic zolpidem to adverse drug reaction reports of parasomnias, amnesia, hallucinations and suicidality. The collection of adverse drug reaction data through spontaneous reporting systems is a mainstay of drug safety monitoring, but a stimulated reporting event such as this often renders such data uninterpretable. As such, we aimed to investigate whether these associations were present before the media cluster and then to quantify the effect of stimulated reporting on those four specific outcomes. Using disproportionality analyses we compared zolpidem to all other drugs in the database, and then separately to each of all hypnotics, then all benzodiazepines, and then temazepam alone, and did so in every year from 2001 to 2008. Year-by-year analyses of Reporting odds ratios for zolpidem exposure and adverse events of interest, adjusted for a number of covariates, revealed an association between zolpidem exposure and parasomnias, amnesia and hallucination both before and after the cluster of media publicity beginning in early 2007. The odds ratios increased significantly after the media publicity for only parasomnias and amnesia. Suicidality was increased in some analyses, but limited data make this outcome difficult to interpret. We conclude that zolpidem adverse drug reaction reports have higher odds for parasomnia, amnesia, hallucination and perhaps suicidality compared to either all other drugs or hypnotics, even before the media publicity cluster. However, the extant literature and the limitations of these spontaneously reported adverse drug reaction data do not allow us to conclude that these events are related causally to zolpidem. PMID:21481053

  16. Association of Hypoglycemic Treatment Regimens With Cardiovascular Outcomes in Overweight and Obese Subjects With Type 2 Diabetes

    DEFF Research Database (Denmark)

    Ghotbi, Adam Ali; Køber, Lars; Finer, Nick;

    2013-01-01

    To assess the association of hypoglycemic treatment regimens with cardiovascular adverse events and mortality in a large population of type 2 diabetic patients at increased cardiovascular risk.......To assess the association of hypoglycemic treatment regimens with cardiovascular adverse events and mortality in a large population of type 2 diabetic patients at increased cardiovascular risk....

  17. [Analysis of the cardiac side effects of antipsychotics: Japanese Adverse Drug Event Report Database (JADER)].

    Science.gov (United States)

    Ikeno, Takashi; Okumara, Yasuyuki; Kugiyama, Kiyotaka; Ito, Hiroto

    2013-08-01

    We analyzed the cases of side effects due to antipsychotics reported to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) from Jan. 2004 to Dec. 2012. We used the Japanese Adverse Drug Event Report Database (JADER) and analyzed 136 of 216,945 cases using the defined terms. We also checked the cardiac adverse effects listed in the package inserts of the antipsychotics involved. We found cases of Ikr blockade resulting in sudden death (49 cases), electrocardiogram QT prolonged (29 cases), torsade de pointes (TdP, 19 cases), ventricular fibrillation (VF, 10 cases). M2 receptor blockade was observed in tachycardia (8 cases) and sinus tachycardia (3 cases). Calmodulin blockade was involved in reported cardiomyopathy (3 cases) and myocarditis (1 case). Multiple adverse events were reported simultaneously in 14 cases. Our search of package inserts revealed warnings regarding electrocardiogram QT prolongation (24 drugs), tachycardia (23), sudden death (18), TdP (14), VF (3), myocarditis (1) and cardiomyopathy (1). We suggest that when an antipsychotic is prescribed, the patient should be monitored regularly with ECG, blood tests, and/or biochemical tests to avoid adverse cardiac effects. PMID:25069255

  18. Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

    Energy Technology Data Exchange (ETDEWEB)

    Showalter, Timothy N., E-mail: tns3b@virginia.edu [Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia (United States); Hegarty, Sarah E. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Rabinowitz, Carol [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Maio, Vittorio [Jefferson School of Population Health, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Hyslop, Terry [Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, North Carolina (United States); Dicker, Adam P. [Department of Radiation Oncology, Kimmel Cancer Center & Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Louis, Daniel Z. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States)

    2015-03-15

    Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

  19. Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

    International Nuclear Information System (INIS)

    Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

  20. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan;

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at...... home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans....

  1. Impact of Adverse Events Following Immunization in Viet Nam in 2013 on chronic hepatitis B infection.

    Science.gov (United States)

    Li, Xi; Wiesen, Eric; Diorditsa, Sergey; Toda, Kohei; Duong, Thi Hong; Nguyen, Lien Huong; Nguyen, Van Cuong; Nguyen, Tran Hien

    2016-02-01

    Adverse Events Following Immunization in Viet Nam in 2013 led to substantial reductions in hepatitis B vaccination coverage (both the birth dose and the three-dose series). In order to estimate the impact of the reduction in vaccination coverage on hepatitis B transmission and future mortality, a widely-used mathematical model was applied to the data from Viet Nam. Using the model, we estimated the number of chronic infections and deaths that are expected to occur in the birth cohort in 2013 and the number of excessive infections and deaths attributable to the drop in immunization coverage in 2013. An excess of 90,137 chronic infections and 17,456 future deaths were estimated to occur in the 2013 birth cohort due to the drop in vaccination coverage. This analysis highlights the importance of maintaining high vaccination coverage and swiftly responding to reported Adverse Events Following Immunization in order to regain consumer confidence in the hepatitis B vaccine. PMID:26055296

  2. Adverse Events of Trivalent Influenza Vaccine among Health Care Workers in Iran

    Directory of Open Access Journals (Sweden)

    M Hajiabdolbaghi

    2009-06-01

    Full Text Available "nBackground: To assess the frequency and type of adverse events after influenza vaccination in Iranian adults."nMethods: Health care workers in 7 medical centers received the influenza vaccine from October 2006 to February 2007 and fol­lowed by phone regarding symptoms experienced after vaccination."nResults: Of 897 adults who participated in the study, local and systemic reactions were reported by 187 (20.8% and 198 (22.1% persons, respectively. The most common local reaction was pain (20.2%, while myalgia (15.8% was the most com­mon systemic reaction. One case of Guillain-barre syndrome was reported."nConclusion: Inactivated influenza vaccine administration did not result in potential adverse events in healthy adults.

  3. Hemorheological and Glycemic Parameters and HDL Cholesterol for the Prediction of Cardiovascular Events

    Directory of Open Access Journals (Sweden)

    Sung Woo Cho

    2016-01-01

    Full Text Available Abstract Background: Hemorheological and glycemic parameters and high density lipoprotein (HDL cholesterol are used as biomarkers of atherosclerosis and thrombosis. Objective: To investigate the association and clinical relevance of erythrocyte sedimentation rate (ESR, fibrinogen, fasting glucose, glycated hemoglobin (HbA1c, and HDL cholesterol in the prediction of major adverse cardiovascular events (MACE and coronary heart disease (CHD in an outpatient population. Methods: 708 stable patients who visited the outpatient department were enrolled and followed for a mean period of 28.5 months. Patients were divided into two groups, patients without MACE and patients with MACE, which included cardiac death, acute myocardial infarction, newly diagnosed CHD, and cerebral vascular accident. We compared hemorheological and glycemic parameters and lipid profiles between the groups. Results: Patients with MACE had significantly higher ESR, fibrinogen, fasting glucose, and HbA1c, while lower HDL cholesterol compared with patients without MACE. High ESR and fibrinogen and low HDL cholesterol significantly increased the risk of MACE in multivariate regression analysis. In patients with MACE, high fibrinogen and HbA1c levels increased the risk of multivessel CHD. Furthermore, ESR and fibrinogen were significantly positively correlated with HbA1c and negatively correlated with HDL cholesterol, however not correlated with fasting glucose. Conclusion: Hemorheological abnormalities, poor glycemic control, and low HDL cholesterol are correlated with each other and could serve as simple and useful surrogate markers and predictors for MACE and CHD in outpatients.

  4. Use of internet search logs to evaluate potential drug adverse events.

    Science.gov (United States)

    Sarntivijai, S; Abernethy, D R

    2014-08-01

    Internet search logs provide an abundant source of data that can be explored for purposes such as identifying drug exposure-adverse event relationships. The methodology to rigorously conduct such evaluations is not well characterized, and the utility of such analyses is not well defined. In this issue, White and colleagues propose an approach using Internet search logs for this purpose and compare it to parallel analyses conducted using the US Food and Drug Administration's spontaneous reporting database. PMID:25056395

  5. Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

    OpenAIRE

    Raschi, Emanuel; Poluzzi, Elisabetta; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Bennie, Marion; Barbui, Corrado; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2013-01-01

    Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abno...

  6. The assessment of adverse events of radioactive iodine therapy in patients with Graves disease

    International Nuclear Information System (INIS)

    Full text: Aim: The aim of the study is to assess the adverse events of RAI in patients with Graves disease. Study design: have analyzed the data of 42 patients (33 women, 9 men, median age 46,6 years) with Graves disease without thyroid ophthalmopathy, who were treated with RAI to control thyrotoxicosis. Radioiodine dose was determent individually and was taken into consideration of goiter volume and turnover of 1321I. Patients received one dose of 131I - median 10,2 (from 2,0 to 34,1 m #N-tilde# i). We asked the patients to fill questionnaire of sings and symptoms about their complaints after treatment. Results: The most frequent adverse events after radioiodine treatment were: fallout hair - in 31%, headache - in 28,5%, muscle pain - in 24,0%, edema of upper and lower eyelids - in 20,0%, pain in joints - in 19,0%, pain in thyroid gland - in 14,0%. Other adverse events were determent rarer: pain in eyeballs - 12,0%, sensation of the pressure in eyeballs - in 12,0%, tension in the field of thyroid gland - in 9,5%, muscle compactions - in 9,5%, diplopia - in 7,1%, deterioration of concomitant chronic diseases - in 7,1%, pain in hypochondrium- in 7,1%, heartburn - in 7,1%, weakness in legs- in 4,8%, dryness skin cover -in 2,4%, sleeplessness - in 2,4%. All adverse events were not serious, were nor demand of administration of special treatment and ended in 5 days after using of radioactive iodine. Conclusion: Radioactive iodine treatment does not entail of significant deterioration of condition of the patients. (author)

  7. Adverse Events Associated with Yoga: A Systematic Review of Published Case Reports and Case Series

    OpenAIRE

    Cramer, Holger; Krucoff, Carol; Dobos, Gustav

    2013-01-01

    While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopeni...

  8. Novel Data Mining Methodologies for Adverse Drug Event Discovery and Analysis

    OpenAIRE

    Harpaz, Rave; DuMouchel, William; Shah, Nigam H; Madigan, David; Ryan, Patrick; Friedman, Carol

    2012-01-01

    Discovery of new adverse drug events (ADEs) in the post-approval period is an important goal of the health system. Data mining methods that can transform data into meaningful knowledge to inform patient safety have proven to be essential. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used in support of ADE discovery and analysis.

  9. Expert Consensus on the Management of Adverse Events from EGFR Tyrosine Kinase Inhibitors in the UK

    OpenAIRE

    Califano, R; Tariq, N.; Compton, S.; Fitzgerald, D A; Harwood, C.A.; R. Lal; Lester, J.; McPhelim, J.; MULATERO, C; Subramanian, S.; Thomas, A; Thatcher, N.; Nicolson, M.

    2015-01-01

    Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) such as gefitinib, erlotinib, and afatinib are standard-of-care for first-line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC). These drugs have a proven benefit in terms of higher response rate, delaying progression and improvement of quality of life over palliative platinum-based chemotherapy. The most common adverse events (AEs) are gastrointestinal (GI) (diarrhoea and stomatitis/mucositis) and c...

  10. Epidermal Growth Factor Receptor Inhibitors: A Review of Cutaneous Adverse Events and Management

    OpenAIRE

    Chanprapaph, K.; Vachiramon, V.; Rattanakaemakorn, P.

    2014-01-01

    Epidermal growth factor inhibitors (EGFRI), the first targeted cancer therapy, are currently an essential treatment for many advance-stage epithelial cancers. These agents have the superior ability to target cancers cells and better safety profile compared to conventional chemotherapies. However, cutaneous adverse events are common due to the interference of epidermal growth factor receptor (EGFR) signaling in the skin. Cutaneous toxicities lead to poor compliance, drug cessation, and psychos...

  11. Adverse Events of Extracorporeal Ultrasound-Guided High Intensity Focused Ultrasound Therapy

    OpenAIRE

    Tinghe Yu; Jun Luo

    2011-01-01

    BACKGROUND: High-intensity focused ultrasound (HIFU) is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU) has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy. METHODS AND FINDINGS: ...

  12. Text Mining for Adverse Drug Events: the Promise, Challenges, and State of the Art

    OpenAIRE

    Harpaz, Rave; Callahan, Alison; Tamang, Suzanne; Low, Yen; Odgers, David; Finlayson, Sam; Jung, Kenneth; LePendu, Paea; Shah, Nigam H.

    2014-01-01

    Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. Text mining is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources—such as biomedical literature, clinical narrat...

  13. Mixed-effects Poisson regression analysis of adverse event reports: The relationship between antidepressants and suicide

    OpenAIRE

    Gibbons, Robert D.; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K.; Bhaumik, Dulal K.; Brown, C Hendricks; Kapur, Kush; Marcus, Sue M.; Hur, Kwan; Mann, J. John

    2008-01-01

    A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Adminis...

  14. Study of the pattern of adverse events following immunization of children in a tertiary care hospital

    OpenAIRE

    Rekha Y. Aherkar; Pradeep K. Deshpande; Ghongane, Balasaheb B.

    2016-01-01

    Background: Success of an immunization programme depends upon awareness regarding usefulness and safety of vaccines. Widespread information on vaccine safety is very essential. Objective of study was to analyze pattern of Adverse Events Following Immunization (AEFI) in children. Methods: Prospective, observational study was carried out at immunization OPD of B. J. Government Medical College and Sassoon General hospital, Pune, where children receiving routine immunization were analyzed and...

  15. The influence of adverse events on the quality of nursing care and patients’ safety

    OpenAIRE

    Maria Mika; Grażyna Nowak-Starz; Ireneusz Kotela

    2015-01-01

    Introduction : High quality of medical services is essential to proper healthcare functioning and to achieve aims. High quality of nursing care should have the same characteristics as the whole healthcare system. Although current healthcare systems focus on best quality medical services, the number of adverse events is increasing. It sometimes happens that a patient suffers injuries not due to his/her illness, but because of poorly organised healthcare. Aim of the research : To assess t...

  16. Portuguese hospitals’ main challenges in implementing Big Data projects for early detection of adverse events

    OpenAIRE

    Aguiar, Ana Oliveira Bianchi de

    2015-01-01

    Big Data has been creating much excitement and promises to solve many of the current health systems’ challenges. A specific application allows predicting adverse events, such as nosocomial infections, 24-48 hours earlier than traditional methods, by analysing in real-time physiological data allied with clinical information, and by extracting knowledge from this stored data. However, the implementation of this kind of projects is not without challenges. Hence, the objective of t...

  17. Evaluating predictive pharmacogenetic signatures of adverse events in colorectal cancer patients treated with fluoropyrimidines.

    Directory of Open Access Journals (Sweden)

    Barbara A Jennings

    Full Text Available The potential clinical utility of genetic markers associated with response to fluoropyrimidine treatment in colorectal cancer patients remains controversial despite extensive study. Our aim was to test the clinical validity of both novel and previously identified markers of adverse events in a broad clinical setting. We have conducted an observational pharmacogenetic study of early adverse events in a cohort study of 254 colorectal cancer patients treated with 5-fluorouracil or capecitabine. Sixteen variants of nine key folate (pharmacodynamic and drug metabolising (pharmacokinetic enzymes have been analysed as individual markers and/or signatures of markers. We found a significant association between TYMP S471L (rs11479 and early dose modifications and/or severe adverse events (adjusted OR = 2.02 [1.03; 4.00], p = 0.042, adjusted OR = 2.70 [1.23; 5.92], p = 0.01 respectively. There was also a significant association between these phenotypes and a signature of DPYD mutations (Adjusted OR = 3.96 [1.17; 13.33], p = 0.03, adjusted OR = 6.76 [1.99; 22.96], p = 0.002 respectively. We did not identify any significant associations between the individual candidate pharmacodynamic markers and toxicity. If a predictive test for early adverse events analysed the TYMP and DPYD variants as a signature, the sensitivity would be 45.5 %, with a positive predictive value of just 33.9 % and thus poor clinical validity. Most studies to date have been under-powered to consider multiple pharmacokinetic and pharmacodynamic variants simultaneously but this and similar individualised data sets could be pooled in meta-analyses to resolve uncertainties about the potential clinical utility of these markers.

  18. Adverse events and technical complaints related to central venous catheters marketed in Brazil

    Directory of Open Access Journals (Sweden)

    Luciene de Oliveira Morais

    2013-06-01

    Full Text Available Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i determine the number of adverse events and technical complaints, (ii verify compliance with the classification criteria defined by the legislation, (iii reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv verify registered companies in Brazil, (v quantify the notifications according to the registered company and product lot, and (vi identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.

  19. Personal Bankruptcy: Reconciling Adverse Events and Strategic Timing Hypotheses Using Heterogeneity in Filing Types

    OpenAIRE

    Li Gan; Tarun Sabarwal; Shuoxun Zhang

    2010-01-01

    The strategic timing and adverse events hypotheses of personal bankruptcy have received particular attention. Existing research focuses on proving or disproving either hypothesis, using a strict interpretation of the role of financial benefit in the filing decision. Using a more realistic framework in which financial benefit may affect the filing decision in both hypotheses, we show that endogeneity of financial benefit is a distinguishing factor between the two hypotheses. Using two differen...

  20. Financial capability, money attitudes and socioeconomic status: risks for experiencing adverse financial events

    OpenAIRE

    von Stumm, Sophie; Fenton-O'Creevy, Mark; Furnham, Adrian

    2013-01-01

    The risk of experiencing adverse financial events (e.g. bankruptcy) depends on the world economy and on individual differences in financial and psychological variables. Analysing data from 109,472 British survey respondents, this study reports the risks associated with financial capabilities, money attitudes, and socio-economic status for suffering negative financial outcomes. The results show that (1) socio-economic status is associated with financial capabilities but not with money attitude...

  1. Under-reporting of maternal and perinatal adverse events in New Zealand

    OpenAIRE

    Farquhar, Cynthia; Armstrong, Sarah; Kim, Boa; Masson, Vicki; Sadler, Lynn

    2015-01-01

    Objectives To determine the proportion of maternal and perinatal mortality and morbidity cases, identified by the Perinatal and Maternal Mortality Review Committee (PMMRC), that are also reported within the annual serious adverse events (SAEs) reports published by the Health Quality and Safety Commission (HQSC). Setting Nationally collated data from the PMMRC and HQSC, New Zealand. Participants Analysis of maternal and perinatal mortality and morbidity data 2009–2012. Interventions Every SAE ...

  2. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

    Science.gov (United States)

    Alicino, Cristiano; Merlano, Caterina; Zappettini, Simona; Schiaffino, Sergio; Della Luna, Giovanni; Accardo, Cristina; Gasparini, Roberto; Durando, Paolo; Icardi, Giancarlo

    2015-01-01

    Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate. PMID:25483520

  3. Comments concerning the real risk of sexual adverse events secondary to the use of 5-ARIs

    Directory of Open Access Journals (Sweden)

    Furio Pirozzi Farina

    2016-01-01

    Full Text Available Treatment-induced sexual dysfunctions (SD are a recurrent and controversial topic in recent literature on the adverse events related to the use of 5-alpha-reductase inhibitors (5ARIs (1, 2. In order to deal adequately with the various aspects of this topic, it is necessary to first cover some of the steps that allow a better definition and understanding of the subject.

  4. Adverse Events of Massage Therapy in Pain-Related Conditions: A Systematic Review

    OpenAIRE

    Ping Yin; Ningyang Gao; Junyi Wu; Gerhard Litscher; Shifen Xu

    2014-01-01

    Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author...

  5. Programmable Infusion Pumps in ICUs: An Analysis of Corresponding Adverse Drug Events

    OpenAIRE

    Nuckols, Teryl K; Bower, Anthony G.; Paddock, Susan M.; Hilborne, Lee H.; Wallace, Peggy; Rothschild, Jeffrey M; Griffin, Anne; Fairbanks, Rollin J; Carlson, Beverly; Panzer, Robert J.; Brook, Robert H.

    2007-01-01

    Background Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. Objectives To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software (“smart pump”) and to suggest potential improvements in smart-pump design. Design Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 ...

  6. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in...... marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  7. An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

    Directory of Open Access Journals (Sweden)

    Szkultecka-Debek Monika

    2014-06-01

    Full Text Available The project was performed within the Polish Society for Pharmacoeconomics (PTFE. The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

  8. Opioid Therapy Pharmacogenomics for Noncancer Pain: Efficacy, Adverse Events, and Costs

    Directory of Open Access Journals (Sweden)

    Yan Xu

    2013-01-01

    Full Text Available Chronic non-cancer pain is a debilitating condition associated with high individual and societal costs. While opioid treatment for pain has been available for centuries, it is associated with high variability in outcome, and a considerable proportion of patients is unable to attain relief from symptoms while suffering adverse events and developing medication dependence. We performed a review of the efficacy of pharmacogenomic markers and their abilities to predict adverse events, dependence, and associated economic costs, focusing on two genes: OPRM1 and CYP2D6. Data sources were articles indexed by PubMed on or before August 6, 2013. Articles were first selected after review of their titles and abstracts, and full papers were read to confirm eligibility. Initially, fifty-two articles were identified. Of these, 17 were relevant to biological actions of pharmacogenomic markers and their effect on therapeutic efficacy, 16 to adverse events, 15 to opioid dependence, and eight to economic costs. In conclusion, increasing costs of opioid therapy have made the advances in pharmacogenomics an attractive solution to personalize care with unclear repercussions related to the impact on costs, morbidity, and outcomes. This intersection of pharmacoeconomics and pharmacogenomics presents a unique platform to further examine current advances in clinical medicine and their utility in cost-effective treatment of chronic pain.

  9. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    Science.gov (United States)

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. PMID:26291578

  10. In vivo biosafety model to assess the risk of adverse events from retroviral and lentiviral vectors.

    Science.gov (United States)

    Bauer, Gerhard; Dao, Mo A; Case, Scott S; Meyerrose, Todd; Wirthlin, Louisa; Zhou, Ping; Wang, Xiuli; Herrbrich, Phillip; Arevalo, Jesusa; Csik, Susie; Skelton, Dianne C; Walker, Jon; Pepper, Karen; Kohn, Donald B; Nolta, Jan A

    2008-07-01

    Serious adverse events in some human gene therapy clinical trials have raised safety concerns when retroviral or lentiviral vectors are used for gene transfer. We evaluated the potential for generating replication-competent retrovirus (RCR) and assessed the risk of occurrence of adverse events in an in vivo system. Human hematopoietic stem and progenitor cells (HSCs) and mesenchymal stem cells (MSCs) transduced with two different Moloney murine leukemia virus (MoMuLV)-based vectors were cotransplanted into a total of 481 immune-deficient mice (that are unable to reject cells that become transformed), and the animals were monitored for 18 months. Animals with any signs of illness were immediately killed, autopsied, and subjected to a range of biosafety studies. There was no detectable evidence of insertional mutagenesis leading to human leukemias or solid tumors in the 18 months during which the animals were studied. In 117 serum samples analyzed by vector rescue assay there was no detectable RCR. An additional 149 mice received HSCs transduced with lentiviral vectors, and were followed for 2-6 months. No vector-associated adverse events were observed, and none of the mice had detectable human immunodeficiency virus (HIV) p24 antigen in their sera. Our in vivo system, therefore, helps to provide an assessment of the risks involved when retroviral or lentiviral vectors are considered for use in clinical gene therapy applications. PMID:18461052

  11. Self-immolation and its adverse life-events risk factors: results from an Iranian population

    Directory of Open Access Journals (Sweden)

    Alireza Ahmadi

    2015-01-01

    Full Text Available Abstract: Background: Despite considerable loss of life by deliberate self-burning in low and middle-income countries, few scholars have examined psychiatric factors such as adverse life events that may be related to self-immolation. Methods: This case-control study investigated adverse life-events as risk factors for self-immolation patients admitted to a burn center serving the western region of Iran. Variables inves-tigated included the following adverse life-events: unplanned pregnancy, infertility, homelessness, financial hardship, problems with friends, intimate relationship break-up , school or university failure, anxiety about school/university performance, problems at work, personal history of suicide attempts, family history of suicide attempts, individual history of mental disorders, and malignant disease. Results: Financial hardship (OR=3.35, 95% CI=1.19-9.90, intimate relationship break-up (OR=5.45, 95% CI=1.20-11.99, and personal history of suicide attempts (OR=7.00, 95% CI=1.38-35.48 were associated with increased risk of self-immolation. Conclusions: This study suggests that financial hardship, intimate relationship break-ups, and personal history of suicide attempts are risk factors for self-immolation. Other variables studied did not play a role as individually protective or risk factors for self-immolation. Further study is needed to substantiate findings of this study and direct research toward tailoring culturally sensitive, empirically-supported interventions for prevention of self-immolation.

  12. Hair and nail adverse events during treatment with targeted therapies for metastatic melanoma.

    Science.gov (United States)

    Dika, Emi; Patrizi, Annalisa; Ribero, Simone; Fanti, Pier Alessandro; Starace, Michela; Melotti, Barbara; Sperandi, Francesca; Piraccini, Bianca Maria

    2016-06-01

    Targeted therapies for melanoma have shown clinical benefit in increasing the survival of metastatic patients. Cutaneous adverse events have been reported, but hair and nail data have been rarely detailed. Patients treated with BRAF and MEK inhibitors for metastatic melanoma underwent dermatological evaluation before the start of each treatment and after every four weeks. Pull test, global photography, dermoscopy/trichoscopy and scalp biopsy were performed. Appendages adverse events were graded using the National Cancer Institute's Common Terminology Criteria. Of the 24 patients included, 14 underwent treatment with a selective BRAF inhibitor; 10 received a combined treatment (dabrafenib/trametinib). Adnexal adverse events were common in the group of patients receiving vemurafenib, and included hair kinking, acute hair loss, and hair colour changes, often present in association, classified as G2 in three patients and G1 in eight. Dabrafenib alone induced hair kinking and colour changes in 60% of the patients. Combined treatment with dabrafenib/trametinib did not induce hair changes. Onycholysis was the most common nail side effect, and the unique side effect of dabrafenib (alone or in combination). Vemurafenib also induced acute paronychia and brittle nails. All nail side effects were graded as G1. Hair and nail side effects during targeted therapy for melanoma are not rare. The early recognition and cure of such side effects by dermatologists is of benefit to ensure the need for dose reduction or drug discontinuation. PMID:27019511

  13. Should we continue using amphotericin B deoxycholate for the treatment of fungal infections? Adverse events and clinical outcomes.

    Science.gov (United States)

    Garbino, Jorge; Markham, Lydia; Matulionyte, Raimonda; Rives, Vincent; Lew, Daniel

    2006-01-01

    Amphotericin B deoxycholate (AmBd) has been a standard therapy for IFI but is associated with high adverse event and mortality rates. A retrospective review was undertaken to describe adverse events and clinical outcomes in adult patients with IFI treated with only AmBd as initial therapy. PMID:16449001

  14. High cardiovascular event rates in patients with asymptomatic carotid stenosis: the REACH Registry

    DEFF Research Database (Denmark)

    Aichner, F T; Topakian, R; Alberts, M J;

    2009-01-01

    BACKGROUND AND PURPOSE: Data on current cardiovascular event rates in patients with asymptomatic carotid artery stenosis (ACAS) are sparse. We compared the 1-year outcomes of patients with ACAS > or =70% versus patients without ACAS in an international, prospective cohort of outpatients.......26%, P = 0.04), cardiovascular death (2.29% vs. 1.52%, P = 0.002), the composite end-point cardiovascular death/myocardial infarction/stroke (6.03% vs. 4.29%, P events (1.41% vs. 0.81%, P = 0.002). In patients with ACAS, Cox regression analyses identified history of cerebrovascular...... ischaemic events as most important predictor of future stroke (HR 3.21, 95% CI 1.82-5.65, P events. Stroke was powerfully predicted by prior cerebrovascular...

  15. Correlation of chronic kidney disease, diabetes and peripheral artery disease with cardiovascular events in patients using stress myocardial perfusion imaging

    International Nuclear Information System (INIS)

    Normal stress myocardial perfusion imaging (MPI) studies generally suggest an excellent prognosis for cardiovascular events. Chronic kidney disease (CKD), diabetes and peripheral artery disease (PAD) have been established as the risk factors for cardiovascular events. However, whether these risk factors significantly predict cardiovascular events in patients with normal stress MPI is unclear. The purpose of this study was to evaluate the prognostic value of these risk factors in patients with normal stress MPI. Patients with normal stress MPI (n=372, male=215 and female=157, age=69 years, CKD without hemodialysis=95, diabetes=99, PAD=19, previous coronary artery disease=116) were followed up for 14 months. Normal stress MPI was defined as a summed stress score of 2 and/or persistent proteinuria. Cardiovascular events included cardiac death, non-fatal myocardial infarction and congestive heart failure requiring hospitalization. Cardiovascular events occurred in 20 of 372 patients (5.4%). In univariate Cox regression analysis, PAD, diabetes, diabetic retinopathy, insulin use, anemia, hypoalbuminemia, CKD, left ventricular ejection fraction and pharmacological stress tests were significant predictors of cardiovascular events. In multivariate Cox regression analysis, PAD, diabetes and CKD were independent and significant predictors for cardiovascular events, and their number was the strongest predictor for cardiovascular events (hazard ratio=21.7, P<0.001). PAD, diabetes and CKD are coexisting, independent and significant risk factors for cardiovascular events, CKD being the strongest predictor. The number of coexisting risk factors is important in predicting cardiovascular events in patients with normal stress MPI. (author)

  16. Adverse Renal, Endocrine, Hepatic, and Metabolic Events during Maintenance Mood Stabilizer Treatment for Bipolar Disorder: A Population-Based Cohort Study

    Science.gov (United States)

    Marston, Louise; Walters, Kate; Geddes, John R.; King, Michael; Osborn, David P. J.

    2016-01-01

    Background There is limited, poorly characterized information about adverse events occurring during maintenance treatment of bipolar disorder. We aimed to determine adverse event rates during treatment with lithium, valproate, olanzapine, and quetiapine. Methods and Findings We conducted a propensity score adjusted cohort study using nationally representative United Kingdom electronic health records from January 1, 1995, until December 31, 2013. We included patients who had a diagnosis of bipolar disorder and were prescribed lithium (n = 2148), valproate (n = 1670), olanzapine (n = 1477), or quetiapine (n = 1376) as maintenance mood stabilizer treatment. Adverse outcomes were chronic kidney disease, thyroid disease, hypercalcemia, weight gain, hypertension, type 2 diabetes mellitus, cardiovascular disease, and hepatotoxicity. The propensity score included important demographic, physical health, and mental health predictors of drug treatment allocation. The median duration of drug treatment was 1.48 y (interquartile range 0.64–3.43). Compared to patients prescribed lithium, those taking valproate, olanzapine, and quetiapine had reduced rates of chronic kidney disease stage 3 or more severe, following adjustment for propensity score, age, and calendar year, and accounting for clustering by primary care practice (valproate hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.45–0.69; p diabetes mellitus, cardiovascular disease, or hepatotoxicity. Despite estimates being robust following sensitivity analyses, limitations include the potential for residual confounding and ascertainment bias and an inability to examine dosage effects. Conclusions Lithium use is associated with more renal and endocrine adverse events but less weight gain than commonly used alternative mood stabilizers. Risks need to be offset with the effectiveness and anti-suicidal benefits of lithium and the potential metabolic side effects of alternative treatment options. PMID:27483368

  17. Cardiovascular events in patients with atherothrombotic disease: a population-based longitudinal study in Taiwan.

    Directory of Open Access Journals (Sweden)

    Wen-Hsien Lee

    Full Text Available BACKGROUND: Atherothrombotic diseases including cerebrovascular disease (CVD, coronary artery disease (CAD, and peripheral arterial disease (PAD, contribute to the major causes of death in the world. Although several studies showed the association between polyvascular disease and poor cardiovascular (CV outcomes in Asian population, there was no large-scale study to validate this relationship in this population. METHODS AND RESULTS: This retrospective cohort study included patients with a diagnosis of CVD, CAD, or PAD from the database contained in the Taiwan National Health Insurance Bureau during 2001-2004. A total of 19954 patients were enrolled in this study. The atherothrombotic disease score was defined according to the number of atherothrombotic disease. The study endpoints included acute coronary syndrome (ACS, all strokes, vascular procedures, in hospital mortality, and so on. The event rate of ischemic stroke (18.2% was higher than that of acute myocardial infarction (5.7% in our patients (P = 0.0006. In the multivariate Cox regression analyses, the adjusted hazard ratios (HRs of each increment of atherothrombotic disease score in predicting ACS, all strokes, vascular procedures, and in hospital mortality were 1.41, 1.66, 1.30, and 1.14, respectively (P≦0.0169. CONCLUSIONS: This large population-based longitudinal study in patients with atherothrombotic disease demonstrated the risk of subsequent ischemic stroke was higher than that of subsequent AMI. In addition, the subsequent adverse CV events including ACS, all stroke, vascular procedures, and in hospital mortality were progressively increased as the increase of atherothrombotic disease score.

  18. Reduction of cardiovascular event rate: different effects of cardiac rehabilitation in CABG and PCI patients

    OpenAIRE

    Hansen, D.; DENDALE, PAUL; Leenders, M; Berger, J.; Raskin, A.; Vaes, J.; Meeusen, R.

    2009-01-01

    Objective - In coronary artery disease, the implementation of a cardiac rehabilitation (CR) programme favourably affects cardiovascular prognosis. However, it remains uncertain whether patients benefit to a similar extent from CR after coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI). In this study, we have assessed whether CR is equally effective for suppressing the two-year cardiovascular event incidence after CABG or PCI. Methods and results - 194 PCI...

