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Sample records for adverse cardiovascular events

  1. Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review

    Directory of Open Access Journals (Sweden)

    Westover Arthur N

    2012-06-01

    Full Text Available Abstract Background There is increasing concern that prescription stimulants may be associated with adverse cardiovascular events such as stroke, myocardial infarction, and sudden death. Public health concerns are amplified by increasing use of prescription stimulants among adults. Methods The objective of this study was to conduct a systematic review of the evidence of an association between prescription stimulant use and adverse cardiovascular outcomes. PUBMED, MEDLINE, EMBASE and Google Scholar searches were conducted using key words related to these topics (MESH: ADHD; Adults; Amphetamine; Amphetamines; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiovascular System; Central Nervous Stimulants; Cerebrovascular; Cohort Studies; Case–control Studies; Death; Death, Sudden, Cardiac; Dextroamphetamine; Drug Toxicity; Methamphetamine; Methylphenidate; Myocardial Infarction; Stimulant; Stroke; Safety. Eligible studies were population-based studies of children, adolescents, or adults using prescription stimulant use as the independent variable and a hard cardiovascular outcome as the dependent variable. Results Ten population-based observational studies which evaluated prescription stimulant use with cardiovascular outcomes were reviewed. Six out of seven studies in children and adolescents did not show an association between stimulant use and adverse cardiovascular outcomes. In contrast, two out of three studies in adults found an association. Conclusions Findings of an association between prescription stimulant use and adverse cardiovascular outcomes are mixed. Studies of children and adolescents suggest that statistical power is limited in available study populations, and the absolute risk of an event is low. More suggestive of a safety signal, studies of adults found an increased risk for transient ischemic attack and sudden death/ventricular arrhythmia. Interpretation was limited due to differences in population, cardiovascular outcome

  2. 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.

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

    Science.gov (United States)

    Chuang, Mei-Hua; Chuang, Tzyy-Ling; Huang, Kung-Yung; Lyu, Shaw-Ruey; Huang, Chih-Yuan; Lee, Ching-Chih

    2014-01-01

    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. PMID:25101124

  4. 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

  5. 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...

  6. 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;

    2015-01-01

    aged ≥70 years that initiated treatment with APs for the first time between 1997 and 2011 (n=91 774, mean age 82±7 years, 35 474 [39%] were men). Incidence rate ratios associated with use of different APs were assessed by multivariable time-dependent Poisson regression models. For the first 30 days...... of 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...... 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...

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

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    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

  8. 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;

    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...

  9. 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...... anhedonia, anxious arousal and general distress/negative affect symptom dimensions. Incident MACCE was defined as fatal or non-fatal; myocardial infarction, unstable angina pectoris, repeat revascularization, heart failure, sustained arrhythmia, stroke or cerebrovascular accident, left ventricular failure...

  10. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Association of non-alcoholic fatty liver disease with major adverse cardiovascular events: A systematic review and meta-analysis

    Science.gov (United States)

    Wu, Shunquan; Wu, Fuquan; Ding, Yingying; Hou, Jun; Bi, Jingfeng; Zhang, Zheng

    2016-01-01

    Increasing evidence connects non-alcoholic fatty liver disease (NAFLD) to cardiovascular disease (CVD). The aim of this study is to assess whether and to what extent the excess risk of CVD is conferred by NAFLD in a meta-analysis. We systematically searched PubMed, EmBase, Web of Science, and Cochrane Library for reports published between 1965 and July 3, 2015. Studies that reported data on association between NAFLD and adverse cardiovascular events or mortality were included. Thirty-four studies (164,494 participants, 21 cross-sectional studies, and 13 cohort studies) were included. NAFLD was not associated with overall mortality (HR = 1.14, 95% CI: 0.99–1.32) and CVD mortality (HR = 1.10, 95% CI: 0.86–1.41). However, NAFLD was associated with an increased risk of prevalent (OR = 1.81, 95% CI: 1.23–2.66) and incident (HR = 1.37, 95% CI: 1.10–1.72) CVD. For some specific CVDs, NAFLD was associated with an increased risk of prevalent (OR = 1.87, 95% CI: 1.47–2.37) and incident (HR = 2.31, 95% CI: 1.46–3.65) coronary artery disease (CAD), prevalent (OR = 1.24, 95% CI: 1.14–1.36) and incident (HR = 1.16, 95% CI: 1.06–1.27) hypertension, and prevalent (OR = 1.32, 95% CI: 1.07–1.62) atherosclerosis. In conclusion, the presence of NAFLD is associated with an increased risk of major adverse cardiovascular events, although it is not related to mortality from all causes or CVD. PMID:27633274

  13. 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.

  14. 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......-month follow-up, we tracked the use of clopidogrel and CCBs and the rate of MACE (composite of myocardial infarction, ischaemic stroke, stent thrombosis, target lesion revascularization, or cardiac death). We used Cox regression to compute hazard ratios, controlling for potential confounders. Results......  Overall, the 12-month risk for MACE was 14·5%. The rate was 130 per 1000 person years for concomitant clopidogrel and CCB use, 106 for clopidogrel without CCB use, 213 for CCB without clopidogrel use, and 248 for no use of either drug. The adjusted hazard ratio for MACE comparing clopidogrel use...

  15. 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

    .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, and 1.35 (1.......15-1.59) for all-cause mortality. When patients with severe psoriasis were used as controls, the adjusted IRRs in patients with HS were 1.00 (0.74-1.35) for MI, 0.93 (0.71-1.22) for ischemic stroke, 1.58 (1.17-2.12) for CV-associated death, 1.08 (0.90-1.29) for MACEs, and 1.09 (0.94-1.28) for all-cause mortality....... CONCLUSIONS AND RELEVANCE: Hidradenitis suppurativa was associated with a significantly increased risk of adverse CV outcomes and all-cause mortality independent of measured confounders. The risk of CV-associated death was higher in patients with HS compared with the risk in those with severe psoriasis...

  16. Depression, anxiety and major adverse cardiovascular and cerebrovascular events in patients following coronary artery bypass graft surgery: A five year longitudinal cohort study

    NARCIS (Netherlands)

    P.J. Tully (Phillip); H.R. Winefield (Helen); R.A. Baker (Robert); J. Denollet (Johan); S.S. Pedersen (Susanne); G.A. Wittert (Gary); D.A. Turnbull (Deborah)

    2015-01-01

    textabstractBackground: 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 theoretic

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

    Directory of Open Access Journals (Sweden)

    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.

  18. Vaccine adverse events.

    Science.gov (United States)

    Follows, Jill

    2012-01-01

    Millions of adults are vaccinated annually against the seasonal influenza virus. An undetermined number of individuals will develop adverse events to the influenza vaccination. Those who suffer substantiated vaccine injuries, disabilities, and aggravated conditions may file a timely, no-fault and no-cost petition for financial compensation under the National Vaccine Act in the Vaccine Court. The elements of a successful vaccine injury claim are described in the context of a claim showing the seasonal influenza vaccination was the cause of Guillain-Barré syndrome.

  19. [Adverse events prevention ability].

    Science.gov (United States)

    Aparo, Ugo Luigi; Aparo, Andrea

    2007-03-01

    The issue of how to address medical errors is the key to improve the health care system performances. Operational evidence collected in the last five years shows that the solution is only partially linked to future technological developments. Cultural and organisational changes are mandatory to help to manage and drastically reduce the adverse events in health care organisations. Classical management, merely based on coordination and control, is inadequate. Proactive, self-organising network based structures must be put in place and managed using adaptive, fast evolving management tools. PMID:17484160

  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 β-Blocker Therapy With Risks of Adverse Cardiovascular Events and Deaths in Patients With Ischemic Heart Disease Undergoing Noncardiac Surgery

    DEFF Research Database (Denmark)

    Andersson, Charlotte; Mérie, Charlotte; Jørgensen, Mads Wissenberg;

    2014-01-01

    , ischemic stroke, cardiovascular death, and all-cause death). OBJECTIVE: To assess the association of β-blocker treatment with major cardiovascular adverse events (MACE) and all-cause mortality in patients with ischemic heart disease undergoing noncardiac surgery. DESIGN, SETTING, PARTICIPANTS, AND EXPOSURE......: Individuals with ischemic heart disease with or without heart failure (HF) and with and without a history of myocardial infarction undergoing noncardiac surgery between October 24, 2004, and December 31, 2009, were identified from nationwide Danish registries. Adjusted Cox regression models were used...... myocardial infarction), but with no significant association in the remaining patients. Results were similar in propensity score-matched analyses. CONCLUSIONS AND RELEVANCE: Among patients with ischemic heart disease undergoing noncardiac surgery, use of β-blockers was associated with lower risk of 30-day...

  2. Validation of the Ability of SYNTAX and Clinical SYNTAX Scores to Predict Adverse Cardiovascular Events After Stent Implantation: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Chen, JiaYuan; Tang, Buzhou; Lin, YongQing; Ru, Ying; Wu, MaoXiong; Wang, Xiaolong; Chen, Qingcai; Chen, YangXin; Wang, JingFeng

    2016-10-01

    To compare the predicative ability of SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) and clinical SYNTAX scores for major adverse cardiac events (MACEs) after stent implantation in patients with coronary artery disease (CAD). Studies were identified by electronic and manual searches. Twenty-six studies were included in the meta-analysis. The pooled C-statistics of SYNTAX score for 1- and 5-year all-cause mortality (ACM) were 0.65 (95% confidence interval [CI]: 0.61-0.68) and 0.62 (95% CI: 0.59-0.65), respectively, with weak heterogeneity. The 1- and 5-year ACM pooled C-statistics for clinical SYNTAX scores were significantly higher at 0.77 and 0.71, respectively (Ps SYNTAX score for predicting 1-year ACM per unit was 1.04 (95% CI: 1.03-1.05). Calibration analysis indicated SYNTAX scores overestimated the risk of major adverse cardiac and cerebrovascular events in each risk stratum. The SYNTAX score demonstrated minimal discrimination in predicting 1- or 5-year adverse cardiovascular events after percutaneous coronary intervention in patients with CAD. The clinical SYNTAX score could further improve the predictive capability for ACM but not MACE.

  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. Aspirin effect on the incidence of major adverse cardiovascular events in patients with diabetes mellitus: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Ghali William A

    2011-04-01

    Full Text Available Abstract Background Aspirin has been recommended for the prevention of major adverse cardiovascular events (MACE, composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death in diabetic patients without previous cardiovascular disease. However, recent meta-analyses have prompted re-evaluation of this practice. The study objective was to evaluate the relative and absolute benefits and harms of aspirin for the prevention of incident MACE in patients with diabetes. Methods We performed a systematic review and meta-analysis on seven studies (N = 11,618 reporting on the use of aspirin for the primary prevention of MACE in patients with diabetes. Two reviewers conducted a systematic search of electronic databases (MEDLINE, EMBASE, the Cochrane Library, and BIOSIS and hand searched bibliographies and clinical trial registries. Reviewers extracted data in duplicate, evaluated the quality of the trials, and calculated pooled estimates. Results A total of 11,618 participants were included in the analysis. The overall risk ratio (RR for MACE was 0.91 (95% confidence intervals, CI, 0.82-1.00 with little heterogeneity among trials (I2 0.0%. Secondary outcomes of interest included myocardial infarction (RR, 0.85; 95% CI, 0.66-1.10, stroke (RR, 0.84; 95% CI, 0.64-1.11, cardiovascular death (RR, 0.95; 95% CI, 0.71-1.27, and all-cause mortality (RR, 0.95; 95% CI, 0.85-1.06. There were higher rates of hemorrhagic and gastrointestinal events. In absolute terms, these relative risks indicate that for every 10,000 diabetic patients treated with aspirin, 109 MACE may be prevented at the expense of 19 major bleeding events (with the caveat that the relative risk for the latter is not statistically significant. Conclusions The studies reviewed suggest that aspirin reduces the risk of MACE in patients with diabetes without cardiovascular disease, while also causing a trend toward higher rates of bleeding and gastrointestinal complications

  5. 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.

  6. A platelet P-selectin test predicts adverse cardiovascular events in patients with acute coronary syndromes treated with aspirin and clopidogrel.

    Science.gov (United States)

    Thomas, Mark R; Wijeyeratne, Yanushi D; May, Jane A; Johnson, Andrew; Heptinstall, Stan; Fox, Susan C

    2014-01-01

    There is wide variation in response to antiplatelet therapy and high on-treatment platelet reactivity is associated with adverse cardiovascular events. The objective here was to determine whether the results of a novel strategy for assessing platelet reactivity (based on P-selectin measurement) are associated with clinical outcomes in patients with acute coronary syndromes (ACS). This was a prospective cohort study of 100 ACS patients taking aspirin and clopidogrel. P-selectin tests designed to assess response to P2Y12 antagonists or aspirin were performed alongside light transmission aggregometry. For the P2Y12 P-selectin test, an optimal cutoff for high platelet reactivity was determined by receiver operating characteristic (ROC) curve analysis. Patients were divided into two cohorts based on this value: patients with (n = 42) or without (n = 58) high platelet reactivity. The primary endpoint was defined as the composite of cardiovascular death, myocardial infarction and stent thrombosis. After 12 months, the primary endpoint occurred in 12 patients. ROC curve analysis determined that the P2Y12 P-selectin test results were predictive of the primary endpoint (area under curve = 0.69, p = 0.046). The primary endpoint occurred more frequently in patients with high on-treatment platelet reactivity compared to those without (21.4% vs. 5.2%; hazard ratio (HR) 4.14; p = 0.026). The P2Y12 P-selectin test results correlated with light transmission aggregometry (Spearman p P-selectin test, only two patients demonstrated high on-treatment platelet reactivity. This study suggests that a P2Y12 P-selectin test is capable of detecting high on-treatment platelet reactivity, which is associated with subsequent cardiovascular events.