  19. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  20. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches

    Directory of Open Access Journals (Sweden)

    Funt D

    2013-12-01

    Full Text Available David Funt,1 Tatjana Pavicic21Mount Sinai Hospital, Department of Plastic Surgery, New York, NY, USA; 2Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Munich, GermanyBackground: The ever-expanding range of dermal filler products for aesthetic soft tissue augmentation is of benefit for patients and physicians, but as indications and the number of procedures performed increase, the number of complications will likely also increase.Objective: To describe potential adverse events associated with dermal fillers and to provide structured and clear guidance on their treatment and avoidance.Methods: Reports of dermal filler complications in the medical literature were reviewed and, based on the publications retrieved and the authors' extensive experience, recommendations for avoiding and managing complications are provided.Results: Different dermal fillers have widely varying properties, associated risks, and injection requirements. All dermal fillers have the potential to cause complications. Most are related to volume and technique, though some are associated with the material itself. The majority of adverse reactions are mild and transient, such as bruising and trauma-related edema. Serious adverse events are rare, and most are avoidable with proper planning and technique.Conclusion: For optimum outcomes, aesthetic physicians should have a detailed understanding of facial anatomy; the individual characteristics of available fillers; their indications, contraindications, benefits, and drawbacks; and ways to prevent and avoid potential complications.Keywords: aesthetic medicine, complications

  1. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary......OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in...... marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  2. Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

    Science.gov (United States)

    Alemzadeh, Homa; Raman, Jaishankar; Leveson, Nancy; Kalbarczyk, Zbigniew; Iyer, Ravishankar K.

    2016-01-01

    Background Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operational practices to avoid incidents in the future. Methods By developing an automated natural language processing tool, we performed a comprehensive analysis of the adverse events reported to the publicly available MAUDE database (maintained by the U.S. Food and Drug Administration) from 2000 to 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the potential causes for catastrophic events such as patient injuries and deaths. Results During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant (mean = 83.4, 95% confidence interval (CI), 74.2–92.7 per 100,000 procedures) over the years. Surgical specialties for which robots are extensively used, such as gynecology and urology, had lower numbers of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9 per 100,000 procedures, Risk Ratio = 2.2, 95% CI, 1.9–2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to

  3. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

    Science.gov (United States)

    Holman, Rury R; Bethel, Mary Angelyn; George, Jyothis; Sourij, Harald; Doran, Zoë; Keenan, Joanne; Khurmi, Nardev S; Mentz, Robert J; Oulhaj, Abderrahim; Buse, John B; Chan, Juliana C; Iqbal, Nayyar; Kundu, Sudeep; Maggioni, Aldo P; Marso, Steven P; Öhman, Peter; Pencina, Michael J; Poulter, Neil; Porter, Lisa E; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F

    2016-04-01

    Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338. PMID:26995376

  4. Solutions to Reduce Cardiovascular Events in Patients with Atrial Fibrillation

    OpenAIRE

    Maurizio Paciaroni; Giancarlo Agnelli

    2012-01-01

    AF is the most common sustained cardiac rhythm disorder and an established risk factor for ischemic stroke. Ischemic strokes which occur in patients with AF are particularly severe and disabling. In addition, stroke recurrence is more common in patients with AF compared with those without it. Previous cerebrovascular events, age, hypertension, diabetes, and heart failure are risk factors for stroke in patients with AF.

  5. Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board

    Science.gov (United States)

    Dorr, David A.; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

    2009-01-01

    Purpose Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients. PMID:19458059

  6. Prevalence, nature and potential preventability of adverse drug events – a population-based medical record study of 4970 adults

    Science.gov (United States)

    Hakkarainen, Katja M; Gyllensten, Hanna; Jönsson, Anna K; Andersson Sundell, Karolina; Petzold, Max; Hägg, Staffan

    2014-01-01

    Aims To estimate the 3 month prevalence of adverse drug events (ADEs), categories of ADEs and preventable ADEs, and the preventability of ADEs among adults in Sweden. Further, to identify drug classes and organ systems associated with ADEs and estimate their seriousness. Methods A random sample of 5025 adults in a Swedish county council in 2008 was drawn from the Total Population Register. All their medical records in 29 inpatient care departments in three hospitals, 110 specialized outpatient clinics and 51 primary care units were reviewed retrospectively in a stepwise manner, and complemented with register data on dispensed drugs. ADEs, including adverse drug reactions (ADRs), sub-therapeutic effects of drug therapy (STEs), drug dependence and abuse, drug intoxications from overdose, and morbidities due to drug-related untreated indication, were detected during a 3 month study period, and assessed for preventability. Results Among 4970 included individuals, the prevalence of ADEs was 12.0% (95% confidence interval (CI) 11.1, 12.9%), and preventable ADEs 5.6% (95% CI 5.0, 6.2%). ADRs (6.9%; 95% CI 6.2, 7.6%) and STEs (6.4%; 95% CI 5.8, 7.1%) were more prevalent than the other ADEs. Of the ADEs, 38.8% (95% CI 35.8–41.9%) was preventable, varying by ADE category and seriousness. ADEs were frequently associated with nervous system and cardiovascular drugs, but the associated drugs and affected organs varied by ADE category. Conclusions The considerable burden of ADEs and preventable ADEs from commonly used drugs across care settings warrants large-scale efforts to redesign safer, higher quality healthcare systems. The heterogeneous nature of the ADE categories should be considered in research and clinical practice for preventing, detecting and mitigating ADEs. PMID:24372506

  7. Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts.

    LENUS (Irish Health Repository)

    Zanoni, Giovanna

    2009-05-26

    A survey conducted among 26 European Countries within the Vaccine European New Integrated Collaboration Effort (VENICE) project assessed the status of organization in prevention and management of adverse events following immunization (AEFI) and level of interconnection, with the aim at individuating points of strength and weakness. The emerging picture is for a strong political commitment to control AEFIs in Member States (MS), but with consistent heterogeneity in procedures, regulations and capacity of systems to collect, analyze and use data, although with great potentialities. Suggestions are posed by authors to promote actions for unifying strategies and policies among MS.

  8. Suspected Yellow Fever Vaccine-Associated Viscerotropic Adverse Events (1973 and 1978), United States

    OpenAIRE

    Monath, Thomas P

    2010-01-01

    Two cases of yellow fever vaccine-associated viscerotropic adverse events (YEL-AVD) were identified by review of correspondence received at the Centers for Disease Control and Prevention (CDC; Ft. Collins, CO). The cases occurred in Indiana and Maryland in 1973 and 1978, respectively. One patient, a 75-year-old man with multi-organ failure died, and the other, a 31-year-old woman, was hospitalized for 14 days. Onset was 3–6 days after vaccination. The illness was characterized by fever, heada...

  9. Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text

    DEFF Research Database (Denmark)

    Eriksson, Robert; Jensen, Peter Bjødstrup; Pletscher-Frankild, Sune;

    2013-01-01

    adverse drug events (ADEs).Materials and methods Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured...... clinical narrative text. We use a named entity recognition (NER) tagger to identify dictionary matches in the text and post-coordination rules to construct ADE compound terms. Finally, we apply post-processing rules and filters to handle, for example, negations and sentences about subjects other than the...

  10. Solutions to Reduce Cardiovascular Events in Patients with Atrial Fibrillation

    Directory of Open Access Journals (Sweden)

    Maurizio Paciaroni

    2012-10-01

    Full Text Available AF is the most common sustained cardiac rhythm disorder and an established risk factor for ischemic stroke. Ischemic strokes which occur in patients with AF are particularly severe and disabling. In addition, stroke recurrence is more common in patients with AF compared with those without it. Previous cerebrovascular events, age, hypertension, diabetes, and heart failure are risk factors for stroke in patients with AF.

  11. Atherosclerosis of the descending aorta predicts cardiovascular events: a transesophageal echocardiography study

    Directory of Open Access Journals (Sweden)

    Havasi Kálmán

    2004-10-01

    Full Text Available Abstract Purpose Previous studies have shown that atherosclerosis of the descending aorta detected by transesophageal echocardiography (TEE is a good marker of coexisting coronary artery disease. The aim of our study was to evaluate whether the presence of atherosclerosis on the descending aorta during TEE has any prognostic impact in predicting cardiovascular events. Material and Methods The study group consisted of 238 consecutive in-hospital patients referred for TEE testing (135 males, 103 females, mean age 58 +/- 11 years with a follow up of 24 months. The atherosclerotic lesions of the descending aorta were scored from 0 (no atherosclerosis to 3 (plaque >5 mm and/or "complex" plaque with ulcerated or mobile parts. Results Atherosclerosis was observed in 102 patients, (grade 3 in 16, and grade 2 in 86 patients whereas 136 patients only had an intimal thickening or normal intimal surface. There were 57 cardiovascular events in the follow-up period. The number of events was higher in the 102 patients with (n = 34 than in the 136 patients without atherosclerosis (n = 23, p =2 (HR 2.4, CI 1.0–5.5 predicted hard cardiovascular events. Conclusion Atherosclerosis of the descending aorta observed during transesophageal echocardiography is a useful predictor of cardiovascular events.

  12. Pharmacovigilance and drug safety in Calabria (Italy: 2012 adverse events analysis

    Directory of Open Access Journals (Sweden)

    Chiara Giofrè

    2013-01-01

    Full Text Available Introduction: Pharmacovigilance (PV is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs, in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA] is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports. Hospital doctors are the main source of this reporting (51.62%. Sorafenib (Nexavar® , the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83% were more frequently reported, whereas the age groups "41-65" (39.07% and "over 65" (27.9% were the most affected. Conclusions: Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports, the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

  13. Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management.

    Science.gov (United States)

    Tuccori, Marco; Montagnani, Sabrina; Mantarro, Stefania; Capogrosso-Sansone, Alice; Ruggiero, Elisa; Saporiti, Alessandra; Antonioli, Luca; Fornai, Matteo; Blandizzi, Corrado

    2014-03-01

    Statins, or 3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors, such as lovastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, rosuvastatin and pitavastatin, are cholesterol-lowering drugs used in clinical practice to prevent coronary heart disease. These drugs are generally well tolerated and have been rarely associated with severe adverse effects (e.g. rhabdomyolysis). Over the years, case series and data from national registries of spontaneous adverse drug reaction reports have demonstrated the occurrence of neuropsychiatric reactions associated with statin treatment. They include behavioural alterations (severe irritability, homicidal impulses, threats to others, road rage, depression and violence, paranoia, alienation, antisocial behaviour); cognitive and memory impairments; sleep disturbance (frequent awakenings, shorter sleep duration, early morning awakenings, nightmares, sleepwalking, night terrors); and sexual dysfunction (impotence and decreased libido). Studies designed to investigate specific neuropsychiatric endpoints have yielded conflicting results. Several mechanisms, mainly related to inhibition of cholesterol biosynthesis, have been proposed to explain the detrimental effects of statins on the central nervous system. Approaches to prevent and manage such adverse effects may include drug discontinuation and introduction of dietary restrictions; maintenance of statin treatment for some weeks with close patient monitoring; switching to a different statin; dose reduction; use of ω-3 fatty acids or coenzyme Q10 supplements; and treatment with psychotropic drugs. The available information suggests that neuropsychiatric effects associated with statins are rare events that likely occur in sensitive patients. Additional data are required, and further clinical studies are needed. PMID:24435290

  14. Paraoxonase 1 Polymorphism and Prenatal Pesticide Exposure Associated with Adverse Cardiovascular Risk Profiles at School Age

    DEFF Research Database (Denmark)

    Andersen, Helle R.; Wohlfahrt-Veje, Christine; Dalgard, Christine;

    2012-01-01

    Background: Prenatal environmental factors might influence the risk of developing cardiovascular disease later in life. The HDL-associated enzyme paraoxonase 1 (PON1) has anti-oxidative functions that may protect against atherosclerosis. It also hydrolyzes many substrates, including organophosphate...... prenatally exposed to pesticides. Methods: Pregnant greenhouse-workers were categorized as high, medium, or not exposed to pesticides. Their children underwent a standardized examination at age 6-to-11 years, where blood pressure, skin folds, and other anthropometric parameters were measured. PON1-genotype...... was determined for 141 children (88 pesticide exposed and 53 unexposed). Serum was analyzed for insulin-like growth factor I (IGF-I), insulin-like growth factor binding protein 3 (IGFBP3), insulin and leptin. Body fat percentage was calculated from skin fold thicknesses. BMI results were converted to...

  15. Perceived Discrimination and Incident Cardiovascular Events: The Multi-Ethnic Study of Atherosclerosis.

    Science.gov (United States)

    Everson-Rose, Susan A; Lutsey, Pamela L; Roetker, Nicholas S; Lewis, Tené T; Kershaw, Kiarri N; Alonso, Alvaro; Diez Roux, Ana V

    2015-08-01

    Perceived discrimination is positively related to cardiovascular disease (CVD) risk factors; its relationship with incident CVD is unknown. Using data from the Multi-Ethnic Study of Atherosclerosis, a population-based multiethnic cohort study of 6,508 adults aged 45-84 years who were initially free of clinical CVD, we examined lifetime discrimination (experiences of unfair treatment in 6 life domains) and everyday discrimination (frequency of day-to-day occurrences of perceived unfair treatment) in relation to incident CVD. During a median 10.1 years of follow-up (2000-2011), 604 incident events occurred. Persons reporting lifetime discrimination in ≥2 domains (versus none) had increased CVD risk, after adjustment for race/ethnicity and sociodemographic factors, behaviors, and traditional CVD risk factors (hazard ratio (HR) = 1.36, 95% confidence interval (CI): 1.09, 1.70) and after control for chronic stress and depressive symptoms (HR = 1.28, 95% CI: 1.01, 1.60). Reported discrimination in 1 domain was unrelated to CVD (HR = 1.05, 95% CI: 0.86, 1.30). There were no differences by race/ethnicity, age, or sex. In contrast, everyday discrimination interacted with sex (P = 0.03). Stratified models showed increased risk only among men (for each 1-standard deviation increase in score, adjusted HR = 1.14, 95% CI: 1.03, 1.27); controlling for chronic stress and depressive symptoms slightly reduced this association (HR = 1.11, 95% CI: 0.99, 1.25). This study suggests that perceived discrimination is adversely related to CVD risk in middle-aged and older adults. PMID:26085044

  16. Association of urinary injury biomarkers with mortality and cardiovascular events.

    Science.gov (United States)

    Sarnak, Mark J; Katz, Ronit; Newman, Anne; Harris, Tamara; Peralta, Carmen A; Devarajan, Prasad; Bennett, Michael R; Fried, Linda; Ix, Joachim H; Satterfield, Suzanne; Simonsick, Eleanor M; Parikh, Chirag R; Shlipak, Michael G

    2014-07-01

    Kidney damage is a common sequela of several chronic pathologic conditions. Whether biomarkers of kidney damage are prognostic for more severe outcomes is unknown. We measured three urinary biomarkers (kidney injury molecule-1 [KIM-1], IL-18, and albumin) in 3010 individuals enrolled in the Health, Aging and Body Composition (Health ABC) study and used Cox proportional hazards models to investigate the associations of urinary KIM-1/creatinine (cr), IL-18/cr, and albumin/cr (ACR) with all-cause mortality and cardiovascular disease (CVD). Multivariable models adjusted for demographics, traditional CVD risk factors, and eGFR. Mean age of participants was 74 years, 49% of participants were men, and 41% of participants were black. During the median 12.4 years of follow-up, 1450 deaths and 797 CVD outcomes occurred. Compared with the lowest quartile, successive quartiles had the following adjusted hazard ratios (HRs; 95% confidence intervals [95% CIs]) for mortality: KIM-1/cr: (1.21; 1.03 to 1.41), (1.13; 0.96 to 1.34), and (1.28; 1.08 to 1.52); IL-18/cr: (1.02; 0.88 to 1.19), (1.16; 0.99 to 1.35), and (1.06; 0.90 to 1.25); ACR: (1.08; 0.91 to 1.27), (1.24; 1.06 to 1.46), and (1.63; 1.39 to 1.91). In similar analyses, only ACR quartiles associated with CVD: (1.19; 0.95 to 1.48), (1.35; 1.08 to 1.67), and (1.54; 1.24 to 1.91). Urinary KIM-1 had a modest association with all-cause mortality but did not associate with CVD, and urinary IL-18 did not associate with either outcome. In contrast, albuminuria strongly associated with all-cause mortality and CVD. Future studies should evaluate reasons for these differences in the prognostic importance of individual kidney injury markers. PMID:24511130

  17. Cardiovascular adverse reactions associated with Guarana: is there a causal effect?

    Science.gov (United States)

    Baghkhani, Leila; Jafari, Mahtab

    2002-01-01

    Herbal supplements have been used as adjuncts to medical therapy for many years by various cultures. Many consumers believe that because herbal supplements are natural products, they are somewhat safer or more effective than traditional prescribed medications. This is also one reason that alternative medicine is growing and gaining more popularity. On the other hand, adverse reactions to herbal supplements or their interactions with patients' current medications are no different than pharmaceutical medicines. We report a case of premature ventricular contraction associated with two herbal supplements. These products contained multiple different herbs and both included large doses of guarana. Guarana, which is found in some supplements marketed in U.S., contains a substantial amount of caffeine. Although the exact cause of tachycardia in our report is not proven, a large amount of caffeine consumption is thought to be a possible causal effect. The purpose of this report is to remind health care professionals to evaluate and educate patients on the use of herbal products and any potential adverse reactions, drug interactions, or possible toxicities. PMID:15277107

  18. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    Directory of Open Access Journals (Sweden)

    Sevliya Öcal Demir

    2016-01-01

    Full Text Available Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients.

  19. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    Science.gov (United States)

    Demir, Sevliya Öcal; Atici, Serkan; Akkoç, Gülşen; Yakut, Nurhayat; İkizoğlu, Nilay Baş; Eralp, Ela Erdem; Soysal, Ahmet; Bakir, Mustafa

    2016-01-01

    Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients. PMID:27313918

  20. Sumatriptan overuse in episodic cluster headache: lack of adverse events, rebound syndromes, drug dependence and tachyphylaxis.

    Science.gov (United States)

    Centonze, V; Bassi, A; Causarano, V; Dalfino, L; Cassiano, M A; Centonze, A; Fabbri, L; Albano, O

    2000-01-01

    This observational study was designed to examine the pattern of sumatriptan use in patients with cluster headache using more than the recommended daily dose of subcutaneously injected (s.c.) sumatriptan. Thirteen patients suffering from episodic cluster headache were asked to record the characteristics of their attacks and drug intake for 1 year. All reported a high daily frequency of attacks (more than 3 per day) and the related overuse of s.c. sumatriptan. The results show that the overall incidence of adverse events among patients receiving sumatriptan injections for the treatment of cluster headache is low. The extended administration of this drug in episodic cluster headache did not result in tolerance problems or tachyphylaxis. Only 4 patients experienced minor adverse events and recovered more slowly than the others. They suffered from migraine without aura and cluster headache, and showed a family history of migraine. Even though they must be viewed with caution, due to the observational nature of the study and the low number of patients included, these results suggest that the profile of sumatriptan may differ in cluster headache compared with migraine. PMID:11062845

  1. e-Prescription: An e-Health System for Preventing Adverse Drug Events in Community Healthcare

    Directory of Open Access Journals (Sweden)

    Irma M. Puspitasari

    2012-03-01

    Full Text Available The paper describes development activities of an e-health system for community health center (Puskesmas with integrated adverse drug events e-prescription module, consist of system design and development, human resource development, e-health system realization, laboratory and implementation test of e-health system. Some e-readiness evaluations were conducted, through a number of field visits and questionnaires. The results had been used in the e-health system design and development, installation of the internet access infrastructure, and implementation of the education and hands-on training for the medical and administrative staff of the healthcare units. After completing the e-health system design and development as well as system realization and laboratory tests stages, a series of field implementation and experiments have been successfully conducted at Puskesmas Babakansari in Bandung. A number of users feed back have been obtained and used for further improvements on both of the software and hardware modules. The e-health system with integrated e-prescription module has successfully developed and shown its expected functions in: patient registration, medical record, paperless prescription, producing the required reports and preventing possible adverse drug events.

  2. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 2013(1).

    Science.gov (United States)

    Tohme, Rania A; François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B; Marston, Barbara J; Date, Kashmira; Mintz, Eric; Katz, Mark A

    2015-06-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1-4, 5-14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours. PMID:25988350

  3. Adverse events in apheresis: An update of the WAA registry data.

    Science.gov (United States)

    Mörtzell Henriksson, M; Newman, E; Witt, V; Derfler, K; Leitner, G; Eloot, S; Dhondt, A; Deeren, D; Rock, G; Ptak, J; Blaha, M; Lanska, M; Gasova, Z; Hrdlickova, R; Ramlow, W; Prophet, H; Liumbruno, G; Mori, E; Griskevicius, A; Audzijoniene, J; Vrielink, H; Rombout, S; Aandahl, A; Sikole, A; Tomaz, J; Lalic, K; Mazic, S; Strineholm, V; Brink, B; Berlin, G; Dykes, J; Toss, F; Axelsson, C G; Stegmayr, B; Nilsson, T; Norda, R; Knutson, F; Ramsauer, B; Wahlström, A

    2016-02-01

    Apheresis with different procedures and devices are used for a variety of indications that may have different adverse events (AEs). The aim of this study was to clarify the extent and possible reasons of various side effects based on data from a multinational registry. The WAA-apheresis registry data focus on adverse events in a total of 50846 procedures in 7142 patients (42% women). AEs were graded as mild, moderate (need for medication), severe (interruption due to the AE) or death (due to AE). More AEs occurred during the first procedures versus subsequent (8.4 and 5.5%, respectively). AEs were mild in 2.4% (due to access 54%, device 7%, hypotension 15%, tingling 8%), moderate in 3% (tingling 58%, urticaria 15%, hypotension 10%, nausea 3%), and severe in 0.4% of procedures (syncope/hypotension 32%, urticaria 17%, chills/fever 8%, arrhythmia/asystole 4.5%, nausea/vomiting 4%). Hypotension was most common if albumin was used as the replacement fluid, and urticaria when plasma was used. Arrhythmia occurred to similar extents when using plasma or albumin as replacement. In 64% of procedures with bronchospasm, plasma was part of the replacement fluid used. Severe AEs are rare. Although most reactions are mild and moderate, several side effects may be critical for the patient. We present side effects in relation to the procedures and suggest that safety is increased by regular vital sign measurements, cardiac monitoring and by having emergency equipment nearby. PMID:26776481

  4. Periodontal Treatment Reduces Risk of Adverse Respiratory Events in Patients With Chronic Obstructive Pulmonary Disease

    Science.gov (United States)

    Shen, Te-Chun; Chang, Pei-Ying; Lin, Cheng-Li; Chen, Chia-Hung; Tu, Chih-Yen; Hsia, Te-Chun; Shih, Chuen-Ming; Hsu, Wu-Huei; Sung, Fung-Chang; Kao, Chia-Hung

    2016-01-01

    Abstract Treatment of periodontal diseases has been associated with benefit outcomes for patients with chronic obstructive pulmonary disease (COPD). However, no population-based cohort study has been conducted. We evaluated this relationship by retrospective cohort study using a large population data. Using the National Health Insurance claims data of Taiwan, we identified 5562 COPD patients with periodontal diseases who had received periodontal treatment as the treatment group. The comparison group was selected at a 1:1 ratio matched by the propensity score estimated with age, sex, date of COPD diagnosis and periodontal treatment, and comorbidities. Both groups were followed up for 5 years to compare risks of acute exacerbation, pneumonia, and acute respiratory failure. The incidence rates of adverse respiratory events were significantly lower in the treatment group than in the comparison group: 3.79 versus 4.21 per 100 person-years for emergency room visits, 2.75 versus 3.65 per 100 person-years for hospitalizations, and 0.66 versus 0.75 per 100 person-years for intensive care unit admissions. The treatment group also had a 37% reduced risk of deaths (1.81 vs 2.87 per 100 person-years), with an adjusted hazard ratio of 0.57 (95% confidence interval 0.52–0.62). Periodontal treatment for COPD patients could reduce the risk of adverse respiratory events and mortality. The adequate periodontal health care is important for COPD patients with periodontal diseases. PMID:27196497

  5. Adverse events associated with yoga: a systematic review of published case reports and case series.

    Directory of Open Access Journals (Sweden)

    Holger Cramer

    Full Text Available While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopenia. Pranayama, hatha yoga, and Bikram yoga were the most common yoga practices; headstand, shoulder stand, lotus position, and forceful breathing were the most common yoga postures and breathing techniques cited. Twenty-seven adverse events (35.5% affected the musculoskeletal system; 14 (18.4% the nervous system; and 9 (11.8% the eyes. Fifteen cases (19.7% reached full recovery; 9 cases (11.3% partial recovery; 1 case (1.3% no recovery; and 1 case (1.3% died. As any other physical or mental practice, yoga should be practiced carefully under the guidance of a qualified instructor. Beginners should avoid extreme practices such as headstand, lotus position and forceful breathing. Individuals with medical preconditions should work with their physician and yoga teacher to appropriately adapt postures; patients with glaucoma should avoid inversions and patients with compromised bone should avoid forceful yoga practices.

  6. A Structured Approach for Investigating the Causes of Medical Device Adverse Events

    Directory of Open Access Journals (Sweden)

    John N. Amoore

    2014-01-01

    Full Text Available Aim. Medical device-related adverse events are often ascribed to “device” or “operator” failure although there are more complex causes. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes. Method. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was explored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework of causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each aspect having detailed subdivisions. The approach was applied to incidents from the literature and an anonymous incident database. Results. The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of “device,” “operator,” or “infrastructure” failures. Applied to incident databases it suggested that causes differ between device types and identified the causes of device unavailability. Discussion. The structured approach enables digging deeper to uncover the wider causes rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology for describing and sharing information on the causes of medical device adverse events.

  7. Adverse effects of androgen deprivation therapy in men with prostate cancer: a focus on metabolic and cardiovascular complications

    Institute of Scientific and Technical Information of China (English)

    Lauren Collins; Shehzad Basaria

    2012-01-01

    Prostate cancer (PCa) is the most common malignancy in men.Prostate being an androgen responsive tissue,androgen deprivation therapy (ADT) is used in the management of locally advanced (improves survival) and metastatic (improves pain and quality of life) PCa.Over the past two decades,the use of ADT has significantly increased as it is also being used in patients with localized disease and those experiencing biochemical recurrences,though without any evidence of survival advantage.Hypogonadism resulting from ADT is associated with decreased muscle mass and strength,increased fat mass,sexual dysfunction,vasomotor symptoms,decreased quality of life,anemia and bone loss.Insulin resistance,diabetes and cardiovascular disease have recently been added to the list of these complications.As the majority of men with PCa die of conditions other than their primary malignancy,recognition and management of these adverse effects is paramount.Here we review data evaluating metabolic and cardiovascular complications of ADT.

  8. Polytraumatization and Trauma Symptoms in Adolescent Boys and Girls: Interpersonal and Noninterpersonal Events and Moderating Effects of Adverse Family Circumstances

    Science.gov (United States)

    Nilsson, Doris Kristina; Gustafsson, Per E.; Svedin, Carl Goran

    2012-01-01

    The objective of this study was to investigate the cumulative effect of interpersonal and noninterpersonal traumatic life events (IPEs and nIPEs, respectively) on the mental health of adolescents and to determine if the adverse impacts of trauma were moderated by adverse family circumstances (AFC). Adolescents (mean age 16.7 years) from the…

  9. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Science.gov (United States)

    2013-10-23

    ... the Federal Register of May 25, 2010 (75 FR 29352), FDA published the notice of availability for a... Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug... availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse...

  10. Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems.

    Directory of Open Access Journals (Sweden)

    Paolo Pellegrino

    Full Text Available OBJECTIVE: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM by considering data from different pharmacovigilance surveillance systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS database and the EudraVigilance post-authorisation module (EVPM were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. RESULTS: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. CONCLUSIONS: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

  11. Increased Adverse Events After Percutaneous Coronary Intervention in Patients With COPD

    Science.gov (United States)

    Enriquez, Jonathan R.; Parikh, Shailja V.; Selzer, Faith; Jacobs, Alice K.; Marroquin, Oscar; Mulukutla, Suresh; Srinivas, Vankeepuram

    2011-01-01

    Background: Previous studies have demonstrated that patients with COPD are at higher risk for death after percutaneous coronary intervention (PCI), but other clinical outcomes and possible associations with adverse events have not been described. Methods: Using waves 1 through 5 (1999-2006) of the National Heart, Lung, and Blood Institute Dynamic Registry, patients with COPD (n = 860) and without COPD (n = 10,048) were compared. Baseline demographics, angiographic characteristics, and in-hospital and 1-year adverse events were compared. Results: Patients with COPD were older (mean age 66.8 vs 63.2 years, P < .001), more likely to be women, and more likely to have a history of diabetes, prior myocardial infarction, peripheral arterial disease, renal disease, and smoking. Patients with COPD also had a lower mean ejection fraction (49.1% vs 53.0%, P < .001) and a greater mean number of significant lesions (3.2 vs 3.0, P = .006). Rates of in-hospital death (2.2% vs 1.1%, P = .003) and major entry site complications (6.6% vs 4.2%, P < .001) were higher in pulmonary patients. At discharge, pulmonary patients were significantly less likely to be prescribed aspirin (92.4% vs 95.3%, P < .001), β-blockers (55.7% vs 76.2%, P < .001), and statins (60.0% vs 66.8%, P < .001). After adjustment, patients with COPD had significantly increased risk of death (hazard ratio [HR] = 1.30, 95% CI = 1.01-1.67) and repeat revascularization (HR = 1.22, 95% CI = 1.02-1.46) at 1 year, compared with patients without COPD. Conclusions: COPD is associated with higher mortality rates and repeat revascularization within 1 year after PCI. These higher rates of adverse outcomes may be associated with lower rates of guideline-recommended class 1 medications prescribed at discharge. PMID:21527507

  12. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems

    Science.gov (United States)

    Perrone, Valentina; Pozzi, Marco; Antoniazzi, Stefania; Clementi, Emilio; Radice, Sonia

    2013-01-01

    Objective To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM) by considering data from different pharmacovigilance surveillance systems. Methods The Vaccine Adverse Event Reporting System (VAERS) database and the EudraVigilance post-authorisation module (EVPM) were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. Results We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. Conclusions This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction. PMID:24147076

  13. A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group

    NARCIS (Netherlands)

    Lacouture, Mario E.; Maitland, Michael L.; Segaert, Siegfried; Setser, Ann; Baran, Robert; Fox, Lindy P.; Epstein, Joel B.; Barasch, Andrei; Einhorn, Lawrence; Wagner, Lynne; West, Dennis P.; Rapoport, Bernardo L.; Kris, Mark G.; Basch, Ethan; Eaby, Beth; Kurtin, Sandra; Olsen, Elise A.; Chen, Alice; Dancey, Janet E.; Trotti, Andy

    2010-01-01

    Accurate grading of dermatologic adverse events (AE) due to epidermal growth factor receptor (EGFR) inhibitors (EGFRIs) is necessary for drug toxicity determinations, interagent comparisons, and supportive care trials. The most widely used severity grading scale, the National Cancer Institute's Comm

  14. Common Carotid Intima-Media Thickness Relates to Cardiovascular Events in Adults Aged

    NARCIS (Netherlands)

    Eikendal, Anouk L. M.; Groenewegen, Karlijn A.; Anderson, Todd J.; Britton, Annie R.; Engstrom, Gunnar; Evans, Greg W.; de Graaf, Jacqueline; Grobbee, Diederick E.; Hedblad, Bo; Holewijn, Suzanne; Ikeda, Ai; Kitagawa, Kazuo; Kitamura, Akihiko; Lonn, Eva M.; Lorenz, Matthias W.; Mathiesen, Ellisiv B.; Nijpels, Giel; Dekker, Jacqueline M.; Okazaki, Shuhei; O'Leary, Daniel H.; Polak, Joseph F.; Price, Jacqueline F.; Robertson, Christine; Rembold, Christopher M.; Rosvall, Maria; Rundek, Tatjana; Salonen, Jukka T.; Sitzer, Matthias; Stehouwer, Coen D. A.; Hoefer, Imo E.; Peters, Sanne A. E.; Bots, Michiel L.; den Ruijter, Hester M.

    2015-01-01

    Although atherosclerosis starts in early life, evidence on risk factors and atherosclerosis in individuals aged <45 years is scarce. Therefore, we studied the relationship between risk factors, common carotid intima-media thickness (CIMT), and first-time cardiovascular events in adults aged <45 year

  15. Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

    NARCIS (Netherlands)

    Holman, Rury R.; Haffner, Steven M.; McMurray, John J.; Bethel, M. Angelyn; Holzhauer, Bjoern; Hua, Tsushung A.; Belenkov, Yuri; Boolell, Mitradev; Buse, John B.; Buckley, Brendan M.; Chacra, Antonio R.; Chiang, Fu-Tien; Charbonnel, Bernard; Chow, Chun-Chung; Davies, Melanie J.; Deedwania, Prakash; Diem, Peter; Einhorn, Daniel; Fonseca, Vivian; Fulcher, Gregory R.; Gaciong, Zbigniew; Gaztambide, Sonia; Giles, Thomas; Horton, Edward; Ilkova, Hasan; Jenssen, Trond; Kahn, Steven E.; Krum, Henry; Laakso, Markku; Leiter, Lawrence A.; Levitt, Naomi S.; Mareev, Viacheslav; Martinez, Felipe; Masson, Chantal; Mazzone, Theodore; Meaney, Eduardo; Nesto, Richard; Pan, Changyu; Prager, Rudolf; Raptis, Sotirios A.; Rutten, Guy E. H. M.; Sandstroem, Herbert; Schaper, Frank; Scheen, Andre; Schmitz, Ole; Sinay, Isaac; Soska, Vladimir; Stender, Steen; Tamas, Gyula; Tognoni, Gianni; Tuomilehto, Jaako; Villamil, Alberto S.; Vozar, Juraj; Califf, Robert M.

    2010-01-01

    BACKGROUND The ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown. METHODS In a double-blind, randomized clinical trial, we assigned 9306 participants with impaired glucose tolerance and either ca

  16. Pulse pressure, left ventricular function and cardiovascular events during antihypertensive treatment (the LIFE study)

    DEFF Research Database (Denmark)

    Gerdts, Eva; Franklin, Stanley; Rieck, Ashild;

    2009-01-01

    systolic function and cardiovascular events was assessed in 883 patients with electrocardiographic LV hypertrophy during 4.8 years of randomized losartan- or atenolol-based treatment within the echocardiographic substudy of the Losartan Intervention For Endpoint reduction in hypertension (LIFE) study...