  7. 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...

  8. 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;

    2014-01-01

    underwent elective primary hip or knee replacement surgery between 2005 and 2011. We used multivariable Cox regression models to calculate the 30-day risks of MACE and mortality associated with 5 BMI groups (underweight (BMI overweight (25-29 kg/m(2)), obese...... 1 (30-34 kg/m(2)), and obese 2 (≥ 35 kg/m(2))). RESULTS: In total, 232 patients (0.7%) had a MACE and 111 (0.3%) died. Compared with overweight, adjusted hazard ratios (HRs) were 1.2 (95% CI: 0.4-3.3), 1.3 (0.95-1.8), 1.6 (1.1-2.2), and 1.0 (0.6-1.9) for underweight, normal weight, obese 1......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...

  9. 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,...

  10. 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

  11. 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.

  12. 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...

  13. 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. 

  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. Cardiovascular events in patients with COPD: TORCH study results

    DEFF Research Database (Denmark)

    Calverley, Peter M A; Anderson, Julie A; Celli, Bartolome;

    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.......2% for placebo, 22.7% for salmeterol, 24.3% for fluticasone propionate and 20.8% for SFC. Although a history of myocardial infarction doubled the probability of cardiovascular adverse events, the event rates remained similar across treatment groups. CONCLUSION: Post hoc analysis of the 3-year TORCH dataset...

  17. 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...... or nonfatal myocardial infarction or ischemic stroke (n = 502). High adiponectin was inversely associated with an increasing number of traditional CV risk factors (p...

  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. 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...

  20. 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

  1. Identifying Adverse Drug Events by Relational Learning.

    Science.gov (United States)

    Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael

    2012-07-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task, related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events. PMID:24955289

  2. Major adverse cardiac events during endurance sports.

    Science.gov (United States)

    Belonje, Anne; Nangrahary, Mary; de Swart, Hans; Umans, Victor

    2007-03-15

    Major adverse cardiac events in endurance exercise are usually due to underlying and unsuspected heart disease. The investigators present an analysis of major adverse cardiac events that occurred during 2 consecutive annual long distance races (a 36-km beach cycling race and a 21-km half marathon) over the past 5 years. All patients with events were transported to the hospital. Most of the 62,862 participants were men (77%; mean age 40 years). Of these, 4 men (3 runners, 1 cyclist; mean age 48 years) collapsed during (n = 2) or shortly after the races, rendering a prevalence of 0.006%. Two patients collapsed after developing chest pain, 1 of whom needed resuscitation at the event site, which was successful. These patients had acute myocardial infarctions and underwent primary angioplasty. The third patient was resuscitated at the site but did not have coronary disease or inducible ventricular tachycardia or ventricular fibrillation and collapsed presumably because of catecholamine-induced ventricular fibrillation. The fourth patient experienced heat stroke and had elevated creatine kinase-MB and troponins in the absence of electrocardiographic changes. In conclusion, the risk for major adverse cardiac events during endurance sports in well-trained athletes is very low.

  3. [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

  4. 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...

  5. 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...

  6. 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...

  7. 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

  8. 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...

  9. 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...

  10. 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...

  11. Endoscopic retrograde cholangiopancreatography-related adverse events: general overview.

    Science.gov (United States)

    Rustagi, Tarun; Jamidar, Priya A

    2015-01-01

    Endoscopic retrograde cholangiopancreatography (ERCP) represents a monumental advance in the management of patients with pancreaticobiliary diseases, but is a complex and technically demanding procedure with the highest inherent risk of adverse events of all routine endoscopic procedures. Overall adverse event rates for ERCP are typically reported as 5-10%. The most commonly reported adverse events include post-ERCP pancreatitis, bleeding, perforation, infection (cholangitis), and cardiopulomary or "sedation related" events. This article evaluates patient-related and procedure-related risk factors for ERCP-related adverse events, and discusses strategies for the prevention, diagnosis and management of these events.

  12. 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...

  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 manual...... reviews, and we therefore believe that it is possible to develop automatic tools for monitoring aspects of patient safety....

  14. Methylmercury exposure and adverse cardiovascular effects in Faroese whalingmen

    DEFF Research Database (Denmark)

    Choi, Anna L; Weihe, Pál; Budtz-Jørgensen, Esben;

    2009-01-01

    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 years previously. Outcome measures included heart rate variability (HRV), blood pressure (BP), common carotid...... intima-media thickness (IMT), and brainstem auditory evoked potentials (BAEP). We carried out multiple regression and structural equation model (SEM) analyses to determine the confounder-adjusted effect of mercury exposure. Taking into account correlations among related measures, we categorized exposure...

  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. Adverse events after hepatitis A B combination vaccine.

    Science.gov (United States)

    Woo, Emily Jane; Miller, Nancy B; Ball, Robert

    2006-03-24

    In May 2001, the U.S. Food and Drug Administration (FDA) approved Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB) for immunization of adults. From May 2001 to September 2003, the Vaccine Adverse Event Reporting System (VAERS) received 305 reports of adverse events after HEPAB. Many events were similar to those reported after the monovalent hepatitis A and B vaccines. Non-serious events included constitutional symptoms and local reactions. Serious events included neurologic, hepatobiliary, and dermatologic conditions, and detailed medical and epidemiological review did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine, except for injection site reactions and some allergic reactions.

  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. Gastrointestinal events with clopidogrel

    DEFF Research Database (Denmark)

    Grove, Erik Lerkevang; Würtz, Morten; Schwarz, Peter;

    2013-01-01

    Clopidogrel prevents cardiovascular events, but has been linked with adverse gastrointestinal (GI) complications, particularly bleeding events.......Clopidogrel prevents cardiovascular events, but has been linked with adverse gastrointestinal (GI) complications, particularly bleeding events....

  20. Adverse pregnancy outcomes and cardiovascular risk factor management.

    Science.gov (United States)

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

    2015-06-01

    Cardiovascular disease (CVD) is the leading health threat to American women. In addition to establish 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 women often use their obstetrician/gynecologist as their primary health provider, this is an opportune time to diagnose and treat CVD risk factors early. Embedding preventive care providers such as nurse practitioners or physician assistants within OB/GYN practices can be considered, with referral to family medicine or internist for ongoing risk assessment and management. The American Heart Association (AHA)/American Stroke Association (ASA) stroke prevention guidelines tailored to women recommend that women with a history of pre-eclampsia can be evaluated for hypertension and other CVD risk factors within 6 months to 1-year post-partum. Given the burden and impact of CVD on women in our society, the entire medical community must work to establish feasible practice and referral patterns for assessment and treatment of CVD risk factors.

  1. Adverse cardiovascular, cerebrovascular, and peripheral vascular effects of marijuana inhalation: what cardiologists need to know.

    Science.gov (United States)

    Thomas, Grace; Kloner, Robert A; Rezkalla, Shereif

    2014-01-01

    Marijuana is the most widely used illicit drug, with approximately 200 million users worldwide. Once illegal throughout the United States, cannabis is now legal for medicinal purposes in several states and for recreational use in 3 states. The current wave of decriminalization may lead to more widespread use, and it is important that cardiologists be made aware of the potential for marijuana-associated adverse cardiovascular effects that may begin to occur in the population at a greater frequency. In this report, the investigators focus on the known cardiovascular, cerebrovascular, and peripheral effects of marijuana inhalation. Temporal associations between marijuana use and serious adverse events, including myocardial infarction, sudden cardiac death, cardiomyopathy, stroke, transient ischemic attack, and cannabis arteritis have been described. In conclusion, the potential for increased use of marijuana in the changing legal landscape suggests the need for the community to intensify research regarding the safety of marijuana use and for cardiologists to maintain an awareness of the potential for adverse effects. PMID:24176069

  2. 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 

  3. [Nursing practice in view of adverse events following vaccination].

    Science.gov (United States)

    Bisetto, Lúcia Helena Linheira; Cubas, Marcia Regina; Malucelli, Andreia

    2011-10-01

    The objectives of this article are to identify the adverse events following vaccination, the focus if nursing practice, using the Post-Vaccination Adverse Events Information System database, and discuss on the nurses' practice on the surveillance for those events. Secondary data were those regarding the vaccines applied in the Brazilian public health system, in the period from 1999 to 2008, totaling 65,442 registers, 59,899 of which were confirmed and 1,403 were associated with another vaccine. The 16 nursing practice events totaled 21,727 registers. Although they account for 35.4% of the registers, the data do not reflect the reality, because their reliability depends on the knowledge network that comprises diagnosis, notification and inclusion in the system. Discussions were made on interventions for the most prevalent events: fever and local events. Most interventions established in the adverse events manual was in agreement with the literature, though there were differences in the content between conducts for the same event due to different vaccines.

  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. Plasma asymmetric dimethylarginine and adverse events in patients with atrial fibrillation referred for coronary angiogram.

    Directory of Open Access Journals (Sweden)

    Tze-Fan Chao

    Full Text Available OBJECTIVES: Elevated plasma levels of asymmetric dimethylarginine (ADMA have been reported to be associated with endothelial dysfunction, inflammation, and oxidative stress in multiple cardiovascular diseases. This study aimed to investigate whether ADMA was a predictor of clinical outcomes in atrial fibrillation (AF. METHODS AND RESULTS: From 2006-2009, 990 individuals were referred to our institution for coronary angiography. Among these patients, 141 subjects with a diagnosis of AF, including 52 paroxysmal AF (PAF and 89 non-paroxysmal AF (non-PAF patients, were identified as the study population. Plasma ADMA levels were measured. An adverse event was defined as the occurrence of ischemic stroke or cardiovascular death. The ADMA levels were higher in AF than non-AF patients (0.50 ± 0.13 versus 0.45 ± 0.07 µmol/L; p<0.001. Besides, non-PAF patients had higher ADMA levels than PAF patients (0.52 ± 0.15 versus 0.48 ± 0.08 µmol/L; p<0.001. During the follow-up of 30.7±14.4 months, 21 patients (14.9% experienced adverse events, including cardiovascular death in 7 patients and ischemic stroke in 14. ADMA level, CHA2DS2-VASc score, and left atrial diameter were independent predictors of adverse events in the multivariate analysis. At a cutoff-value of 0.55 µmol/L, the Kaplan-Meier survival analysis showed that patients with a high ADMA level had a higher event rate during the follow-up period. CONCLUSIONS: A higher level of ADMA was a risk factor of adverse events in AF patients, which was independent from the CHA2DS2-VASc score. It deserves to further study whether ADMA could potentially refine the clinical risk stratification in AF.

  6. Reliability of adverse symptom event reporting by clinicians

    Science.gov (United States)

    Li, Yuelin; Coffey, Charles W.; Sit, Laura; Shaw, Mary; Lavene, Dawn; Bennett, Antonia V.; Fruscione, Mike; Rogak, Lauren; Hay, Jennifer; Gönen, Mithat; Schrag, Deborah; Basch, Ethan

    2013-01-01

    Purpose Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk–benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit. Methods A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26–91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials. Results The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%). Conclusion Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered. PMID:21984468

  7. 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

  8. 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...

  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. 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;

    2013-01-01

    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....

  11. 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...

  12. 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

  13. Aortic pulse wave velocity improves cardiovascular event prediction

    DEFF Research Database (Denmark)

    Ben-Shlomo, Yoav; Spears, Melissa; Boustred, Chris;

    2014-01-01

    To determine whether aortic pulse wave velocity (aPWV) improves prediction of cardiovascular (CVD) events beyond conventional risk factors.......To determine whether aortic pulse wave velocity (aPWV) improves prediction of cardiovascular (CVD) events beyond conventional risk factors....

  14. 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....

  15. 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

  16. Adverse Drug Event Prevention: 2014 Action Plan Conference.

    Science.gov (United States)

    Ducoffe, Aaron R; Baehr, Avi; Peña, Juliet C; Rider, Briana B; Yang, Sandra; Hu, Dale J

    2016-09-01

    Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.