  17. Prediction of Cardiovascular Events in Statin-Treated Stable Coronary Patients by Lipid and Nonlipid Biomarkers

    NARCIS (Netherlands)

    B.J. Arsenault; P. Barter; D.A. Demicco; W. Bao; G.M. Preston; J.C. LaRosa; S.M. Grundy; P. Deedwania; H. Greten; N.K. Wenger; J. Shepherd; D.D. Waters; J.J.P. Kastelein

    2010-01-01

    Objectives The aim of this study was to investigate the relationship between lipid and nonlipid biomarker levels achieved during statin therapy and the incidence of major cardiovascular events (MCVEs) in patients with stable coronary heart disease (CHD). Background Several plasma nonlipid biomarkers

  18. Multiple Biomarkers for the Prediction of First Major Cardiovascular Events and Death

    Science.gov (United States)

    Few investigations have evaluated the incremental usefulness of multiple biomarkers from distinct biologic pathways for predicting the risk of cardiovascular events. We measured 10 biomarkers in 3209 participants attending a routine examination cycle of the Framingham Heart Study: the levels of C-r...

  19. Elevated cardiac troponin I predicts cardiovascular or cerebrovascular events in hypertensive patients

    International Nuclear Information System (INIS)

    Objective: Whether elevated cTnI is associated with cardiovascular or cerebrovascular events in patients with hypertension (HT) without left ventricular(LV) systolic dysfunction is not clear. Method: We measured cTnI serum level in 170 patients with essential HT without LV systolic dysfunction (LVEF 55%),renal failure,and prior cardiovascular or cerebrovascular diseases. Besides, control group of 40 normal presons was established and following up (45±38)months. Results: Level of cTnI was elevated (≥0.04 ng/ml) in 15 (8.8%) of the 170 patients and in 0 (0%) of the 40 normal controls. The rate of diabetes mellitus(DM), the cardiothoracic ratio, serum NT-proBNP value, and LV mass index were significantly higher in patients with than without elevated cTnI (DM, 9/15 versus 25/155, P2, P=0.0001). Kaplan-Meier analysis demonstrated that significantly fewer (P<0.000001) patients with, than without elevated cTnI remained free of events (hospitalization due to cardiovascular or cerebrovascular disease). Stepwise Cox multivariate analysis revealed that elevated cTnT (hazard ratio, 6.59, P=0.000001) and smoking (hazard ratio, 2.26, P=0.04) were independent predictors of events. Conclusion: The present findings indicate that cTnI is a biomarker and useful predictor of future cardiovascular or cerebrovascular events in hypertensive patients. (authors)

  20. Stimulants and Cardiovascular Events in Youth with Attention-Deficit/Hyperactivity Disorder

    Science.gov (United States)

    Olfson, Mark; Huang, Cecilia; Gerhard, Tobias; Winterstein, Almut G.; Crystal, Stephen; Allison, Paul D.; Marcus, Steven C.

    2012-01-01

    Objective: This study examined associations between stimulant use and risk of cardiovascular events and symptoms in youth with attention-deficit/hyperactivity disorder and compared the risks associated with methylphenidate and amphetamines. Method: Claims were reviewed of privately insured young people 6 to 21 years old without known…

  1. Evaluation of Adverse Events Noted in Children Receiving Continuous Infusions of Dexmedetomidine in the Intensive Care Unit

    Science.gov (United States)

    Honey, Brooke L.; Harrison, Donald L.; Gormley, Andrew K.; Johnson, Peter N.

    2010-01-01

    OBJECTIVES Dexmedetomidine is an α2-adrenergic receptor agonist with sedative and analgesic effects in mechanically ventilated adults and children. Safety and efficacy data are limited in children. The purpose of this study is to retrospectively identify the incidence and types of adverse events noted in children receiving continuous infusions of dexmedetomidine and evaluate potential risk factors for adverse events. METHODS Between July 1, 2006, and July 31, 2007, data were collected on all children (< 18 years) who received continuous infusions of dexmedetomidine. Data collection included demographics, dexmedetomidine regimen, and type/number of adverse events. The primary endpoint was the total number of adverse events noted, including: transient hypertension, hypotension, neurological manifestations, apnea, and bradycardia. Secondary endpoints included categorization of each type of adverse event and an assessment of risk factors. A logistic regression model was used to assess the relationship of adverse events with independent variables including length of ICU stay, cumulative dose, peak infusion rate, duration of therapy, PRISM III score, and bolus dose. RESULTS Thirty-six patients received dexmedetomidine representing 41 infusions. The median age was 16 months (range, 0.1–204 months) and median PRISM III score was 2 (range, 0–18). Eighteen (43.9%) patients received a bolus dose of dexmedetomidine. The median cumulative dose (mcg/kg) and peak dose (mcg/kg/hr) were 8.5 (range, 2.2–193.7) and 0.5 (range, 0.2–0.7), respectively. Dexmedetomidine was continued for a median of 20 (range, 3–263) hours. Six (14.6%) patients were slowly tapered off the continuous infusions. Twenty-one adverse events were noted in 17 patients, including 4 neurologic manifestations. Fourteen patients required interventions for adverse events. ICU length of stay was the only independent risk factor (p=0.036) for development of adverse events. CONCLUSIONS Several potential

  2. The Risk Assessment of Adverse Events of Nursing Activities as the Element of Quality Management in Healhcare

    OpenAIRE

    Wiśniewska Malgorzata Z.; Grudowski Piotr; Konieczyńska Emila

    2015-01-01

    The purpose of the paper is to present MedCARVER+Shock method and Pareto analysis and its usability for the risk assessment of adverse events of nursing activities. 888 activities carried out by all 190 nurses working at the District Hospital X located in Poland were taken into account. During the research the qualitative approach was used. As the result sixteen groups of nursing activities causing the highest risk of adverse events were selected. Special attention required in: admission of a...

  3. Computerized surveillance of opioid-related adverse drug events in perioperative care: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Gattis Katherine G

    2009-08-01

    Full Text Available Abstract Background Given the complexity of surgical care, perioperative patients are at high risk of opioid-related adverse drug events. Existing methods of detection, such as trigger tools and manual chart review, are time-intensive which makes sustainability challenging. Using strategic rule design, computerized surveillance may be an efficient, pharmacist-driven model for event detection that leverages existing staff resources. Methods Computerized adverse drug event surveillance uses a logic-based rules engine to identify potential adverse drug events or evolving unsafe clinical conditions. We extended an inpatient rule (administration of naloxone to detect opioid-related oversedation and respiratory depression to perioperative care at a large academic medical center. Our primary endpoint was the adverse drug event rate. For all patients with a naloxone alert, manual chart review was performed by a perioperative clinical pharmacist to assess patient harm. In patients with confirmed oversedation, other patient safety event databases were queried to determine if they could detect duplicate, prior, or subsequent opioid-related events. Results We identified 419 cases of perioperative naloxone administration. Of these, 101 were given postoperatively and 69 were confirmed as adverse drug events after chart review yielding a rate of 1.89 adverse drug events/1000 surgical encounters across both the inpatient and ambulatory settings. Our ability to detect inpatient opioid adverse drug events increased 22.7% by expanding surveillance into perioperative care. Analysis of historical surveillance data as well as a voluntary reporting database revealed that 11 of our perioperative patients had prior or subsequent harmful oversedation. Nine of these cases received intraoperative naloxone, and 2 had received naloxone in the post-anesthesia care unit. Pharmacist effort was approximately 3 hours per week to evaluate naloxone alerts and confirm adverse drug

  4. Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib

    OpenAIRE

    Lipsky, Andrew H.; Farooqui, Mohammed Z.H.; Tian, Xin; Martyr, Sabrina; Cullinane, Ann M.; Nghiem, Khanh; Sun, Clare; Valdez, Janet; Niemann, Carsten U.; Herman, Sarah E. M.; Saba, Nakhle; Soto, Susan; Marti, Gerald; Uzel, Gulbu; Holland, Steve M.

    2015-01-01

    Ibrutinib is associated with bleeding-related adverse events of grade ≤2 in severity, and infrequently with grade ≥3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤2 bleeding-related adverse events in 55% of 85 patients. No grade ≥3 events occur...

  5. Neurologic adverse events associated with smallpox vaccination in the United States – response and comment on reporting of headaches as adverse events after smallpox vaccination among military and civilian personnel

    Directory of Open Access Journals (Sweden)

    Schumm Walter R

    2006-11-01

    Full Text Available Abstract Background Accurate reporting of adverse events occurring after vaccination is an important component of determining risk-benefit ratios for vaccinations. Controversy has developed over alleged underreporting of adverse events within U.S. military samples. This report examines the accuracy of adverse event rates recently published for headaches, and examines the issue of underreporting of headaches as a function of civilian or military sources and as a function of passive versus active surveillance. Methods A report by Sejvar et al was examined closely for accuracy with respect to the reporting of neurologic adverse events associated with smallpox vaccination in the United States. Rates for headaches were reported by several scholarly sources, in addition to Sejvar et al, permitting a comparison of reporting rates as a function of source and type of surveillance. Results Several major errors or omissions were identified in Sejvar et al. The count of civilian subjects vaccinated and the totals of both civilians and military personnel vaccinated were reported incorrectly by Sejvar et al. Counts of headaches reported in VAERS were lower (n = 95 for Sejvar et al than for Casey et al (n = 111 even though the former allegedly used 665,000 subjects while the latter used fewer than 40,000 subjects, with both using approximately the same civilian sources. Consequently, rates of nearly 20 neurologic adverse events reported by Sejvar et al were also incorrectly calculated. Underreporting of headaches after smallpox vaccination appears to increase for military samples and for passive adverse event reporting systems. Conclusion Until revised or corrected, the rates of neurologic adverse events after smallpox vaccinated reported by Sejvar et al must be deemed invalid. The concept of determining overall rates of adverse events by combining small civilian samples with large military samples appears to be invalid. Reports of headaches as adverse events

  6. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

  7. Systemic Hemodynamic Atherothrombotic Syndrome and Resonance Hypothesis of Blood Pressure Variability: Triggering Cardiovascular Events.

    Science.gov (United States)

    Kario, Kazuomi

    2016-07-01

    Blood pressure (BP) exhibits different variabilities and surges with different time phases, from the shortest beat-by-beat to longest yearly changes. We hypothesized that the synergistic resonance of these BP variabilites generates an extraordinarily large dynamic surge in BP and triggers cardiovascular events (the resonance hypothesis). The power of pulses is transmitted to the peripheral sites without attenuation by the large arteries, in individuals with stiffened arteries. Thus, the effect of a BP surge on cardiovascular risk would be especially exaggerated in high-risk patients with vascular disease. Based on this concept, our group recently proposed a new theory of systemic hemodynamic atherothromboltic syndrome (SHATS), a vicious cycle of hemodynamic stress and vascular disease that advances organ damage and triggers cardiovascular disease. Clinical phenotypes of SHATS are large-artery atherothombotic diseases such as stroke, coronary artery disease, and aortic and pheripheral artery disease; small-artery diseases, and microcirculation-related disease such as vascular cognitive dysfunction, heart failure, and chronic kidney disease. The careful consideration of BP variability and vascular diseases such as SHATS, and the early detection and management of SHATS, will achieve more effective individualized cardiovascular protection. In the near future, information and communication technology-based 'anticipation medicine' predicted by the changes of individual BP values could be a promising approach to achieving zero cardiovascular events. PMID:27482253

  8. Systemic Hemodynamic Atherothrombotic Syndrome and Resonance Hypothesis of Blood Pressure Variability: Triggering Cardiovascular Events

    Science.gov (United States)

    2016-01-01

    Blood pressure (BP) exhibits different variabilities and surges with different time phases, from the shortest beat-by-beat to longest yearly changes. We hypothesized that the synergistic resonance of these BP variabilites generates an extraordinarily large dynamic surge in BP and triggers cardiovascular events (the resonance hypothesis). The power of pulses is transmitted to the peripheral sites without attenuation by the large arteries, in individuals with stiffened arteries. Thus, the effect of a BP surge on cardiovascular risk would be especially exaggerated in high-risk patients with vascular disease. Based on this concept, our group recently proposed a new theory of systemic hemodynamic atherothromboltic syndrome (SHATS), a vicious cycle of hemodynamic stress and vascular disease that advances organ damage and triggers cardiovascular disease. Clinical phenotypes of SHATS are large-artery atherothombotic diseases such as stroke, coronary artery disease, and aortic and pheripheral artery disease; small-artery diseases, and microcirculation-related disease such as vascular cognitive dysfunction, heart failure, and chronic kidney disease. The careful consideration of BP variability and vascular diseases such as SHATS, and the early detection and management of SHATS, will achieve more effective individualized cardiovascular protection. In the near future, information and communication technology-based 'anticipation medicine' predicted by the changes of individual BP values could be a promising approach to achieving zero cardiovascular events. PMID:27482253

  9. Adverse events in humans associated with accidental exposure to the livestock brucellosis vaccine RB51.

    Science.gov (United States)

    Ashford, David A; di Pietra, Jennifer; Lingappa, Jairam; Woods, Christopher; Noll, Heather; Neville, Bridget; Weyant, Robbin; Bragg, Sandra L; Spiegel, Richard A; Tappero, Jordan; Perkins, Bradley A

    2004-09-01

    Brucella abortus strain RB51 vaccine, is an attenuated live bacterial vaccine that was licensed conditionally by the Center for Veterinary Biologics, Veterinary Services, Animal and Plant Health Inspection Service, USDA, on 23 February 1996, for vaccination of cattle in the United States. Accidental human inoculations can occur during vaccination of cattle, and previous live Brucella vaccines designed for cattle have been known to cause brucellosis in humans. The Centers for Disease Control and Prevention (CDC) established passive surveillance for accidental inoculation with the RB51 vaccine in the United States to determine if this veterinary vaccine is associated with human disease, to describe the circumstances of accidental inoculation, to evaluate the potential efficacy of post-exposure chemoprophylaxis, and to develop recommendations for post-exposure management following exposure to RB51. Reports were received from 26 individuals. Accidental exposure to RB51 occurred by needle stick injury in 21 people (81%), conjunctival spray exposure in four (15%), and spray exposure of an open wound in one (4%) individual. At least one systemic symptom was reported in 19 (73%) people, including three (12%) who reported persistent local reactions with systemic involvement. One case required surgery, and B. abortus strain RB51 was isolated from the wound of that individual. Seven cases reported no adverse event associated with accidental exposure. Nine cases reported previous exposure to Brucella vaccines, including one case who also reported a previous diagnosis of brucellosis following exposure to S19 vaccine. Accidental needle stick injuries and conjunctival or open wound exposures of humans with the RB51 vaccine are associated with both local and systemic adverse events in the United States that are consistent with brucellosis; however, it remains undetermined if strain RB51 vaccine can cause systemic brucellosis in humans. Early culture attempts on those exposed and

  10. A case-control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events.

    Science.gov (United States)

    Geier, David A; Geier, Mark R

    2015-07-01

    GARDASIL (Merck & Co., Inc., Whitehouse Station, NJ, USA) is a quadrivalent human papillomavirus (HPV4) vaccine. An epidemiological study was undertaken to evaluate concerns about the potential for HPV4 vaccination to induce serious autoimmune adverse events (SAAEs). The vaccine adverse event reporting system (VAERS) database was examined for adverse event reports associated with vaccines administered from January 2006 through December 2012 to recipients between 18 and 39 years old with a listed residence in the USA and a specified female gender. It was observed that cases with the SAAE outcomes of gastroenteritis (odds ratio (OR) = 4.6, 95% confidence interval (CI) = 1.3-18.5), arthritis (OR = 2.5, 95% CI = 1.4-4.3), systemic lupus erythematosus (OR = 5.3, 95% CI = 1.5-20.5), vasculitis (OR = 4, 95% CI = 1.01-16.4), alopecia (OR = 8.3, 95% CI = 4.5-15.9), or CNS conditions (OR = 1.8, 95% CI = 1.04-2.9) were significantly more likely than controls to have received HPV4 vaccine (median onset of SAAE symptoms from 6 to 55 days post-HPV4 vaccination). Cases with the outcomes of Guillain-Barre syndrome (OR = 0.75, 95% CI = 0.42-1.3) or thrombocytopenia (OR = 1.3, 95% CI = 0.48-3.5) were no more likely than controls to have received HPV4 vaccine. Cases with the general health outcomes of infection (OR = 0.72, 95% CI = 0.27-1.7), conjunctivitis (OR = 0.88, 95% CI = 0.29-2.7), or diarrhea (OR = 1.01, 95% CI = 0.83-1.22) were no more likely than controls to have received HPV4 vaccine. Previous case series of SAAEs and biological plausibility support the observed results. Additional studies should be conducted to further evaluate the potential biological mechanisms involved in HPV4 vaccine-associated SAAEs in animal model systems, and to examine the potential epidemiological relationship between HPV4 vaccine-associated SAAEs in other databases and populations. PMID:25535199

  11. Protocol for analyses of adverse event data from randomized controlled trials of statin therapy.

    Science.gov (United States)

    2016-06-01

    The Cholesterol Treatment Trialists' (CTT) Collaboration was originally established to conduct individual participant data meta-analyses of major vascular events, cause-specific mortality, and site-specific cancers in large, long-term, randomized trials of statin therapy (and other cholesterol-modifying treatments). The results of the trials of statin therapy and their associated meta-analyses have shown that statins significantly reduce the risk of major vascular events without any increase in the risk of nonvascular causes of death or of site-specific cancer, but do produce small increases in the incidence of myopathy, diabetes, and, probably, hemorrhagic stroke. The CTT Collaboration has not previously sought data on other outcomes, and so a comprehensive meta-analysis of all adverse events recorded in each of the eligible trials has not been conducted. This protocol prospectively describes plans to extend the CTT meta-analysis data set so as to provide a more complete understanding of the nature and magnitude of any other effects of statin therapy. PMID:27264221

  12. Treatment compliance and severe adverse events limit the use of tyrosine kinase inhibitors in refractory thyroid cancer

    Directory of Open Access Journals (Sweden)

    Chrisoulidou A

    2015-09-01

    Full Text Available Alexandra Chrisoulidou, Stylianos Mandanas, Efterpi Margaritidou, Lemonia Mathiopoulou, Maria Boudina, Konstantinos Georgopoulos, Kalliopi Pazaitou-PanayiotouDepartment of Endocrinology, Theagenio Cancer Hospital, Thessaloniki, GreeceObjective: The aim of the present study was to assess patient compliance with tyrosine kinase inhibitor (TKI treatment used for refractory and progressive thyroid cancer, in addition to the efficacy and serious adverse events associated with these agents.Methods: We retrospectively analyzed data from adult patients with metastatic differentiated or medullary thyroid cancer unresponsive to conventional treatment and treated with TKIs. Patients received treatment until disease progression or onset of serious adverse events, or until they expressed an intention to stop treatment.Results: Twenty-four patients received TKIs. The median duration of treatment was four (range: 1–19 cycles. The most frequent adverse events were fatigue, nausea, diarrhea, hypertension, and stomatitis, and the most severe were nasal bleeding, diarrhea, heart failure, rhabdomyolysis, renal failure, QT prolongation, neutropenia, and severe fatigue. Dose reduction was required in eight patients, while five decided to terminate TKI therapy because adverse events impaired their everyday activities. During therapy, two patients showed a partial response and three showed stable disease. The lungs were the metastatic sites favoring a response to treatment.Conclusion: Patient selection and meticulous pretreatment education are necessary in order to ensure adherence with TKI therapy. If adverse events appear, dose reduction or temporary treatment interruption may be offered because some adverse events resolve with continuation of treatment. In the event of serious adverse events, treatment discontinuation is necessary. Keywords: medullary thyroid carcinoma, differentiated thyroid cancer, TKIs, sorafenib, sunitinib, vandetanib

  13. A curated and standardized adverse drug event resource to accelerate drug safety research.

    Science.gov (United States)

    Banda, Juan M; Evans, Lee; Vanguri, Rami S; Tatonetti, Nicholas P; Ryan, Patrick B; Shah, Nigam H

    2016-01-01

    Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies. PMID:27193236

  14. [Adverse drug events of older patients presenting in the emergency department].

    Science.gov (United States)

    Malinovska, Alexandra; Bingisser, Roland; Nickel, Christian H

    2015-12-01

    The effect of medication is always a balance between their beneficial effects and any adverse reactions they might elicit. The main risk for adverse drug events {ADEs) is polypharmacy, which is the simultaneous use of multiple drugs.This often applies to older patients, who suffer from multiple diseases and therefore take multiple medications. Thus, itis not surprising, that ADEs are frequention older patients and account up to 16% of emergency visits. It is still under discussion, whether age is an independent risk factor for ADEs. However, there are some age-related changes in the pharmacokinetic and pharmacodynamics properties of many drugs, which may influence the highly fragile balance between benefit and harm in older patients. Though there are multiple risk factors for and causes of ADEs, it could be shown that a lot of ADEs are preventable and even predictable: Budnitz eta/. showed that almost two thirds of emergency hospitalisations occur due to four medication classes: warfarin, oral antiplatelet agents, insulin and oral hypoglycaemic agents. Nevertheless, only 40-60% ofA DEs are recognized in the emergency department. This might be explained by the broad clinical symptoms, ranging from bleeding due to anticoagulants to the more nonspecific symptom of weakness due to hyponatraemia secondary to thiazide diuretics. Detecting and avoiding ADEs could be aided by using lists such as Beers criteria or STOPP/FART which list medications which are potentially inappropriate for older patients. PMID:26654810

  15. Data-driven Markov models and their application in the evaluation of adverse events in radiotherapy

    CERN Document Server

    Abler, Daniel; Davies, Jim; Dosanjh, Manjit; Jena, Raj; Kirkby, Norman; Peach, Ken

    2013-01-01

    Decision-making processes in medicine rely increasingly on modelling and simulation techniques; they are especially useful when combining evidence from multiple sources. Markov models are frequently used to synthesize the available evidence for such simulation studies, by describing disease and treatment progress, as well as associated factors such as the treatment's effects on a patient's life and the costs to society. When the same decision problem is investigated by multiple stakeholders, differing modelling assumptions are often applied, making synthesis and interpretation of the results difficult. This paper proposes a standardized approach towards the creation of Markov models. It introduces the notion of ‘general Markov models’, providing a common definition of the Markov models that underlie many similar decision problems, and develops a language for their specification. We demonstrate the application of this language by developing a general Markov model for adverse event analysis in radiotherapy ...

  16. ADEpedia: a scalable and standardized knowledge base of Adverse Drug Events using semantic web technology.

    Science.gov (United States)

    Jiang, Guoqian; Solbrig, Harold R; Chute, Christopher G

    2011-01-01

    A source of semantically coded Adverse Drug Event (ADE) data can be useful for identifying common phenotypes related to ADEs. We proposed a comprehensive framework for building a standardized ADE knowledge base (called ADEpedia) through combining ontology-based approach with semantic web technology. The framework comprises four primary modules: 1) an XML2RDF transformation module; 2) a data normalization module based on NCBO Open Biomedical Annotator; 3) a RDF store based persistence module; and 4) a front-end module based on a Semantic Wiki for the review and curation. A prototype is successfully implemented to demonstrate the capability of the system to integrate multiple drug data and ontology resources and open web services for the ADE data standardization. A preliminary evaluation is performed to demonstrate the usefulness of the system, including the performance of the NCBO annotator. In conclusion, the semantic web technology provides a highly scalable framework for ADE data source integration and standard query service. PMID:22195116

  17. Neuropsychiatric adverse events during prophylaxis against malaria by using mefloquine before traveling

    Directory of Open Access Journals (Sweden)

    Osama Al-Amer

    2015-01-01

    Full Text Available Malaria is one of the most common infectious diseases, resulting in the deaths of millions of children around the world. The disease causes approximately half a million to 2.5 million people to die annually. People can only get malaria by being bitten by an infective female Anopheles mosquito that transmits malaria from infected individuals. The increase in international travel and the spread of malaria around the world has resulted in an increased risk of malaria infection. Prophylactic drugs are used to prevent the spread of malaria and to protect individuals in endemic areas. The most efficacious drug for treatment and prophylaxis against malaria is mefloquine (MQ, an antimalarial drug used especially as a prophylaxis against Plasmodium falciparum and as a treatment for malaria. MQ is also used to prevent the treatment of chloroquine-resistant P. falciparum malaria. This review focuses on the advantages of MQ and its adverse events.

  18. Evidence Report: Risk of Crew Adverse Health Event Due to Altered Immune Response

    Science.gov (United States)

    Crucian, Brian; Sams, Clarence F.

    2013-01-01

    The Risk of Crew Adverse Health Event Due to Altered Immune Response is identified by the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) as a recognized risk to human health and performance in space. The HRP Program Requirements Document (PRD) defines these risks. This Evidence Report provides a summary of the evidence that has been used to identify and characterize this risk. It is known that human immune function is altered in- and post-flight, but it is unclear at present if such alterations lead to increased susceptibility to disease. Reactivation of latent viruses has been documented in crewmembers, although this reactivation has not been directly correlated with immune changes or with observed diseases. As described in this report, further research is required to better characterize the relationships between altered immune response and susceptibility to disease during and after spaceflight. This is particularly important for future deep-space exploration missions.

  19. [Patient safety - definition and epidemiology of adverse events, errors and incidents].

    Science.gov (United States)

    Koppenberg, J

    2012-06-01

    Multiple studies in the last years on patient safety brought this issue into focus for healthcare workers, but also politics and public. It is evident, that patient safety in health care is not longer a "nice to have", but an absolutely "must", analog others high risk industries. This article presents the most important basis principles of patient safety. The development from the error- to the safety culture is described. The terms adverse event, error and incident are defined as well other important terms and possible human pitfalls. At the end epidemiology correlations are presented, to underline the importance of patient safety in medicine. This article should help to understand the terminology of patient safety, to be able to understand the real important ideas and context of patient safety. PMID:22653716

  20. Risk prediction models for major adverse cardiac event (MACE) following percutaneous coronary intervention (PCI): A review

    Science.gov (United States)

    Manan, Norhafizah A.; Abidin, Basir

    2015-02-01

    Five percent of patients who went through Percutaneous Coronary Intervention (PCI) experienced Major Adverse Cardiac Events (MACE) after PCI procedure. Risk prediction of MACE following a PCI procedure therefore is helpful. This work describes a review of such prediction models currently in use. Literature search was done on PubMed and SCOPUS database. Thirty literatures were found but only 4 studies were chosen based on the data used, design, and outcome of the study. Particular emphasis was given and commented on the study design, population, sample size, modeling method, predictors, outcomes, discrimination and calibration of the model. All the models had acceptable discrimination ability (C-statistics >0.7) and good calibration (Hosmer-Lameshow P-value >0.05). Most common model used was multivariate logistic regression and most popular predictor was age.

  1. Perioperative Adverse Respiratory Events in Overweight/Obese Children: Systematic Review.

    Science.gov (United States)

    Kiekkas, Panagiotis; Stefanopoulos, Nikolaos; Bakalis, Nick; Kefaliakos, Antonios; Konstantinou, Evangelos

    2016-02-01

    Childhood obesity is associated with numerous respiratory disorders, which may be aggravated when general anesthesia is administered. This systematic review aimed to investigate and synthesize the published literature on the associations between childhood obesity and perioperative adverse respiratory events (PAREs). By using key terms, observational studies published between 1990 and 2014 in English-language journals indexed by Cumulative Index for Nursing and Allied Health Literature, PubMed, Web of Science, Cochrane Database, and EMBASE were searched for reports of relevant associations. Nine articles were considered eligible for inclusion. In all studies, significant univariate and multivariate associations were reported between obesity and increased risk for PAREs in pediatric patients, mainly for hypoxemia, upper airway obstruction, and difficult mask ventilation. Appropriate strategies for preventing PAREs in obese children need to be followed by health care professionals. Multicenter studies are also recommended for ensuring high generalizability of reported associations and elucidating underlying mechanisms that link obesity to PAREs. PMID:26847776

  2. Patient-reported outcomes and the evolution of adverse event reporting in oncology.

    Science.gov (United States)

    Trotti, Andy; Colevas, A Dimitrios; Setser, Ann; Basch, Ethan

    2007-11-10

    Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans. PMID:17991931

  3. Discontinuation symptoms and taper/poststudy-emergent adverse events with desvenlafaxine treatment for major depressive disorder.

    Science.gov (United States)

    Montgomery, Stuart A; Fava, Maurizio; Padmanabhan, Sudharshan K; Guico-Pabia, Christine J; Tourian, Karen A

    2009-11-01

    The objective of this study was to assess discontinuation symptoms with desvenlafaxine (administered as desvenlafaxine succinate) treatment for major depressive disorder. Data were analyzed from nine 8-week, double-blind (DB), placebo-controlled studies of desvenlafaxine (50, 100, 200, or 400 mg/day; placebo, n = 319; desvenlafaxine, n = 578) and a relapse-prevention study [12-week, open-label (OL) 200 or 400 mg/day desvenlafaxine (n = 373); 6-month DB placebo (n = 73) or desvenlafaxine (n = 118)]. Rates of taper/poststudy-emergent adverse events were summarized. Discontinuation-Emergent Signs and Symptoms (DESS) checklist scores were analyzed in treatment completers at the end of OL and DB treatment. The most common (> or = 5%) taper/poststudy-emergent adverse events among desvenlafaxine patients were dizziness, nausea, headache, irritability, diarrhea, anxiety, abnormal dreams, fatigue, and hyperhidrosis. In the short-term studies, the highest DESS scores observed for desvenlafaxine groups occurred at first assessment after discontinuation of all active treatment (1.9-5.7). Desvenlafaxine 50- and 100-mg/day groups had significantly increased scores versus placebo (P values < or = 0.028). DESS scores increased significantly for patients discontinuing 12-week, OL desvenlafaxine 200 and 400 mg/day doses compared with those continuing desvenlafaxine (P values < or = 0.022). After the 6-month DB phase, DESS scores increased significantly compared with placebo for patients discontinuing 400 mg/day only (P = 0.029). In conclusion, cessation of desvenlafaxine use is associated with discontinuation symptoms after both short-term and long-term treatment. PMID:19779354

  4. Opportunities for Web-based Drug Repositioning: Searching for Potential Antihypertensive Agents with Hypotension Adverse Events

    Science.gov (United States)

    Wang, Kejian; Wan, Mei; Wang, Rui-Sheng

    2016-01-01

    Background Drug repositioning refers to the process of developing new indications for existing drugs. As a phenotypic indicator of drug response in humans, clinical side effects may provide straightforward signals and unique opportunities for drug repositioning. Objective We aimed to identify drugs frequently associated with hypotension adverse reactions (ie, the opposite condition of hypertension), which could be potential candidates as antihypertensive agents. Methods We systematically searched the electronic records of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) through the openFDA platform to assess the association between hypotension incidence and antihypertensive therapeutic effect regarding a list of 683 drugs. Results Statistical analysis of FAERS data demonstrated that those drugs frequently co-occurring with hypotension events were more likely to have antihypertensive activity. Ranked by the statistical significance of frequent hypotension reporting, the well-known antihypertensive drugs were effectively distinguished from others (with an area under the receiver operating characteristic curve > 0.80 and a normalized discounted cumulative gain of 0.77). In addition, we found a series of antihypertensive agents (particularly drugs originally developed for treating nervous system diseases) among the drugs with top significant reporting, suggesting the good potential of Web-based and data-driven drug repositioning. Conclusions We found several candidate agents among the hypotension-related drugs on our list that may be redirected for lowering blood pressure. More important, we showed that a pharmacovigilance system could alternatively be used to identify antihypertensive agents and sustainably create opportunities for drug repositioning. PMID:27036325

  5. Atypical antipsychotics olanzapine, quetiapine, and risperidone and risk of acute major cardiovascular events in young and middle-aged adults

    DEFF Research Database (Denmark)

    Pasternak, Björn; Svanström, Henrik; Ranthe, Mattis F;

    2014-01-01

    risperidone (n = 14,134). The primary outcome was any major cardiovascular event (composite of cardiovascular mortality, acute coronary syndrome, or ischemic stroke) within 1 year following treatment initiation. Cox regression was used to estimate hazard ratios (HRs) while on current antipsychotic monotherapy......BACKGROUND: A number of serious cardiovascular safety concerns related to the use of atypical antipsychotics, compared with no use, have emerged, but nearly all reports are from studies of older patients. We aimed to compare the risk of cardiovascular events between the three most commonly used...... in the outpatient setting, adjusting for an outcome-specific disease risk score. RESULTS: The crude rate of any major cardiovascular event was 5.3 per 1,000 person-years among olanzapine users, 3.4 in quetiapine users, and 5.2 in risperidone users. Compared with risperidone, the risk of any major cardiovascular...

  6. Adverse events in patients initiated on dabigatran etexilate therapy in a pharmacist-managed anticoagulation clinic

    Directory of Open Access Journals (Sweden)

    Donaldson M

    2013-06-01

    Full Text Available Background: Vitamin K antagonists have been the treatment of choice in preventing thromboembolic events, but problems such as frequent dose adjustment and monitoring of coagulation status, including multiple drug and food interactions, make their use difficult. Dabigatran etexilate is a new oral direct thrombin inhibitor not requiring routine monitoring and since its approval in the United States, many clinicians have been interested in utilizing this new therapy. Objective: This study documented adverse drug events (ADEs recorded in patients started on dabigatran therapy, including those who were previously controlled on warfarin and those who were anticoagulant naïve. Methods: In an outpatient pharmacist-managed anticoagulation clinic, a total of 221 patients were initiated on dabigatran therapy over an 18-month period. 43.0% of these patients were previously controlled on warfarin.Results: 54 of the 221 patients (24.4% developed an ADE while on dabigatran. The average time to event was 48.4 days. Nine of the fifty-four patients experienced a major bleeding ADE; six patients developed a serious non-bleeding ADE. Five of these fifteen patients died; one death was directly related to dabigatran therapy. The remaining thirty-nine of the fifty-four patients experienced a clinically relevant non-major ADE. Of the fifty-four patients who experienced an ADE, thirty were male. The average age was 73.8 years and the average weight was 92.8kg. Fifty-four percent of those who experienced an ADE were previously anticoagulant naïve.Conclusions: While many clinicians have been interested in utilizing the new direct thrombin inhibitor dabigatran etexilate, this new therapy is not without risks. This study documented adverse drug events in 24.4% of patients who were initiated on dabigatran etexilate therapy over an eighteen month period. ADEs were more common in patients who were anticoagulant naïve prior to dabigatran etexilate therapy and not those who

  7. The Prevalence of Childhood Adversity among Healthcare Workers and Its Relationship to Adult Life Events, Distress and Impairment

    Science.gov (United States)

    Maunder, Robert G.; Peladeau, Nathalie; Savage, Diane; Lancee, William J.

    2010-01-01

    Objective: We investigated the prevalence of childhood adversity among healthcare workers and if such experiences affect responses to adult life stress. Methods: A secondary analysis was conducted of a 2003 study of 176 hospital-based healthcare workers, which surveyed lifetime traumatic events, recent life events, psychological distress, coping,…

  8. Cardiovascular toxicities of biological therapies

    DEFF Research Database (Denmark)

    Ryberg, Marianne

    2013-01-01

    effects. One serious adverse effect is the risk of cardiovascular dysfunction. Some targeted therapies, eg, treatment with monoclonal antibodies or angiogenesis inhibitors, have shown an increased risk of cardiac events. Their influence on the cardiovascular system, however, seems to be transient, but...

  9. Anhedonia Predicts Major Adverse Cardiac Events and Mortality in Patients 1 Year After Acute Coronary Syndrome

    Science.gov (United States)

    Davidson, Karina W.; Burg, Matthew M.; Kronish, Ian M.; Shimbo, Daichi; Dettenborn, Lucia; Mehran, Roxana; Vorchheimer, David; Clemow, Lynn; Schwartz, Joseph E.; Lespérance, Francois; Rieckmann, Nina

    2010-01-01

    Context Depression is a consistent predictor of recurrent events and mortality in ACS patients, but it has 2 core diagnostic criteria with distinct biological correlates—depressed mood and anhedonia. Objective To determine if depressed mood and/or anhedonia (loss of pleasure or interest) predict 1-year medical outcomes for patients with Acute Coronary Syndrome (ACS). Design Observational cohort study of post-ACS patients hospitalized between May 2003 and June 2005. Within one week of admission, patients underwent a structured psychiatric interview to assess clinically impairing depressed mood, anhedonia, and major depressive episode (MDE); also assessed were the Global Registry of Acute Coronary Events risk score, Charlson comorbidity index, left ventricular ejection fraction, antidepressant use, and depressive symptom severity. Setting Coronary care and cardiac care step-down units of 3 university hospitals in New York and Connecticut. Participants Consecutive sample of 453 ACS patients (aged 25–93 years; 42% women). Main Outcomes Measures All-cause mortality (ACM) and documented major adverse cardiac events (MACE; myocardial infarction, hospitalization for unstable angina, or urgent revascularization) were actively surveyed for 1 year after admission. Results There were 67 events (16 deaths and 51 MACE; 14.8%). 108 (24%) and 77 (17%) patients with anhedonia and depressed mood, respectively. After controlling for sex, age, and medical covariates, anhedonia (adjusted hazard ratio, 1.58; 95% confidence interval, 1.16–2.14; P<.01) and MDE (adjusted hazard ratio, 1.48; 95% confidence interval, 1.07–2.04; P=.02) were significant predictors of combined MACE/ACM, but depressed mood was not. Anhedonia continued to significantly predict outcomes controlling for MDE diagnosis and depressive symptom severity, each of which were no longer significant. Conclusions Anhedonia identifies risk for MACE/ACM beyond that of established medical prognostic indicators

  10. High intake of dietary tyramine does not deteriorate glucose handling and does not cause adverse cardiovascular effects in mice.

    Science.gov (United States)

    Carpéné, Christian; Schaak, Stéphane; Guilbeau-Frugier, Céline; Mercader, Josep; Mialet-Perez, Jeanne

    2016-09-01

    Tyramine is naturally occurring in food and induces pressor responses. Low-tyramine diets are recommended for patients treated with MAO inhibitors to avoid the fatal hypertensive crisis sadly known as "cheese effect". Hence, tyramine intake is suspected to have toxicological consequences in humans, while its administration to type 1 diabetic rodents has been reported to improve glucose tolerance. We investigated in mice whether prolonged tyramine ingestion could alter glucose homeostasis, insulin sensitivity, adipose tissue physiology or cardiovascular functions. Tyramine was added at 0.04 or 0.14 % in the drinking water since this was estimated to increase by 10- to 40-fold the spontaneous tyramine intake of control mice fed a standard diet. Ten to 12 weeks of such tyramine supplementation did not influence body weight gain, adiposity or food consumption. Both doses (reaching approx. 300 and 1100 μmol tyramine/kg bw/day) decreased nonfasting blood glucose but did not modify glucose tolerance or fasting levels of glucose, insulin or circulating lipids. Blood pressure was not increased in tyramine-drinking mice, while only the higher tested dose moderately increased heart rate without change in its variability. Markers of cardiac tissue injury or oxidative stress remained unaltered, except an increased hydrogen peroxide production in heart preparations. In isolated adipocytes, tyramine inhibited lipolysis similarly in treated and control groups, as did insulin. The lack of serious adverse cardiovascular effects of prolonged tyramine supplementation in normoglycemic mice together with the somewhat insulin-like effects found on adipose cells should lead to reconsider favourably the risk/benefit ratio of the intake of this dietary amine. PMID:26634369

  11. High-Sensitivity C-Reactive Protein as a Predictor of Cardiovascular Events after ST-Elevation Myocardial Infarction

    International Nuclear Information System (INIS)

    The association between high-sensitivity C-reactive protein and recurrent major adverse cardiovascular events (MACE) in patients with ST-elevation myocardial infarction who undergo primary percutaneous coronary intervention remains controversial. To investigate the potential association between high-sensitivity C-reactive protein and an increased risk of MACE such as death, heart failure, reinfarction, and new revascularization in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. This prospective cohort study included 300 individuals aged >18 years who were diagnosed with ST-elevation myocardial infarction and underwent primary percutaneous coronary intervention at a tertiary health center. An instrument evaluating clinical variables and the Thrombolysis in Myocardial Infarction (TIMI) and Global Registry of Acute Coronary Events (GRACE) risk scores was used. High-sensitivity C-reactive protein was determined by nephelometry. The patients were followed-up during hospitalization and up to 30 days after infarction for the occurrence of MACE. Student's t, Mann-Whitney, chi-square, and logistic regression tests were used for statistical analyses. P values of ≤0.05 were considered statistically significant. The mean age was 59.76 years, and 69.3% of patients were male. No statistically significant association was observed between high-sensitivity C-reactive protein and recurrent MACE (p = 0.11). However, high-sensitivity C-reactive protein was independently associated with 30-day mortality when adjusted for TIMI [odds ratio (OR), 1.27; 95% confidence interval (CI), 1.07-1.51; p = 0.005] and GRACE (OR, 1.26; 95% CI, 1.06-1.49; p = 0.007) risk scores. Although high-sensitivity C-reactive protein was not predictive of combined major cardiovascular events within 30 days after ST-elevation myocardial infarction in patients who underwent primary angioplasty and stent implantation, it was an independent predictor

  12. High-Sensitivity C-Reactive Protein as a Predictor of Cardiovascular Events after ST-Elevation Myocardial Infarction

    Energy Technology Data Exchange (ETDEWEB)

    Ribeiro, Daniel Rios Pinto; Ramos, Adriane Monserrat; Vieira, Pedro Lima; Menti, Eduardo; Bordin, Odemir Luiz Jr.; Souza, Priscilla Azambuja Lopes de; Quadros, Alexandre Schaan de; Portal, Vera Lúcia, E-mail: veraportal.pesquisa@gmail.com [Programa de Pós-Graduação em Ciências da Saúde: Cardiologia - Instituto de Cardiologia/Fundação Universitária de Cardiologia, Porto Alegre, RS (Brazil)

    2014-07-15

    The association between high-sensitivity C-reactive protein and recurrent major adverse cardiovascular events (MACE) in patients with ST-elevation myocardial infarction who undergo primary percutaneous coronary intervention remains controversial. To investigate the potential association between high-sensitivity C-reactive protein and an increased risk of MACE such as death, heart failure, reinfarction, and new revascularization in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. This prospective cohort study included 300 individuals aged >18 years who were diagnosed with ST-elevation myocardial infarction and underwent primary percutaneous coronary intervention at a tertiary health center. An instrument evaluating clinical variables and the Thrombolysis in Myocardial Infarction (TIMI) and Global Registry of Acute Coronary Events (GRACE) risk scores was used. High-sensitivity C-reactive protein was determined by nephelometry. The patients were followed-up during hospitalization and up to 30 days after infarction for the occurrence of MACE. Student's t, Mann-Whitney, chi-square, and logistic regression tests were used for statistical analyses. P values of ≤0.05 were considered statistically significant. The mean age was 59.76 years, and 69.3% of patients were male. No statistically significant association was observed between high-sensitivity C-reactive protein and recurrent MACE (p = 0.11). However, high-sensitivity C-reactive protein was independently associated with 30-day mortality when adjusted for TIMI [odds ratio (OR), 1.27; 95% confidence interval (CI), 1.07-1.51; p = 0.005] and GRACE (OR, 1.26; 95% CI, 1.06-1.49; p = 0.007) risk scores. Although high-sensitivity C-reactive protein was not predictive of combined major cardiovascular events within 30 days after ST-elevation myocardial infarction in patients who underwent primary angioplasty and stent implantation, it was an independent predictor

  13. Osteoprotegerin in Chronic Kidney Disease: Associations with Vascular Damage and Cardiovascular Events.

    Science.gov (United States)

    Yilmaz, Mahmut Ilker; Siriopol, Dimitrie; Saglam, Mutlu; Unal, Hilmi Umut; Karaman, Murat; Gezer, Mustafa; Kilinc, Ali; Eyileten, Tayfun; Guler, Ahmet Kerem; Aydin, İbrahim; Vural, Abdulgaffar; Oguz, Yusuf; Covic, Adrian; Ortiz, Alberto; Kanbay, Mehmet

    2016-08-01

    Vascular injury and dysfunction contribute to cardiovascular disease, the leading cause of death in patients with chronic kidney disease (CKD). Osteoprotegerin (OPG) is a soluble member of the tumor necrosis factor receptor superfamily that has been linked to atherogenesis and endothelial dysfunction. Elevated circulating OPG levels predict future cardiovascular events (CVE). Our aim was to evaluate the determinants of circulating OPG levels, to investigate the relationship between OPG and markers of vascular damage and to test whether OPG improves risk stratification for future CVE beyond traditional and renal-specific risk factors in a CKD population. 291 patients with CKD stage 1-5 not on dialysis were included in the study. In the multivariate analysis, OPG was a significant predictor for flow-mediated dilatation, but not for carotid intima media thickness levels. During follow-up (median 36 months, IQR = 32-42 months), 87 patients had CVE. In the Cox survival analysis, OPG levels were independently associated with CVE even after adjustment for traditional and renal-specific cardiovascular risk factors. The addition of OPG to a model based on commonly used cardiovascular factors significantly improved the reclassification abilities of the model for predicting CVE. We show for the first time that OPG improves risk stratification for CVE in a non-dialysis CKD population, above and beyond a model with established traditional and renal-specific cardiovascular risk factors, including estimated glomerular filtration rate and fibroblast growth factor 23. PMID:27016924

  14. Relationship between microalbuminuria and cardiovascular events in patients with diabetes and hypertention

    Directory of Open Access Journals (Sweden)

    S.M. Safavi

    2006-07-01

    Full Text Available Background: Hypertention and diabetes are important risk factors for cardiovascular disease. studies have shown that microalbuminuria is a strong predictor of cardiov-ascular disease in different population.In this study the relation of microalbuminuria with diabetes and hypertention as risk factors of atherosclerosis disease were investi-gated. Methods: Two hundered twenty eight patients with angiographically confirmed coronary atherosclerotic lesions, (mean age 60 ± 0.5 SD referred to Madani Hospital, Tabriz, Iran were studied .This patients according to the number of diseased vessels were classified in two groups. The levels of glucose and creatinine and that of post parandial glucose were determined in venous blood samples by standard methods. Immunoturbidimetric method was employed in the measurement of microalbuminuria. The results were analysed by statistical tests. Results: The increased albumin/creatinine ratio was markedly correlated with fasting blood sugar, systolic and diastolic blood pressure (P 0.05. Conclusion: The relationship between diabetes and microalbuminuria was meaningful. According to atherosclerotic lesions a marked correlation was also noticed between microalbuminuria and diabetes. These facts may contribute to the higher cardiovascular risk in diabetic patients. An associated between hypertension and microalbuminuria was noticed. The result suggests that although risk factors such as hypertension and diabetes are known to cause cardiovascular disease, microalbuminuria may in fact be a better indicator of established microvascular damage and better predictor of cardiov-ascular events.

  15. Asthma and suicide-related adverse events: a review of observational studies

    Directory of Open Access Journals (Sweden)

    N. Iessa

    2011-12-01

    Full Text Available Suicide is a major public health concern. There are several risk factors associated with suicide. Chronic illnesses, such as asthma, have been linked to an increased risk of suicide-related events. This study reviews the evidence of an association between asthma and suicide using published epidemiological observational studies. An electronic search using PubMed and EMBASE was performed. Studies that investigated the association of asthma with suicide-related behaviour were selected. Studies were examined to form a descriptive analysis. Six observational studies met the selection criteria, of which at least one suicide-related adverse event was studied. Three studies investigated completed suicide, two suicide attempts and four suicide ideation. Two of the studies focused on individuals aged <18 yrs. Evidence from observational data support the hypothesis of an association between asthma and suicide-related behaviour (ideation, attempts and completion; however, epidemiological studies, with more objective measures and larger sample sizes, adjusting for a wider scope of suicide-related confounding factors (e.g. comorbidities, and with a longitudinal design, are needed for a more conclusive answer.

  16. Risk of Major Adverse Cardiovascular Events and All-Cause Mortality in Patients With Hidradenitis Suppurativa

    DEFF Research Database (Denmark)

    Egeberg, Alexander; Gislason, Gunnar H; Hansen, Peter R

    2016-01-01

    (42 941.7 person-years) all-cause deaths occurred during follow-up. Adjusted (age, sex, socioeconomic status, smoking, comorbidity, and medication) IRRs (95% CIs) were 1.57 (1.14-2.17) for MI, 1.33 (1.01-1.76) for ischemic stroke, 1.95 (1.42-2.67) for CV-associated death, 1.53 (1.27-1.86) for MACEs...... those with severe psoriasis. The results call for increased awareness of this association and for studies of its clinical consequences....

  17. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan

    Directory of Open Access Journals (Sweden)

    Nobuhiro Handa

    2015-09-01

    Comments: Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.

  18. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

    Science.gov (United States)

    Bielefeldt, Klaus

    2016-01-01

    AIM: To investigate the nature and severity of AE related to sacral neurostimulation (SNS). METHODS: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse events, requiring an active intervention. Those problems were operationally defined as infection, device removal explant or need for lead and/or generator replacement. In addition, we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August - October of 2015. Events were included if the report specifically mentioned gastrointestinal (GI), bowel and FI as indication and if the narrative did not focus on bladder symptoms. The classification, reporter, the date of the recorded complaint, time between initial implant and report, the type of AE, steps taken and outcome were extracted from the report. In cases of device removal or replacement, we looked for confirmatory comments by healthcare providers or the manufacturer. RESULTS: Published studies reported adverse events and reoperation rates for 1954 patients, followed for 27 (1-117) mo. Reoperation rates were 18.6% (14.2-23.9) with device explants accounting for 10.0% (7.8-12.7) of secondary surgeries; rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up. During the period examined, the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication. A total of 652 reports met the inclusion criteria, with 52.7% specifically listing FI. Lack or loss of benefit (48.9%), pain or dysesthesia (27.8%) and complication at the generator implantation site (8.7%) were most commonly listed. Complaints led to secondary surgeries in 29.7% of the AE. Reoperations were performed to explant (38.2%) or replace (46.5%) the device or a lead, or revise the generator pocket (14.6%). Conservative management changes mostly involved changes in stimulation

  19. Determinants for achieving the LDL-C target of lipid control for secondary prevention of cardiovascular events in Taiwan.

    Directory of Open Access Journals (Sweden)

    Li-Ting Ho

    Full Text Available Epidemiological and clinical studies have clearly established the link between low-density lipoprotein cholesterol (LDL-C and atherosclerosis-related cardiovascular consequences. Although it has been a common practice for physicians to prescribe lipid-lowering therapy for patients with dyslipidemia, the achievement rate is still not satisfied in Taiwan. Therefore, the determinants for achieving the LDL-C target needed to be clarified for better healthcare of the patients with dyslipidemia.This registry-type prospective observational study enrolled the patients with cardiovascular diseases (coronary artery disease (CAD and cerebrovascular disease (CVD from 18 medical centers across Taiwan, and clinically followed them for five years. At every clinical visit, vital signs, clinical endpoints, adverse events, concurrent medications and laboratory specimens were obtained as thoroughly as possible. The lipid profile (total cholesterol, high-density lipoprotein cholesterol, LDL-C, triglyceride, liver enzymes, and creatinine phosphokinase were evaluated at baseline, and every year thereafter. The cross sectional observational data was analyzed for this report.Among the 3,486 registered patients, 54% had their LDL-C < 100 mg/dL. By univariate analysis, the patients achieving the LDL-C target were associated with older age, more male sex, taller height, lower blood pressure, more under lipid-lowering therapy, more smoking cessation, more history of CAD, DM, physical activity, but less history of CVD. The multivariate analysis showed statin therapy was the most significant independent determinant for achieving the treatment target, followed by age, history of CAD, diabetes, blood pressure, and sex. However, most patients were on regimens of very-low to low equipotent doses of statins.Although the lipid treatment guideline adherence is improving in recent years, only 54% of the patients with cardiovascular diseases have achieved their LDL-C target in Taiwan

  20. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Science.gov (United States)

    Davies, Emma C; Chandler, Clare I R; Innocent, Simeon H S; Kalumuna, Charles; Terlouw, Dianne J; Lalloo, David G; Staedke, Sarah G; Haaland, Ane

    2012-01-01

    The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality

  1. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Directory of Open Access Journals (Sweden)

    Emma C Davies

    Full Text Available The wide-scale roll-out of artemisinin combination therapies (ACTs for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV relies on adverse event (AE reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings

  2. The predictive value of arterial and valvular calcification for mortality and cardiovascular events

    OpenAIRE

    Nicoll, Rachel; Michael Y. Henein

    2014-01-01

    A review of the predictive ability of arterial and valvular calcification has shown an additive effect of calcification in more than 1 location in predicting mortality and coronary heart disease, with mitral annual calcification being a particularly strong predictor. In individual arteries and valves there is a clear association between calcification presence, extent and progression and future cardiovascular events and mortality in asymptomatic, symptomatic and high risk patients, although ad...

  3. Associations between stress disorders and cardiovascular disease events in the Danish population

    OpenAIRE

    Gradus, Jaimie L; Farkas, Dóra Körmendiné; Svensson, Elisabeth; Ehrenstein, Vera; Lash, Timothy L; Milstein, Arnold; Adler, Nancy ,; Sørensen, Henrik Toft

    2015-01-01

    Objectives Post-traumatic stress disorder (PTSD) is a well-documented risk factor for cardiovascular disease (CVD). However, it is unknown whether another common stress disorder—adjustment disorder—is also associated with an increased risk of CVD and whether gender modifies these associations. The aim of this study was to examine the overall and gender-stratified associations between PTSD and adjustment disorder and 4 CVD events. Design Prospective cohort study utilising Danish national regis...

  4. Identification of major cardiovascular events in patients with diabetes using primary care data

    OpenAIRE

    Pouwels, Koen Bernardus; Voorham, Jaco; Hak, Eelko; Denig, Petra

    2016-01-01

    Background Routine primary care data are increasingly being used for evaluation and research purposes but there are concerns about the completeness and accuracy of diagnoses and events captured in such databases. We evaluated how well patients with major cardiovascular disease (CVD) can be identified using primary care morbidity data and drug prescriptions. Methods The study was conducted using data from 17,230 diabetes patients of the GIANTT database and Dutch Hospital Data register. To esti...

  5. The association of hypertriglyceridemia with cardiovascular events and pancreatitis: a systematic review and meta-analysis

    OpenAIRE

    Murad M Hassan; Hazem Ahmad; Coto-Yglesias Fernando; Dzyubak Svitlana; Gupta Shabnum; Bancos Irina; Lane Melanie A; Erwin Patricia J; Berglund Lars; Elraiyah Tarig; Montori Victor M

    2012-01-01

    Abstract Background Hypertriglyceridemia may be associated with important complications. The aim of this study is to estimate the magnitude of association and quality of supporting evidence linking hypertriglyceridemia to cardiovascular events and pancreatitis. Methods We conducted a systematic review of multiple electronic bibliographic databases and subsequent meta-analysis using a random effects model. Studies eligible for this review followed patients longitudinally and evaluated quantita...

  6. Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy

    Science.gov (United States)

    Egholm, Gro; Thim, Troels; Madsen, Morten; Sørensen, Henrik Toft; Pedersen, Jan Bech; Eggert Jensen, Svend; Jensen, Lisette Okkels; Kristensen, Steen Dalby; Bøtker, Hans Erik; Maeng, Michael

    2016-01-01

    Background and study aims: Dual antiplatelet therapy (DAPT) is recommended following percutaneous coronary intervention (PCI) with drug-eluting stent (DES). DAPT is a risk factor for gastrointestinal bleeding. We aimed to quantify (1) the rate of gastroscopy within 12 months after PCI, (2) the rate of adverse cardiac events and gastroscopy-related bleeding complications within 30 days of gastroscopy, and (3) the association between antiplatelet therapy and these events. Patients and methods: Patients receiving gastroscopy within 12 months of PCI were identified and two nested case-control analyses were performed within the PCI cohort by linking Danish medical registries. Cases were patients with adverse cardiac events (cardiac death, myocardial infarction, or stent thrombosis) or hemostatic intervention. In both studies, controls were patients with gastroscopy including biopsy without adverse cardiac events and hemostatic intervention, respectively. Medical records were reviewed to obtain information on exposure to DAPT. Results: We identified 22 654 PCI patients of whom 1497 patients (6.6 %) underwent gastroscopy. Twenty-two patients (1.5 %) suffered an adverse cardiac event, 93 patients (6.2 %) received hemostatic intervention during or within 30 days of the index gastroscopy. Interrupting DAPT was associated with a 3.46 times higher risk of adverse cardiac events (95 %CI 0.49 – 24.7). Discontinuation of one antiplatelet agent did not increase the risk (OR 0.65, 95 %CI 0.17 – 2.47). No hemostatic interventions were caused by endoscopic complications. Conclusion: Gastroscopy can be safely performed in PCI patients treated with DES and single antiplatelet therapy while interruption of DAPT may be associated with an increased risk of adverse cardiac events. PMID:27227109

  7. Safe Oral Triiodo-L-Thyronine Therapy Protects from Post-Infarct Cardiac Dysfunction and Arrhythmias without Cardiovascular Adverse Effects.

    Directory of Open Access Journals (Sweden)

    Viswanathan Rajagopalan

    Full Text Available A large body of evidence suggests that thyroid hormones (THs are beneficial for the treatment of cardiovascular disorders. We have shown that 3 days of triiodo-L-thyronine (T3 treatment in myocardial infarction (MI rats increased left ventricular (LV contractility and decreased myocyte apoptosis. However, no clinically translatable protocol is established for T3 treatment of ischemic heart disease. We hypothesized that low-dose oral T3 will offer safe therapeutic benefits in MI.Adult female rats underwent left coronary artery ligation or sham surgeries. T3 (~6 μg/kg/day was available in drinking water ad libitum immediately following MI and continuing for 2 month(s (mo. Compared to vehicle-treated MI, the oral T3-treated MI group at 2 mo had markedly improved anesthetized Magnetic Resonance Imaging-based LV ejection fraction and volumes without significant negative changes in heart rate, serum TH levels or heart weight, indicating safe therapy. Remarkably, T3 decreased the incidence of inducible atrial tachyarrhythmias by 88% and improved remodeling. These were accompanied by restoration of gene expression involving several key pathways including thyroid, ion channels, fibrosis, sympathetic, mitochondria and autophagy.Low-dose oral T3 dramatically improved post-MI cardiac performance, decreased atrial arrhythmias and cardiac remodeling, and reversed many adverse changes in gene expression with no observable negative effects. This study also provides a safe and effective treatment/monitoring protocol that should readily translate to humans.

  8. Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

    OpenAIRE

    Ficheur, Grégoire; Chazard, Emmanuel; Beuscart, Jean-Baptiste; Merlin, Béatrice; Luyckx, Michel; Beuscart, Régis

    2014-01-01

    Background Adverse drug reactions and adverse drug events (ADEs) are major public health issues. Many different prospective tools for the automated detection of ADEs in hospital databases have been developed and evaluated. The objective of the present study was to evaluate an automated method for the retrospective detection of ADEs with hyperkalaemia during inpatient stays. Methods We used a set of complex detection rules to take account of the patient’s clinical and biological context and th...

  9. Transfusion-related adverse events at the tertiary care center in North India: An institutional hemovigilance effort

    OpenAIRE

    Bhattacharya Prasun; Marwaha Neelam; Dhawan Hari; Roy Pallab; Sharma R

    2011-01-01

    Aim: This study was designed to analyze the incidence and spectrum of adverse effects of blood transfusion so as to initiate measures to minimize risks and improve overall transfusion safety in the institute. Materials and Methods: During the period from July 2002 to July 2003 all the adverse events related to transfusion of blood and blood components in various clinical specialties were recorded. They were analyzed and classified on the basis of their clinical features and laboratory tests. ...

  10. Therapeutic effects and associated adverse events of multikinase inhibitors in metastatic renal cell carcinoma: A meta-analysis

    OpenAIRE

    TAN, QINXIANG; WANG, WEIHUA; LONG, YOUHONG; CHEN, GUOZI

    2015-01-01

    This study aimed to compare the therapeutic effects and adverse events of the multikinase inhibitors sorafenib, sunitinib, pazopanib and axitinib in advanced renal cell carcinoma (RCC). A meta-analysis of randomized controlled trials was performed to assess the effects of multikinase inhibitors among patients with advanced RCC. The data of median progression-free survival (PFS), median overall survival (OS), progressive disease rate (PDR), objective response rate (ORR) and grade 3/4 adverse e...

  11. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS)

    Science.gov (United States)

    Ali, A. K.

    2013-01-01

    Background: Immunosuppression by biologic response modifiers (BRM) is a crucial component for successful organ transplantation. In addition to their variable effectiveness in the prevention of organ rejection, these medications have safety concerns that complicate therapeutic outcomes in organ transplant patients. Objective: This study aims at identifying and characterizing safety signals of serious adverse events associated with exposure to BRM among organ transplant patients in a real-world environment. Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionality analysis to indentify serious adverse events. Associations between drugs and events were measured by empirical Bayes geometric mean (EBGM) and the corresponding 95% confidence intervals (EB05–EB95). Associations with EBGM≥2 were considered significant safety signals. Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6% of them (n=1,711) met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199) were significant (EBGM≥2). Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyte immunoglobulin (ATI) and cyclosporine contributed to the majority of significant signals. The following significant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension, serum sickness, infusion-related reaction, and anaphylactic reaction); for azathioprine (alternaria infection, fungal skin infection, and lymphoproliferative disorder); for cyclosporine (neurotoxicity, graft vs. host disease, and thyroid cancer); for cyclophosphamide (disease progression); for daclizumab (cytomegalovirus infection); and for tacrolimus (coma and tremor). 33.6% of these events contributed to patient death (n=67); 6.5% were life-threatening (n=13); 32.1% lead to hospitalization (n=64); and 27.6% resulted in other serious outcomes (n=55). Conclusion: Utilization

  12. Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases.

    Science.gov (United States)

    Sasaoka, Sayaka; Matsui, Toshinobu; Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Natsumi; Hane, Yuuki; Motooka, Yumi; Hatahira, Haruna; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2016-01-01

      The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome. PMID:26935094

  13. Neutralization of IL-8 prevents the induction of dermatologic adverse events associated with the inhibition of epidermal growth factor receptor

    DEFF Research Database (Denmark)

    Bangsgaard, Nannie; Houtkamp, Mischa; Schuurhuis, Danita H;

    2012-01-01

    to treatment. Currently, the pathways involved in EGFR inhibitor-induced rash are poorly understood and few treatment options for this adverse event are available. Here, we developed a model for induction of papulopustular rash in healthy human volunteers by subcutaneous injection of the anti-EGFR monoclonal......, characterized by acute follicular neutrophil-rich hair follicle inflammation, and thus mimicked adverse events induced by systemic administration of EGFR inhibitors. In this model, we tested the hypothesis that neutrophils, attracted by IL-8, play a central role in the observed rash. Indeed, concomitant local...... repeat dose treatment with HuMab-10F8, a neutralizing human antibody against IL-8, reduced the rash. Inhibition of IL-8 can therefore ameliorate dermatological adverse events induced by treatment with EGFR inhibitors....

  14. Seamless prevention of adverse events from tattooing: integrated strategy emphasising the customer-tattooist interaction.

    Science.gov (United States)

    Serup, Jørgen

    2015-01-01

    The boom in tattooing has been paralleled by more frequent adverse events, which may be localised in the skin or systemic and manifested clinically or latent. Infections, allergic reactions from red-coloured tattoos and papulo-nodular reactions from black tattoos dominate. Mild complaints are very common, with 1/5 of all tattooed individuals having acquired sensitivity to sunlight in the tattooed skin. The potential risk of cancer due to potential carcinogens in some tattoo inks has hitherto not manifested in clinical reports, despite the millions of people who have been tattooed over many decades. A risk of death from tattooing remains associated with severe infection, i.e. sepsis. Preventive strategies may rely on focused preventions, and sterility and preservation of ink is essential, rational and knowledge-based. The chemical and particle contents of ink nanoparticles cannot be unrestricted; however, focused control of ink is facing many uncertainties, including analytical problems, lack of identification of allergens in ink and discrepancies between the content of potential carcinogens and manifestation of cancer in the clinic. The concept of seamless prevention is introduced as a pragmatic strategy that emphasises the customer-tattooist interaction, which is the 'engine' of tattoo safety. This strategy amalgamates the range of narrow-scope preventive instruments and shall ensure that any relevant instrument is used actively and without deficiency or drop out, thus resulting in a complete orchestration of a multi-targeted strategy. High-priority elements of this strategy shall facilitate a qualified 'go' or 'no go' decision by the customer before the tattoo is made and should involve informed consent, qualification of the tattooist and the parlour, including supplies of inks etc., and attention to hygienic security. Records and documentation of tattoo cases with complications and the culprit inks as well as the establishment of national or European

  15. ApoL1 levels in high density lipoprotein and cardiovascular event presentation in patients with familial hypercholesterolemia.

    Science.gov (United States)

    Cubedo, Judit; Padró, Teresa; Alonso, Rodrigo; Mata, Pedro; Badimon, Lina

    2016-06-01

    HDL composition rather than HDL-cholesterol (HDL-C) levels seems to be a key determinant of HDL-induced atheroprotection. Heterozygous familial hypercholesterolemia (FH) patients, with lifelong exposure to high LDL levels, show a high prevalence of premature coronary artery disease. We hypothesized that HDL of FH patients might have a modified protein composition and investigated the proteomic signature of HDL obtained from FH patients and their unaffected relatives. HDLs were characterized by 2D electrophoresis/MS in 10 families from the SAFEHEART cohort (3 individuals/family: 2 with genetic FH diagnosis and 1 non-FH relative) clinically characterized and treated as per guidelines. FH patients had lower apoA-I levels and a differential HDL distribution profile of apoL1 and apoA-IV. ELISA validation revealed decreased apoL1 serum levels in FH patients. ApoL1 levels were able to predict presentation of an ischemic cardiac event, and apoL1/HDL-C ratio was associated with the survival rate after the event. FH patients who died because of a fatal cardiac event had lower apoL1 and LCAT content in HDL3 an average of 3.5 years before the event than those who survived. Changes in HDL protein composition could affect patients' prognosis. The proteomic profile of apoL1 is modified in HDLs of high cardiovascular risk patients, and apoL1 plasma levels are significantly lower in serum and in HDL3 of patients that will suffer an adverse cardiac event within 3 years. PMID:27112635

  16. Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib

    DEFF Research Database (Denmark)

    Lipsky, Andrew H; Farooqui, Mohammed Z H; Tian, Xin;

    2015-01-01

    Ibrutinib is associated with bleeding-related adverse events of grade ≤2 in severity, and infrequently with grade ≥3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated t......Ibrutinib is associated with bleeding-related adverse events of grade ≤2 in severity, and infrequently with grade ≥3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator......-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤2 bleeding-related adverse events in 55% of 85 patients. No grade ≥3 events occurred. Median time to event was 49 days. The cumulative incidence of an event plateaued by 6 months...... 19 patients on ibrutinib (often transiently). Collagen and adenosine diphosphate induced platelet aggregation was tested using whole blood aggregometry. Compared to normal controls, response to both agonists was decreased in all patients with chronic lymphocytic leukemia, whether on ibrutinib or not...

  17. Adaptation options for wheat in Europe will be limited by increased adverse weather events under climate change.

    Science.gov (United States)

    Trnka, Miroslav; Hlavinka, Petr; Semenov, Mikhail A

    2015-11-01

    Ways of increasing the production of wheat, the most widely grown cereal crop, will need to be found to meet the increasing demand caused by human population growth in the coming decades. This increase must occur despite the decrease in yield gains now being reported in some regions, increased price volatility and the expected increase in the frequency of adverse weather events that can reduce yields. However, if and how the frequency of adverse weather events will change over Europe, the most important wheat-growing area, has not yet been analysed. Here, we show that the accumulated probability of 11 adverse weather events with the potential to significantly reduce yield will increase markedly across all of Europe. We found that by the end of the century, the exposure of the key European wheat-growing areas, where most wheat production is currently concentrated, may increase more than twofold. However, if we consider the entire arable land area of Europe, a greater than threefold increase in risk was predicted. Therefore, shifting wheat production to new producing regions to reduce the risk might not be possible as the risk of adverse events beyond the key wheat-growing areas increases even more. Furthermore, we found a marked increase in wheat exposure to high temperatures, severe droughts and field inaccessibility compared with other types of adverse events. Our results also showed the limitations of some of the presently debated adaptation options and demonstrated the need for development of region-specific strategies. Other regions of the world could be affected by adverse weather events in the future in a way different from that considered here for Europe. This observation emphasizes the importance of conducting similar analyses for other major wheat regions. PMID:26577595

  18. Cardioversion and Risk of Adverse Events with Dabigatran versus Warfarin-A Nationwide Cohort Study.

    Directory of Open Access Journals (Sweden)

    Jannik Langtved Pallisgaard

    Full Text Available Cardioversion can rapidly and effectively restore sinus rhythm in patients with persistent atrial fibrillation. Since 2011 dabigatran has been available as an alternative to warfarin to prevent thromboembolic events in patients with non-valvular atrial fibrillation undergoing cardioversion. We studied time to cardioversion, risk of adverse events, and risk of readmission with atrial fibrillation after cardioversion according to anticoagulation therapy.Through the nationwide Danish registries we included 1,230 oral anticoagulation naïve patients with first time non-valvular atrial fibrillation and first time cardioversion from 2011 to 2012; 37% in the dabigatran group (n = 456, and 63% in the warfarin group (n = 774. Median time to cardioversion was 4.0 (interquartile range [IQR] 2.9 to 6.5 and 6.9 (IQR 3.9 to 12.1 weeks in the dabigatran and warfarin groups respectively, and the adjusted odds ratio of cardioversion within the first 4 weeks was 2.3 (95% confidence interval [CI] 1.7 to 3.1 in favor of dabigatran. The cumulative incidence of composite endpoint of stroke, bleeding or death were 2.0% and 1.0% at 30 weeks in the warfarin and dabigatran groups respectively, with an adjusted hazard ratio of 1.33 (95% CI 0.33 to 5.42. Cumulative incidence of readmission with atrial fibrillation after 30 weeks were 9% and 11% in the warfarin and dabigatran groups, respectively, and an adjusted hazard ratio of 0.66 (95% CI 0.41 to 1.08.Anticoagulation treatment with dabigatran allows shorter time to cardioversion for atrial fibrillation than warfarin, and appears to be an effective and safe alternative treatment strategy to warfarin.