  17. Correlation between paraoxonase 1 Q192R polymorphism and cardiovascular adverse events after treatment with clopidogrel: a Meta-analysis%对氧磷酶1 Q192R基因多态性与氯吡格雷治疗后心血管不良事件相关性的Meta分析

    Institute of Scientific and Technical Information of China (English)

    李新刚; 赵坤; 鲁燕侠; 赵志刚; 刘振华

    2015-01-01

    目的 评价对氧磷酶1(paraoxonase 1 ,PON1) Q192R基因多态性与氯吡格雷治疗后发生心血管不良事件的相关性. 方法 检索Web of Knowledge、PubMed、ScienceDirect、Embase、Cochrane Library,中国知网、万方数据库和维普中文科技期刊数据库(建库到2015年3月),收集符合纳入标准的前瞻性队列研究,采用Review Manager 5.3软件进行Meta分析.结果 采用比值比(OR)及其95%置信区间(CI)表示. 结果共有12项研究纳入Meta分析,患者共10 090例,其中亚洲人2 113例、欧洲人7 396例,北美洲人581例;PON1 Q192R基因型为QQ者4 096例,QR+ RR者5 994例.研究质量评价结果均为高质量.亚洲人群亚组中PON1 192QQ基因型者心血管事件发生率为8.1% (38/472),QR+ RR基因型者为10.8%(177/1 641),OR=1.06,95% CI为0.64 ~ 1.75,P=0.82;北美洲人群亚组中PON1 192QQ基因型者心血管事件发生率为10.4% (27/260),QR+ RR基因型者为10.9% (35/321),OR =0.95,95% CI为0.56 ~ 1.63,P=0.42;欧洲人群亚组中PON1 192QQ基因型者心血管事件发生率为6.5% (217/3 364),QR+ RR基因型者为5.6% (225/4 032),OR=1.21,95% CI为0.85 ~ 1.73,P=0.28.3个亚组合并后,PON1 192QQ基因型者心血管事件发生率为6.9% (282/4 096),QR+ RR基因型者为7.3% (437/5 994),OR=1.13,95% CI为0.89 ~ 1.44,P=0.33.漏斗图分析表明纳入研究不存在明显的发表偏倚或选择性偏倚. 结论 PON1 Q192R基因多态性与氯吡格雷治疗后的心血管不良事件之间没有明显相关性.%Objective To evaluate the correlation between paraoxonase 1 (PON1) Q192R polymorphism and cardiovascular adverse events in patients treated with clopidogrel.Methods Web of Knowledge, PubMed, ScienceDirect, Embase, Cochrane Library, China National Knowledge Infrastructure,Wanfang, and CQVIP were searched from the inception to March 2015 and prospective cohort studies in accordance with the criteria were collected.Meta-analysis was performed using Rev

  18. 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

  19. 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...

  20. 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...

  1. The reasons of the nursing staff to notify adverse events

    Directory of Open Access Journals (Sweden)

    Miriam Cristina Marques da Silva de Paiva

    2014-10-01

    Full Text Available OBJECTIVE: this research aimed to understand the motivation for reporting adverse events from the perspective of nursing staff in the work environment.METHOD: qualitative study that used the phenomenology of Alfred Schutz for reference, which offers a systematic approach to understand the social aspects of human action. Data were collected by open interviews with 17 nurses and 14 technicians/assistant nurses in a university hospital.RESULTS: motivation was revealed through six categories: all types of occurrences must be reported; the incident report is an auxiliary instrument to health care provision management; the culture of punishment in transition; nurses as the agents responsible for voluntary reporting; sharing problems with higher management and achieving quality in the work process.DISCUSSION: it was unveiled that, when reporting adverse events, team members perceived themselves to be in a collaborative relationship with the institution and trusted that they would receive administrative support and professional security, which encouraged them to continue reporting. Reporting allows health care professionals to share responsibilities with managers and encourages corrective actions.FINAL CONSIDERATIONS: the study revealed the nursing staff's motivation for adverse event reporting, contributing to reflections on institutional policies aimed at patient safety in health care.

  2. 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

  3. 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

  4. 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...

  5. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis

    DEFF Research Database (Denmark)

    Fellström, Bengt C; Jardine, Alan G; Schmieder, Roland E;

    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...

  6. 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.

  7. Milan PM1 Induces Adverse Effects on Mice Lungs and Cardiovascular System

    Directory of Open Access Journals (Sweden)

    Francesca Farina

    2013-01-01

    Full Text Available Recent studies have suggested a link between inhaled particulate matter (PM exposure and increased mortality and morbidity associated with cardiorespiratory diseases. Since the response to PM1 has not yet been deeply investigated, its impact on mice lungs and cardiovascular system is here examined. A repeated exposure to Milan PM1 was performed on BALB/c mice. The bronchoalveolar lavage fluid (BALf and the lung parenchyma were screened for markers of inflammation (cell counts, tumor necrosis factor-α (TNF-α; macrophage inflammatory protein-2 (MIP-2; heme oxygenase-1 (HO-1; nuclear factor kappa-light-chain-enhancer of activated B cells p50 subunit (NFκB-p50; inducible nitric oxide synthetase (iNOS; endothelial-selectin (E-selectin, cytotoxicity (lactate dehydrogenase (LDH; alkaline phosphatase (ALP; heat shock protein 70 (Hsp70; caspase-8-p18, and a putative pro-carcinogenic marker (cytochrome 1B1 (Cyp1B1. Heart tissue was tested for HO-1, caspase-8-p18, NFκB-p50, iNOS, E-selectin, and myeloperoxidase (MPO; plasma was screened for markers of platelet activation and clot formation (soluble platelet-selectin (sP-selectin; fibrinogen; plasminogen activator inhibitor 1 (PAI-1. PM1 triggers inflammation and cytotoxicity in lungs. A similar cytotoxic effect was observed on heart tissues, while plasma analyses suggest blood-endothelium interface activation. These data highlight the importance of lung inflammation in mediating adverse cardiovascular events following increase in ambient PM1 levels, providing evidences of a positive correlation between PM1 exposure and cardiovascular morbidity.

  8. Adverse metabolic and cardiovascular consequences of circadian misalignment.

    Science.gov (United States)

    Scheer, Frank A J L; Hilton, Michael F; Mantzoros, Christos S; Shea, Steven A

    2009-03-17

    There is considerable epidemiological evidence that shift work is associated with increased risk for obesity, diabetes, and cardiovascular disease, perhaps the result of physiologic maladaptation to chronically sleeping and eating at abnormal circadian times. To begin to understand underlying mechanisms, we determined the effects of such misalignment between behavioral cycles (fasting/feeding and sleep/wake cycles) and endogenous circadian cycles on metabolic, autonomic, and endocrine predictors of obesity, diabetes, and cardiovascular risk. Ten adults (5 female) underwent a 10-day laboratory protocol, wherein subjects ate and slept at all phases of the circadian cycle-achieved by scheduling a recurring 28-h "day." Subjects ate 4 isocaloric meals each 28-h "day." For 8 days, plasma leptin, insulin, glucose, and cortisol were measured hourly, urinary catecholamines 2 hourly (totaling approximately 1,000 assays/subject), and blood pressure, heart rate, cardiac vagal modulation, oxygen consumption, respiratory exchange ratio, and polysomnographic sleep daily. Core body temperature was recorded continuously for 10 days to assess circadian phase. Circadian misalignment, when subjects ate and slept approximately 12 h out of phase from their habitual times, systematically decreased leptin (-17%, P work. PMID:19255424

  9. 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

  10. 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.

  11. 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....

  12. Adverse Event and Complication Management in Gastrointestinal Endoscopy.

    Science.gov (United States)

    Richter, James M; Kelsey, Peter B; Campbell, Emily J

    2016-03-01

    Gastrointestinal endoscopy is a remarkably safe set of diagnostic and therapeutic techniques, and yet a small number of significant complications and adverse events are expected. Serious complications may have a material effect on the patient's health and well-being. They need to be anticipated and prevented if possible and managed effectively when identified. When complications occur they need to be discussed frankly with patients and their families. Informed consent, prevention, early detection, reporting, and systems improvement are critical aspects of effective complication management. Optimal complication management may improve patient satisfaction and outcome, as well as preserving the reputation and confidence of the endoscopist, and may minimize litigation.

  13. 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...

  14. 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...

  15. Frequency of adverse events after vaccination with different vaccinia strains.

    Directory of Open Access Journals (Sweden)

    Mirjam Kretzschmar

    2006-08-01

    Full Text Available BACKGROUND: Large quantities of smallpox vaccine have been stockpiled to protect entire nations against a possible reintroduction of smallpox. Planning for an appropriate use of these stockpiled vaccines in response to a smallpox outbreak requires a rational assessment of the risks of vaccination-related adverse events, compared to the risk of contracting an infection. Although considerable effort has been made to understand the dynamics of smallpox transmission in modern societies, little attention has been paid to estimating the frequency of adverse events due to smallpox vaccination. Studies exploring the consequences of smallpox vaccination strategies have commonly used a frequency of approximately one death per million vaccinations, which is based on a study of vaccination with the New York City Board of Health (NYCBH strain of vaccinia virus. However, a multitude of historical studies of smallpox vaccination with other vaccinia strains suggest that there are strain-related differences in the frequency of adverse events after vaccination. Because many countries have stockpiled vaccine based on the Lister strain of vaccinia virus, a quantitative evaluation of the adverse effects of such vaccines is essential for emergency response planning. We conducted a systematic review and statistical analysis of historical data concerning vaccination against smallpox with different strains of vaccinia virus. METHODS AND FINDINGS: We analyzed historical vaccination data extracted from the literature. We extracted data on the frequency of postvaccinal encephalitis and death with respect to vaccinia strain and age of vaccinees. Using a hierarchical Bayesian approach for meta-analysis, we estimated the expected frequencies of postvaccinal encephalitis and death with respect to age at vaccination for smallpox vaccines based on the NYCBH and Lister vaccinia strains. We found large heterogeneity between findings from different studies and a time-period effect

  16. 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

  17. Bisphosphonates and risk of cardiovascular events: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Dae Hyun Kim

    Full Text Available Some evidence suggests that bisphosphonates may reduce atherosclerosis, while concerns have been raised about atrial fibrillation. We conducted a meta-analysis to determine the effects of bisphosphonates on total adverse cardiovascular (CV events, atrial fibrillation, myocardial infarction (MI, stroke, and CV death in adults with or at risk for low bone mass.A systematic search of MEDLINE and EMBASE through July 2014 identified 58 randomized controlled trials with longer than 6 months in duration that reported CV events. Absolute risks and the Mantel-Haenszel fixed-effects odds ratios (ORs and 95% confidence intervals (CIs of total CV events, atrial fibrillation, MI, stroke, and CV death were estimated. Subgroup analyses by follow-up duration, population characteristics, bisphosphonate types, and route were performed.Absolute risks over 25-36 months in bisphosphonate-treated versus control patients were 6.5% versus 6.2% for total CV events; 1.4% versus 1.5% for atrial fibrillation; 1.0% versus 1.2% for MI; 1.6% versus 1.9% for stroke; and 1.5% versus 1.4% for CV death. Bisphosphonate treatment up to 36 months did not have any significant effects on total CV events (14 trials; ORs [95% CI]: 0.98 [0.84-1.14]; I2 = 0.0%, atrial fibrillation (41 trials; 1.08 [0.92-1.25]; I2 = 0.0%, MI (10 trials; 0.96 [0.69-1.34]; I2 = 0.0%, stroke (10 trials; 0.99 [0.82-1.19]; I2 = 5.8%, and CV death (14 trials; 0.88 [0.72-1.07]; I2 = 0.0% with little between-study heterogeneity. The risk of atrial fibrillation appears to be modestly elevated for zoledronic acid (6 trials; 1.24 [0.96-1.61]; I2 = 0.0%, not for oral bisphosphonates (26 trials; 1.02 [0.83-1.24]; I2 = 0.0%. The CV effects did not vary by subgroups or study quality.Bisphosphonates do not have beneficial or harmful effects on atherosclerotic CV events, but zoledronic acid may modestly increase the risk of atrial fibrillation. Given the large reduction in fractures with bisphosphonates, changes in

  18. Acute and prolonged adverse effects of temperature on mortality from cardiovascular diseases.

    Directory of Open Access Journals (Sweden)

    Yu-Kai Lin

    Full Text Available BACKGROUND: Cardiovascular diseases are the leading causes of death worldwide, especially for developed countries. Elevated mortality from cardiovascular diseases has been shown related to extreme temperature. We thus assessed the risk of mortality from cerebrovascular diseases, heart diseases, and ischemic heart disease (IHD in relation to temperature profiles in four subtropical metropolitans (Taipei, Taichung, Tainan, and Kaohsiung from 1994 to 2007 in Taiwan. METHODS: Distributed lag non-linear models were applied to estimate the cumulative relative risks (RRs with confidence intervals of cause-specific mortality associated with daily temperature from lag 0 to 20 days, and specific effect of extreme temperature episodes with PM10, NOx, and O3, and other potential confounders controlled. Estimates for cause-specific mortalities were then pooled by random-effect meta-analysis. RESULTS: Comparing to centered temperature at 27 °C, the cumulative 4-day (lag 0 to 3 risk of mortality was significantly elevated at 31 °C for cerebrovascular diseases (RR = 1.14; 95% CI: 1.00, 1.31 and heart diseases (RR =  1.22; 95% CI: 1.02, 1.46 , but not for IHD (RR =  1.09; 95% CI: 0.99, 1.21. To the other extreme, at 15 °C, the cumulative 21-day (lag 0 to 20 risk of mortality were also remarkably increased for cerebrovascular diseases, heart diseases, and IHD (RRs  =  1.48 with 95% CI: 1.04, 2.12, 2.04 with 95% CI: 1.61, 2.58, and 1.62 with 95% CI: 1.30, 2.01, respectively. Mortality risks for cardiovascular diseases were generally highest on the present day (lag 0 of extreme heat. No particular finding was detected on prolonged extreme temperature event by pooling estimations for cause-specific mortality. CONCLUSIONS: Low temperature was associated with greater risk of mortality from cardiovascular diseases in comparison with that of high temperature. Adverse effects of extreme temperatures are acute at the beginning of exposure.