  19. Blood rheology at term in normal pregnancy and in patients with adverse outcome events.

    Science.gov (United States)

    von Tempelhoff, Georg-Friedrich; Velten, Eva; Yilmaz, Asli; Hommel, Gerhard; Heilmann, Lothar; Koscielny, Jürgen

    2009-01-01

    Plasma volume expansion of more than 1.5 l and sustainable activation of the hemostatic system that results in a steady rise of the fibrinogen/fibrin turnover are contemporary physiological events during normal pregnancy. In contrast, adverse outcome of pregnancy i.e. pre-eclampsia commonly coincide with hemo concentration and over activation of blood coagulation both of which alter blood rheology. On the basis of 4,985 consecutively recorded singleton pregnancies values range of blood rheological parameters in women with normal and complicated outcome of pregnancy at the time of their delivery were compared. Plasma viscosity (pv) was determined using KSPV 1 Fresenius and RBC aggregation (stasis: E0 and low shear: E1) using MA1-Aggregometer; Myrenne. Seventy-nine point four percent (n=3,959) had normal pregnancy outcome and 1,026 with adverse outcome of pregnancy had pre-eclampsia (8.4%; n=423), had newborn with a birth-weight < 2,500 g (9.5%; n=473), had early-birth before week 37 (9.3%; n=464), and/or were diagnosed with intra uterine growth retardation (IUGR) (5.0%; n=250). In women with normal pregnancy outcome mean (+/-SD) of pv was 1.31+/-0.09 mPa s, of E0 was 21.6+/-5.3, and of E1 was 38.4+/-7.9 while in women with adverse outcome means for rheological parameters were statistically significantly different i.e. pv: 1.32+/-0.08 mPa s; p=0.006, E0: 22.1+/-5.5; p=0.002 and E1: 39.5+/-8.5; p=0.0006. Subgroup analysis revealed statistical significant lower pv in women who either had pre term delivery or a low birth-weight child (p<0.005) as compared to women who had normal pregnancy outcome while patients with pre-eclampsia had markedly higher low shear and stasis RBC aggregation (p<0.0001). None of the rheological results at term were correlated with either maternal age (r<0.04), BMI (r<0.09), maternal weight gain until delivery (r<0.04), or fetal outcome such as APGAR-score (r<0.09) art. pH in the umbilical cord (-0.05

  20. Adverse event management strategies: optimizing treatment with regorafenib in patients with metastatic colorectal cancer.

    Science.gov (United States)

    Mitchell, Jessica; Khoukaz, Taline; McNeal, Deborah; Brent, Lori

    2014-04-01

    Patients with metastatic colorectal cancer (mCRC) frequently experience treatment-related adverse events (AEs), which may lead to nonadherence or discontinuation from their treatment regimen. In the phase 3 CORRECT study, the addition of regorafenib to best supportive care (BSC) significantly increased overall survival and progression-free survival compared with placebo plus BSC in patients with mCRC who had progressed on all approved standard care therapies. Although regorafenib showed an acceptable safety profile, patients experienced treatment-related AEs such as hand-foot skin reaction, hypertension, oral mucositis, diarrhea, fatigue, and liver abnormalities. The goal of this article is to help oncology nurses implement a strategic, proactive approach to AE management in patients mCRC treated with regorafenib. The article reviews the most common AEs associated with regorafenib in patients who participated in the CORRECT study and provides a strategy and practical measures that nurses can apply to AE management. In addition, the article provides direction and guidance for educating patients and their caregivers on recognizing and managing potential side effects of regorafenib. PMID:24675266

  1. High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

    Science.gov (United States)

    Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

    2010-01-01

    Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates. PMID:21347109

  2. Managing the Risk of Adverse Events Using the Example of a Hospital in Wroclaw

    Directory of Open Access Journals (Sweden)

    Kaleta Agata Lisiewicz

    2014-12-01

    Full Text Available Health Care Centres are institutions which, because of their specificity and character, are particularly exposed to various kinds of risk. One of the most important and most frequently used methods of risk management is the black spots method. The research material collected for the study comes from one of the hospitals in Wrocław. All hospital stays of the C22 (Face and Jaw Surgery Ward and H05 (Injury and Orthopaedics Surgery Ward settlement groups (DRG were analysed - a total of 178 hospitalisations. The black spots method was used in the study, which consisted of risk identification, the ordering of threats and proposals for remedial actions. Using the black spots method, it was possible to identify adverse events that occurred during the hospitalisation of patients with H05 and C22 DRGs in the Injury and Orthopaedics Surgery Ward and Facial and Jaw Surgery Ward. In both cases, the treatment costs for patients with complications were higher than for the stays without complications.

  3. Biological treatment in rheumatic diseases: results from a longitudinal surveillance: adverse events.

    Science.gov (United States)

    Konttinen, L; Honkanen, V; Uotila, T; Pöllänen, J; Waahtera, M; Romu, M; Puolakka, K; Vasala, M; Karjalainen, A; Luukkainen, R; Nordström, D C

    2006-08-01

    The objective of this study was to assess the long-term safety and tolerability of biologicals in a clinical setting. Data on adverse events (AEs) have been collected over a 5-year period by means of detailed reports sent in to the National Register of Biological Treatment in Finland (ROB-FIN) and validated by information collected by the National Agency for Medicines. Three hundred and eight reports on AEs were filed, concerning a total of 248 patients; this corresponds to 17% of all patients in the ROB-FIN register who started biological treatments. Skin reactions and infections comprised 35 and 28% of the AEs, respectively. Some cases of tuberculosis and other infections, heart failure and demyelinating conditions were seen. Our work demonstrates no unexpected AEs in a Finnish patient cohort consisting of rheumatoid arthritis and spondylarthropathy patients, although many of them were treated with combination treatments in common use in Finland. Biological treatment appears safe in the hands of the Finnish rheumatologists. PMID:16402217

  4. A simple Bayesian approach to quantifying confidence level of adverse event incidence proportion in small samples.

    Science.gov (United States)

    Liu, Fang

    2016-01-01

    In both clinical development and post-marketing of a new therapy or a new treatment, incidence of an adverse event (AE) is always a concern. When sample sizes are small, large sample-based inferential approaches on an AE incidence proportion in a certain time period no longer apply. In this brief discussion, we introduce a simple Bayesian framework to quantify, in small sample studies and the rare AE case, (1) the confidence level that the incidence proportion of a particular AE p is over or below a threshold, (2) the lower or upper bounds on p with a certain level of confidence, and (3) the minimum required number of patients with an AE before we can be certain that p surpasses a specific threshold, or the maximum allowable number of patients with an AE after which we can no longer be certain that p is below a certain threshold, given a certain confidence level. The method is easy to understand and implement; the interpretation of the results is intuitive. This article also demonstrates the usefulness of simple Bayesian concepts when it comes to answering practical questions. PMID:26098967

  5. Data-driven Markov models and their application in the evaluation of adverse events in radiotherapy

    International Nuclear Information System (INIS)

    Decision-making processes in medicine rely increasingly on modelling and simulation techniques; they are especially useful when combining evidence from multiple sources. Markov models are frequently used to synthesize the available evidence for such simulation studies, by describing disease and treatment progress, as well as associated factors such as the treatment's effects on a patient's life and the costs to society. When the same decision problem is investigated by multiple stakeholders, differing modelling assumptions are often applied, making synthesis and interpretation of the results difficult. This paper proposes a standardized approach towards the creation of Markov models. It introduces the notion of 'general Markov models', providing a common definition of the Markov models that underlie many similar decision problems, and develops a language for their specification. We demonstrate the application of this language by developing a general Markov model for adverse event analysis in radiotherapy and argue that the proposed method can automate the creation of Markov models from existing data. The approach has the potential to support the radiotherapy community in conducting systematic analyses involving predictive modelling of existing and upcoming radiotherapy data. We expect it to facilitate the application of modelling techniques in medical decision problems beyond the field of radiotherapy, and to improve the comparability of their results. (author)

  6. On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events

    Science.gov (United States)

    Späth, Peter J.; Granata, Guido; La Marra, Fabiola; Kuijpers, Taco W.; Quinti, Isabella

    2015-01-01

    Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase of the off-label uses, a topic dealt with in another contribution to this special issue of Frontiers in Immunology. A part of the success is the adverse event (AE) profile of IgG concentrates which is, even at life-long need for therapy, excellent. Transmission of pathogens in the last decade could be entirely controlled through the antecedent introduction by authorities of a regulatory network and installing quality standards by the plasma fractionation industry. The cornerstone of the regulatory network is current good manufacturing practice. Non-infectious AEs occur rarely and mainly are mild to moderate. However, in recent times, the increase in frequency of hemolytic and thrombotic AEs raised worrying questions on the possible background for these AEs. Below, we review elements of non-infectious AEs, and particularly focus on hemolysis and thrombosis. We discuss how the introduction of plasma fractionation by ion-exchange chromatography and polishing by immunoaffinity chromatographic steps might alter repertoire of specificities and influence AE profiles and efficacy of IgG concentrates. PMID:25699039

  7. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    Science.gov (United States)

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. PMID:26518315

  8. Affective and Cardiovascular Responding to Unpleasant Events from Adolescence to Old Age: Complexity of Events Matters

    Science.gov (United States)

    Wrzus, Cornelia; Muller, Viktor; Wagner, Gert G.; Lindenberger, Ulman; Riediger, Michaela

    2013-01-01

    Two studies investigated the "overpowering hypothesis" as a possible explanation for the currently inconclusive empirical picture on age differences in affective responding to unpleasant events. The overpowering hypothesis predicts that age differences in affective responding are particularly evident in highly resource-demanding situations that…

  9. Erectile dysfunction and cardiovascular events in diabetic men: a meta-analysis of observational studies.

    Directory of Open Access Journals (Sweden)

    Tomohide Yamada

    Full Text Available BACKGROUND: Several studies have shown that erectile dysfunction (ED influences the risk of cardiovascular events (CV events. However, a meta-analysis of the overall risk of CV events associated with ED in patients with diabetes has not been performed. METHODOLOGY/PRINCIPAL FINDINGS: We searched MEDLINE and the Cochrane Library for pertinent articles (including references published between 1951 and April 22, 2012. English language reports of original observational cohort studies and cross-sectional studies were included. Pooled effect estimates were obtained by random effects meta-analysis. A total of 3,791 CV events were reported in 3 cohort studies and 9 cross-sectional studies (covering 22,586 subjects. Across the cohort studies, the overall odds ratio (OR of diabetic men with ED versus those without ED was 1.74 (95% confidence interval [CI]: 1.34-2.27; P0.05. Moreover, meta-regression analysis found no relationship between the method used to assess ED (questionnaire or interview, mean age, mean hemoglobin A(1c, mean body mass index, or mean duration of diabetes and the risk of CV events or CHD. In the cross-sectional studies, the OR of diabetic men with ED versus those without ED was 3.39 (95% CI: 2.58-4.44; P<0.001 for CV events (N = 9, 3.43 (95% CI: 2.46-4.77; P<0.001 for CHD (N = 7, and 2.63 (95% CI: 1.41-4.91; P = 0.002 for peripheral vascular disease (N = 5. CONCLUSION/SIGNIFICANCE: ED was associated with an increased risk of CV events in diabetic patients. Prevention and early detection of cardiovascular disease are important in the management of diabetes, especially in view of the rapid increase in its prevalence.

  10. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS

    Directory of Open Access Journals (Sweden)

    A. K. Ali

    2013-04-01

    Full Text Available Background: Immunosuppression by biologic response modifiers (BRM is a crucial component for successfulorgan transplantation. In addition to their variable effectiveness in the prevention of organ rejection,these medications have safety concerns that complicate therapeutic outcomes in organ transplantpatients.Objective: This study aims at identifying and characterizing safety signals of serious adverse events associatedwith exposure to BRM among organ transplant patients in a real-world environment.Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionalityanalysis to indentify serious adverse events. Associations between drugs and events weremeasured by empirical Bayes geometric mean (EBGM and the corresponding 95% confidence intervals(EB05–EB95. Associations with EBGM≥2 were considered significant safety signals.Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6%of them (n=1,711 met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199 weresignificant (EBGM≥2. Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyteimmunoglobulin (ATI and cyclosporine contributed to the majority of significant signals. The followingsignificant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension,serum sickness, infusion-related reaction, and anaphylactic reaction; for azathioprine (alternariainfection, fungal skin infection, and lymphoproliferative disorder; for cyclosporine (neurotoxicity,graft vs. host disease, and thyroid cancer; for cyclophosphamide (disease progression; for daclizumab(cytomegalovirus infection; and for tacrolimus (coma and tremor. 33.6% of these events contributedto patient death (n=67; 6.5% were life-threatening (n=13; 32.1% lead to hospitalization (n=64; and27.6% resulted in other serious outcomes (n=55.Conclusion: Utilization of BRM for the

  11. ADVERSE EVENTS POST-DTAP AND DTwP VACCINATION IN THAI CHILDREN.

    Science.gov (United States)

    Fortuna, Librada; Sirivichayakul, Chukiat; Watanaveeradej, Veerachai; Soonthornworasiri, Ngamphol; Sitcharungsi, Raweerat

    2015-07-01

    We conducted a prospective study to compare the development of fever (axillary T ≥ 37.9 °C) within 4 hours of vaccination, determine the proportion of children who develop high fever (T ≥ 39°C) and evaluate parental days missed from work due to their children's vaccination with either the diphtheria-tetanus-whole cell pertussis (DTwP) or diphtheria-tetanus-acellular pertussis (DTaP) vaccine. The results of this study can help physicians and parents decide whether to have their child vaccinated with the DTwP or more expensive DTaP vaccine. We studied 140 healthy Thai children aged 2 months to 6 years from December 2011 to March 2012 who presented for vaccination. Parents recorded their child's temperature, local and systemic adverse reactions and missed days from work due to these adverse events on a diary card. Of the 140 participants, 72 received the DTwP vaccine and 68 received the DTaP vaccine. The median (IQR) age was 4 (2-6) months and the median weight was 7.1 (5.6-8.7) kg. Twenty children developed fever (axillary T ≥ 37.9°C) within 4 hours following vaccination, 17 (23.6%) had received the DTwP vaccine and 3 (4.4%) had received the DTaP vaccine (p = 0.040). One child (1.4%) who had received the DTwP vaccine and none who received the DTaP vaccine developed high fever (T ≥ 39°C) within 4 hours of vaccination (p = 0.329). Parents of two children who received the DTwP vaccine and one child who received the DTaP vaccine missed work following vaccination (p = 0.059). In conclusion, children who received the DTwP vaccines were more likely to have early post-vaccination fever and higher fever but there was no significant difference between the two groups in parental days lost from work. PMID:26867397

  12. Small artery structure is an independent predictor of cardiovascular events in essential hypertension

    DEFF Research Database (Denmark)

    Mathiassen, Ole Norling; Buus, Niels Henril; Sihm, Inger;

    2007-01-01

    Objective Structural abnormality of resistance arteries is a characteristic pathophysiological phenomenon in essential hypertension and can be assessed in vitro as an increase in the media : lumen ratio (M : L) of isolated small arteries. We have investigated whether M: L is a risk predictor in......). Conclusion Abnormal resistance artery structure independently predicts cardiovascular events in essential hypertensive patients at moderate risk. J Hypertens 25:1021-1026 Q 2007 Lippincott Williams & Wilkins. Journal of Hypertension 2007, 25:1021-1026...... uncomplicated essential hypertensive patients. Recently, high M: L was demonstrated as a prognostic marker in patients at high cardiovascular risk, including normotensive type 2 diabetic patients. Since diabetes is associated with pressure-independent changes in M: L, the relevance of this finding to essential...

  13. Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy

    OpenAIRE

    Egholm, Gro; Thim, Troels; Madsen, Morten; Sørensen, Henrik Toft; Pedersen, Jan Bech; Eggert Jensen, Svend; Jensen, Lisette Okkels; Kristensen, Steen Dalby; Bøtker, Hans Erik; Maeng, Michael

    2016-01-01

    Background and study aims: Dual antiplatelet therapy (DAPT) is recommended following percutaneous coronary intervention (PCI) with drug-eluting stent (DES). DAPT is a risk factor for gastrointestinal bleeding. We aimed to quantify (1) the rate of gastroscopy within 12 months after PCI, (2) the rate of adverse cardiac events and gastroscopy-related bleeding complications within 30 days of gastroscopy, and (3) the association between antiplatelet therapy and these events. Patients and methods: ...

  14. TYPES OF TREMOR IN PATIENTS WITH CEREBROVASCULAR DISEASES AND CARDIOVASCULAR EVENTS

    Directory of Open Access Journals (Sweden)

    Petrov Igor

    2016-03-01

    Full Text Available Introduction: Tremor can occur as a part of the clinical feature of cerebrovascular diseases. Many patients with cerebral stroke have cardiovascular diseases as a comorbidity or complication of stroke; sometimes cardiovascular events can lead to embolic stroke. Aim: To present types of tremor in patients with cerebrovascular diseases and cardiovascular events and diabetes mellitus type 2, clinical characteristics of tremor and investigations used. Material and methods: In our study we included 36 patients, 24 men and 12 women, that were examined and followed for 3 years, from 2012-2015. All patients were subjected to the following investigations: neurological examination, laboratory analysis, computerized tomography of brain, magnetic resonance imaging and electroencephalography. In cardiovascular patients we also performed Doppler sonography of carotid arteries, electrocardiography, cardiac ultrasound. The patients were examined and treated by cardiologists. Results: Of all patients 22% had cerebral infarction, 41% atherosclerosis, 36% multiple lacunar infarctions and 28% diabetes mellitus type 2. Three patients with cerebral infarction had chorea, hemiballismus, dystonia and dystonic tremor, three had postural tremor and two cerebellar intention tremor. Atherosclerotic patients had atherosclerotic action tremor, while diabetic patients predominantly presented with action-type tremor. Electroencephalography showed irritative basic brain activity with slow waves, while carotid arteries stenosis was diagnosed by Doppler sonography. Computerized tomography of the brain and magnetic resonance imaging revealed cerebrovascular diseases in certain areas. Patients with cardiomyopathy, rhythm disorders, high blood pressure, hyperlipidemia was investigated and medically treated by a cardiologist. Conclusion: In cerebrovascular diseases different types of tremor can occur as the result of the damage of the extrapyramidal system.

  15. "All that palsies is not Bell's" - The need to define Bell's palsy as an adverse event following immunization

    NARCIS (Netherlands)

    Rath, Barbara; Linder, Thomas; Cornblath, David; Hudson, Michael; Fernandopulle, Rohini; Hartmann, Katharina; Heininger, Ulrich; Izurieta, Hector; Killion, Leslie; Kokotis, Pangiotis; Oleske, James; Vajdy, Michael; Wong, Virginia

    2007-01-01

    Bell's palsy has been reported as an adverse event following immunization (AEFI). Review of the published literature reveals that several characteristics have been used to describe Bell's palsy, which differ significantly from author to author. Evidently, the definition of "Bell's palsy" remains con

  16. Can preventable adverse events be predicted among hospitalized older patients? The development and validation of a predictive model.

    NARCIS (Netherlands)

    Steeg, L. van de; Langelaan, M.; Wagner, C.

    2014-01-01

    Objective: To develop and validate a predictive model for preventable adverse events (AEs) in hospitalized older patients, using clinically important risk factors that are readily available on admission. Design: Data from two retrospective patient record review studies on AEs were used. Risk factors

  17. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

    International Nuclear Information System (INIS)

    Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods

  18. Analysis of incidence and nursing care for oral adverse events induced by chest or pelvic irradiation combined with chemotherapy

    International Nuclear Information System (INIS)

    The aim of this study was to clarify incidence and severity of oral adverse events induced by chemoradiotherapy and to explore efficient nursing-intervention or oral-care for the oral complications. Seventy-nine subjects who were treated with chemoradiotherapy at the radiation oncology unit of Gunma University Hospital were retrospectively analyzed using collected data from patients' medical chart including location of tumor, details of treatment, incidence and care of oral adverse events. Oral adverse events occurred in 7 (9%) of 79 patients. The complication rate in patients with lung or esophageal cancer was much higher than that with rectal or cervical cancer. All patients with the events received a total irradiation dose of 60 Gy in 30 fractions or higher. Oral mucositis was observed in 5 patients given antimetabolic chemotherapeutic agents, but they were successfully treated with steroids and/or gargles. Our results suggest that early intervention of oral care may reduce risks of developing severe oral adverse effects induced by chemoradiotherapy. (author)

  19. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients.

    LENUS (Irish Health Repository)

    Hamilton, Hilary

    2011-06-13

    Previous studies have not demonstrated a consistent association between potentially inappropriate medicines (PIMs) in older patients as defined by Beers criteria and avoidable adverse drug events (ADEs). This study aimed to assess whether PIMs defined by new STOPP (Screening Tool of Older Persons\\' potentially inappropriate Prescriptions) criteria are significantly associated with ADEs in older people with acute illness.

  20. Imagery special issue: intrusive images and memories of earlier adverse events in patients with obsessive compulsive disorder.

    NARCIS (Netherlands)

    Speckens, A.E.M.; Hackmann, A.; Ehlers, A.; Cuthbert, B.

    2007-01-01

    Mental imagery is increasingly considered to be an important feature in anxiety disorders. The aim of this study was to investigate the prevalence and characteristics of mental images in obsessive compulsive disorder (OCD) and their possible association with earlier adverse events. A consecutive sam

  1. Pulmonary function and CT biomarkers as risk factors for cardiovascular events in male lung cancer screening participants: the NELSON study

    International Nuclear Information System (INIS)

    The objective of this study was to investigate the association of spirometry and pulmonary CT biomarkers with cardiovascular events. In this lung cancer screening trial 3,080 male participants without a prior cardiovascular event were analysed. Fatal and non-fatal cardiovascular events were included. Spirometry included forced expiratory volume measured in units of one-second percent predicted (FEV1%predicted) and FEV1 divided by forced vital capacity (FVC; FEV1/FVC). CT examinations were quantified for coronary artery calcium volume, pulmonary emphysema (perc15) and bronchial wall thickness (pi10). Data were analysed via a Cox proportional hazard analysis, net reclassification improvement (NRI) and C-indices. 184 participants experienced a cardiovascular event during a median follow-up of 2.9 years. Age, pack-years and smoking status adjusted hazard ratios were 0.992 (95 % confidence interval (CI) 0.985-0.999) for FEV1%predicted, 1.000 (95%CI 0.986-1.015) for FEV1/FVC, 1.014 (95%CI 1.005-1.023) for perc15 per 10 HU, and 1.269 (95%CI 1.024-1.573) for pi10 per 1 mm. The incremental C-index (3, an increase in C-index of 0.076 and an NRI of 16.9 % (P < 0.0001). Pulmonary CT biomarkers and spirometry measurements were significantly associated with cardiovascular events, but did not contain clinically relevant independent prognostic information for cardiovascular events. (orig.)

  2. Adverse events and outcomes of procedural sedation and analgesia in major trauma patients

    Directory of Open Access Journals (Sweden)

    Robert S Green

    2015-01-01

    Full Text Available Context: Trauma patients requiring procedural sedation and analgesia (PSA may have increased risk of adverse events (AEs and poor outcomes. Aims: To determine the incidence of AEs in adult major trauma patients who received PSA and to evaluate their postprocedural outcomes. Settings and Design: Retrospective analysis of adult patients (age >16 who received PSA between 2006 and 2014 at a Canadian academic tertiary care center. Materials and Methods: We compared the incidence of PSA-related AEs in trauma patients with nontrauma patients. Postprocedural outcomes including Intensive Care Unit admission, length of hospital stay, and mortality were compared between trauma patients who did or did not receive PSA. Statistical Analysis Used: Descriptive statistics and multivariable logistic regression. Results: Overall, 4324 patients received PSA during their procedure, of which 101 were trauma patients (107 procedures. The majority (77% of these 101 trauma patients were male, relatively healthy (78% with American Society of Anesthesiologists Physical Status [ASA-PS] 1, and most (85% of the 107 procedures were orthopedic manipulations. PSA-related AEs were experienced by 45.5% of the trauma group and 45.9% of the nontrauma group. In the trauma group, the most common AEs were tachypnea (23% and hypotension (20%. After controlling for age, gender, and ASA-PS, trauma patients were more likely than nontrauma patients to develop hypotension (odds ratio 1.79; 95% confidence interval 1.11-2.89. Conclusion: Although trauma patients were more likely than nontrauma patients to develop hypotension during PSA, their outcomes were not worse compared to trauma patients who did not have PSA.

  3. Predictors of Adverse Events for Ankle Fractures: An Analysis of 6800 Patients.

    Science.gov (United States)

    Dodd, Ashley C; Lakomkin, Nikita; Attum, Basem; Bulka, Catherine; Karhade, Aditya V; Douleh, Diana G; Mir, Hassan; Jahangir, A Alex; Obremskey, William T; Sethi, Manish K

    2016-01-01

    Ankle fractures are one of the most common injuries seen by orthopedic surgeons. It is therefore essential to understand the risks associated with their treatment. Using the American College of Surgeons National Surgical Quality Improvement Program(®) database from 2006 to 2013, the patient demographics, comorbidities, and 30-day complications were collected for 5 types of ankle fractures. A bivariate analysis was used to compare the patient demographics, comorbidities, and complications across all Common Procedural Terminology codes. A multivariable logistic regression model was then used to assess the odds of minor and major postoperative complications within 30 days after open treatment. A total of 6865 patients were included in the analysis. Of these patients, 2507 (36.5%) had bimalleolar ankle fractures. The overall rate of adverse events for ankle fractures was low. Bimalleolar fractures had the greatest rate of major (2.6%, n = 64), minor (3.8%, n = 94), and total (5.7%, n = 143) complications. When controlling for individual patient characteristics, bimalleolar fractures were associated with 4.92 times the odds (95% confidence interval 1.80 to 13.5; p = .002) of developing a complication compared with those with a medial malleolar fracture. The risk factors driving postoperative complications for all ankle fractures were age >65 years, obesity, diabetes, American Society of Anesthesiologists score >2, and functional status (p ankle fractures was low, bimalleolar fractures were associated with 5 times the odds of developing a complication compared with medial malleolar fractures. Orthopedic surgeons must be aware of the risk factors that increase the rate of ankle fracture complications to improve patients' quality of care. PMID:27086177

  4. Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events

    Directory of Open Access Journals (Sweden)

    McCready Mariana

    2007-05-01

    Full Text Available Abstract Background Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. Objective To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. Software architecture DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Results Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. Discussion This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. Conclusion The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License.

  5. 10-Year cardiovascular event risks for women who experienced hypertensive disorders in late pregnancy: the HyRAS study

    Directory of Open Access Journals (Sweden)

    Ponjee Gabrielle

    2010-06-01

    Full Text Available Abstract Background Cardiovascular disease is the cause of death in 32% of women in the Netherlands. Prediction of an individual's risk for cardiovascular disease is difficult, in particular in younger women due to low sensitive and specific tests for these women. 10% to 15% of all pregnancies are complicated by hypertensive disorders, the vast majority of which develop only after 36 weeks of gestation. Preeclampsia and cardiovascular disease in later life show both features of "the metabolic syndrome" and atherosclerosis. Hypertensive disorders in pregnancy and cardiovascular disease may develop by common pathophysiologic pathways initiated by similar vascular risk factors. Vascular damage occurring during preeclampsia or gestational hypertension may contribute to the development of future cardiovascular disease, or is already present before pregnancy. At present clinicians do not systematically aim at the possible cardiovascular consequences in later life after a hypertensive pregnancy disorder at term. However, screening for risk factors after preeclampsia or gestational hypertension at term may give insight into an individual's cardiovascular risk profile. Methods/Design Women with a history of preeclampsia or gestational hypertension will be invited to participate in a cohort study 2 1/2 years after delivery. Participants will be screened for established modifiable cardiovascular risk indicators. The primary outcome is the 10-year cardiovascular event risk. Secondary outcomes include differences in cardiovascular parameters, SNP's in glucose metabolism, and neonatal outcome. Discussion This study will provide evidence on the potential health gains of a modifiable cardiovascular risk factor screening program for women whose pregnancy was complicated by hypertension or preeclampsia. The calculation of individual 10-year cardiovascular event risks will allow identification of those women who will benefit from primary prevention by tailored

  6. A comparative study on patient safety with reference to methods of detection of adverse events in a tertiary care hospital in North India

    OpenAIRE

    Moonis Mirza; Farooq A. Jan; Fayaz Ahmad Sofi; Rauf Ahmad Wani

    2016-01-01

    Background: Considerable investments have been made to devise methods to detect actual and potential adverse events in health care in order to address risk and improve patient safety. Objective of the study was to compare the methods of detection of number of adverse events taking place in admitted patients. Method: A prospective study for a period of one year. Three adverse events detection modules were studied, i.e. current record review, Incident reporting and cases discussed in Mortal...

  7. Cardiovascular disease risk factors for women. A life course-events perspective

    OpenAIRE

    Arora Chander P.; Hobel C. J.

    2010-01-01

    Cardiovascular disease (CVD) in women is the most common cause of death and in 2009 accounted for one third of all deaths. The purpose of this paper is to present what conditions during pregnancy and during the pre-menopause period lead to a greater risk of CVD. The early recognition and the application of interventions may decrease this risk. To emphasize this point we have taken a «Life course-events perspective». Current data suggests that genetic predisposition to disease in conjunction w...

  8. Automatic prediction of cardiovascular and cerebrovascular events using heart rate variability analysis.

    Directory of Open Access Journals (Sweden)

    Paolo Melillo

    Full Text Available There is consensus that Heart Rate Variability is associated with the risk of vascular events. However, Heart Rate Variability predictive value for vascular events is not completely clear. The aim of this study is to develop novel predictive models based on data-mining algorithms to provide an automatic risk stratification tool for hypertensive patients.A database of 139 Holter recordings with clinical data of hypertensive patients followed up for at least 12 months were collected ad hoc. Subjects who experienced a vascular event (i.e., myocardial infarction, stroke, syncopal event were considered as high-risk subjects. Several data-mining algorithms (such as support vector machine, tree-based classifier, artificial neural network were used to develop automatic classifiers and their accuracy was tested by assessing the receiver-operator characteristics curve. Moreover, we tested the echographic parameters, which have been showed as powerful predictors of future vascular events.The best predictive model was based on random forest and enabled to identify high-risk hypertensive patients with sensitivity and specificity rates of 71.4% and 87.8%, respectively. The Heart Rate Variability based classifier showed higher predictive values than the conventional echographic parameters, which are considered as significant cardiovascular risk factors.Combination of Heart Rate Variability measures, analyzed with data-mining algorithm, could be a reliable tool for identifying hypertensive patients at high risk to develop future vascular events.

  9. Vaccine Adverse Events Reported during the First Ten Years (1998–2008 after Introduction in the State of Rondonia, Brazil

    Directory of Open Access Journals (Sweden)

    Mônica P. L. Cunha

    2013-01-01

    Full Text Available Despite good safety records, vaccines given to young children can cause adverse events. We investigated the reported adverse events following immunization (AEFI of vaccines given to children of less than seven years of age during the first ten years (1998 to 2008 in the state of Rondonia, Brazil. We worked with the events related to BCG (Bacillus Calmett-Guérin, HB (hepatitis B, DTwP/Hib (diphtheria-tetanus-pertussis+Hemophillus influenza b, DTP (diphtheria-tetanus-pertussis, MMR (mumps, measles, rubella, and YF (yellow fever vaccines because they were part of the recommended scheme. The number of doses of vaccines given was 3,231,567 with an average of AEFI of 57.2/year during the studied period. DTwP/Hib was responsible for 298 (57.8%, DTP 114 (22.9%, HB 31 (6%, MMR 28 (5.4%, BCG 24 (4.7%, and YF 20 (3.9% of the reported AEFI. The combination of the AEFI for DTwP/Hib vaccines showed the highest number of systemic (61.4% and local events (33.8%. Young children (≤1-year old were more susceptible to AEFI occurring in the 6 hours (54.2% following vaccine uptake. This study suggests significant differences in reactogenicity of vaccines and that despite limitations of the AEFI Brazilian registry system we cannot ignore underreporting and should use the system to expand our understanding of adverse events and effects.

  10. Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy

    DEFF Research Database (Denmark)

    Egholm, Gro; Thim, Troels; Madsen, Morten;

    2016-01-01

    of adverse cardiac events and gastroscopy-related bleeding complications within 30 days of gastroscopy, and (3) the association between antiplatelet therapy and these events. PATIENTS AND METHODS: Patients receiving gastroscopy within 12 months of PCI were identified and two nested case......BACKGROUND AND STUDY AIMS: Dual antiplatelet therapy (DAPT) is recommended following percutaneous coronary intervention (PCI) with drug-eluting stent (DES). DAPT is a risk factor for gastrointestinal bleeding. We aimed to quantify (1) the rate of gastroscopy within 12 months after PCI, (2) the rate......-control analyses were performed within the PCI cohort by linking Danish medical registries. Cases were patients with adverse cardiac events (cardiac death, myocardial infarction, or stent thrombosis) or hemostatic intervention. In both studies, controls were patients with gastroscopy including biopsy without...

  11. Transfusion-related adverse events at the tertiary care center in North India: An institutional hemovigilance effort

    Directory of Open Access Journals (Sweden)

    Bhattacharya Prasun

    2011-01-01

    Full Text Available Aim: This study was designed to analyze the incidence and spectrum of adverse effects of blood transfusion so as to initiate measures to minimize risks and improve overall transfusion safety in the institute. Materials and Methods: During the period from July 2002 to July 2003 all the adverse events related to transfusion of blood and blood components in various clinical specialties were recorded. They were analyzed and classified on the basis of their clinical features and laboratory tests. Attempt was also made to study the predisposing risk factors. Results: During the study period 56,503 blood and blood components were issued to 29,720 patients. A total of 105 adverse reactions due to transfusion were observed during the study period. A majority of the adverse reactions was observed in hemato-oncology patients 43% (n = 45 and in presensitized patient groups 63% (n = 66. FNHTR 41% (n = 43 and allergic reactions 34% (n = 36 were the most common of all types of adverse transfusion reactions, followed by AcHTR 8.56% (n = 9. Majority of these AcHTR were due to unmonitored storage of blood in the refrigerator of wards resulting in hemolysis due to thermal injury. Less frequently observed reactions were anaphylactoid reactions (n = 4, bacterial sepsis (n = 4, hypervolemia (n = 2, hypocalcemia (n = 2, TRALI (n = 1, DHTR (n = 1, and TAGvHD (n = 1. Conclusion: Analysis of transfusion-related adverse outcomes is essential for improving safety. Factors such as improvement of blood storage conditions outside the blood bank, improvement in cross-matching techniques, careful donor screening, adherence to good manufacturing practices while component preparation, bedside monitoring of transfusion, and documentation of adverse events will help in reducing transfusion-related morbidity and mortality.

  12. Severe adverse events related to tattooing: An retrospective analysis of 11 years

    Directory of Open Access Journals (Sweden)

    Uwe Wollina

    2012-01-01

    Full Text Available Background: The incidence of tattoos has been increased markedly during the last 20 years. Aims: To analyze the patient files for severe adverse medical reactions related to tattooing. Settings: Academic Teaching Hospital in South-East Germany. Materials and Methods: Retrospective investigation from March 2001 to May 2012. Results: The incidence of severe adverse medical reactions has been estimated as 0.02%. Infectious and non-infectious severe reactions have been observed. The consequences were medical drug therapies and surgery. Conclusions: Tattooing may be associated with severe adverse medical reactions with significant morbidity. Regulations, education and at least hygienic controls are tools to increase consumer safety.

  13. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database

    OpenAIRE

    Abe, Junko; Umetsu, Ryogo; Mataki, Kanako; Kato, Yamato; Ueda, Natsumi; NAKAYAMA, Yoko; Hane, Yuuki; Matsui, Toshinobu; Hatahira, Haruna; Sasaoka, Sayaka; Motooka, Yumi; Hara, Hideaki; Kato, Zenichiro; Kinosada, Yasutomi; Inagaki, Naoki

    2016-01-01

    Background Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions associated with fatal disorders. Although many causes of SJS/TEN have been proposed, the time-to-onset for SJS/TEN and the relationship between aging and SJS/TEN are still not clear. Therefore, the aim of this study was to determine the relationship between aging and SJS/TEN using the Japanese Adverse Drug Event Report (JADER) database and analyze the time-to-onset profile of ...

  14. Integrated Analysis of Genetic and Proteomic Data Identifies Biomarkers Associated with Adverse Events Following Smallpox Vaccination

    Science.gov (United States)

    Complex clinical outcomes, such as adverse reaction to vaccination, arise from the concerted interactions among the myriad components of a biological system. Therefore, comprehensive etiological models can be developed only through the integrated study of multiple types of experi...

  15. Prediction of First Cardiovascular Disease Event in Type 1 Diabetes Mellitus

    DEFF Research Database (Denmark)

    Vistisen, Dorte; Andersen, Gregers Stig; Hansen, Christian Stevns;

    2016-01-01

    BACKGROUND: Patients with type 1 diabetes mellitus are at increased risk of developing cardiovascular disease (CVD), but they are currently undertreated. There are no risk scores used on a regular basis in clinical practice for assessing the risk of CVD in type 1 diabetes mellitus. METHODS...... AND RESULTS: From 4306 clinically diagnosed adult patients with type 1 diabetes mellitus, we developed a prediction model for estimating the risk of first fatal or nonfatal CVD event (ischemic heart disease, ischemic stroke, heart failure, and peripheral artery disease). Detailed clinical data including...... lifestyle factors were linked to event data from validated national registers. The risk prediction model was developed by using a 2-stage approach. First, a nonparametric, data-driven approach was used to identify potentially informative risk factors and interactions (random forest and survival tree...

  16. Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

    Science.gov (United States)

    Raschi, Emanuel; Poluzzi, Elisabetta; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Bennie, Marion; Barbui, Corrado; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2013-01-01

    Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID). Results Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia). Conclusions This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  17. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Emanuel Raschi

    Full Text Available BACKGROUND: Antipsychotics (APs have been associated with risk of torsade de Pointes (TdP. This has important public health implications. Therefore, (a we exploited the public FDA Adverse Event Reporting System (FAERS to characterize their torsadogenic profile; (b we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. METHODS: FAERS data (2004-2010 were analyzed based on the following criteria: (1 ≥ 4 cases of TdP/QT abnormalities; (2 Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers; (3 ≥ 4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD; (4 Significant ROR for VA/SCD; (5 Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled to group E (unclear/uncertain signal: only 2/5 criteria. Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID. RESULTS: Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone. In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia to 13.99 (France, 2009. Considerable increment of Group A agents was found in several Countries (+3.47 in France: the exposure to olanzapine increased across all Countries (+1.84 in France and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009. Among Group B drugs, levomepromazine peaked 3.78 (Serbia; fluphenazine 1.61 (Slovenia. CONCLUSIONS: This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  18. Unrequested information from routine diagnostic chest CT predicts future cardiovascular events

    International Nuclear Information System (INIS)

    An increase in the number of CT investigations will likely result in a an increase in unrequested information. Clinical relevance of these findings is unknown. This is the first follow-up study to investigate the prognostic relevance of subclinical coronary (CAC) and aortic calcification (TAC) as contained in routine diagnostic chest CT in a clinical care population. The follow-up of 10,410 subjects (>40 years) from a multicentre, clinical care-based cohort of patients included 240 fatal to 275 non-fatal cardiovascular disease (CVD) events (mean follow-up 17.8 months). Patients with a history of CVD were excluded. Coronary (0-12) and aortic calcification (0-8) were semi-quantitatively scored. We used Cox proportional-hazard models to compute hazard ratios to predict CVD events. CAC and TAC were significantly and independently predictive of CVD events. Compared with subjects with no calcium, the adjusted risk of a CVD event was 3.7 times higher (95% CI, 2.7-5.2) among patients with severe coronary calcification (CAC score ≥6) and 2.7 times higher (95% CI, 2.0-3.7) among patients with severe aortic calcification (TAC score ≥5). Subclinical vascular calcification on CT is a strong predictor of incident CVD events in a routine clinical care population. (orig.)

  19. Atherosclerosis profile and incidence of cardiovascular events: a population-based survey

    Directory of Open Access Journals (Sweden)

    Bullano Michael F

    2009-09-01

    Full Text Available Abstract Background Atherosclerosis is a chronic progressive disease often presenting as clinical cardiovascular disease (CVD events. This study evaluated the characteristics of individuals with a diagnosis of atherosclerosis and estimated the incidence of CVD events to assist in the early identification of high-risk individuals. Methods Respondents to the US SHIELD baseline survey were followed for 2 years to observe incident self-reported CVD. Respondents had subclinical atherosclerosis if they reported a diagnosis of narrow or blocked arteries/carotid artery disease without a past clinical CVD event (heart attack, stroke or revascularization. Characteristics of those with atherosclerosis and incident CVD were compared with those who did not report atherosclerosis at baseline but had CVD in the following 2 years using chi-square tests. Logistic regression model identified characteristics associated with atherosclerosis and incident events. Results Of 17,640 respondents, 488 (2.8% reported having subclinical atherosclerosis at baseline. Subclinical atherosclerosis was associated with age, male gender, dyslipidemia, circulation problems, hypertension, past smoker, and a cholesterol test in past year (OR = 2.2 [all p Conclusion Self-report of subclinical atherosclerosis identified an extremely high-risk group with a >25% risk of a CVD event in the next 2 years. These characteristics may be useful for identifying individuals for more aggressive diagnostic and therapeutic efforts.

  20. Application of the structured history taking of medication use tool to optimise prescribing for older patients and reduce adverse events.

    Science.gov (United States)

    Cullinan, Shane; O'Mahony, Denis; Byrne, Stephen

    2016-04-01

    Background Older patients, due to polypharmacy, co-morbidities and often multiple prescribing doctors are particularly susceptible to medication history errors, leading to adverse drug events, patient harm and increased costs. Medication reconciliation at the point of admission to hospital can reduce medication discrepancies and adverse events. The Structured HIstory taking of Medication use (SHiM) tool was developed to provide a structure to the medication reconciliation process. There has been very little research with regards to SHiM, it's application to older patients and it's potential to reduce adverse events. Objective To determine whether application of SHiM could optimise older patients' prescriptions on admission to hospital, and in-turn reduce adverse events, compared to standard care. Setting A sub-study of a large clinical trial involving hospital inpatients over the age of 65 in five hospitals across Europe. Method A modified version of SHiM was used to obtain accurate drug histories for patients after the attending physician had obtained a medication list via standard methods. Discrepancies between the two lists were recorded and classified, and the clinical relevance of the discrepancies was determined. Whether discrepancies in patients' medication histories, as revealed by SHiM, resulted in actual clinical consequences was then investigated. As this study was carried out during the observation phase of the clinical trial, results were not communicated to the medical teams. Main outcome measure Discrepancies between medication lists and whether these resulted in clinical consequences. Results SHiM was applied to 123 patients. The mean age of the participants was 78 (±6). 200 discrepancies were identified. 90 patients (73 %) had at least one discrepancy with a median of 1.0 discrepancies per patient (IQR 0.00-2.25). 53 (26.5 %) were classified as 'unlikely to cause patient discomfort or clinical deterioration', 145 (72.5 %) as 'having potential

  1. In a subgroup of high-risk Asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events.

    Directory of Open Access Journals (Sweden)

    Antonio L Dans

    Full Text Available BACKGROUND AND OBJECTIVES: Results of the recently published ONTARGET study (The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial showed that telmisartan (80 mg/day was non-inferior to ramipril (10 mg/day in reducing cardiovascular events. Clinicians in Asia doubt tolerability of these doses for their patients. We therefore analyzed data from this study and a parallel study TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease. Our objectives were to compare Asians and non-Asians with respect to the following: 1 Effectiveness of telmisartan vs. ramipril in reducing cardiovascular events;2 Proportions who reached the full dose of telmisartan, ramipril or placebo; and3 Proportions of overall discontinuations, and discontinuations due to adverse effects. METHOD: The ONTARGET study randomized 25,620 patients at risk of cardiovascular events to ramipril, telmisartan, or their combination. The primary composite endpoint was death caused by cardiovascular disease, acute MI, stroke, and hospitalization because of congestive heart failure. TRANSCEND randomized 5926 high-risk patients with a history of intolerance to ACE-inhibitors to telmisartan or placebo. The primary outcome was the same. In this substudy, we compared Asians and non-Asians as to how well they tolerated telmisartan (given in both studies and ramipril (given in ONTARGET. RESULTS: 1 Telmisartan was non-inferior to ramipril in lowering the primary endpoint among Asians (RR = 0.92; 95% CI: 0.74, 1.13; 2 more Asians achieved the full dose of either drug; 3 less withdrew (overall; and 4 less withdrew for adverse effects. Furthermore, telmisartan was better tolerated than ramipril. This advantage was greater among Asians. CONCLUSION AND SIGNIFICANCE: Although Asians had lower BMI than non-Asians, Asians tolerated both drugs better. Regulatory agencies require reporting of safety and effectiveness data by

  2. [Nonsteroid anti-inflammatory drugs (NSAID) and risk of cardiovascular events. Literature review and clinical implications].

    Science.gov (United States)

    Temporelli, Pier Luigi; Zito, Giovanni Battista; Pedretti, Roberto Franco; Belisarii, Franceso Iachini; Putortí, Giuseppe; Faggiano, Pompilio

    2014-09-01

    Non steroid anti-inflammatory drugs (NSAIDs) are largely used for treatment of acute and chronic pain, even for long periods of time (months or years). While it is known that their use is frequently associated with gastrointestinal damage, including major bleedings from peptic ulcer, the risk of cardiovascular events related to NSAID has received much less attention. However, there is a large body of evidence showing that NSAIDs (both "traditional", such as diclofenac or indobufen, and selective cyclooxygenase inhibitors, COX-2) are associated with a significant increase of risk of cardiovascular events, both fatal and nonfatal. Consequently, several options have been proposed for the treatment of pain, including the use of analgesic drugs with different mechanisms of action, such as the opiates. Of interest, the Italian Drug Agency (AIFA) published a few years ago a warning (Nota 66) on the careful prescription of NSAIDs in patients with overt heart disease, such as coronary artery disease and heart failure. Aim of this paper is to present the current status of knowledge on the proper use of NSAIDs and other analgesic drugs in the management of acute and chronic pain. PMID:26058269

  3. Endothelial Progenitor Cells Predict Cardiovascular Events after Atherothrombotic Stroke and Acute Myocardial Infarction. A PROCELL Substudy.

    Directory of Open Access Journals (Sweden)

    Elisa Cuadrado-Godia

    Full Text Available The aim of this study was to determine prognostic factors for the risk of new vascular events during the first 6 months after acute myocardial infarction (AMI or atherothrombotic stroke (AS. We were interested in the prognostic role of endothelial progenitor cells (EPC and circulating endothelial cells (CEC.Between February 2009 and July 2012, 100 AMI and 50 AS patients were consecutively studied in three Spanish centres. Patients with previously documented coronary artery disease or ischemic strokes were excluded. Samples were collected within 24h of onset of symptoms. EPC and CEC were studied using flow cytometry and categorized by quartiles. Patients were followed for up to 6 months. NVE was defined as new acute coronary syndrome, transient ischemic attack (TIA, stroke, or any hospitalization or death from cardiovascular causes. The variables included in the analysis included: vascular risk factors, carotid intima-media thickness (IMT, atherosclerotic burden and basal EPC and CEC count. Multivariate survival analysis was performed using Cox regression analysis.During follow-up, 19 patients (12.66% had a new vascular event (5 strokes; 3 TIAs; 4 AMI; 6 hospitalizations; 1 death. Vascular events were associated with age (P = 0.039, carotid IMT≥0.9 (P = 0.044, and EPC count (P = 0.041 in the univariate analysis. Multivariate Cox regression analysis showed an independent association with EPC in the lowest quartile (HR: 10.33, 95%CI (1.22-87.34, P = 0.032] and IMT≥0.9 [HR: 4.12, 95%CI (1.21-13.95, P = 0.023].Basal EPC and IMT≥0.9 can predict future vascular events in patients with AMI and AS, but CEC count does not affect cardiovascular risk.

  4. Prediabetes and cardiovascular risk alert programs - useful tools for preventing diabetes mellitus and cardiovascular events in primary medicine.

    Science.gov (United States)

    Virgolici, Horia; Virgolici, Bogdana; Purcarea, Victor

    2015-01-01

    We propose alert programs, made in Excel using VBA, for general practitioners, in order not to miss the diagnosis of prediabetes and cardiovascular risk factors for their patients and to improve their management. PMID:25991138

  5. Incidence and Risk Factors of Serious Adverse Events during Antituberculous Treatment in Rwanda: A Prospective Cohort Study

    Science.gov (United States)

    Lorent, Natalie; Sebatunzi, Osee; Mukeshimana, Gloria; Van den Ende, Jef; Clerinx, Joannes

    2011-01-01

    Background Tuberculosis (TB) and TB-human immunodeficiency virus infection (HIV) coinfection is a major public health concern in resource-limited settings. Although TB treatment is challenging in HIV-infected patients because of treatment interactions, immunopathological reactions, and concurrent infections, few prospective studies have addressed this in sub-Saharan Africa. In this study we aimed to determine incidence, causes of, and risk factors for serious adverse events among patients on first-line antituberculous treatment, as well as its impact on antituberculous treatment outcome. Methods and findings Prospective observational cohort study of adults treated for TB at the Internal Medicine department of the Kigali University Hospital from May 2008 through August 2009. Of 263 patients enrolled, 253 were retained for analysis: median age 35 (Interquartile range, IQR 28–40), 55% male, 66% HIV-positive with a median CD4 count 104 cells/mm3 (IQR 44–248 cells/mm3). Forty percent had pulmonary TB, 43% extrapulmonary TB and 17% a mixed form. Sixty-four (26%) developed a serious adverse event; 58/167 (35%) HIV-infected vs. 6/86 (7%) HIV-uninfected individuals. Commonest events were concurrent infection (n = 32), drug-induced hepatitis (n = 24) and paradoxical reactions/TB-IRIS (n = 23). HIV-infection (adjusted Hazard Ratio, aHR 3.4, 95% Confidence Interval, CI 1.4–8.7) and extrapulmonary TB (aHR 2, 95%CI 1.1–3.7) were associated with an increased risk of serious adverse events. For TB/HIV co-infected patients, extrapulmonary TB (aHR 2.0, 95%CI 1.1–3.9) and CD4 count <100 cells/mm3 at TB diagnosis (aHR 1.7, 95%CI 1.0–2.9) were independent predictors. Adverse events were associated with an almost two-fold higher risk of unsuccessful treatment outcome at 6 months (HR 1.89, 95%CI 1.3–3.0). Conclusion Adverse events frequently complicate the course of antituberculous treatment and worsen treatment outcome, particularly in patients with

  6. Incidence and risk factors of serious adverse events during antituberculous treatment in Rwanda: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Natalie Lorent

    Full Text Available BACKGROUND: Tuberculosis (TB and TB-human immunodeficiency virus infection (HIV coinfection is a major public health concern in resource-limited settings. Although TB treatment is challenging in HIV-infected patients because of treatment interactions, immunopathological reactions, and concurrent infections, few prospective studies have addressed this in sub-Saharan Africa. In this study we aimed to determine incidence, causes of, and risk factors for serious adverse events among patients on first-line antituberculous treatment, as well as its impact on antituberculous treatment outcome. METHODS AND FINDINGS: Prospective observational cohort study of adults treated for TB at the Internal Medicine department of the Kigali University Hospital from May 2008 through August 2009. Of 263 patients enrolled, 253 were retained for analysis: median age 35 (Interquartile range, IQR 28-40, 55% male, 66% HIV-positive with a median CD4 count 104 cells/mm(3 (IQR 44-248 cells/mm(3. Forty percent had pulmonary TB, 43% extrapulmonary TB and 17% a mixed form. Sixty-four (26% developed a serious adverse event; 58/167 (35% HIV-infected vs. 6/86 (7% HIV-uninfected individuals. Commonest events were concurrent infection (n = 32, drug-induced hepatitis (n = 24 and paradoxical reactions/TB-IRIS (n = 23. HIV-infection (adjusted Hazard Ratio, aHR 3.4, 95% Confidence Interval, CI 1.4-8.7 and extrapulmonary TB (aHR 2, 95%CI 1.1-3.7 were associated with an increased risk of serious adverse events. For TB/HIV co-infected patients, extrapulmonary TB (aHR 2.0, 95%CI 1.1-3.9 and CD4 count <100 cells/mm3 at TB diagnosis (aHR 1.7, 95%CI 1.0-2.9 were independent predictors. Adverse events were associated with an almost two-fold higher risk of unsuccessful treatment outcome at 6 months (HR 1.89, 95%CI 1.3-3.0. CONCLUSION: Adverse events frequently complicate the course of antituberculous treatment and worsen treatment outcome, particularly in patients with extrapulmonary

  7. Magnesium and the risk of cardiovascular events: a meta-analysis of prospective cohort studies.

    Directory of Open Access Journals (Sweden)

    Xinhua Qu

    Full Text Available BACKGROUND: Prospective studies that have examined the association between dietary magnesium intake and serum magnesium concentrations and the risk of cardiovascular disease (CVD events have reported conflicting findings. We undertook a meta-analysis to evaluate the association between dietary magnesium intake and serum magnesium concentrations and the risk of total CVD events. METHODOLOGY/PRINCIPAL FINDINGS: We performed systematic searches on MEDLINE, EMBASE, and OVID up to February 1, 2012 without limits. Categorical, linear, and nonlinear, dose-response, heterogeneity, publication bias, subgroup, and meta-regression analysis were performed. The analysis included 532,979 participants from 19 studies (11 studies on dietary magnesium intake, 6 studies on serum magnesium concentrations, and 2 studies on both with 19,926 CVD events. The pooled relative risks of total CVD events for the highest vs. lowest category of dietary magnesium intake and serum magnesium concentrations were 0.85 (95% confidence interval 0.78 to 0.92 and 0.77 (0.66 to 0.87, respectively. In linear dose-response analysis, only serum magnesium concentrations ranging from 1.44 to 1.8 mEq/L were significantly associated with total CVD events risk (0.91, 0.85 to 0.97 per 0.1 mEq/L (P(nonlinearity= 0.465. However, significant inverse associations emerged in nonlinear models for dietary magnesium intake (P(nonlinearity= 0.024. The greatest risk reduction occurred when intake increased from 150 to 400 mg/d. There was no evidence of publication bias. CONCLUSIONS/SIGNIFICANCE: There is a statistically significant nonlinear inverse association between dietary magnesium intake and total CVD events risk. Serum magnesium concentrations are linearly and inversely associated with the risk of total CVD events.

  8. Relation between adverse events associated with allopurinol and renal function in patients with gout

    OpenAIRE

    Vazquez-Mellado, J; E. Morales; Pacheco-Tena, C; Burgos-Vargas, R

    2001-01-01

    BACKGROUND—Because serious adverse reactions to allopurinol have been related to a reduce creatinine clearance rate and prolonged half life of oxypurinol, it has been recommended that the dose should be adjusted according to the rate of creatinine clearance. However, in some patients with gout the dose is not sufficient to reduce serum levels of uric acid (⩽390 µmol/l) and to halt disease progression.
OBJECTIVE—To determine the prevalence of adverse reactions attributable to allopurinol in pa...

  9. Motor palsies of cranial nerves (excluding VII) after vaccination: Reports to the US Vaccine Adverse Event Reporting System

    OpenAIRE

    Woo, Emily Jane; Winiecki, Scott K.; Ou, Alan C

    2013-01-01

    We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty re...

  10. Can preventable adverse events be predicted among hospitalized older patients? The development and validation of a predictive model.

    OpenAIRE

    Steeg, L. van de; Langelaan, M.; Wagner, C.

    2014-01-01

    Objective: To develop and validate a predictive model for preventable adverse events (AEs) in hospitalized older patients, using clinically important risk factors that are readily available on admission. Design: Data from two retrospective patient record review studies on AEs were used. Risk factors included patient characteristics as well as admission and organizational characteristics. Multilevel logistical regression analysis was used to develop the model. Backward elimination was applied ...

  11. Pirfenidone in idiopathic pulmonary fibrosis: expert panel discussion on the management of drug-related adverse events

    OpenAIRE

    Bendstrup, Elisabeth; Cottin, Vincent; Dewint, Pieter; Egan, Jim J. J.; Ferguson, James; Groves, Richard; Hellström, Per M; Kreuter, Michael; Toby M. Maher; Molina-Molina, Maria; Nordlind, Klas; Sarafidis, Alexandre; Vancheri, Carlo

    2014-01-01

    Pirfenidone is currently the only approved therapy for idiopathic pulmonary fibrosis, following studies demonstrating that treatment reduces the decline in lung function and improves progression-free survival. Although generally well tolerated, a minority of patients discontinue therapy due to gastrointestinal and skin-related adverse events (AEs). This review summarizes recommendations based on existing guidelines, research evidence, and consensus opinions of expert authors, with the aim of ...

  12. Pirfenidone in idiopathic pulmonary fibrosis: Expert panel discussion on the management of drug-related adverse events

    OpenAIRE

    Costabel, U.; Bendstrup, Elisabeth; Cottin, Vincent; Dewint, Pieter; Egan, Jim J; Ferguson, James; Groves, Richard; Hellström, A.-L.; Kreuter, Michael; Maher, Toby; Molina-Molina, Maria; Nordlind, Klas; Sarafidis, Alexandre; Vancheri, Carlo

    2014-01-01

    textabstractPirfenidone is currently the only approved therapy for idiopathic pulmonary fibrosis, following studies demonstrating that treatment reduces the decline in lung function and improves progression-free survival. Although generally well tolerated, a minority of patients discontinue therapy due to gastrointestinal and skin-related adverse events (AEs). This review summarizes recommendations based on existing guidelines, research evidence, and consensus opinions of expert authors, with...

  13. A Canadian perspective on the safe administration of bendamustine and the prevention and management of adverse events

    OpenAIRE

    Koolwine, J.; Crosbie, T.; Gazzé, G.; Turner, R.; Wiernikowski, J.; Assaily, W.

    2014-01-01

    Although bendamustine has been used to treat lymphoproliferative disorders for decades, it has only recently been approved for use in Canada. Thus, Canadian recommendations on the administration of bendamustine and the management of common adverse events (aes) are needed. This article highlights effective management and assessment strategies recommended by Canadian nurses and pharmacists for the most common aes arising from the use of bendamustine in patients with chronic lymphocytic leukemia...

  14. A retrospective study on the incidences of adverse drug events and analysis of the contributing trigger factors

    OpenAIRE

    Sam, Aaseer Thamby; Lian Jessica, Looi Li; Parasuraman, Subramani

    2015-01-01

    Objectives: To retrospectively determine the extent and types of adverse drug events (ADEs) from the patient cases sheets and identify the contributing factors of medication errors. To assess causality and severity using the World Health Organization (WHO) probability scale and Hartwig's scale, respectively. Methods: Hundred patient case sheets were randomly selected, modified version of the Institute for Healthcare Improvement (IHI) Global Trigger Tool was utilized to identify the ADEs; caus...

  15. Percutaneous Coronary Intervention using a Full Metal Jacket with Drug-eluting Stents: Major Adverse Cardiac Events at One Year

    OpenAIRE

    Calé, Rita; Teles, Rui Campante; Almeida, Manuel; do Rosário, Ingrid; Sousa, Pedro Jerónimo; Brito, João; Raposo, Luís; Gonçalves, Pedro Araújo; Gabriel, Henrique Mesquita; Mendes, Miguel

    2013-01-01

    Background The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety. Objectives To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring > 60 mm in length, for very long lesions. Methods We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our si...

  16. Adverse Events Following Immunization (AEFI) in Children under 7- year of Age during 2014 in Hamedan Province, Iran

    OpenAIRE

    Salman Khazaei; Shahab Rezaeian; Mohsen Razani; Ali Zahiri; Mohammad Saatchi; Somayeh Khazaei; Abollah Mohammadian Hafshjani; Mahfam Darvishi

    2016-01-01

    Background: The surveillance of adverse events following immunization (AEFI) is essential to improve high standard of vaccine safety, and maintain public trust in immunization programs. This study aimed to determine the AEFI and their related factors in children. Materials and Methods: This cross-sectional study including all children under 7- year of age, in Hamadan Province, the West of Iran, in 2014. All of the AEFI related with Bacille Calmette-Guérin (BCG), Diphtheria, Pertussis, and Tet...

  17. Temporal analysis of pain responders and common adverse events: when do these first appear following treatment with pregabalin

    Directory of Open Access Journals (Sweden)

    Parsons B

    2015-06-01

    Full Text Available Bruce Parsons, Birol Emir, Andrew Clair Pfizer, New York, NY, USA Background: Pregabalin is an α2δ ligand indicated in the USA for treatment of a number of chronic pain conditions, including diabetic peripheral neuropathy, postherpetic neuralgia, pain associated with spinal cord injury, and fibromyalgia. A greater understanding of when patients first respond to treatment with pregabalin and when adverse events emerge, or worsen, could aid design of new proof-of-concept studies and help guide treatment of patients. Methods: This was an analysis of five randomized, placebo-controlled, double-blind trials (between 8 and 16 weeks in duration of flexible-dose pregabalin (150–600 mg/day. Individual patient data were pooled into three groups by disease condition: diabetic peripheral neuro-pathy or postherpetic neuralgia (n=514, spinal cord injury (n=356, and fibromyalgia (n=498. Responders were classified as having a ≥30% and/or ≥50% reduction in mean pain score from baseline; once a patient responded, they were not scored subsequently (and were excluded from the responder analysis. The emergence of adverse events at each week was also recorded. Results: The majority of the 30% and 50% responders emerged within the first 3–4 weeks with pregabalin, but were more uniformly distributed across the 6 weeks of the analysis with placebo. The majority of common adverse events also emerged within the first 3–4 weeks of pregabalin treatment. Conclusion: These data suggest that the majority of pain responders and common adverse events emerge within 3–4 weeks of treatment with pregabalin. These data could advise new proof-of-concept studies and guide clinical management. Keywords: neuropathic pain, fibromyalgia, clinical trial design

  18. The Impact of Outpatient Chemotherapy-Related Adverse Events on the Quality of Life of Breast Cancer Patients

    OpenAIRE

    Tomoya Tachi; Hitomi Teramachi; Kazuhide Tanaka; Shoko Asano; Tomohiro Osawa; Azusa Kawashima; Masahiro Yasuda; Takashi Mizui; Takumi Nakada; Yoshihiro Noguchi; Teruo Tsuchiya; Chitoshi Goto

    2015-01-01

    The objective of our study was to clarify the impact of adverse events associated with the initial course of outpatient chemotherapy on the quality of life of breast cancer patients. We conducted a survey to assess the quality of life in 48 breast cancer patients before and after receiving their first course of outpatient chemotherapy at Gifu Municipal Hospital. Patients completed the European Quality of Life 5 Dimensions and Quality of Life Questionnaire for Cancer Patients Treated with Anti...

  19. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    OpenAIRE

    Keith B. Hoffman; Brian M. Overstreet; Murali Doraiswamy, P.

    2013-01-01

    Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs) across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA) approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to appr...

  20. Treatment compliance and severe adverse events limit the use of tyrosine kinase inhibitors in refractory thyroid cancer

    OpenAIRE

    Chrisoulidou A; Mandanas S; Margaritidou E; Mathiopoulou L; Boudina M; Georgopoulos K; Pazaitou-Panayiotou K

    2015-01-01

    Alexandra Chrisoulidou, Stylianos Mandanas, Efterpi Margaritidou, Lemonia Mathiopoulou, Maria Boudina, Konstantinos Georgopoulos, Kalliopi Pazaitou-PanayiotouDepartment of Endocrinology, Theagenio Cancer Hospital, Thessaloniki, GreeceObjective: The aim of the present study was to assess patient compliance with tyrosine kinase inhibitor (TKI) treatment used for refractory and progressive thyroid cancer, in addition to the efficacy and serious adverse events associated with these agents.Methods...

  1. Effects of Hurricane Katrina and Other Adverse Life Events on Adolescent Female Offenders: A Test of General Strain Theory

    OpenAIRE

    Robertson, Angela R.; Stein, Judith A.; Schaefer-Rohleder, Lacey

    2010-01-01

    This study tested Agnew’s General Strain Theory (GST) by examining the roles of anger, anxiety, and maladaptive coping in mediating the relationship between strain and three outcomes (serious delinquency, minor delinquency, and continued involvement in the juvenile justice system) among adolescent female offenders (N = 261). Strains consisted of adverse life events and exposure to Hurricane Katrina. Greater exposure to Hurricane Katrina was directly related to serious delinquency and maladapt...

  2. Impact of High-Normal Blood Pressure Measured in Emergency Room on Adverse Cardiac Events in Acute Myocardial Infarction

    OpenAIRE

    Yoon, Nam Sik; Jeong, Myung Ho; Ahn, Youngkeun; Kim, Jong Hyun; Chae, Shung Chull; Kim, Young Jo; Hur, Seung Ho; Seong, In Whan; Hong, Taek Jong; Choi, Donghoon; Cho, Myeong Chan; Kim, Chong Jin; Seung, Ki Bae; Chung, Wook Sung; Jang, Yang Soo

    2012-01-01

    Background and Objectives Prehypertension according to JNC7 is common and is associated with increased vascular mortality. The importance of management in high-normal blood pressure (BP) is underemphasized. Subjects and Methods We analyzed major adverse cardiac events (MACEs) in the Korea Acute Myocardial Infarction Registry in normal BP (group I) and high-normal BP (group II) patients. Results Among 14871 patients, 159 (61±12.3 years, 122 males) satisfied the study indication. Six-month and ...

  3. Pirfenidone in Idiopathic Pulmonary Fibrosis: Expert Panel Discussion on the Management of Drug-Related Adverse Events

    OpenAIRE

    Costabel, U.; Bendstrup, Elisabeth; Cottin, Vincent; Dewint, Pieter; Egan, Jim J; Ferguson, James; Groves, Richard; Hellström, A.-L.; Kreuter, Michael; Maher, Toby; Molina-Molina, Maria; Nordlind, Klas; Sarafidis, Alexandre; Vancheri, Carlo

    2014-01-01

    Pirfenidone is currently the only approved therapy for idiopathic pulmonary fibrosis, following studies demonstrating that treatment reduces the decline in lung function and improves progression-free survival. Although generally well tolerated, a minority of patients discontinue therapy due to gastrointestinal and skin-related adverse events (AEs). This review summarizes recommendations based on existing guidelines, research evidence, and consensus opinions of expert authors, with the aim of ...

  4. The Role of Early-Life Conditions in the Cognitive Decline due to Adverse Events Later in Life

    OpenAIRE

    Van Den Berg, Gerard J.; Deeg, Dorly J H; Lindeboom, Maarten; Portrait, France

    2010-01-01

    Cognitive functioning of elderly individuals may be affected by events such as the loss of a (grand)child or partner or the onset of a serious chronic condition, and by negative economic shocks such as job loss or the reduction of pension benefits. It is conceivable that the impact of such events is stronger if conditions early in life were adverse. In this paper we address this using a Dutch longitudinal database that follows elderly individuals for more than 15 years and contains informatio...

  5. The Risk Assessment of Adverse Events of Nursing Activities as the Element of Quality Management in Healhcare

    Directory of Open Access Journals (Sweden)

    Wiśniewska Malgorzata Z.