  19. 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;

    2015-01-01

    drawn immediately before PCI. Plasma MR-proANP was measured using an automated processing assay. Endpoints were all-cause mortality (n = 137) and the combined endpoint (n = 170) of major adverse cardiovascular events (MACE) defined as cardiovascular mortality and admission due to recurrent MI, ischaemic...... 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 smoking, previous MI, BMI, eGFR, CRP, peak...

  20. 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.

  1. Sporting events affect spectators' cardiovascular mortality: it is not just a game.

    Science.gov (United States)

    Leeka, Justin; Schwartz, Bryan G; Kloner, Robert A

    2010-11-01

    Physiologic and clinical triggers, including mental stress, anxiety, and anger, often precipitate acute myocardial infarction and cardiovascular death. Sporting events can acutely increase cardiovascular event and death rates. A greater impact is observed in patients with known coronary artery disease and when stressful features are present, including a passionate fan, a high-stakes game, a high-intensity game, a loss, and a loss played at home. Sporting events affect cardiovascular health through neuroendocrine responses and possibly an increase in high-risk behaviors. Acute mental stress increases the activity of the hypothalamic-pituitary-adrenocortical axis and the sympathetic-adrenal-medullary system while impairing vagal tone and endothelial function. Collectively, these mechanisms increase myocardial oxygen demand and decrease myocardial oxygen supply while also increasing the risk of arrhythmias and thrombosis. Measures can be taken to reduce cardiovascular risk, including the use of beta-blockers and aspirin, stress management, transcendental meditation, and avoidance of high-risk activities, such as smoking, eating fatty foods, overeating, and abusing alcohol and illicit drugs. Sporting events have the potential to adversely affect spectators' cardiovascular health, and protective measures should be considered.

  2. 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...

  3. 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

  4. 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.

  5. 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...

  6. 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

  7. 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.

  8. 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.

  9. High-molecular-weight adiponectin does not predict cardiovascular events in patients with type 2 diabetes.

    Science.gov (United States)

    Krzyzanowska, Katarzyna; Aso, Yoshimasa; Mittermayer, Friedrich; Inukai, Toshihiko; Brix, Johanna; Schernthaner, Guntram

    2009-04-01

    Low circulating high-molecular-weight (HMW) adiponectin might be associated with increased cardiovascular risk. This study aimed to investigate the relationship between HMW adiponectin and cardiovascular events in patients with type 2 diabetes mellitus (T2DM) with an adverse cardiovascular risk profile. The investigation took place in a specialized outpatient clinic for metabolic diseases and included 147 patients with T2DM following a cross-sectional and a prospective study protocol. Ninety patients had macrovascular disease at baseline defined as preexisting coronary artery disease, previous stroke, or peripheral artery disease. HMW adiponectin measured by enzyme-linked immunosorbent assay (Fujirebio, Tokyo, Japan) and routine clinical parameters were determined in all patients at baseline. The occurrence of new cardiovascular events (myocardial infarction, stroke, and all-cause mortality) during the follow-up period was evaluated. No significant correlations between traditional cardiovascular risk markers and HMW adiponectin could be detected. HMW adiponectin did not differ between subjects with and without macrovascular disease at baseline (3.5 [interquartile range [IQR]: 2.2-5.7] mg/L vs 4.0 [IQR: 2.5-7.1] mg/L). During a follow-up of 19.3 (IQR: 16-25) months, 61 endpoints (41 myocardial infarctions, 10 strokes, and 10 deaths) were observed. A 1-standard-deviation increment of log-transformed HMW adiponectin was not significantly associated with the occurrence of cardiovascular events (Adjusted hazard ratio [HR]: 0.95; 95% confidence interval [CI]: 0.58-1.54; P = 0.835). In conclusion, HMW adiponectin was not related to present macrovascular disease and is not associated with future cardiovascular events in high-risk patients with T2DM. It is unlikely that HMW adiponectin has significant vasoprotective effects in these patients.

  10. 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)

  11. 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.

  12. Telmisartan to prevent recurrent stroke and cardiovascular events

    DEFF Research Database (Denmark)

    Yusuf, Salim; Diener, Hans-Christoph; Sacco, Ralph L;

    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...

  13. 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.

  14. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea.

    Science.gov (United States)

    McEvoy, R Doug; Antic, Nick A; Heeley, Emma; Luo, Yuanming; Ou, Qiong; Zhang, Xilong; Mediano, Olga; Chen, Rui; Drager, Luciano F; Liu, Zhihong; Chen, Guofang; Du, Baoliang; McArdle, Nigel; Mukherjee, Sutapa; Tripathi, Manjari; Billot, Laurent; Li, Qiang; Lorenzi-Filho, Geraldo; Barbe, Ferran; Redline, Susan; Wang, Jiguang; Arima, Hisatomi; Neal, Bruce; White, David P; Grunstein, Ron R; Zhong, Nanshan; Anderson, Craig S

    2016-09-01

    Background Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain. Methods After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood. Results Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea-hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood. Conclusions Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and

  15. 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

  16. 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

    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......', '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...

  17. Effect of Administrative HDL-C Level on Adverse Cardiovascular Events After Discharge in Elder Patients With ST-segment Elevation Myocardial Infarction%老年ST段抬高型心肌梗死患者入院时高密度脂蛋白胆固醇水平对出院后不良心血管事件的影响研究

    Institute of Scientific and Technical Information of China (English)

    刘永; 葛华; 房玲

    2014-01-01

    Objective: To investigate the effect of administrative HDL-C (high density lipoprotein cholesterol) level on adverse cardiovascular events after discharge in elder patients with ST-segment elevation myocardial infarction (STEMI). Methods: A total of 325 STEMI patients treated in our hospital from 2010-04 to 2012-07 were retrospectively studied. According to administrative HDL-C level, the patients were divided into 2 groups as High HDL-C group, n=139 and Low HDL-C group, n=186. The basic and clinical conditions, in-hospital treatment, death and the medication, adverse cardiovascular events during 6 and 12 months follow-up period were compared between 2 groups. Results: The patients with in-hospital reperfusion therapy was higher in Low HDL-C group, and Low HDL-C group had the higher ratio of emergent PCI treatment, all P Conclusion: The lower administrative HDL-C level in elder patients with STEMI had the higher risk of adverse cardiovascular events after discharge.%目的:探讨分析老年ST段抬高型心肌梗死(STEMI)患者入院时高密度脂蛋白胆固醇(HDL-C)水平对出院后心血管不良事件发生情况的影响。  方法:选取我院于2010-04至2012-07收治的325例老年STEMI患者,根据患者的HDL-C水平将其分为HDL-C高组(139例)与HDL-C低组(186例)。对比分析两组患者基线资料、临床资料、在院期间所接受的治疗、死亡情况、随访期间药物使用情况及不良心血管事件发生情况。  结果:HDL-C低组入院后接受再灌注治疗的比例高于HDL-C高组(P  结论:入院时HDL-C水平低的STEMI患者出院后发生不良心血管事件的风险更高。

  18. 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

  19. Maternal Obesity During Pregnancy Associates With Premature Mortality and Major Cardiovascular Events in Later Life.

    Science.gov (United States)

    Lee, Kuan Ken; Raja, Edwin A; Lee, Amanda J; Bhattacharya, Sohinee; Bhattacharya, Siladitya; Norman, Jane E; Reynolds, Rebecca M

    2015-11-01

    One in 5 pregnant women is obese but the impact on later health is unknown. We aimed to determine whether maternal obesity during pregnancy associates with increased premature mortality and later life major cardiovascular events. Maternity records of women who gave birth to their first child between 1950 and 1976 (n=18 873) from the Aberdeen Maternity and Neonatal databank were linked to the National Register of Deaths, Scotland and Scottish Morbidity Record. The effect of maternal obesity at first antenatal visit on death and hospital admissions for cardiovascular events was tested using time-to-event analysis with Cox proportional hazard regression to compare outcomes of mothers in underweight, overweight, or obese body mass index (BMI) categories compared with normal BMI. Median follow-up was at 73 years. All-cause mortality was increased in women who were obese during pregnancy (BMI>30 kg/m(2)) versus normal BMI after adjustment for socioeconomic status, smoking, gestation at BMI measurement, preeclampsia, and low birth weight (hazard ratio, 1.35; 95% confidence interval, 1.02-1.77). In adjusted models, overweight and obese mothers had increased risk of hospital admission for a cardiovascular event (1.16; 1.06-1.27 and 1.26; 1.01-1.57) compared with normal BMI mothers. Adjustment for parity largely unchanged the hazard ratios (mortality: 1.43, 1.09-1.88; cardiovascular events overweight: 1.17, 1.07-1.29; and obese: 1.30, 1.04-1.62). In conclusion, maternal obesity is associated with increased risk of premature death and cardiovascular disease. Pregnancy and early postpartum could represent an opportunity for interventions to identify obesity and reduce its adverse consequences.

  20. 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

  1. OSLER and ODYSSEY LONG TERM: PCSK9 inhibitors on the right track of reducing cardiovascular events.

    Science.gov (United States)

    Hassan, Mohamed

    2015-01-01

    Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors have emerged as a novel treatment option in patients with hypercholesterolemia. Evolocumab and alirocumab have achieved consistent and significant (around 60%) reduction in low-density lipoprotein cholesterol (LDL-C) levels when added to statin therapy in short term studies. The Open-Label Study of Long-term Evaluation Against LDL-C (OSLER), and The Long-term Safety and Tolerability of Alirocumab in High Cardiovascular Risk Patients with Hypercholesterolemia Not Adequately Controlled with Their Lipid Modifying Therapy (ODYSSEY LONG TERM) studies are two phase 3, multicentre, randomized, placebo controlled studies that were conducted to evaluate the long term efficacy and safety of evolocumab and alirocumab respectively in reducing lipids and cardiovascular (CV) events. Both studies demonstrated additional 48-53% reduction of CV events when added to statin therapy. Most adverse events occurred with similar frequency in the two groups; however the rate of neurocognitive adverse events was higher with evolocumab and alirocumab than with placebo. These data provide strong support for the notion that lower LDL-C goal is better, and may confirm the role of PCSK9 inhibitors as a new frontier in lipid management. The results of larger long-term outcome studies are still awaited.

  2. 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...

  3. 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 ...

  4. 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...

  5. 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.

  6. 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

  7. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

    Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

    2009-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adve

  8. 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....

  9. 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...

  10. 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...

  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. 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

  13. Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review

    Science.gov (United States)

    Golder, Su; Wright, Kath

    2016-01-01

    Background We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events. Methods and Findings Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95

  14. ED 07-4 IS EXERCISE-INDUCED HYPERTENSION ASSOCIATED WITH ADVERSE CARDIOVASCULAR OUTCOMES?

    Science.gov (United States)

    Sharman, James

    2016-09-01

    Millions of clinical exercise stress tests are conducted annually worldwide. The fundamental rationale underlying the conduct of these tests is that cardiovascular irregularities may be revealed during an exercise bout that would otherwise remain unnoticed if testing was only conducted under resting conditions. In order to reveal electrocardiographic abnormalities indicative of cardiac disease, maximal intensity exercise may need to be undertaken, whereas the presence of hypertension can be revealed by the blood pressure response at low to moderate intensity exercise. Therefore, exercise blood pressure measured carefully under standardised conditions should be a useful tool to identify individuals at increased cardiovascular risk. Independent investigators have consistently shown that exercise blood pressure at low to moderate intensities predicts adverse cardiovascular outcomes independent from resting blood pressure and conventional cardiovascular risk factors. This talk will present evidence in support of exercise-induced hypertension as a clinical observation requiring additional follow up care. Future needs in terms of better understanding the mechanisms of exercise hypertension and determination of exercise hypertension thresholds will also be detailed. PMID:27642909

  15. 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;

    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...... a 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....

  16. 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,…

  17. Adverse events in children and adolescents treated with quetiapine

    DEFF Research Database (Denmark)

    Jakobsen, Klaus D; Wallach-Kildemoes, Helle; Bruhn, Christina H;

    2016-01-01

    Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...