    2015-02-01

    Full Text Available The purpose of the paper is to present MedCARVER+Shock method and Pareto analysis and its usability for the risk assessment of adverse events of nursing activities. 888 activities carried out by all 190 nurses working at the District Hospital X located in Poland were taken into account. During the research the qualitative approach was used. As the result sixteen groups of nursing activities causing the highest risk of adverse events were selected. Special attention required in: admission of a patient to the ward, sterilization, verbal communication with the patient, using of intravenous cannulas, needles, syringes, devices for transfusion of infusion liquids, servicing of hospital rooms, first aid in life-threatening situations, using medical devices and equipment. Ten basic causes of the risk of adverse events were identified, among others: lack of trainings, of modern equipment, of staff, failure to comply with procedures, lack of staff supervision, poor quality of ancillary materials, lack of management commitment. Finally MedCARVER+Shock method and Pareto analysis usability has been confirmed but it appeared that it is time-consuming and requires support from skilled professionals. Several suggestions have been put forward to improve the utility of MedCARVER+Shock.

  6. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

    Science.gov (United States)

    Jiang, Guoqian; Wang, Liwei; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2013-01-01

    A semantically coded knowledge base of adverse drug events (ADEs) with severity information is critical for clinical decision support systems and translational research applications. However it remains challenging to measure and identify the severity information of ADEs. The objective of the study is to develop and evaluate a semantic web based approach for building a knowledge base of severe ADEs based on the FDA Adverse Event Reporting System (AERS) reporting data. We utilized a normalized AERS reporting dataset and extracted putative drug-ADE pairs and their associated outcome codes in the domain of cardiac disorders. We validated the drug-ADE associations using ADE datasets from SIDe Effect Resource (SIDER) and the UMLS. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the ADEs into the CTCAE in the Web Ontology Language (OWL). We identified and validated 2,444 unique Drug-ADE pairs in the domain of cardiac disorders, of which 760 pairs are in Grade 5, 775 pairs in Grade 4 and 2,196 pairs in Grade 3. PMID:23920604

  7. Serum interleukin-10 levels and adverse events in patients with acute coronary syndrome: a systematic review and meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Liu Jun; Jia Yanjun; Li Xiaolin; Xu Ruixia; Zhu Chenggang; Guo Yuanlin; Wu Naqiong

    2014-01-01

    Background Several studies investigating the prognostic utility of interleukin-10 (IL-10) in patients with acute coronary syndrome (ACS) have provided conflicting findings.The aim of the study was to assess the existing evidence regarding association between serum IL-10 levels and adverse events.Methods Literature search was performed in PubMed,EMBASE,and Cochrane Trials Register databases from their inception to September 30,2012.In addition,reference lists of the included articles and their related citations in PubMed were also reviewed for additional pertinent studies.Results A total of 12 eligible studies comprising a total of 5882 patients were identified.The pooled relative risks for both studies reporting the risk estimates by IL-10 categories and studies reporting the risk estimates by unit IL-10 indicated an association between high IL-10 levels and adverse events.Sensitivity and subgroup analysis indicated that the results obtained in IL-10 categories were not stable.Conclusions Data from our meta-analysis supported the existence of a relationship between high serum IL-10 levels and adverse events in patients with ACS.Large study with longer follow-up is needed to confirm the findings.

  8. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    Directory of Open Access Journals (Sweden)

    Keith B. Hoffman

    2013-07-01

    Full Text Available Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS. We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.

  9. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    Science.gov (United States)

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events. PMID:22566442

  10. Values for preventing influenza-related morbidity and vaccine adverse events in children

    Directory of Open Access Journals (Sweden)

    Schwartz Benjamin

    2005-03-01

    Full Text Available Abstract Background Influenza vaccination recently has been recommended for children 6–23 months old, but is not currently recommended for routine use in non-high-risk older children. Information on disease impact, costs, benefits, risks, and community preferences could help guide decisions about which age and risk groups should be vaccinated and strategies for improving coverage. The objective of this study was to measure preferences and willingness-to-pay for changes in health-related quality of life associated with uncomplicated influenza and two rarely-occurring vaccination-related adverse events (anaphylaxis and Guillain-Barré syndrome in children. Methods We conducted telephone interviews with adult members selected at random from a large New England HMO (n = 112. Respondents were given descriptions of four health outcomes: uncomplicated influenza in a hypothetical 1-year-old child of their own, uncomplicated influenza in a hypothetical 14-year-old child of their own, anaphylaxis following vaccination, and Guillain-Barré syndrome. "Uncomplicated influenza" did not require a physician's visit or hospitalization. Preferences (values for these health outcomes were measured using time-tradeoff and willingness-to-pay questions. Time-tradeoff questions asked the adult to assume they had a child and to consider how much time from the end of their own life they would be willing to surrender to avoid the health outcome in the child. Results Respondents said they would give a median of zero days of their lives to prevent an episode of uncomplicated influenza in either their (hypothetical 1-year-old or 14-year-old, 30 days to prevent an episode of vaccination-related anaphylaxis, and 3 years to prevent a vaccination-related case of Guillain-Barré syndrome. Median willingness-to-pay to prevent uncomplicated influenza in a 1-year-old was $175, uncomplicated influenza in a 14-year-old was $100, anaphylaxis $400, and Guillain-Barré syndrome $4000

  11. Hematological Adverse events and Sustained Viral Response in Children Undergoing Therapy for Chronic Hepatitis C Infection

    Directory of Open Access Journals (Sweden)

    Malgorzata Pawlowska

    2011-12-01

    Full Text Available Background: Treatment of hepatitis C virus (HCV infection with interferon (IFN and ribavirin (RBV is associated with adverse events, which may affect the patient's adherence to the treatment regimen and the treatment efficacy.Objectives: The aim of this study was to assess the sustained viral response (SVR and interdependence between the haematological characteristics (leukocyte count, platelet count, and haemoglobin levels in patients with chronic hepatitis C (CHC infection during treatment with IFN and RBV.Patients and Methods: We conducted a retrospective cohort study of 170 children with CHC infection who completed treatment with IFN-α and RBV. The children were divided into 2 groups: the first group (group I, n = 119 underwent a 48-week course of treatment with recombinant IFN α-2b (Intron A at a dosage of 3 MU 3 times a week subcutaneously and RBV at a dosage of 15 mg/kg per day orally, and the second group (group II, n = 51 was administered pegylated IFN (peg-IFN-α-2b (PegIntron at a dosage of 1.5 μg/kg per week subcutaneously and RBV at a dosage of 15 mg/kg per day orally for 48 weeks. The dose of IFN was not adjusted but that of ribavirin was in 2 children from group II. Hematological growth factors and erythropoietin were not used. SVR was defined as undetectable serum HCV RNA 24 weeks after the end of treatment (study week 72. Serum HCV RNA was determined by performing polymerase chain reaction, and the HCV genotypes and hematological parameters were evaluated. Serum HCV RNA levels were analysed by descriptive statistics. Means and standard deviations were calculated for values collected at the baseline, on the 12th and 48th weeks during treatment, and after 24 weeks of untreated follow-up (study week 72.Results: Eighty-six (50% of the 170 patients who underwent treatment achieved SVR: 62 (51% out of 119 children from group I and 24 (47% out of 51 from group II. The mean serum hemoglobin levels and leukocyte and platelet counts at

  12. Dust events as a risk factor for daily hospitalization for respiratory and cardiovascular diseases in Minqin, China

    Science.gov (United States)

    Meng, Ziqiang; Lu, Bin

    Dust events are common air pollution events in parts of the world with arid, semi-arid, or desert areas. There is little research on the association between respiratory and cardiovascular health and dust events in places which are close to the deserts. The aim of this study is to evaluate the health effects of dust events in a location where traffic and industry are underdeveloped and dust events are most frequent in China. The setting allows the opportunity to reduce confounding by anthropogenically derived particulate matter and to confirm the health effects of dust events. The present study was done using daily counts of hospitalizations in Minqin (1994-2003) for respiratory and cardiovascular diseases (International Classification of Diseases, Tenth revision) for males and females. Using a semi-parametric generalized additive model and controlling for long-term temporal trends, day of the week, meteorological factors, and seasonal influence, counts of hospitalization were analyzed for dust events in a Poisson regression. Relative risks (RRs) were used to estimate the risk of dust events for respiratory and cardiovascular hospitalizations. In the year-round model, dust events with a lag of 3 days were significantly associated with total respiratory hospitalization for males and females, with RRs of 1.14 (95% confidence interval (CI) 1.01-1.29) and 1.18 (95% CI 1.00-1.41); dust events with a lag of 4 days were significantly associated with upper respiratory tract infection (URTI) in males (RR 1.28, 95% CI 1.04-1.59), and dust events with a lag of 6 days were significantly associated with pneumonia in males, with an RR of 1.17 (95% CI 1.00-1.38). A significant association between dust events with a lag of 3 days and hypertension in males was also found (RR 1.30, 95% CI 1.03,1.64). In the seasonal analysis model, the associations between the dust events and respiratory and cardiovascular hospitalizations were stronger in spring and in winter, respectively. The

  13. Social network, presence of cardiovascular events and mortality in hypertensive patients.

    Science.gov (United States)

    Menéndez-Villalva, C; Gamarra-Mondelo, M T; Alonso-Fachado, A; Naveira-Castelo, A; Montes-Martínez, A

    2015-07-01

    The aim of this study was to ascertain the relationship between social network and the appearance of mortality (cardiovascular events (CVEs)) in patients with arterial hypertension (AHT). This is a cohort study of 236 patients with a 9-year follow-up. Measurements included age, sex, blood pressure (BP), diabetes, hypercholesterolemia, marital status, social network, social support, stage of family life cycle (FLC), mortality and CVEs. Patients with a low social network registered higher global mortality (hazards ratio (HR) 2.6 (95% confidence interval (CI) 1.3; 5.5)) as did the oldest patients (HR 5.6 (1.9; 16.8)), men (HR 3.5 (95% CI 1.3; 9.3)) and subjects in the last FLC stages (HR 4.3 (95% CI 1.3;14.1)). Patients with low social support registered higher cardiovascular mortality (HR 2.6 (95% CI 1.1; 6.1)) as did the oldest patients (HR 12.4 (95% CI 2.8; 55.2)) and those with diabetes (HR 3.00 (95% CI 1.2; 7.6)). Patients with a low social network registered more CVEs (HR 2.1 (95% CI 1.1; 4.1)) than patients with an adequate network, as did the oldest patients (HR 3.1 (95% CI 1.4; 6.9)), subjects who presented with a higher grade of severity of AHT (HR 2.7 (1.3; 5.5)) and those in the last FLC stages (HR 2.5 (95% CI 1.0; 6.2)). A low social network is associated with mortality and the appearance of CVEs in patients with AHT. Low functional social support is associated with the appearance of cardiovascular mortality. PMID:25500900

  14. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study

    DEFF Research Database (Denmark)

    Worm, Signe Westring; Sabin, Caroline; Weber, Rainer;

    2010-01-01

    BACKGROUND. The risk of myocardial infarction (MI) in patients with human immunodeficiency virus (HIV) infection has been assessed in 13 anti-HIV drugs in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. METHODS. Poisson regression models were adjusted for cardiovascular risk...... factors, cohort, calendar year, and use of other antiretroviral drugs and assessed the association between MI risk and cumulative (per year) or recent (current or in the past 6 months) use of antiretroviral drugs, with >30,000 person-years of exposure. RESULTS. Over 178,835 person-years, 580 patients...

  15. The Modification Effect of Influenza Vaccine on Prognostic Indicators for Cardiovascular Events after Acute Coronary Syndrome: Observations from an Influenza Vaccination Trial

    Directory of Open Access Journals (Sweden)

    Apirak Sribhutorn

    2016-01-01

    Full Text Available Introduction. The prognosis of acute coronary syndrome (ACS patients has been improved with several treatments such as antithrombotics, beta-blockers, and angiotensin-converting enzyme inhibitors (ACEI as well as coronary revascularization. Influenza vaccination has been shown to reduce adverse outcomes in ACS, but no information exists regarding the interaction of other treatments. Methods. This study included 439 ACS patients from Phrommintikul et al. A single dose of inactivated influenza vaccine was given by intramuscular injection in the vaccination group. The cardiovascular outcomes were described as major cardiovascular events (MACEs which included mortality, hospitalization due to ACS, and hospitalization due to heart failure (HF. The stratified and multivariable Cox’s regression analysis was performed. Results. The stratified Cox’s analysis by influenza vaccination for each cardiovascular outcome and discrimination of hazard ratios showed that beta-blockers had an interaction with influenza vaccination. Moreover, the multivariable hazard ratios disclosed that influenza vaccine is associated with a significant reduction of hospitalization due to HF in patients who received beta-blockers (HR = 0.05, 95% CI = 0.004–0.71, P=0.027, after being adjusted for prognostic indicators (sex, dyslipidemia, serum creatinine, and left ventricular ejection fraction. Conclusions. The influenza vaccine was shown to significantly modify the effect of beta-blockers in ACS patients and to reduce the hospitalization due to HF. However, further study of a larger population and benefits to HF patients should be investigated.

  16. Pulmonary function and CT biomarkers as risk factors for cardiovascular events in male lung cancer screening participants: the NELSON study

    Energy Technology Data Exchange (ETDEWEB)

    Takx, Richard A.P.; Hoesein, Firdaus A.A.M.; Mali, Willem P.T.M.; Leiner, Tim; Jong, Pim A. de [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Vliegenthart, Rozemarijn [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands); University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen (Netherlands); Isgum, Ivana [University Medical Center Utrecht, Image Sciences Institute, Utrecht (Netherlands); Koning, Harry J. de; Aalst, Carlijn M. van der [Erasmus Medical Center Rotterdam, Department of Public Health, Rotterdam (Netherlands); Zanen, Pieter; Lammers, Jan-Willem J. [University Medical Center Utrecht, Department of Pulmonology, Utrecht (Netherlands); Groen, Harry J.M. [University Medical Center Groningen, Department of Pulmonology, Groningen (Netherlands); Rikxoort, Eva M. van; Ginneken, Bram van [Radboud University Nijmegen Medical Centre, Department of Radiology, Nijmegen (Netherlands); Institute for Medical Image Computing, Fraunhofer MEVIS, Bremen (Germany); Schmidt, Michael [Institute for Medical Image Computing, Fraunhofer MEVIS, Bremen (Germany); Oudkerk, Matthijs [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands)

    2015-01-15

    The objective of this study was to investigate the association of spirometry and pulmonary CT biomarkers with cardiovascular events. In this lung cancer screening trial 3,080 male participants without a prior cardiovascular event were analysed. Fatal and non-fatal cardiovascular events were included. Spirometry included forced expiratory volume measured in units of one-second percent predicted (FEV{sub 1}%predicted) and FEV{sub 1} divided by forced vital capacity (FVC; FEV{sub 1}/FVC). CT examinations were quantified for coronary artery calcium volume, pulmonary emphysema (perc15) and bronchial wall thickness (pi10). Data were analysed via a Cox proportional hazard analysis, net reclassification improvement (NRI) and C-indices. 184 participants experienced a cardiovascular event during a median follow-up of 2.9 years. Age, pack-years and smoking status adjusted hazard ratios were 0.992 (95 % confidence interval (CI) 0.985-0.999) for FEV{sub 1}%predicted, 1.000 (95%CI 0.986-1.015) for FEV{sub 1}/FVC, 1.014 (95%CI 1.005-1.023) for perc15 per 10 HU, and 1.269 (95%CI 1.024-1.573) for pi10 per 1 mm. The incremental C-index (<0.015) and NRI (<2.8 %) were minimal. Coronary artery calcium volume had a hazard ratio of 1.046 (95%CI 1.034-1.058) per 100 mm{sup 3}, an increase in C-index of 0.076 and an NRI of 16.9 % (P < 0.0001). Pulmonary CT biomarkers and spirometry measurements were significantly associated with cardiovascular events, but did not contain clinically relevant independent prognostic information for cardiovascular events. (orig.)

  17. MR-proANP improves prediction of mortality and cardiovascular events in patients with STEMI

    DEFF Research Database (Denmark)

    Lindberg, Søren; Jensen, Jan Skov; Pedersen, Sune H; Galatius, Søren; Goetze, Jens P; Mogelvang, Rasmus

    2015-01-01

    stroke or heart failure. RESULTS: During 5-year follow-up, MR-proANP was associated with increased risk of all-cause mortality and MACE (both p < 0.001). After adjustment for confounding risk factors (age, gender, hypertension, diabetes, hypercholesterolaemia, smoking, previous MI, BMI, eGFR, CRP, peak...... elevated in cardiovascular disease and predicts outcome in heart failure. However, knowledge of the prognostic value in acute myocardial infarction remains limited. METHODS: We prospectively included 680 patients with STEMI treated with primary-PCI, from September 2006 to December 2008. Blood samples were...... in MR-proANP. MR-proANP significantly increased C-statistics and reclassified 26% of the patients for all-cause mortality and 34% for MACE into higher or lower risk categories, matching actual event rates more accurately. CONCLUSIONS: Plasma MR-proANP independently predicts all-cause mortality and...

  18. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events

    DEFF Research Database (Denmark)

    Robinson, Jennifer G; Farnier, Michel; Krempf, Michel;

    2015-01-01

    BACKGROUND: Alirocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9), has been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy. Larger and longer-term studies are needed to establish safety...... with an acceptable side-effect profile), with or without other lipid-lowering therapy. Patients were randomly assigned in a 2:1 ratio to receive alirocumab (150 mg) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks. The primary efficacy end point was the percentage change in...... and efficacy. METHODS: We conducted a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated...

  19. Detecting drugs and adverse events from Spanish health social media streams

    OpenAIRE

    Revert Arenaz, Ricardo

    2014-01-01

    Adverse Drug Reactions (ADRs) are the 4th cause of death in hospitalized patients. Despite the importance of clinical trials, they have many limitations mainly based on time and population. Therefore, other ways of spotting ADRs had to be created, as for instance, the healthcare professionals reporting systems and the spontaneous patients reporting systems created by the FDA or the EMA. Nevertheless, it has been proven that the results obtained are not yet as satisfactory as expected. Heal...

  20. Cardiac adverse effects of nicotine replacement therapy.

    Science.gov (United States)

    2015-12-01

    Smoking markedly increases the risk of cardiovascular disease. Nicotine replacement therapy is available to assist in smoking cessation. To assess the cardiac adverse effects of nicotine replacement therapy, we conducted a review of the literature using the standard Prescrire methodology. A meta-analysis of 21 randomised, placebo-controlled trials published in early 2014 included a total of 11 647 patients, including 828 patients at high risk of cardiovascular events and 187 patients with acute coronary disorders. It showed that nicotine replacement therapy was associated with an increased risk of cardiac disorders, particularly palpitations, which are a known adverse effect of smoking. Among patients at high cardiovascular risk, 1.2% experienced a serious cardiovascular event, with no statistically significant difference versus placebo. Bupropion and varenicline both have serious adverse effects and have been less extensively evaluated in patients at high cardiovascular risk. In practice, when a drug is needed to assist in smoking cessation, nicotine appears to be a reasonable choice. Nicotine replacement therapy exposes patients to a risk of palpitations but rarely to serious cardiac disorders, even in individuals with a cardiovascular history. In addition, these adverse effects are better documented than those of bupropion and varenidine in such patients. Nonetheless, the cardiac effects of nicotine call for prudent use of nicotine replacement therapy: the minimum effective dose should be sought, and the goal should be total nicotine withdrawal. PMID:26788573

  1. Patients with premature cardiovascular disease and a positive family history for cardiovascular disease are prone to recurrent events

    NARCIS (Netherlands)

    T.A. Mulders; Z. Meyer; C. van der Donk; A.A. Kroon; I. Ferreira; C.D.A. Stehouwer; S.J. Pinto-Sietsma

    2011-01-01

    Background: Premature cardiovascular disease (CVD) is treated in the same way as CVD of advanced age. However, in patients with premature CVD and a family history of CVD, different -possibly genetic-mechanisms may underlie this disease, which current medical treatment is not targeted to. This sugges

  2. Financial compensation for radiotherapy-related adverse events in a judicial system where proof of medical negligence is not required

    International Nuclear Information System (INIS)

    Purpose: To examine the frequency of adverse events related to radiation therapy that lead to financial compensation in a judicial system that is not based on litigation in court but on statutory insurance where proof of medical negligence is not required for obtaining compensation. Methods and Materials: In Finland, an injured patient does not sue through the courts, but submits an insurance claim to the Patient Insurance Association. Proof of medical negligence is not required for obtaining compensation. We reviewed all filed claims associated with radiotherapy presented to the Patient Insurance Association from May 1987 to January 1999. During this time period, 1,732,000 patient visits to radiation therapy units were made, and the estimated number of radiotherapy treatments was 86,600. The data collected included descriptions of the adverse events, examination of the radiation therapy procedures followed, assessment of the causal relation of the event to radiotherapy by the therapists involved and by independent reviewers, and the sums used for compensation. Results: Only 102 patients (about 0.1%) had filed a claim for financial compensation, and in 18 (0.02%) cases the claim led to compensation. The mean national annual expenditure used for compensation was $35,200, and the sums paid in single cases ranged from $310 to $287,430 (median, $1,970). The expenditure used for compensating adverse radiation events was about $4 per treated patient, which is about 0.3% of all radiation therapy costs. Conclusions: The frequency of radiation therapy injuries that are financially compensated can remain low in an insurance-based judicial system where no litigation or attorneys are involved

  3. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2011-02-01

    Full Text Available Abstract Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1 informal and 2 formal complaints by patients/relatives, 3 medico-legal claims by patients/relatives and 4 incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6% adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals

  4. Elevation of urinary liver-type fatty acid binding protein after cardiac catheterization related to cardiovascular events

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    Kamijo-Ikemori A

    2015-08-01

    Full Text Available Atsuko Kamijo-Ikemori,1,3 Nobuyuki Hashimoto,2 Takeshi Sugaya,1 Katsuomi Matsui,1 Mikako Hisamichi,1 Yugo Shibagaki,1 Fumihiko Miyake,2 Kenjiro Kimura1 1Department of Nephrology and Hypertension, 2Department of Cardiology, 3Department of Anatomy, St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan Purpose: Contrast medium (CM induces tubular hypoxia via endothelial damage due to direct cytotoxicity or viscosity. Urinary liver-type fatty acid binding protein (L-FABP increases along with tubular hypoxia and may be a detector of systemic circulation injury. The aim of this study was to evaluate the clinical usefulness of detecting increases in urinary L-FABP levels due to administration of CM, as a prognostic biomarker for cardiovascular disease in patients without occurrence of CM-induced nephropathy undergoing cardiac catheterization procedure (CCP. Methods: Retrospective longitudinal analyses of the relationship between urinary L-FABP levels and occurrence of cardiovascular events were performed (n=29. Urinary L-FABP was measured by ELISA before CCP, and at 6, 12, 24, and 48 hours after CCP. Results: Urinary L-FABP levels were significantly higher at 12 hours (P<0.05 and 24 hours (P<0.005 after CCP compared with before CCP, only in the patients with occurrence of cardiovascular events (n=17, but not in those without cardiovascular events (n=12. The parameter with the largest area under the curve (0.816 for predicting the occurrence of cardiovascular events was the change in urinary L-FABP at 24 hours after CCP. The difference in urinary L-FABP levels (ΔL-FABP ≥11.0 µg/g creatinine between before CCP and at 24 hours after CCP was a risk factor for the occurrence of cardiovascular events (hazard ratio, 4.93; 95% confidence interval, 1.27–19.13; P=0.021. Conclusion: Measurement of urinary L-FABP before CCP and at 24 hours after CCP in patients with mild to moderate renal dysfunction may be an important indicator for risk

  5. Drug adverse events and drop-out risk: a clinical case.

    Science.gov (United States)

    Scoyni, R M; Aiello, L; Trani, I; Felli, B; Masin, A M R; Camponi, V; Dignazio, L; Cortese, M; Pacitti, M T; Carratelli, D; Morocutti, C

    2007-01-01

    We report a brief discussion on a clinical case of a female patient, 85 years old, affected by severe cognitive impairment and chronic obstructive pulmonary disease (COPD). The patient was not taking drugs at home (apart from promazine: 10 drops when necessary to control her behavioral diseases). A previous neuropsychological evaluation had shown a severe cognitive impairment MMSE=16/30; ADL=3/6; IADL=0/8) due to multiple brain ischemic areas (confirmed in 2003 by MRI neuroimaging). When the patient was admitted to our center she was able to perform some basic activities of daily living such as eating and walking and was not too confused. She was included in cognitive rehabilitation groups. Since she showed signs of Parkinsonism, a therapy based on omeprazol 20mg, acetylsalicylic acid, donepezil 10mg, pramipexol 0.18 mg, nimodipine 10 drops, levodopa+carbidopa 100/25mg was started. A few days later she became sleepy during daytime and, once, she lost her balance and fell. She was not self-sufficient any more. At first this was attributed to a lung infection that the patient had, but her state continue after the infection was completely cured with appropriate antibiotics therapy. At that point an adverse drug reaction was suspected and therapy with pramipexol 0.18 mg was interrupted. In a few days the patient regained her previous level of consciousness and self-sufficiency. We consider this a typical case of complex management in a patient with dementia and comorbidity in which adverse drug reactions can play an important role in lowering the level of cognitive functions. In this case the relationship with the family of the patient was made difficult by the attitude of the patient's daughter who decided, after the onset of the adverse drug reaction, to interrupt her mother's stay in our center even at risk of the worst consequences. PMID:17317475

  6. Scintigraphic calf perfusion symmetry after exercise and prediction of cardiovascular events: One stone to kill two birds?

    International Nuclear Information System (INIS)

    Background: Peripheral arterial disease (PAD) is commonly associated with a high cardiovascular mortality and morbidity as a marker of plurifocal atherosclerosis. Whether exercise thallium perfusion muscular asymmetry in the legs associated with PAD has prognostic value is unknown. Such a hypothesis was evaluated in a prospective study which remains the gold standard in clinical research. Methods and results: Scintigraphic calf perfusion symmetry after exercise (SCPSE) was measured at the end of a maximal or symptom-limited treadmill exercise test in 358 patients with known or suspected coronary artery disease (CAD). During the follow-up period (mean 85.3±32.8 months), 93 cardiovascular events and deaths (incident cases) occurred. Among those incident cases, the percentage of subjects with higher SCPSE values (third tertile) was 45.2%, versus 29.1% in controls (lower tertiles) (p=0.005). In stepwise multivariate analysis performed with the Cox proportional hazards model, previous CAD and SCPSE were the only significant independent predictors of prognosis. The multivariate relative risk of cardiovascular death or event in subjects with higher values of SCPSE was 1.94 (95% CI: 1.15-3.21; p<0.01). Conclusions: Scintigraphic calf perfusion asymmetry after exercise was independently associated with incident cardiovascular events in high-risk subjects. This index, which is easily and quickly calculated, could be used for evaluation of cardiovascular risk

  7. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

    Science.gov (United States)

    Begier, Elizabeth M; Burwen, Dale R; Haber, Penina; Ball, Robert

    2004-03-15

    Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis. PMID:14999618

  8. Cardiovascular events in patients received combined fibrate/statin treatment versus statin monotherapy: Acute Coronary Syndrome Israeli Surveys data.

    Directory of Open Access Journals (Sweden)

    Alexander Tenenbaum

    Full Text Available BACKGROUND: The effect of combination of fibrate with statin on major adverse cardiovascular events (MACE following acute coronary syndrome (ACS hospitalization is unclear. The main aim of this study was to investigate the 30-day rate of MACE in patients who participated in the nationwide ACS Israeli Surveys (ACSIS and were treated on discharge with a fibrate (mainly bezafibrate and statin combination vs. statin alone. METHODS: The study population comprised 8,982 patients from the ACSIS 2000, 2002, 2004, 2006, 2008 and 2010 enrollment waves who were alive on discharge and received statin. Of these, 8,545 (95% received statin alone and 437 (5% received fibrate/statin combination. MACE was defined as a composite measure of death, recurrent MI, recurrent ischemia, stent thrombosis, ischemic stroke and urgent revascularization. RESULTS: Patients from the combination group were younger (58.1±11.9 vs. 62.9±12.6 years. However, they had significantly more co-morbidities (hypertension, diabetes, current smokers and unfavorable cardio-metabolic profiles (with respect to glucose, total cholesterol, triglyceride and HDL-cholesterol. Development of MACE was recorded in 513 (6.0% patients from the statin monotherapy group vs. 13 (3.2% from the combination group, p = 0.01. 30-day re-hospitalization rate was significantly lower in the combination group: 68 (15.6% vs. 1691 (19.8% of patients, respectively; p = 0.03. Multivariable analysis identified the fibrate/statin combination as an independent predictor of reduced risk of MACE with odds ratio of 0.54, 95% confidence interval 0.32-0.94. CONCLUSION: A significantly lower risk of 30-day MACE rate was observed in patients receiving combined fibrate/statin treatment following ACS compared with statin monotherapy. However, caution should be exercised in interpreting these findings taking into consideration baseline differences between our observational study groups.

  9. Trend analysis of the adverse event cause in nuclear power plants

    International Nuclear Information System (INIS)

    The adverse incidents which occurred in domestic and U. S. nuclear power plants during the period from 2003 to 2008 were classified by the cause classification method developed by INSS. From the results, it is clarified that the most frequent cause both in Japan and the U.S. is 'maintenance errors' accounting for approximately 40% of the total causes. Among 'maintenance errors', 'imperfect planning' is the most frequent one in the U. S. and increased from fiscal year 2007 in Japan. 'Workers error' has reduced its frequency by half in the U. S. and is staying at more frequent level in Japan. From the result of tendency analysis, corrective action against 'imperfect planning' and/or the effective use of incident information is thought to become effective to reduce the frequency of adverse incidents. Therefore, future subjects should include a study of alternative methods to analyze 'imperfect planning' which enable supplemented current RCA. At the same time, it should also be a theme to consider the proper ways of making incident reports to have the worker or planner easily extract lessons learned from them, as well as understanding the importance of utilizing incident information such as NUCIA. (author)

  10. A study of adverse events associated with the use of Immunosuppressive agents in kidney transplanted Patients

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    Sharma Love

    2012-09-01

    Full Text Available Introduction: Kidney transplantation provides a l i f e saving treatment for patients wi th End Stage Renal Disease (ESRD. But total success after transplantation is hugely dependent on proper course of immunosuppressive therapy. The rationale behind this study was to monitor, analyse, and evaluate the AEs and ADRs associated with immunosuppressive drugs and to document the pharmacotherapeutic actions taken for its management. Methodology: The study was Retrospective and medical data of all patients (as per inclusion/exclusion criteria admitted during the Study Period was analysed. Results: A total of 95 patients were enrolled in the study and incidence rate of patient affected due to ADR was found to be 75.78 % and overall 352 AEs were documented. Causality and Severity assessment of ADRs were done which showed Probabale (47, and Moderate (47 respectively. Out of 84 ADRs, 80 ADRs were Not preventable. Furthermore significant relation was observed (p<0.005 among various factors, drugs and suspected ADRs. Conclusion: The results of this study show that immunosuppressive drugs may cause serious and frequent adverse effects. So, special monitoring and regular follow up of patients are required to minimise the risk and frequency of these adverse effects.

  11. Patients with primary membranous nephropathy are at high risk of cardiovascular events.

    Science.gov (United States)

    Lee, Taewoo; Derebail, Vimal K; Kshirsagar, Abhijit V; Chung, Yunro; Fine, Jason P; Mahoney, Shannon; Poulton, Caroline J; Lionaki, Sophia; Hogan, Susan L; Falk, Ronald J; Cattran, Daniel C; Hladunewich, Michelle; Reich, Heather N; Nachman, Patrick H

    2016-05-01

    Here we conducted a retrospective study to examine the risk of cardiovascular events (CVEs) relative to that of end-stage renal disease (ESRD) in patients with primary membranous nephropathy, in a discovery cohort of 404 patients. The cumulative incidence of CVEs was estimated in the setting of the competing risk of ESRD with risk factors for CVEs assessed by multivariable survival analysis. The observed cumulative incidences of CVEs were 4.4%, 5.4%, 8.2%, and 8.8% at 1, 2, 3, and 5 years respectively in the primary membranous nephropathy cohort. In the first 2 years after diagnosis, the risk for CVEs was similar to that of ESRD in the entire cohort, but exceeded it among patients with preserved renal function. Accounting for traditional risk factors and renal function, the severity of nephrosis at the time of the event (hazard ratio 2.1, 95% confidence interval 1.1 to 4.3) was a significant independent risk factor of CVEs. The incidence and risk factors of CVEs were affirmed in an external validation cohort of 557 patients with primary membranous nephropathy. Thus early in the course of disease, patients with primary membranous nephropathy have an increased risk of CVEs commensurate to, or exceeding that of ESRD. Hence, reduction of CVEs should be considered as a therapeutic outcome measure and focus of intervention in primary membranous nephropathy. PMID:26924046

  12. Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review.

    Science.gov (United States)

    Goldstein, Christina L; Macwan, Kevin; Sundararajan, Kala; Rampersaud, Y Raja

    2016-03-01

    OBJECT The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). METHODS A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. RESULTS The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias. PMID:26565767

  13. Eventos adversos relacionados à profilaxia anti-retroviral em acidentes ocupacionais Adverse events relating to antiretroviral prophylaxis for occupational accidents

    Directory of Open Access Journals (Sweden)

    Eduardo Alexandrino Servolo Medeiros

    2007-04-01

    Full Text Available O objetivo do estudo foi descrever os eventos adversos clínicos e laboratoriais secundários ao uso dos agentes anti-retrovirais em indivíduos submetidos à quimioprofilaxia. Foram avaliados 37 funcionários de um hospital universitário submetidos à quimioprofilaxia com quatro esquemas de medicação anti-retroviral após exposição ocupacional a fluidos de pacientes contaminados com infecção pelo vírus da imunodeficiência humana. Trinta e dois (86,5% desenvolveram eventos adversos clínicos ou laboratoriais. A profilaxia teve que ser suspensa em dois profissionais (5,4% em virtude das reações ocorridas. Os eventos adversos relacionados à quimioprofilaxia para infecção por HIV em funcionários de saúde, vítimas de acidente ocupacional foram freqüentes. Porém, raramente foi necessário retirar a medicação anti-retroviral.The objective of the study was to describe adverse events detected clinically or in the laboratory that were secondary to the use of antiretroviral agents among individuals undergoing antiretroviral prophylaxis. Evaluations were performed on 37 teaching hospital employees who underwent prophylaxis using four regimens of antiretroviral medication following occupational exposition to contaminated fluids from patients with human immunodeficiency virus infection. Thirty-two (86.5% developed adverse events detected clinically or in the laboratory. The prophylaxis administered to two professionals (5.4% had to be suspended because of the reactions that occurred. Adverse events relating to prophylaxis for HIV infection in health care workers who were victims of occupational accidents were frequent. However, it was rarely necessary to withdraw the antiretroviral medication.