  18. Cardiovascular risk factors and events in women with androgen excess.

    Science.gov (United States)

    Macut, D; Antić, I B; Bjekić-Macut, J

    2015-03-01

    Androgen excess (AE) was approximated to be present in 7% of the adult population of women. Polycystic ovary syndrome (PCOS) is the most prevalent among them, followed by idiopathic hirsutism (IH), congenital adrenal hyperplasia (CAH), hyperandrogenic insulin-resistant acanthosis nigricans (HAIRAN) syndrome, and androgen-secreting neoplasms (ASNs). Increased cardiovascular risk was implicated in women with AE. Serum testosterone independently increases risk for cardiovascular disease (CVD), and correlates even with indices of subclinical atherosclerosis in various populations of postmenopausal women. Hyperandrogenism in PCOS is closely related to the aggravation of abdominal obesity, and together with insulin resistance forming the metabolic core for the development of CVD. However, phenotypic variability of PCOS generates significant influence on the cardiometabolic risks. Numerous risk factors in PCOS lead to 5-7 times higher risk for CVD and over 2-fold higher risk for coronary heart disease and stroke. However, issue on the cardiometabolic risk in postmenopausal women with hyperandrogenic history is still challenging. There is a significant overlapping in the CVD characteristics of women with PCOS and variants of CAH. Relevant clinical data on the prevalence and cardiometabolic risk and events in women with IH, HAIRAN syndrome or ASNs are scarce. The effects of various oral contraceptives (OCs) and antiandrogenic compounds on metabolic profile are varying, and could be related to the selected populations and different therapy regiments mainly conducted in women with PCOS. It is assumed relation of OCs containing antiandrogenic progestins to the increased risk of cardiovascular and thromboembolic events.

  19. 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

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

    Directory of Open Access Journals (Sweden)

    N. V. Dmitrieva

    2013-01-01

    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.

  1. 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.

  2. 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.

  3. Angiographic adverse events during percutaneous coronary intervention fail to predict creatine kinase-MB elevation.

    Science.gov (United States)

    Blankenship, James C; Islam, M Ashequl; Wood, G Craig; Iliadis, Elias A

    2004-09-01

    We attempted to determine if aggressive detection of angiographic adverse events during coronary intervention could predict subsequent creatine kinase (CK)-MB elevations. During coronary intervention, both fluoroscopy and cine angiography were used to detect angiographic adverse events. At least one angiographic adverse event occurred in 133/251 (53%) of procedures. CK-MB elevation occurred in 24% of procedures. Slow flow during the procedure (P=0.002) and chest discomfort at the end of the procedure (P=0.007) were the strongest predictors of CK-MB elevation. Among procedures with no angiographic adverse events, CK-MB elevation occurred in 15/121 (12%), accounting for 25% of CK-MB elevations. We conclude that CK-MB elevation occurs after angiographically uncomplicated coronary interventions even when angiographic adverse events are aggressively detected. Routine monitoring of cardiac enzymes is necessary to detect all patients who will experience myocardial injury after coronary intervention.

  4. Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases

    Directory of Open Access Journals (Sweden)

    Kumutnart Chanprapaph

    2015-01-01

    Full Text Available Background: Previous reports regarding the cutaneous adverse events of epidermal growth factor receptor inhibitors are mostly limited to small case reports and case series, mainly involving Caucasian patients. Aims: We describe the trends in the clinical presentation of Asian patients who had cutaneous adverse events induced by epidermal growth factor receptor inhibitors and to explore the relationship between skin adverse events and tumor response. Methods: From 2006 to 2010, medical records of Thai patients with non-small cell lung cancer receiving epidermal growth factor receptor inhibitors were retrieved and analyzed. Results: In all, 99 patients were reviewed and analyzed. Erlotinib and gefitinib were commenced in 75 (75.8% and 24 (24.2% patients, respectively. Cutaneous adverse events occurred in 43 (57.3% patients receiving erlotinib and in 15 (62.5% patients receiving gefitinib. The most common adverse event was xerosis (52.5%. Less common adverse events included papulo-pustular eruption (27.3%, erythematous maculopapular rash (11.1%, mucositis (6.7%, paronychia (5.1%, and trichomegaly (2%. Elderly patients had a higher occurrence of xerosis. The presence of cutaneous adverse events was significantly higher in subjects who had a tumor response. Limitations: The limitations of study include its retrospective nature, and the initial screening of cutaneous adverse events was done by non-dermatologists. Conclusions: Cutaneous adverse events due to epidermal growth factor receptor inhibitors are not uncommon in the Asian population. We found a positive correlation between the occurrences of cutaneou adverse events and tumor response supporting the view that they are surrogate markers for therapeutic response.

  5. 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

  6. 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.

  7. 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

  8. 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......, the corresponding IRRs were 0·99 (95% CI: 0·97, 1·02), 0·99 (95% CI: 0·92, 1·05), and 0·85 (95% CI: 0·77, 0·94), respectively. Conclusions There was generally no evidence of an association between prenatal influenza exposure and acute MI or stroke in adulthood. However, survivor bias and left truncation of outcomes...

  9. 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...

  10. Adverse events of acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders.

    Science.gov (United States)

    List, T; Helkimo, M

    1992-10-01

    Occlusal splint therapy and acupuncture have been found to provide positive treatment in a number of studies. As with other therapies, adverse events may occur. In this paper, adverse event refers to any reaction to a treatment besides the intended treatment effect--irrespective of any correlation between the treatment and the reaction. This reaction can be positive, as well as negative, to the patient. In the present study, 61 patients with craniomandibular dysfunction (CMD) were treated with acupuncture or occlusal splint therapy and the adverse events were carefully recorded. The results show that the profile of the adverse events differed between the two treatment modes. Acupuncture seemed to have adverse events of a more general nature, e.g., relaxed feeling, improved sleep, temporarily increased pain; whereas, adverse events of occlusal splint therapy seemed to be more locally related to the orofacial region, e.g., increased/decreased salivation and tension in the teeth. The majority of the patients responded positively to both treatment modalities. Only in a few cases did the patients consider the treatment uncomfortable. No serious adverse event or complication was observed in this study.

  11. Paraoxonase 1 polymorphism and prenatal pesticide exposure associated with adverse cardiovascular risk profiles at school age.

    Directory of Open Access Journals (Sweden)

    Helle R Andersen

    Full Text Available 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 pesticides. A common polymorphism, PON1 Q192R, affects both properties, but a potential interaction between PON1 genotype and pesticide exposure on cardiovascular risk factors has not been investigated. We explored if the PON1 Q192R genotype affects cardiovascular risk factors in school-age children 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 age and sex specific Z-scores. RESULTS: Prenatally pesticide exposed children carrying the PON1 192R-allele had higher abdominal circumference, body fat content, BMI Z-scores, blood pressure, and serum concentrations of leptin and IGF-I at school age than unexposed children. The effects were related to the prenatal exposure level. For children with the PON1 192QQ genotype, none of the variables was affected by prenatal pesticide exposure. CONCLUSION: Our results indicate a gene-environment interaction between prenatal pesticide exposure and the PON1 gene. Only exposed children with the R-allele developed adverse cardiovascular risk profiles thought to be associated with the R-allele.

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

    Science.gov (United States)

    Andersen, Helle R.; Wohlfahrt-Veje, Christine; Dalgård, Christine; Christiansen, Lene; Main, Katharina M.; Nellemann, Christine; Murata, Katsuyuki; Jensen, Tina K.; Skakkebæk, Niels E.; Grandjean, Philippe

    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 pesticides. A common polymorphism, PON1 Q192R, affects both properties, but a potential interaction between PON1 genotype and pesticide exposure on cardiovascular risk factors has not been investigated. We explored if the PON1 Q192R genotype affects cardiovascular risk factors in school-age children 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 age and sex specific Z-scores. Results Prenatally pesticide exposed children carrying the PON1 192R-allele had higher abdominal circumference, body fat content, BMI Z-scores, blood pressure, and serum concentrations of leptin and IGF-I at school age than unexposed children. The effects were related to the prenatal exposure level. For children with the PON1 192QQ genotype, none of the variables was affected by prenatal pesticide exposure. Conclusion Our results indicate a gene-environment interaction between prenatal pesticide exposure and the PON1 gene. Only exposed children with the R-allele developed adverse cardiovascular risk profiles thought to be associated with the R-allele. PMID:22615820

  13. Analysis of Withdrawn Drugs Because of Cardiovascular Adverse Reactions%因心血管不良反应撤市的药物情况分析

    Institute of Scientific and Technical Information of China (English)

    毛璐; 高杰

    2013-01-01

    OBJECTIVE: To investigate the drugs withdrawn from the market because of cardiovascular adverse reactions in recent years, and to sum up the characteristics leading to cardiovascular adverse reactions and provide reference for rational use of drugs in the clinic. METHODS: Retrieved from domestic and foreign literature databases and the Internet, the data of drugs withdrawn from the market because of cardiovascular adverse reactions and related information were collected and summarized in recent years. RESULTS: In recent years because of cardiovascular events, more than ten drugs were withdrawn, involving non-steroidal anti-inflammatory drugs, diet pills, anti-histamine, etc. CONCLUSION: The cardiovascular adverse drug reactions should be noticed. The dosage and combined use of drugs should be standardized, in order to improve the safety and effectiveness of clinical medication.%目的:调查近年来因心血管不良反应撤市的药品情况,总结其引发心血管不良反应的特点,为临床合理使用药物提供借鉴.方法:检索国内外文献数据库及互联网,收集近年来因引起心血管不良反应而撤市的药物及其相关信息,并进行总结.结果:近年来在国内外因心血管事件撤市的药品涉及非甾体抗炎药、减肥药、抗组胺药等十余品种.结论:临床应警惕药物的心血管不良反应,规范用药剂量及合并药物,提高临床用药的有效性和安全性.

  14. 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.)

  15. 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.)

  16. 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.

  17. Sacral Nerve Stimulation for Constipation: Suboptimal Outcome and Adverse Events

    DEFF Research Database (Denmark)

    Maeda, Yasuko; Lundby, Lilli; Buntzen, Steen;

    2010-01-01

    Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events....

  18. Resting heart rate and risk of adverse cardiovascular outcomes in asymptomatic aortic stenosis

    DEFF Research Database (Denmark)

    Greve, Anders M; Bang, Casper N; Berg, Ronan M G;

    2015-01-01

    ) study of asymptomatic mild-to-moderate AS patients. Primary endpoint in this substudy was major cardiovascular events (MCEs) and secondary outcomes its individual components. Multivariable Cox-models using serially-measured RHR were used to examine the prognostic impact of RHR per se. RESULTS: 1563...... mortality (HR 1.3 per 10min(-1) faster, 95% CI: 1.0-1.7, both p≤0.03). Updating RHR with annual in-study reexaminations, time-varying RHR was highly associated with excess MCEs (HR 1.1 per 10min(-1) faster, 95% CI: 1.1-1.3) and cardiovascular mortality (HR 1.4 per 10min(-1) faster, 95% CI: 1.2-1.7, both p≤0...

  19. Glycopeptide antibiotics: evolving resistance, pharmacology and adverse event profile.

    Science.gov (United States)

    Henson, Karl Evans R; Levine, Miriam T; Wong, Eunice Ann H; Levine, Donald P

    2015-01-01

    The first glycopeptide antibiotic was vancomycin, isolated from the soil in the 1950s; since then, the class has expanded to include teicoplanin and the new semisynthetic glycopeptides dalbavancin, oritavancin and telavancin. They are bactericidal, active against most Gram-positive organisms, and in a concentration-dependent manner, inhibit cell wall synthesis. Resistance to vancomycin has emerged, especially among enterococci and Staphylococcus aureus through a variety of mechanisms. This emerging resistance to vancomycin makes proper dosing and monitoring of the area under the curve/MIC critically important. The chief adverse effect of vancomycin is nephrotoxicity, which is also intricately related to its dose. The efficacy of the semisynthetic glycopeptides has been demonstrated in skin and soft-tissue infections, but remains to be seen in serious methicillin-resistant Staphylococcus aureus infections.

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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

  5. Occurrence and prevention of surgical adverse events for quality improvement of surgical care.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Wagner, C.; Groenewegen, P.P.; Wal, G. van der

    2008-01-01

    Objective: To assess the occurrence, impact, type of adverse outcomes, causes and preventability of surgical adverse events (AEs) among hospitalised patients for quality improvement of surgical care. Methods: A retrospective patient records review study was performed in a random sample of 7926 patie

  6. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Science.gov (United States)

    2010-04-01

    ... adverse ruling. 2004.28 Section 2004.28 Housing and Urban Development Regulations Relating to Housing and... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... § 2004.23. (2) Petition for review. Within five business days of the filing of a Notice, the person...

  7. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. METHODS AND FINDINGS: We received...... the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on Pub...... group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1...

  8. 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...

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

    OpenAIRE

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

    2015-01-01

    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....

  10. 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...

  11. 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...

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16.  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...

  17. 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.

  18. Emotional Suppression Mediates the Relation Between Adverse Life Events and Adolescent Suicide: Implications for Prevention

    Science.gov (United States)

    Kaplow, Julie B.; Gipson, Polly Y.; Horwitz, Adam G.; Burch, Bianca N.; King, Cheryl A.

    2016-01-01

    Suicidal ideation substantially increases the odds of future suicide attempts, and suicide is the second leading cause of death among adolescents. A history of adverse life events has been linked with future suicidal ideation and attempts, although studies examining potential mediating variables have been scarce. One probable mediating mechanism is how the individual copes with adverse life events. For example, certain coping strategies appear to be more problematic than others in increasing future psychopathology, and emotional suppression in particular has been associated with poor mental health outcomes in adults and children. However, no studies to date have examined the potential mediating role of emotional suppression in the relation between adverse life events and suicidal thoughts/behavior in adolescence. The goal of the current study was to examine emotional suppression as a mediator in the relation between childhood adversity and future suicidal thoughts/behaviors in youth. A total of 625 participants, aged 14–19 years, seeking ER services were administered measures assessing adverse life events, coping strategies, suicidal ideation in the last 2 weeks, and suicide attempts in the last month. The results suggest that emotional suppression mediates the relation between adversity and both (1) suicidal thoughts and (2) suicide attempts above and beyond demographic variables and depressive symptoms. This study has important implications for interventions aimed at preventing suicidal thoughts and behavior in adolescents with histories of adversity. PMID:23412949

  19. 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

    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......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...... cardiovascular disease event rates compared to patients treated with other anti-psoriatic therapies....

  20. 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.

  1. Evidence-based interventions to reduce adverse events in hospitals: a systematic review of systematic reviews

    Science.gov (United States)

    Zegers, Marieke; Hesselink, Gijs; Geense, Wytske; Vincent, Charles; Wollersheim, Hub

    2016-01-01

    Objective To provide an overview of effective interventions aimed at reducing rates of adverse events in hospitals. Design Systematic review of systematic reviews. Data sources PubMed, CINAHL, PsycINFO, the Cochrane Library and EMBASE were searched for systematic reviews published until October 2015. Study selection English-language systematic reviews of interventions aimed at reducing adverse events in hospitals, including studies with an experimental design and reporting adverse event rates, were included. Two reviewers independently assessed each study's quality and extracted data on the study population, study design, intervention characteristics and adverse patient outcomes. Results Sixty systematic reviews with moderate to high quality were included. Statistically significant pooled effect sizes were found for 14 types of interventions, including: (1) multicomponent interventions to prevent delirium; (2) rapid response teams to reduce cardiopulmonary arrest and mortality rates; (3) pharmacist interventions to reduce adverse drug events; (4) exercises and multicomponent interventions to prevent falls; and (5) care bundle interventions, checklists and reminders to reduce infections. Most (82%) of the significant effect sizes were based on 5 or fewer primary studies with an experimental study design. Conclusions The evidence for patient-safety interventions implemented in hospitals worldwide is weak. The findings address the need to invest in high-quality research standards in order to identify interventions that have a real impact on patient safety. Interventions to prevent delirium, cardiopulmonary arrest and mortality, adverse drug events, infections and falls are most effective and should therefore be prioritised by clinicians. PMID:27687901

  2. 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

  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. 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

    .5-448), of 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...

  5. An analysis of risk factors and adverse events in ambulatory surgery

    Directory of Open Access Journals (Sweden)

    Kent C

    2014-06-01

    Full Text Available Christopher Kent, Julia Metzner, Laurent BollagDepartment of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle, WA, USAAbstract: Care for patients undergoing ambulatory procedures is a broad and expanding area of anesthetic and surgical practice. There were over 35 million ambulatory surgical procedures performed in the US in 2006. Ambulatory procedures are diverse in both type and setting, as they span the range from biopsies performed under local anesthesia to intra-abdominal laparoscopic procedures, and are performed in offices, freestanding ambulatory surgery centers, and ambulatory units of hospitals. The information on adverse events from these varied settings comes largely from retrospective reviews of sources, such as quality-assurance databases and closed malpractice claims. Very few if any ambulatory procedures are emergent, and in comparison to the inpatient population, ambulatory surgical patients are generally healthier. They are still however subject to most of the same types of adverse events as patients undergoing inpatient surgery, albeit at a lower frequency. The only adverse events that could be considered to be unique to ambulatory surgery are those that arise out of the circumstance of discharging a postoperative patient to an environment lacking skilled nursing care. There is limited information on these types of discharge-related adverse events, but the data that are available are reviewed in an attempt to assist the practitioner in patient selection and discharge decision making. Among ambulatory surgical patients, particularly those undergoing screening or cosmetic procedures, expectations from all parties involved are high, and a definition of adverse events can be expanded to include any occurrence that interrupts the rapid throughput of patients or interferes with early discharge and optimal patient satisfaction. This review covers all types of adverse events, but focuses on the more

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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,...

  12. Adverse events of anti-tumor necrosis factor α therapy in ankylosing spondylitis.

    Directory of Open Access Journals (Sweden)

    Qiang Tong

    Full Text Available This study aims to investigate the prevalence of short-term and long-term adverse events associated with tumor necrosis factor-α (TNF-α blocker treatment in Chinese Han patients suffering from ankylosing spondylitis (AS.The study included 402 Chinese Han AS patients treated with TNF-α blockers. Baseline data was collected. All patients were monitored for adverse events 2 hours following administration. Long-term treatment was evaluated at 8, 12, 52 and 104 weeks follow-up for 172 patients treated with TNF-α blockers.Short-term adverse events occurred in 20.15% (81/402, including rash (3.5%; 14/402, pruritus (1.2%; 5/402, nausea (2.2%; 9/402, headache (0.7%; 3/402, skin allergies (4.0%; 16/402, fever (0.5%; 2/402, palpitations (3.0%; 12/402, dyspnea (0.5%; 2/402, chest pain (0.2%; 1/402, [corrected] abdominal pain (1.0%; 4/402, hypertension (2.2%; 9/402, papilledema (0.5%; 2/402, laryngeal edema (0.2%; 1/402 and premature ventricular contraction (0.2%; 1/402. Long-term adverse events occurred in 59 (34.3%; 59/172 patients, including pneumonia (7.6%; 13/172, urinary tract infections (9.9%; 17/172, otitis media (4.7%; 8/172, tuberculosis are (3.5%; 6/172 [corrected], abscess (1.2%; 2/172, oral candidiasis (0.6%; 1/172, elevation of transaminase (1.7%; 3/172, anemia (1.2%; 2/172, hematuresis (0.6%; 1/172, constipation (2.3%; 4/172, weight loss (0.6%; 1/172, exfoliative dermatitis (0.6%; 1/172. CRP, ESR and disease duration were found to be associated with an increased risk of immediate and long-term adverse events (P<0.05. Long-term treatment with Infliximab was associated with more adverse events than rhTNFR-Fc (P<0.01.This study reports on the prevalence of adverse events in short-term and long-term treatment with TNF-α blocker monotherapy in Chinese Han AS patients. Duration of disease, erythrocyte sedimentation rate, and c-reactive protein serum levels were found to be associated with increased adverse events with anti-TNF-α therapy. Long

  13. 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

  14. 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.

  15. Adverse event reporting for herbal medicines: a result of market forces.

    Science.gov (United States)

    Walji, Rishma; Boon, Heather; Barnes, Joanne; Austin, Zubin; Baker, G Ross; Welsh, Sandy

    2009-05-01

    Herbal products are readily available over the counter in health food stores and are often perceived to be without risk. The current Canadian adverse event reporting system suffers from severe underreporting, resulting in a scarcity of safety data on herbal products. Twelve health food store personnel in the Greater Toronto Area were interviewed about their responses to herbal product-related adverse reactions. They generally fostered customer loyalty by offering generous return policies, which included collecting contact information to be sent to the manufacturers with the returned product. Thus, despite the public's lack of knowledge about the formal reporting system, adverse reaction information was directed to manufacturers whenever it resulted in a product return. The relationship between health food stores, industry and Health Canada provides a new opportunity to facilitate adverse event reporting. Additional information could be collected during the return process, and educational initiatives could be implemented to augment current post-market surveillance procedures for herbal products. PMID:20436811

  16. 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....

  17. 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. ...

  18. 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

  19. Shattering world assumptions: A prospective view of the impact of adverse events on world assumptions.

    Science.gov (United States)

    Schuler, Eric R; Boals, Adriel

    2016-05-01

    Shattered Assumptions theory (Janoff-Bulman, 1992) posits that experiencing a traumatic event has the potential to diminish the degree of optimism in the assumptions of the world (assumptive world), which could lead to the development of posttraumatic stress disorder. Prior research assessed the assumptive world with a measure that was recently reported to have poor psychometric properties (Kaler et al., 2008). The current study had 3 aims: (a) to assess the psychometric properties of a recently developed measure of the assumptive world, (b) to retrospectively examine how prior adverse events affected the optimism of the assumptive world, and (c) to measure the impact of an intervening adverse event. An 8-week prospective design with a college sample (N = 882 at Time 1 and N = 511 at Time 2) was used to assess the study objectives. We split adverse events into those that were objectively or subjectively traumatic in nature. The new measure exhibited adequate psychometric properties. The report of a prior objective or subjective trauma at Time 1 was related to a less optimistic assumptive world. Furthermore, participants who experienced an intervening objectively traumatic event evidenced a decrease in optimistic views of the world compared with those who did not experience an intervening adverse event. We found support for Shattered Assumptions theory retrospectively and prospectively using a reliable measure of the assumptive world. We discuss future assessments of the measure of the assumptive world and clinical implications to help rebuild the assumptive world with current therapies. (PsycINFO Database Record

  20. 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

    Background and aim: Rituximab (RTX) therapy has shown promising results in Graves´ disease (GD), with or without ophthalmopathy. We examined the occurrence of adverse events in GD patients treated with RTX. Subjects and methods: Ten patients received RTX and methimazole, while ten patients received...... had the third highest increase in immunoglobulin deposition on monocytes by day 14. The arthralgias persisted in two of the patients, despite glucocorticoid rescue therapy. Conclusions: We report articular adverse events in three and gastrointestinal symptoms in two out of ten GD patients who received...

  1. 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...

  2. 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.

  3. 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.

  4. 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;

    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......, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. CONCLUSION: Data on adverse events in tables......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...

  5. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Tepel, Martin; van der Giet, Markus; Statz, Mario;

    2003-01-01

    Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown.......Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown....

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

    Directory of Open Access Journals (Sweden)

    K. Chanprapaph

    2014-01-01

    Full Text Available 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 psychosocial discomfort. This paper summarizes the current knowledge concerning the presentation and management of skin toxicity from EGFRI. The common dermatologic adverse events are papulopustules and xerosis. Less common findings are paronychia, regulatory abnormalities of hair growth, maculopapular rash, mucositis, and postinflammatory hyperpigmentation. Radiation enhances EGFRI rash due to synergistic toxicity. There is a positive correlation between the occurrence and severity of cutaneous adverse effects and tumor response. To date, prophylactic systemic tetracycline and tetracycline class antibiotics have proven to be the most effective treatment regime.

  7. 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...

  8. 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

  9. Antipsychotics and torsadogenic risk : Signals emerging from the US FDA adverse event reporting system database

    NARCIS (Netherlands)

    E. Poluzzi (Elisabetta); E. Raschi (Emanuel); A. Koci (Ariola); U. Moretti (Ugo); E. Spina (Edoardo); E.R. Behr (Elijah ); M.C.J.M. Sturkenboom (Miriam); F. de Ponti (Fabrizio)

    2013-01-01

    textabstractBackground: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System

  10. 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…

  11. 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

  12. Variation in the rates of adverse events between hospitals and hospital departments.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Spreeuwenberg, P.; Wagner, C.; Wal, G. van der; Groenewegen, P.P.

    2011-01-01

    Objective: The objective of this study was to analyze the variation in the rates of adverse events (AEs), and preventable AEs, between hospitals and hospital departments in order to investigate the room for improvement in reducing AEs at both levels. In addition, we explored the extent to which pati

  13. 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

  14. Excess length of stay and economic consequences of adverse events in Dutch hospital patients.

    NARCIS (Netherlands)

    Hoogervorst-Schilp, J.; Langelaan, M.; Spreeuwenberg, P.; Bruijne, M.C. de; Wagner, C.

    2015-01-01

    Background: To investigate the average and extrapolated excess length of stay and direct costs of adverse events (AEs) and preventable AEs in Dutch hospitals, and to evaluate patient characteristics associated with excess length of stay and costs. Methods: Data of a large retrospective patient recor

  15. Application of Knowledge Discovery in Databases Methodologies for Predictive Models for Pregnancy Adverse Events

    Science.gov (United States)

    Taft, Laritza M.

    2010-01-01

    In its report "To Err is Human", The Institute of Medicine recommended the implementation of internal and external voluntary and mandatory automatic reporting systems to increase detection of adverse events. Knowledge Discovery in Databases (KDD) allows the detection of patterns and trends that would be hidden or less detectable if analyzed by…

  16. Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: A retrospective analysis

    NARCIS (Netherlands)

    Mafirakureva, Nyashadzaishe; Khoza, Star; Mvere, David A.; Chitiyo, McLeod E.; Postma, Maarten J.; Van Hulst, Marinus

    2014-01-01

    Background. Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and meth

  17. 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

  18. 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.