  14. Adverse events in childhood and chronic widespread pain in adult life: Results from the 1958 British Birth Cohort Study.

    Science.gov (United States)

    Jones, Gareth T; Power, Chris; Macfarlane, Gary J

    2009-05-01

    Chronic widespread pain (CWP) is a common and frequently disabling condition. Several studies have shown that early life adversity is associated with CWP in later life; however, the majority are retrospective and suffer from potential recall bias. Using data from the 1958 British Birth Cohort Study, the aim of the current study was to examine, prospectively, the relationship between childhood physical and psychological adversity and CWP in adulthood. At 7 yrs data were collected, by parental report, on physically traumatic events (hospitalisation following a road traffic accident, or for surgery); and factors indicating poor social and psychological environment (periods in local authority care, death of a parent; or parental divorce, alcoholism, or financial hardship). CWP was assessed at 45 yrs using self-completion questionnaires. The relationship between childhood events and CWP was examined using Poisson regression. 7571 individuals provided pain data at 45 yrs (71.5%). There was no association between childhood surgery and CWP in adulthood (relative risk: 1.0; 95%CI: 0.9-1.1). However, children who had been hospitalised following a road traffic accident experienced a significant increase in the risk of future CWP (1.5; 1.05-2.1). Children who had resided in institutional care also experienced an increase in the risk of CWP (1.7; 1.3-2.4) as did those who experienced maternal death (2.0; 1.08-3.7) and familial financial hardship (1.6; 1.3-1.9). Further these associations were not explained by adult psychological distress or social class. To prevent long-term consequences of adverse childhood events, future research should study the mechanisms, in particular the biological mechanisms, underlying these relationships. PMID:19304391

  15. Adverse Events during Immunotherapy against Grass Pollen-Induced Allergic Rhinitis - Differences between Subcutaneous and Sublingual Treatment

    DEFF Research Database (Denmark)

    Aasbjerg, Kristian; Dalhoff, Kim Peder; Backer, Vibeke

    2015-01-01

    Allergic rhinitis (AR) triggered by grass pollen is a common disease, affecting millions of people worldwide. Treatment consists of symptom-alleviating drugs, such as topical corticosteroids or antihistamines. Another option is potentially curative immunotherapy, currently available as sublingual...... and subcutaneous treatment. We investigated the potential differences in the prevalence and severity of adverse events related to subcutaneous and sublingual immunotherapy (SLIT) against grass pollen-induced AR. A thorough literature search was performed with PubMed and EMBASE. The findings were compared...

  16. Questionnaire about the Adverse Events and Side Effects Following Botulinum Toxin A Treatment in Patients with Cerebral Palsy

    OpenAIRE

    Izabela Blaszczyk; Nazli Poorsafar Foumani; Christina Ljungberg; Mikael Wiberg

    2015-01-01

    Botulinum toxin A (BoNT-A) injections for treatment of spasticity in patients with cerebral palsy (CP) have been used for about two decades. The treatment is considered safe but a low frequency of adverse events (AE) has been reported. A good method to report AEs is necessary to verify the safety of the treatment. We decided to use an active surveillance of treatment-induced harm using a questionnaire we created. We studied the incidence of reported AEs and side effects in patients with CP tr...

  17. Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events

    OpenAIRE

    Cozac, Vitalii V.; Ehrensperger, Michael M.; Gschwandtner, Ute; Hatz, Florian; Meyer, Antonia; Monsch, Andreas U.; Schuepbach, Michael; Taub, Ethan; Fuhr, Peter

    2016-01-01

    International audience Objective: To investigate the incidence of serious adverse events (SAE) of subthalamic deep brain stimulation (STN-DBS) in elderly patients with Parkinson's disease (PD). Methods: We investigated a group of 26 patients with PD who underwent STN-DBS at mean age 63.2 ± 3.3 years. The operated patients from the EARLYSTIM study (mean age 52.9 ± 6.6) were used as a comparison group. Incidences of SAE were compared between these groups. Results: A higher incidence of psych...

  18. Gender-specific secondary prevention? Differential psychosocial risk factors for major cardiovascular events

    Science.gov (United States)

    Kure, Christina E; Chan, Yih-Kai; Ski, Chantal F; Thompson, David R; Carrington, Melinda J

    2016-01-01

    Objective To explore the psychosocial determinants and interhospital variability on a major acute cardiovascular event (MACE), during follow-up of a multicenter cohort of patients hospitalised with heart disease, participating in a nurse-led secondary prevention programme. Methods Outcome data were retrospectively analysed from 602 cardiac inpatients randomised to postdischarge standard care (n=296), or home-based intervention (n=306), with prolonged follow-up of individualised multidisciplinary support. Baseline psychosocial profiling comprised depressive status, health-related quality of life (HRQoL), social isolation and mild cognitive impairment (MCI). Multivariate analyses examined the independent correlates of a composite 2-year MACE rate of all-cause mortality and unplanned cardiovascular-related hospitalisation, according to gender. Results Participants were aged 70±10 years, 431 (72%) were men and 377 (63%) had coronary artery disease. During 2-year follow-up, 165 (27%) participants (114 men, 51 women; p=0.431) experienced a MACE. Independent correlates of a MACE in men were depressive status (OR 1.95, 95% CI 1.06 to 3.58; p=0.032), low physical HRQoL (OR 0.98, 95% CI 0.96 to 1.00; p=0.027) and increasing comorbidity (OR 1.14, 95% CI 1.04 to 1.25; p=0.004). In women, age (OR 1.06, 95% CI 1.02 to 1.12; p=0.008), MCI (OR 2.38, 95% CI 1.09 to 5.18; p=0.029) and hospital site predicted a MACE (OR 2.32, 95% CI 1.09 to 4.93; p=0.029). Conclusions Psychological determinants, cognitive impairment and responses to secondary prevention are different for men and women with heart disease and appear to modulate cardiovascular-specific outcomes. Early detection of psychosocial factors through routine screening and gender-specific secondary prevention is encouraged. Trial registration number 12608000014358. PMID:27099759

  19. Genetic determinants of cardiovascular events among women with migraine: a genome-wide association study.

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    Markus Schürks

    Full Text Available BACKGROUND: Migraine is associated with an increased risk for cardiovascular disease (CVD. Both migraine and CVD are highly heritable. However, the genetic liability for CVD among migraineurs is unclear. METHODS: We performed a genome-wide association study for incident CVD events during 12 years of follow-up among 5,122 migraineurs participating in the population-based Women's Genome Health Study. Migraine was self-reported and CVD events were confirmed after medical records review. We calculated odds ratios (OR and 95% confidence intervals (CI and considered a genome-wide p-value <5×10(-8 as significant. RESULTS: Among the 5,122 women with migraine 164 incident CVD events occurred during follow-up. No SNP was associated with major CVD, ischemic stroke, myocardial infarction, or CVD death at the genome-wide level; however, five SNPs showed association with p<5×10(-6. Among migraineurs with aura rs7698623 in MEPE (OR = 6.37; 95% CI 3.15-12.90; p = 2.7×10(-7 and rs4975709 in IRX4 (OR = 5.06; 95% CI 2.66-9.62; p = 7.7×10(-7 appeared to be associated with ischemic stroke, rs2143678 located close to MDF1 with major CVD (OR = 3.05; 95% CI 1.98-4.69; p = 4.3×10(-7, and the intergenic rs1406961 with CVD death (OR = 12.33; 95% CI 4.62-32.87; p = 5.2×10(-7. Further, rs1047964 in BACE1 appeared to be associated with CVD death among women with any migraine (OR = 4.67; 95% CI 2.53-8.62; p = 8.0×10(-7. CONCLUSION: Our results provide some suggestion for an association of five SNPs with CVD events among women with migraine; none of the results was genome-wide significant. Four associations appeared among migraineurs with aura, two of those with ischemic stroke. Although our population is among the largest with migraine and incident CVD information, these results must be treated with caution, given the limited number of CVD events among women with migraine and the low minor allele frequencies for three of the SNPs

  20. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events

    Directory of Open Access Journals (Sweden)

    Turakhia Mintu P

    2008-07-01

    Full Text Available Abstract Background Adherence to clinical practice guidelines for management of cardiovascular disease (CVD is suboptimal. The purposes of this study were to identify practice patterns and barriers among U.S. general internists and family physicians in regard to cardiovascular risk management, and examine the association between physician characteristics and cardiovascular risk management. Methods A case vignette survey focused on cardiovascular disease risk management was distributed to a random sample of 12,000 U.S. family physicians and general internists between November and December 2006. Results Responses from a total of 888 practicing primary care physicians who see 60 patients per week were used for analysis. In an asymptomatic patient at low risk for cardiovascular event, 28% of family physicians and 37% of general internists made guideline-based preventive choices for no antiplatelet therapy (p Conclusion Despite the benefits demonstrated for managing cardiovascular risks, gaps remain in primary care practitioners' management of risks according to guideline recommendations. Innovative educational approaches that address barriers may facilitate the implementation of guideline-based recommendations in CVD risk management.

  1. Adverse events in patients initiated on dabigatran etexilate therapy in a pharmacist-managed anticoagulation clinic

    OpenAIRE

    Donaldson M; Norbeck AO

    2013-01-01

    Background: Vitamin K antagonists have been the treatment of choice in preventing thromboembolic events, but problems such as frequent dose adjustment and monitoring of coagulation status, including multiple drug and food interactions, make their use difficult. Dabigatran etexilate is a new oral direct thrombin inhibitor not requiring routine monitoring and since its approval in the United States, many clinicians have been interested in utilizing this new therapy. Objective: This study docume...

  2. Adverse Events Lead to Drug Discontinuation More Commonly among Patients Who Receive Nafcillin than among Those Who Receive Oxacillin.

    Science.gov (United States)

    Viehman, J Alexander; Oleksiuk, Louise-Marie; Sheridan, Kathleen R; Byers, Karin E; He, Peimei; Falcione, Bonnie A; Shields, Ryan K

    2016-05-01

    Nafcillin and oxacillin are used interchangeably in clinical practice, yet few studies have evaluated the safety of these two agents. Our objective was to compare the differential tolerabilities of nafcillin and oxacillin among hospitalized patients. We conducted a retrospective cohort study of all patients who received 12 g/day of nafcillin or oxacillin for at least 24 h. Two hundred twenty-four patients were included. Baseline characteristics and comorbidities were similar among patients receiving nafcillin (n = 160) and those receiving oxacillin (n = 64). Hypokalemia, defined as a potassium level of ≤3.3 mmol/liter or ≤2.9 mmol/liter or as a ≥0.5-mmol/liter decrease from the baseline level, occurred more frequently among patients who received nafcillin (51%, 20%, and 56%, respectively) than among those who received oxacillin (17%, 3%, and 34%, respectively; P oxacillin (18% versus 6%; P = 0.03). Overall, 18% of patients who received nafcillin discontinued therapy prematurely due to adverse events, compared to 2% of patients who received oxacillin (P = 0.0004). Nafcillin treatment is associated with higher rates of adverse events and treatment discontinuation than oxacillin among hospitalized adult patients. These findings have important implications for patients in both inpatient and outpatient settings, particularly patients who require long-term therapy and cannot be monitored routinely. Future randomized controlled studies evaluating the efficacy, costs, and tolerability of nafcillin versus oxacillin are warranted. PMID:26976858

  3. A drug-adverse event extraction algorithm to support pharmacovigilance knowledge mining from PubMed citations.

    Science.gov (United States)

    Wang, Wei; Haerian, Krystl; Salmasian, Hojjat; Harpaz, Rave; Chase, Herbert; Friedman, Carol

    2011-01-01

    Adverse drug events (ADEs) create a serious problem causing substantial harm to patients. An executable standardized knowledgebase of drug-ADE relations which is publicly available would be valuable so that it could be used for ADE detection. The literature is an important source that could be used to generate a knowledgebase of drug-ADE pairs. In this paper, we report on a method that automatically determines whether a specific adverse event (AE) is caused by a specific drug based on the content of PubMed citations. A drug-ADE classification method was initially developed to detect neutropenia based on a pre-selected set of drugs. This method was then applied to a different set of 76 drugs to determine if they caused neutropenia. For further proof of concept this method was applied to 48 drugs to determine whether they caused another AE, myocardial infarction. Results showed that AUROC was 0.93 and 0.86 respectively. PMID:22195210

  4. Race/Ethnic Differences in the Associations of the Framingham Risk Factors with Carotid IMT and Cardiovascular Events.

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    Crystel M Gijsberts

    Full Text Available Clinical manifestations and outcomes of atherosclerotic disease differ between ethnic groups. In addition, the prevalence of risk factors is substantially different. Primary prevention programs are based on data derived from almost exclusively White people. We investigated how race/ethnic differences modify the associations of established risk factors with atherosclerosis and cardiovascular events.We used data from an ongoing individual participant meta-analysis involving 17 population-based cohorts worldwide. We selected 60,211 participants without cardiovascular disease at baseline with available data on ethnicity (White, Black, Asian or Hispanic. We generated a multivariable linear regression model containing risk factors and ethnicity predicting mean common carotid intima-media thickness (CIMT and a multivariable Cox regression model predicting myocardial infarction or stroke. For each risk factor we assessed how the association with the preclinical and clinical measures of cardiovascular atherosclerotic disease was affected by ethnicity.Ethnicity appeared to significantly modify the associations between risk factors and CIMT and cardiovascular events. The association between age and CIMT was weaker in Blacks and Hispanics. Systolic blood pressure associated more strongly with CIMT in Asians. HDL cholesterol and smoking associated less with CIMT in Blacks. Furthermore, the association of age and total cholesterol levels with the occurrence of cardiovascular events differed between Blacks and Whites.The magnitude of associations between risk factors and the presence of atherosclerotic disease differs between race/ethnic groups. These subtle, yet significant differences provide insight in the etiology of cardiovascular disease among race/ethnic groups. These insights aid the race/ethnic-specific implementation of primary prevention.

  5. Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

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    Francesca Scicchitano

    2012-01-01

    Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  6. Causal Factors and Adverse Events of Aviation Accidents and Incidents Related to Integrated Vehicle Health Management

    Science.gov (United States)

    Reveley, Mary S.; Briggs, Jeffrey L.; Evans, Joni K.; Jones, Sharon M.; Kurtoglu, Tolga; Leone, Karen M.; Sandifer, Carl E.

    2011-01-01

    Causal factors in aviation accidents and incidents related to system/component failure/malfunction (SCFM) were examined for Federal Aviation Regulation Parts 121 and 135 operations to establish future requirements for the NASA Aviation Safety Program s Integrated Vehicle Health Management (IVHM) Project. Data analyzed includes National Transportation Safety Board (NSTB) accident data (1988 to 2003), Federal Aviation Administration (FAA) incident data (1988 to 2003), and Aviation Safety Reporting System (ASRS) incident data (1993 to 2008). Failure modes and effects analyses were examined to identify possible modes of SCFM. A table of potential adverse conditions was developed to help evaluate IVHM research technologies. Tables present details of specific SCFM for the incidents and accidents. Of the 370 NTSB accidents affected by SCFM, 48 percent involved the engine or fuel system, and 31 percent involved landing gear or hydraulic failure and malfunctions. A total of 35 percent of all SCFM accidents were caused by improper maintenance. Of the 7732 FAA database incidents affected by SCFM, 33 percent involved landing gear or hydraulics, and 33 percent involved the engine and fuel system. The most frequent SCFM found in ASRS were turbine engine, pressurization system, hydraulic main system, flight management system/flight management computer, and engine. Because the IVHM Project does not address maintenance issues, and landing gear and hydraulic systems accidents are usually not fatal, the focus of research should be those SCFMs that occur in the engine/fuel and flight control/structures systems as well as power systems.

  7. Adverse Life Events and Psychopathology and Prosocial Behavior in Late Adolescence: Testing the Timing, Specificity, Accumulation, Gradient, and Moderation of Contextual Risk

    Science.gov (United States)

    Flouri, Eirini; Kallis, Constantinos

    2007-01-01

    A study examines the role of contextual risk in psychopathology and prosocial behavior in adolescents. The results show that risk accumulation matters instead of specificity and that the number of adverse life events is nonmultiplicative with psychopathology.

  8. Incidence and risk factors of major cardiovascular events in a multicentre HIV cohort

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    L Carenzi

    2012-11-01

    Full Text Available Cardiovascular (CV [1] and cerebrovascular [2] events threaten HIV+ subjects, affecting them earlier as compared to the general population and the current algorithms seem inadequate to estimate the CV risk, in particular concerning the weight of drugs, immunity and virus-related inflammation as risk factors. We analysed three Italian HIV cohorts from January 2005 to August 2011, extracting cases of acute myocardial infarction (AMI or stroke. We analysed at the time of the event the subjects’ age, the risk factors, the Framingham score, the antiviral regimen and the time spent on each drug, the CDC stage, the nadir CD4+ T cells and the outcome. Out of 4893 patients 92 experienced major CV events (76 AMI and 19 stroke, 2 subjects having both and 10 died, at a median age of 50 years (range 33–77. Classical risk factors were widely represented, mainly smoke (72.8% and dyslipidemia (53.3%. Three young subjects had no risk factors and dramatic coronary patterns, leading in one case to transplantation. No one ever had pathological bone fractures, and only 4/81 had GFR <60 mL/min (range 33.6–57.4. The median 10 years’ Framingham score was 10.5 (range 1–31. Abacavir had been taken by 19 subjects, equal to tenofovir and less than zidovudine (n=55, and lopinavir/ritonavir by 20, and no single drug emerged as risk. The median time spent on abacavir and/or on lopinavir/ritonavir was 48 weeks (range 1–552 and 106 weeks (range 8–256, respectively. One patient was antiretroviral–naïve. The CD4 nadir was 183/mm3 and 41.3% were CDC stage C. Although infrequent (1.8%, major CV events affect HIV people at younger age. Classical risk factors are common, while no drug effect emerged clearly. HIV infection was managed late in most of the patients. Early initiation of HAART [3] and reduction of risk factors seem the key points for preventing the occurrence of CV disease.

  9. The suspected unexpected and serious adverse events of antiretroviral drugs used as HIV prophylaxis in HIV uninfected persons

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    Ewa Pietraszkiewicz

    2014-11-01

    Full Text Available Introduction: With increased usage of antiretroviral drugs (ARVs in HIV uninfected persons proper reporting on suspected unexpected serious adverse reactions (SUSARs and continued insight into serious adverse events (SAEs is needed for adequate information on ARVs safety in such populations. Methods: We have evaluated medical documentation of persons receiving ARVs after non-occupationally HIV exposure (nPEP during five concomitant years (2009–2013. SAEs and SUSARs were evaluated by two HIV physicians and defined according to international standards. In statistical methods, Kaplan Meier survival analysis was used to estimate the probability of SAE and Cox proportional hazard models to identify independent predictors of developing SAE. Only the first SAE was included in these analyses. Results: In total, 375 persons received nPEP. The most common reason was needle stick (43%, followed by unprotected sexual intercourse (17%, rape (10% and first aid (10%. In 84 (22% cases, the source patient was either known to be HIV positive or within a high risk group (active injecting drug user. In total, 170 SAEs were reported, 139 persons had only one SAE and majority developed it within first two weeks. The most frequent first SAEs were gastrointestinal disorders (22%, followed by general symptoms (9%, hypersensitivity reactions (1.6% and CNS symptoms (1.3%. The remaining events were laboratory abnormalities of liver and kidney function, haematological disorders, other and unknown, each contributing to less than 1% of all patients. 8 (2.1% patients have developed a SUSAR (bradycardia, vivid dreams, lymphadenopathy of the neck, increased platelet count, swelling and pain of large joints, swelling of lower limbs, peripheral oedema and loss of concentration. 22 (5.9% persons discontinued nPEP due to adverse event and 19 (5.1% required a paid sick leave from work. In multivariate analyzes, only age was independent predictor of developing SAE (HR 1.17; [95% CI

  10. Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

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    Nomura K

    2015-06-01

    Full Text Available Kaori Nomura,1 Kunihiko Takahashi,2 Yasushi Hinomura,3 Genta Kawaguchi,4 Yasuyuki Matsushita,5 Hiroko Marui,6 Tatsuhiko Anzai,7 Masayuki Hashiguchi,8 Mayumi Mochizuki8 1Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, 2Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, 3Japan Pharmaceutical Information Center, 4Global Pharmacovigilance, Kissei Pharmaceutical Co Ltd, Tokyo, 5Medical Affairs Department, Daiichi Sankyo Co Ltd, 6Drug Safety Division, Chugai Pharmaceutical Co Ltd, 7Data Science Center, EPS Corporation, 8Faculty of Pharmacy, Keio University, Tokyo, Japan Background: The use of a statistical approach to analyze cumulative adverse event (AE reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection. Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER database and the US Food and Drug Administration Adverse Event Reporting System (FAERS, and how they affect signal detection.Methods: Two AE data sources from 2010 were examined, ie, JADER cases (JP and Japanese cases extracted from the FAERS (FAERS-JP. Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS, were used on drug-event combinations for three substances frequently recorded in both systems.Results: The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37 in the JP and 3.3±3.5 (maximum 62 in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and

  11. Design and Implementation of Cell-PREVEN: A Real-Time Surveillance System for Adverse Events Using Cell Phones in Peru

    OpenAIRE

    Curioso, Walter H; Karras, Bryant T; Campos, Pablo E; Buendía, Clara; Holmes, King K.; Kimball, Ann Marie

    2005-01-01

    With more clinical trials involving evaluations of new drugs or vaccines, monitoring for early detection of adverse events is essential. The overall goal of this study was to develop an interactive-computer system using cell phones for real-time collection and transmission of adverse events related to metronidazole administration among female sex workers (FSW) in Peru. We developed an application for cell phones in Spanish, called Cell-PREVEN, based on a system from Voxiva I...

  12. What can we learn from patient claims? - A retrospective analysis of incidence and patterns of adverse events after orthopaedic procedures in Sweden

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    Öhrn Annica

    2012-01-01

    Full Text Available Abstract Background Objective data on the incidence and pattern of adverse events after orthopaedic surgical procedures remain scarce, secondary to the reluctance for encompassing reporting of surgical complications. The aim of this study was to analyze the nature of adverse events after orthopaedic surgery reported to a national database for patient claims in Sweden. Methods In this retrospective review data from two Swedish national databases during a 4-year period were analyzed. We used the "County Councils' Mutual Insurance Company", a national no-fault insurance system for patient claims, and the "National Patient Register at the National Board of Health and Welfare". Results A total of 6,029 patient claims filed after orthopaedic surgery were assessed during the study period. Of those, 3,336 (55% were determined to be adverse events, which received financial compensation. Hospital-acquired infections and sepsis were the most common causes of adverse events (n = 741; 22%. The surgical procedure that caused the highest rate of adverse events was "decompression of spinal cord and nerve roots" (code ABC**, with 168 adverse events of 17,507 hospitals discharges (1%. One in five (36 of 168; 21.4% injured patient was seriously disabled or died. Conclusions We conclude that patients undergoing spinal surgery run the highest risk of being severely injured and that these patients also experienced a high degree of serious disability. The most common adverse event was related to hospital acquired infections. Claims data obtained in a no-fault system have a high potential for identifying adverse events and learning from them.

  13. Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

    OpenAIRE

    Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

    2015-01-01

    Background International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. Methods It was a doc...

  14. Acute myocardial infarction versus other cardiovascular events in community-acquired pneumonia

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    Stefano Aliberti

    2015-09-01

    Full Text Available The aim of the present study was to define the prevalence, characteristics, risk factors and impact on clinical outcomes of acute myocardial infarction (AMI versus other cardiovascular events (CVEs in patients with community-acquired pneumonia (CAP. This was an international, multicentre, observational, prospective study of CAP patients hospitalised in eight hospitals in Italy and Switzerland. Three groups were identified: those without CVEs, those with AMI and those with other CVEs. Among 905 patients, 21 (2.3% patients experienced at least one AMI, while 107 (11.7% patients experienced at least one other CVE. Patients with CAP and either AMI or other CVEs showed a higher severity of the disease than patients with CAP alone. Female sex, liver disease and the presence of severe sepsis were independent predictors for the occurrence of AMI, while female sex, age >65 years, neurological disease and the presence of pleural effusion predicted other CVEs. In-hospital mortality was significantly higher among those who experienced AMI in comparison to those experiencing other CVEs (43% versus 21%, p=0.039. The presence of AMI showed an adjusted odds ratio for in-hospital mortality of 3.57 (p=0.012 and for other CVEs of 2.63 (p=0.002. These findings on AMI versus other CVEs as complications of CAP may be important when planning interventional studies on cardioprotective medications.

  15. Depression Following Thrombotic Cardiovascular Events in Elderly Medicare Beneficiaries: Risk of Morbidity and Mortality

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    Christopher M. Blanchette

    2009-01-01

    Full Text Available Purpose. Depression and antidepressant use may independently increase the risk of acute myocardial infarction and mortality in adults. However, no studies have looked at the effect of depression on a broader thrombotic event outcome, assessed antidepressant use, or evaluated elderly adults. Methods. A cohort of 7,051 community-dwelling elderly beneficiaries who experienced a thrombotic cardiovascular event (TCE were pooled from the 1997 to 2002 Medicare Current Beneficiary Survey and followed for 12 months. Baseline characteristics, antidepressant utilization, and death were ascertained from the survey, while indexed TCE, recurrent TCE, and depression (within 6 months of indexed TCE were taken from ICD-9 codes on Medicare claims. Time to death and first recurrent TCE were assessed using descriptive and multivariate statistics. Results. Of the elders with a depression claim, 71.6% had a recurrent TCE and 4.7% died within 12 months of their indexed TCE, compared to 67.6% and 3.9% of those elders without a depression claim. Of the antidepressant users, 72.6% experienced a recurrent TCE and 3.9% died, compared to 73.7% and 4.6% in the subset of selective serotonin reuptake inhibitor (SSRI users. Depression was associated with a shorter time to death (P=.008 in the unadjusted analysis. However, all adjusted comparisons revealed no effect by depression, antidepressant use, or SSRI use. Conclusions. Depression was not associated with time to death or recurrent TCEs in this study. Antidepressant use, including measures of any antidepressant use and SSRI use, was not associated with shorter time to death or recurrent TCE.

  16. Milano summer particulate matter (PM10 triggers lung inflammation and extra pulmonary adverse events in mice.

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    Francesca Farina

    Full Text Available Recent studies have suggested a link between particulate matter (PM exposure and increased mortality and morbidity associated with pulmonary and cardiovascular diseases; accumulating evidences point to a new role for air pollution in CNS diseases. The purpose of our study is to investigate PM10sum effects on lungs and extra pulmonary tissues. Milano PM10sum has been intratracheally instilled into BALB/c mice. Broncho Alveolar Lavage fluid, lung parenchyma, heart and brain were screened for markers of inflammation (cell counts, cytokines, ET-1, HO-1, MPO, iNOS, cytotoxicity (LDH, ALP, Hsp70, Caspase8-p18, Caspase3-p17 for a putative pro-carcinogenic marker (Cyp1B1 and for TLR4 pathway activation. Brain was also investigated for CD68, TNF-α, GFAP. In blood, cell counts were performed while plasma was screened for endothelial activation (sP-selectin, ET-1 and for inflammation markers (TNF-α, MIP-2, IL-1β, MPO. Genes up-regulation (HMOX1, Cyp1B1, IL-1β, MIP-2, MPO and miR-21 have been investigated in lungs and blood. Inflammation in the respiratory tract of PM10sum-treated mice has been confirmed in BALf and lung parenchyma by increased PMNs percentage, increased ET-1, MPO and cytokines levels. A systemic spreading of lung inflammation in PM10sum-treated mice has been related to the increased blood total cell count and neutrophils percentage, as well as to increased blood MPO. The blood-endothelium interface activation has been confirmed by significant increases of plasma ET-1 and sP-selectin. Furthermore PM10sum induced heart endothelial activation and PAHs metabolism, proved by increased ET-1 and Cyp1B1 levels. Moreover, PM10sum causes an increase in brain HO-1 and ET-1. These results state the translocation of inflammation mediators, ultrafine particles, LPS, metals associated to PM10sum, from lungs to bloodstream, thus triggering a systemic reaction, mainly involving heart and brain. Our results provided additional insight into the toxicity

  17. Combined Value of Red Blood Cell Distribution Width and Global Registry of Acute Coronary Events Risk Score for Predicting Cardiovascular Events in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

    Science.gov (United States)

    Zhao, Na; Mi, Lan; Liu, Xiaojun; Pan, Shuo; Xu, Jiaojiao; Xia, Dongyu; Liu, Zhongwei; Zhang, Yong; Xiang, Yu; Yuan, Zuyi; Guan, Gongchang; Wang, Junkui

    2015-01-01

    Global Registry of Acute Coronary Events (GRACE) risk score and red blood cell distribution width (RDW) content can both independently predict major adverse cardiac events (MACEs) in patients with acute coronary syndrome (ACS). We investigated the combined predictive value of RDW and GRACE risk score for cardiovascular events in patients with ACS undergoing percutaneous coronary intervention (PCI) for the first time. We enrolled 480 ACS patients. During a median follow-up time of 37.2 months, 70 (14.58%) patients experienced MACEs. Patients were divided into tertiles according to the baseline RDW content (11.30–12.90, 13.00–13.50, 13.60–16.40). GRACE score was positively correlated with RDW content. Multivariate Cox analysis showed that both GRACE score and RDW content were independent predictors of MACEs (hazard ratio 1.039; 95% confidence interval [CI] 1.024–1.055; p < 0.001; 1.699; 1.294–2.232; p < 0.001; respectively). Furthermore, Kaplan–Meier analysis demonstrated that the risk of MACEs increased with increasing RDW content (p < 0.001). For GRACE score alone, the area under the receiver operating characteristic (ROC) curve for MACEs was 0.749 (95% CI: 0.707–0.787). The area under the ROC curve for MACEs increased to 0.805 (0.766–0.839, p = 0.034) after adding RDW content. The incremental predictive value of combining RDW content and GRACE risk score was significantly improved, also shown by the net reclassification improvement (NRI = 0.352, p < 0.001) and integrated discrimination improvement (IDI = 0.023, p = 0.002). Combining the predictive value of RDW and GRACE risk score yielded a more accurate predictive value for long-term cardiovascular events in ACS patients who underwent PCI as compared to each measure alone. PMID:26468876

  18. Combined Value of Red Blood Cell Distribution Width and Global Registry of Acute Coronary Events Risk Score for Predicting Cardiovascular Events in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

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    Na Zhao

    Full Text Available Global Registry of Acute Coronary Events (GRACE risk score and red blood cell distribution width (RDW content can both independently predict major adverse cardiac events (MACEs in patients with acute coronary syndrome (ACS. We investigated the combined predictive value of RDW and GRACE risk score for cardiovascular events in patients with ACS undergoing percutaneous coronary intervention (PCI for the first time. We enrolled 480 ACS patients. During a median follow-up time of 37.2 months, 70 (14.58% patients experienced MACEs. Patients were divided into tertiles according to the baseline RDW content (11.30-12.90, 13.00-13.50, 13.60-16.40. GRACE score was positively correlated with RDW content. Multivariate Cox analysis showed that both GRACE score and RDW content were independent predictors of MACEs (hazard ratio 1.039; 95% confidence interval [CI] 1.024-1.055; p < 0.001; 1.699; 1.294-2.232; p < 0.001; respectively. Furthermore, Kaplan-Meier analysis demonstrated that the risk of MACEs increased with increasing RDW content (p < 0.001. For GRACE score alone, the area under the receiver operating characteristic (ROC curve for MACEs was 0.749 (95% CI: 0.707-0.787. The area under the ROC curve for MACEs increased to 0.805 (0.766-0.839, p = 0.034 after adding RDW content. The incremental predictive value of combining RDW content and GRACE risk score was significantly improved, also shown by the net reclassification improvement (NRI = 0.352, p < 0.001 and integrated discrimination improvement (IDI = 0.023, p = 0.002. Combining the predictive value of RDW and GRACE risk score yielded a more accurate predictive value for long-term cardiovascular events in ACS patients who underwent PCI as compared to each measure alone.

  19. Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.

    Science.gov (United States)

    Joseph, Serene A; Montresor, Antonio; Casapía, Martín; Pezo, Lidsky; Gyorkos, Theresa W

    2016-07-01

    Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas. PMID:27139441

  20. Dose-Effect Relationships for Adverse Events After Cranial Radiation Therapy in Long-term Childhood Cancer Survivors

    International Nuclear Information System (INIS)

    Purpose: To evaluate the prevalence and severity of clinical adverse events (AEs) and treatment-related risk factors in childhood cancer survivors treated with cranial radiation therapy (CRT), with the aim of assessing dose-effect relationships. Methods and Materials: The retrospective study cohort consisted of 1362 Dutch childhood cancer survivors, of whom 285 were treated with CRT delivered as brain irradiation (BI), as part of craniospinal irradiation (CSI), and as total body irradiation (TBI). Individual CRT doses were converted into the equivalent dose in 2-Gy fractions (EQD2). Survivors had received their diagnoses between 1966 and 1996 and survived at least 5 years after diagnosis. A complete inventory of Common Terminology Criteria for Adverse Events grade 3.0 AEs was available from our hospital-based late-effect follow-up program. We used multivariable logistic and Cox regression analyses to examine the EQD2 in relation to the prevalence and severity of AEs, correcting for sex, age at diagnosis, follow-up time, and the treatment-related risk factors surgery and chemotherapy. Results: There was a high prevalence of AEs in the CRT group; over 80% of survivors had more than 1 AE, and almost half had at least 5 AEs, both representing significant increases in number of AEs compared with survivors not treated with CRT. Additionally, the proportion of severe, life-threatening, or disabling AEs was significantly higher in the CRT group. The most frequent AEs were alopecia and cognitive, endocrine, metabolic, and neurologic events. Using the EQD2, we found significant dose-effect relationships for these and other AEs. Conclusion: Our results confirm that CRT increases the prevalence and severity of AEs in childhood cancer survivors. Furthermore, analyzing dose-effect relationships with the cumulative EQD2 instead of total physical dose connects the knowledge from radiation therapy and radiobiology with the clinical experience