  19. Adverse events following vaccination against human papillomavirus : Results of the 2010 campaign in the Netherlands

    NARCIS (Netherlands)

    van ' t Klooster TM; Kemmeren JM; Vermeer-de Bondt PE; Oostvogels B; Phaff T; de Melker HE; van der Maas NAT; EPI; cib

    2011-01-01

    In 2010 werden er minder bijwerkingen gemeld na vaccinatie tegen HPV dan in 2009. Ook zijn er in 2010, net als in 2009, geen onverwachte of volgens de criteria ernstige bijwerkingen (Serious Adverse Events) gemeld die door het vaccin zijn veroorzaakt.

    In 2010 zijn meisjes die geb

  20. Neuropsychiatric Adverse Events of Varenicline A Systematic Review of Published Reports

    NARCIS (Netherlands)

    Ahmed, Amir I. A.; Ali, Abdullah N. A.; Kramers, Cees; Harmark, Linda V. D.; Burger, David M.; Verhoeven, Willem M. A.

    2013-01-01

    Introduction: Over the past years, the impact of varenicline in patients with mental illness has been debated as serious neuropsychiatric adverse events (AEs) have been reported with varenicline use. Aim: To identify and summarize published case reports of neuropsychiatric AEs ascribed to vareniclin

  1. 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

    OpenAIRE

    Schumm Walter R

    2006-01-01

    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 acti...

  2. 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

  3. 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

  4. 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

  5. A perspective from clinical and business ethics on adverse events in hospitalized patients.

    Science.gov (United States)

    Wagner, J T; Meier, C; Higdon, T

    1997-11-01

    Adverse events occur in a significant, but undetermined, number of hospitalized patients. These types of patient injuries are more often the result of faulty systems than human maleficence. A culture exists among health care providers that discourages the reporting of such events and resists the implementation of formal efforts to eliminate them. This resistance serves to perpetuate the problem. Both business and clinical ethics argue that sound reasons exist for hospitals to reduce, if not eliminate, adverse events. To do so is cost effective, particularly in a managed care environment. It is also at the heart of responsible professional behavior. Physicians are afforded an opportunity to be at the forefront in this quality improvement effort.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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.

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

    DEFF Research Database (Denmark)

    Sabin, Caroline A.; Nielsen, Lene Ryom; De Wit, Stephane;

    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-positive......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...

  15. [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

  16. 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

  17. 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.

  18. 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....

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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...

  6. 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.

  7. Genomic and metabolomic advances in the identification of disease and adverse event biomarkers.

    Science.gov (United States)

    Mendrick, Donna L; Schnackenberg, Laura

    2009-10-01

    Incomplete knowledge of tissue pathogenesis is hampering the identification of biomarkers for the appropriate therapeutic targets to prevent or inhibit disease processes, and the prediction and diagnosis of injury due to disease and adverse events of drug therapy. The revolution in genomics and metabolomics, combined with advanced bioinformatics and computational methods for mining such large, complex data sets, are beginning to provide critical insights into tissue injury. Such results will move us closer to the promise of personalized medicine.

  8. 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

  9. 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...

  10. 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...

  11. 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...

  12. 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.

  13. 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.

  14. 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: ...

  15. 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...

  16. 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 ...

  17. 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 ...

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

    DEFF Research Database (Denmark)

    Khashan, Ali; Abel, Kathryn; McNamee, R.;

    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...... during the first trimester. DESIGN: Population-based study. SETTING: Denmark. PARTICIPANTS: In a cohort of 1.38 million Danish births from 1973 to 1995, mothers were considered exposed if 1 (or more) of their close relatives died or was diagnosed with cancer, acute myocardial infarction, or stroke...

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. Enhancing adverse drug event detection in electronic health records using molecular structure similarity: application to pancreatitis.

    Directory of Open Access Journals (Sweden)

    Santiago Vilar

    Full Text Available BACKGROUND: Adverse drug events (ADEs detection and assessment is at the center of pharmacovigilance. Data mining of systems, such as FDA's Adverse Event Reporting System (AERS and more recently, Electronic Health Records (EHRs, can aid in the automatic detection and analysis of ADEs. Although different data mining approaches have been shown to be valuable, it is still crucial to improve the quality of the generated signals. OBJECTIVE: To leverage structural similarity by developing molecular fingerprint-based models (MFBMs to strengthen ADE signals generated from EHR data. METHODS: A reference standard of drugs known to be causally associated with the adverse event pancreatitis was used to create a MFBM. Electronic Health Records (EHRs from the New York Presbyterian Hospital were mined to generate structured data. Disproportionality Analysis (DPA was applied to the data, and 278 possible signals related to the ADE pancreatitis were detected. Candidate drugs associated with these signals were then assessed using the MFBM to find the most promising candidates based on structural similarity. RESULTS: The use of MFBM as a means to strengthen or prioritize signals generated from the EHR significantly improved the detection accuracy of ADEs related to pancreatitis. MFBM also highlights the etiology of the ADE by identifying structurally similar drugs, which could follow a similar mechanism of action. CONCLUSION: The method proposed in this paper provides evidence of being a promising adjunct to existing automated ADE detection and analysis approaches.

  4. The inter-rater agreement of retrospective assessment of adverse events does not improve with two reviewers.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Wagner, C.; Groenewegen, P.P.; Wal, G. van der; Vet, H.C.W. de

    2008-01-01

    Methods: In the Dutch Adverse Event Study, 4272 records of discharged or deceased patients in 2004 from 21 Dutch hospitals were independently reviewed by two physicians (physician A+B) for the determination of adverse events (AEs) and their degree of preventability. In case of disagreement between t

  5. 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

  6. Antipsychotics for behavioural and psychological problems in elderly people with dementia: a systematic review of adverse events.

    NARCIS (Netherlands)

    Iersel, M.B. van; Zuidema, S.U.; Koopmans, R.T.C.M.; Verhey, F.R.J.; Olde Rikkert, M.G.M.

    2005-01-01

    OBJECTIVE: Although antipsychotics are important in the treatment of behavioural and psychological symptoms of dementia (BPSD), they have moderate efficacy and often cause adverse events. Recent safety warnings about increased frequency of cerebrovascular adverse events in elderly patients who use a

  7. Antipsychotics for behavioural and psychological problems in elderly people with dementia : a systematic review of adverse events

    NARCIS (Netherlands)

    van Iersel, Marianne B; Zuidema, Sytse U; Koopmans, Raymond T C M; Verhey, Frans R J; Olde Rikkert, Marcel G M

    2005-01-01

    OBJECTIVE: Although antipsychotics are important in the treatment of behavioural and psychological symptoms of dementia (BPSD), they have moderate efficacy and often cause adverse events. Recent safety warnings about increased frequency of cerebrovascular adverse events in elderly patients who use a

  8. 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

  9. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    DEFF Research Database (Denmark)

    Pfeffer, Marc A; Burdmann, Emmanuel A; Chen, Chao-Yin;

    2009-01-01

    : the composite end point of death or cardiovascular morbidity (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia). The composite end point of death or need for long-term renal replacement therapy also is a primary end point. CONCLUSIONS: With several......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......-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia....

  10. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  11. 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

  12. 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;

    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......, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. CONCLUSION: Data on adverse events in tables...

  13. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  14. The role of adverse childhood experiences in cardiovascular disease risk: a review with emphasis on plausible mechanisms.

    Science.gov (United States)

    Su, Shaoyong; Jimenez, Marcia P; Roberts, Cole T F; Loucks, Eric B

    2015-10-01

    Childhood adversity, characterized by abuse, neglect, and household dysfunction, is a problem that exerts a significant impact on individuals, families, and society. Growing evidence suggests that adverse childhood experiences (ACEs) are associated with health decline in adulthood, including cardiovascular disease (CVD). In the current review, we first provide an overview of the association between ACEs and CVD risk, with updates on the latest epidemiological evidence. Second, we briefly review plausible pathways by which ACEs could influence CVD risk, including traditional risk factors and novel mechanisms. Finally, we highlight the potential implications of ACEs in clinical and public health. Information gleaned from this review should help physicians and researchers in better understanding potential long-term consequences of ACEs and considering adapting current strategies in treatment or intervention for patients with ACEs.

  15. 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

  16. 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.

  17. 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

  18. Baseline albuminuria predicts the efficacy of blood pressure-lowering drugs in preventing cardiovascular events

    NARCIS (Netherlands)

    Boersma, C.; Postma, M.J.; Visser, S.T.; Atthobari, J.; de Jong, P.E.; de Jong-van den Berg, L.T.; Gansevoort, R.T.

    2008-01-01

    AIMS Albuminuria has been proven to be associated with cardiovascular (CV) events in specific patient populations, but also in the general population. This study aimed to investigate whether the efficacy of blood pressure-lowering agents in preventing CV events depends on baseline urinary albumin ex

  19. 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....

  20. 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...

  1. 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)

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

    Science.gov (United States)

    van Oppenraaij, R H F; Jauniaux, E; Christiansen, O B; Horcajadas, J A; Farquharson, R G; Exalto, N

    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 covering the period 1980-2008. RESULTS Clinically relevant associations of adverse outcome in the subsequent pregnancy with an odds ratio (OR) > 2.0 after complications in a previous pregnancy are the risk of perinatal death after a single previous miscarriage, the risk of very preterm delivery (VPTD) 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 pregnancy with an OR > 2.0 after complications in the index pregnancy are the risk of LBW and very low birthweight (VLBW) after a threatened miscarriage, the risk of pregnancy-induced hypertension, pre-eclampsia, placental abruption, preterm delivery (PTD), small for gestational age and low 5-min Apgar score after detection of an intrauterine haematoma, the risk of VPTD and intrauterine growth restriction after a crown-rump length discrepancy, the risk of VPTD, LBW and VLBW after a vanishing twin phenomenon and the risk of PTD, LBW and low 5-min Apgar score in a pregnancy complicated by severe 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 uncontrolled studies. Larger population-based controlled studies are needed to confirm these findings. Nevertheless, identification of these risks will improve obstetric care. PMID:19270317

  3. 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.

  4. 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

  5. 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...

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

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    . 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). In the AMI study...... the necessary laboratory data. iv The screening study (Article 3) revealed that most cases of preventable adverse drug events concern admissions with hyperglycemia, reduced renal function and recurrent AMI, related to inadequate treatment or monitoring. The AMI indicator study (Article 4) revealed that 77...

  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. Incidence of adverse events among healthcare workers following H1N1 Mass immunization in Ghana

    DEFF Research Database (Denmark)

    Ankrah, Daniel N A; Mantel-Teeuwisse, Aukje K; De Bruin, Marie L;

    2013-01-01

    BACKGROUND: Cases of the A(H1N1) 2009 influenza were first recorded in Ghana in July 2009. In June 2010 when prioritized vaccination against the novel A(H1N1) 2009 influenza virus started in the country, health workers were among the selected groups to receive the vaccination. OBJECTIVE: The aim...... of this study was to determine the distribution and types of adverse events reported following immunization of healthcare workers at the Korle-Bu Teaching Hospital from the day vaccination started until 1 week after the end of vaccination. METHODS: Safety data collected during the A(H1N1) 2009 influenza...

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

    Directory of Open Access Journals (Sweden)

    Ping Yin

    2014-01-01

    Full Text Available 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, year of publication, country of occurrence, participant related (age, sex or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low.

  10. 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

  11. Adverse drug events associated with vitamin K antagonists: factors of therapeutic imbalance

    Directory of Open Access Journals (Sweden)

    El-Helou N

    2013-03-01

    Full Text Available Nancy El-Helou, Amal Al-Hajje, Rola Ajrouche, Sanaa Awada, Samar Rachidi, Salam Zein, Pascale SalamehClinical and Epidemiological Research Laboratory, Faculty of Pharmacy, Lebanese University, Beirut, LebanonBackground: Adverse drug events (ADE occur frequently during treatment with vitamin K antagonists (AVK and contribute to increase hemorrhagic risks.Methods: A retrospective study was conducted over a period of 2 years. Patients treated with AVK and admitted to the emergency room of a tertiary care hospital in Beirut were included. The aim of the study was to identify ADE characterized by a high international normalized ratio (INR and to determine the predictive factors responsible for these events. Statistical analysis was performed with the SPSS statistical package.Results: We included 148 patients. Sixty-seven patients (47.3% with an INR above the therapeutic range were identified as cases. The control group consisted of 81 patients (54.7% with an INR within the therapeutic range. Hemorrhagic complications were observed in 53.7% of cases versus 6.2% of controls (P < 0.0001. No significant difference was noticed between cases and controls regarding the indication and the dose of AVK. Patients aged over 75 years were more likely to present an INR above the therapeutic range (58.2%, P = 0.049. Recent infection was present in 40.3% of cases versus 6.2% of controls (P < 0.0001 and hypoalbuminemia in 37.3% of cases versus 6.1% of controls (P < 0.0001. Treatment with antibiotics, amiodarone, and anti-inflammatory drugs were also factors of imbalance (P < 0.0001.Conclusion: Many factors may be associated with ADE related to AVK. Monitoring of INR and its stabilization in the therapeutic range are important for preventing these events.Keywords: adverse drug events, vitamin K antagonists, bleeding risks, therapeutic imbalance

  12. 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.

  13. Defining molecular initiating events in the adverse outcome pathway framework for risk assessment.

    Science.gov (United States)

    Allen, Timothy E H; Goodman, Jonathan M; Gutsell, Steve; Russell, Paul J

    2014-12-15

    Consumer and environmental safety decisions are based on exposure and hazard data, interpreted using risk assessment approaches. The adverse outcome pathway (AOP) conceptual framework has been presented as a logical sequence of events or processes within biological systems which can be used to understand adverse effects and refine current risk assessment practices in ecotoxicology. This framework can also be applied to human toxicology and is explored on the basis of investigating the molecular initiating events (MIEs) of compounds. The precise definition of the MIE has yet to reach general acceptance. In this work we present a unified MIE definition: an MIE is the initial interaction between a molecule and a biomolecule or biosystem that can be causally linked to an outcome via a pathway. Case studies are presented, and issues with current definitions are addressed. With the development of a unified MIE definition, the field can look toward defining, classifying, and characterizing more MIEs and using knowledge of the chemistry of these processes to aid AOP research and toxicity risk assessment. We also present the role of MIE research in the development of in vitro and in silico toxicology and suggest how, by using a combination of biological and chemical approaches, MIEs can be identified and characterized despite a lack of detailed reports, even for some of the most studied molecules in toxicology.

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  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. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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…

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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...

  10. 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

  11. 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.

  12. Presence of the metabolic syndrome (MS) is not a better predictor of cardiovascular disease (CVD) than the sum of its components in HIV-infected individuals. Data Collection on Adverse Events of Anti-HIV Drugs (The D:A:D study)

    DEFF Research Database (Denmark)

    Worm, Signe W; Sabin, Caroline A; Reiss, Peter;

    2009-01-01

    Objectives: It is much debated whether the MS contributes additional information over and above that provided by the individual components of the syndrome alone. Amongst HIV-infected individuals, we investigated whether any particular combinations of the components of the MS definition...... are associated with a higher risk of CVD. Research Design and Methods: We followed 33,347 HIV-infected individuals in a prospective observational study. The effect of combinations of components of the MS (low HDL cholesterol, high triglycerides, high BMI, hypertension and diabetes mellitus) on the risk CVD......) and validation (remaining 30%). Results: In the training dataset, 671 patients experienced a CVD event over 110,652 person-years. Unadjusted, MS at study enrolment (>/=3 of the factors) was associated with a 2.89 higher risk of CVD (95% confidence interval [CI] 2.34, 3.59; p=0.0001) compared with individuals...

  13. 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 age and sex...

  14. 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

  15. Endothelial progenitor cells and cardiovascular events in patients with chronic kidney disease--a prospective follow-up study.

    Directory of Open Access Journals (Sweden)

    Johan Lorenzen

    Full Text Available BACKGROUND: Endothelial progenitor cells (EPCs mediate vascular repair and regeneration. Their number in peripheral blood is related to cardiovascular events in individuals with normal renal function. METHODS: We evaluated the association between functionally active EPCs (cell culture and traditional cardiovascular risk factors in 265 patients with chronic kidney disease stage V receiving hemodialysis therapy. Thereafter, we prospectively assessed cardiovascular events, e.g. myocardial infarction, percutaneous transluminal coronary angioplasty (including stenting, aorto-coronary bypass, stroke and angiographically verified stenosis of peripheral arteries, and cardiovascular death in this cohort. RESULTS: In our patients EPCs were related only to age (r=0.154; p=0.01. During a median follow-up period of 36 months 109 (41% patients experienced a cardiovascular event. In a multiple Cox regression analysis, we identified EPCs (p=0.03 and patient age (p=0.01 as the only independent variables associated with incident cardiovascular events. Moreover, a total of 70 patients died during follow-up, 45 of those due to cardiovascular causes. Log rank test confirmed statistical significance for EPCs concerning incident cardiovascular events (p=0.02. CONCLUSIONS: We found a significant association between the number of functionally active EPCs and cardiovascular events in patients with chronic kidney disease. Thus, defective vascular repair and regeneration may be responsible, at least in part, for the enormous cardiovascular morbidity in this population.

  16. 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

  17. 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

  18. 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...

  19. 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

  20. Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events

    NARCIS (Netherlands)

    McMurray, John J.; Holman, Rury R.; Haffner, Steven M.; 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 It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. METHODS In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with i

  1. 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

  2. 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)

  3. 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

  4. 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.

  5. Infliximab in patients with psoriasis and other inflammatory diseases: evaluation of adverse events in the treatment of 168 patients*

    Science.gov (United States)

    Antonio, João Roberto; Sanmiguel, Jessica; Cagnon, Giovana Viotto; Augusto, Marília Silveira Faeda; de Godoy, Moacir Fernandes; Pozetti, Eurides Maria Oliveira

    2016-01-01

    Background Psoriasis is immune-mediated chronic inflammatory disease with preference for skin and joints. The skin involvement occurs by hyperproliferation and abnormal differentiation of keratinocytes. It is associated with comorbidities, mainly related to the clinical manifestations of the metabolic syndrome. Increased TNF-alpha expression (TNF-α) is related to its pathophysiology. Infliximab is an intravenous drug that acts neutralizing the biological activity of TNF-α and prevents the binding of the molecule to the target cell receptor, inhibiting cell proliferation of psoriasis and other diseases mediated by TNF-α. A lot of infusion reactions have been described in the literature. Objective To evaluate the adverse effects of intravenous treatment with infliximab, analyzing patients with psoriasis compared to those with other chronic inflammatory diseases (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis). Method Analysis of medical records and adverse events of 168 patients undergoing infliximab infusion for psoriasis and chronic inflammatory diseases treatment. Results 168 patients who have used infliximab were evaluated, 24 had psoriasis and 144 had chronic inflammatory diseases. Only 2 (8.3%) patients with psoriasis showed adverse events requiring treatment discontinuation, and just 6 (4.2%) female patients with chronic inflammatory diseases experienced adverse events. Conclusion Infliximab is a safe drug, with a low percentage of adverse events and there were more adverse events in women with chronic inflammatory diseases and in patients who received more infliximab infusions. PMID:27438197

  6. [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

  7. Annual report on adverse events related with vaccines use in Calabria (Italy: 2012

    Directory of Open Access Journals (Sweden)

    Orietta Staltari

    2013-01-01

    Full Text Available Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs; therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs and 18 (3.9% were probably induced by vaccination. AVEs were common in females (almost 77.7% and in children aged 0-3 years. The largest number of non-serious AVEs involved "skin and subcutaneous tissue disorders" and "general disorders and administration site conditions." In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations.

  8. 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

  9. Dermatologic adverse events to chemotherapeutic agents, Part 2: BRAF inhibitors, MEK inhibitors, and ipilimumab.

    Science.gov (United States)

    Choi, Jennifer Nam

    2014-03-01

    The advent of novel targeted chemotherapeutic agents and immunotherapies has dramatically changed the arena of cancer treatment in recent years. BRAF inhibitors, MEK inhibitors, and ipilimumab are among the newer chemotherapy drugs that are being used at an increasing rate. Dermatologic adverse events to these medications are common, and it is important for dermatologists and oncologists alike to learn to recognize and treat such side effects in order to maintain both patients' quality of life and their anticancer treatment. This review describes the cutaneous side effects seen with BRAF inhibitors (eg, maculopapular eruption, photosensitivity, squamoproliferative growths, melanocytic proliferations), MEK inhibitors (eg, papulopustular eruption), and ipilimumab (eg, maculopapular eruption, vitiligo), with a mention of vismodegib and anti-PD-1 agents.

  10. Ontology-based knowledge management for personalized adverse drug events detection.

    Science.gov (United States)

    Cao, Feng; Sun, Xingzhi; Wang, Xiaoyuan; Li, Bo; Li, Jing; Pan, Yue

    2011-01-01

    Since Adverse Drug Event (ADE) has become a leading cause of death around the world, there arises high demand for helping clinicians or patients to identify possible hazards from drug effects. Motivated by this, we present a personalized ADE detection system, with the focus on applying ontology-based knowledge management techniques to enhance ADE detection services. The development of electronic health records makes it possible to automate the personalized ADE detection, i.e., to take patient clinical conditions into account during ADE detection. Specifically, we define the ADE ontology to uniformly manage the ADE knowledge from multiple sources. We take advantage of the rich semantics from the terminology SNOMED-CT and apply it to ADE detection via the semantic query and reasoning. PMID:21893837

  11. Development of a Virtual Learning Environment addressing adverse events in nursing.

    Science.gov (United States)

    Xelegati, Rosicler; Évora, Yolanda Dora Martinez

    2011-01-01

    The authors have developed a Virtual Learning Environment (VLE) addressing the management of adverse events to promote continuing education for nurses, including the following themes: pressure ulcer, medication errors, phlebitis, fall, and loss of nasogastroenteral probes. The pedagogical framework was grounded on the information processing theory and this applied study used the Computer Assisted Instruction (CAI) model to develop the program. The environment was developed with HTML language through Microsoft Office Word 2003®. The authors developed evaluation exercises in each module through the Hot Potatoes program, version 6.0 for Windows. The conclusion is that the methodology utilized was appropriate for achieving the proposed objectives. In the future, the authors will assess the developed product and verify the possibility of using it in nursing services. PMID:22030583

  12. 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.

  13. Constructing Clinical Decision Support Systems for Adverse Drug Event Prevention: A Knowledge-based Approach.

    Science.gov (United States)

    Koutkias, Vassilis; Kilintzis, Vassilis; Stalidis, George; Lazou, Katerina; Collyda, Chrysa; Chazard, Emmanuel; McNair, Peter; Beuscart, Regis; Maglaveras, Nicos

    2010-11-13

    A knowledge-based approach is proposed that is employed for the construction of a framework suitable for the management and effective use of knowledge on Adverse Drug Event (ADE) prevention. The framework has as its core part a Knowledge Base (KB) comprised of rule-based knowledge sources, that is accompanied by the necessary inference and query mechanisms to provide healthcare professionals and patients with decision support services in clinical practice, in terms of alerts and recommendations on preventable ADEs. The relevant Knowledge Based System (KBS) is developed in the context of the EU-funded research project PSIP (Patient Safety through Intelligent Procedures in Medication). In the current paper, we present the foundations of the framework, its knowledge model and KB structure, as well as recent progress as regards the population of the KB, the implementation of the KBS, and results on the KBS verification in decision support operation.

  14. Understanding the organisational context for adverse events in the health services: the role of cultural censorship.

    Science.gov (United States)

    Hart, E; Hazelgrove, J

    2001-12-01

    This paper responds to the current emphasis on organisational learning in the NHS as a means of improving healthcare systems and making hospitals safer places for patients. Conspiracies of silence have been identified as obstacles to organisational learning, covering error and hampering communication. In this paper we question the usefulness of the term and suggest that "cultural censorship", a concept developed by the anthropologist Robin Sherriff, provides a much needed insight into cultures of silence within the NHS. Drawing on a number of illustrations, but in particular the Ritchie inquiry into the disgraced gynaecologist Rodney Ledward, we show how the defining characteristics of cultural censorship can help us to understand how adverse events get pushed underground, only to flourish in the underside of organisational life.

  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. 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.

  17. 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

    improve patient safety if coupled with training and organisational support2. Insight into the nature of reported critical incidents and adverse events can be used in writing in situ simulation scenarios and thus lead to interventions that enhance patient safety. The patient safety literature emphasises...... analysis and short-term observations in the design of in situ simulation. - Deliver and evaluate the usability of in situ simulation training to interprofessional emergency teams. Methods The project has a triple strategy: 1) Patient safety data analysis and literature review, 2) Video observational study...... and patient safety in dynamic domains of healthcare: a review of the literature. Acta Anaesthesiol Scand 2009; 53(2):143-151. (4) Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nursing 2008; 68:62-107. (5) Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006; 3...

  18. [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

  19. 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

  20. Association of hypothyroidism with adverse events in patients with heart failure receiving cardiac resynchronization therapy.

    Science.gov (United States)

    Sharma, Ajay K; Vegh, Eszter; Orencole, Mary; Miller, Alexandra; Blendea, Dan; Moore, Stephanie; Lewis, Gregory D; Singh, Jagmeet P; Parks, Kimberly A; Heist, E Kevin

    2015-05-01

    Hypothyroidism is associated with an adverse prognosis in cardiac patients in general and in particular in patients with heart failure (HF). The aim of this study was to evaluate the impact of hypothyroidism on patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of level of control of hypothyroidism on risk of adverse events after CRT implantation was also evaluated. We included consecutive patients in whom a CRT device was implanted from April 2004 to April 2010 at our institution with sufficient follow-up data available for analysis; 511 patients were included (age 68.5±12.4 years, women 20.4%); 84 patients with a clinical history of hypothyroidism, on treatment with thyroid hormone repletion or serum thyroid-stimulating hormone level≥5.00 μU/ml, were included in the hypothyroid group. The patients were followed for up to 3 years after implant for a composite end point of hospitalization for HF, left ventricular assist device placement, or heart transplant and cardiac death; 215 composite end point events were noted in this period. In a multivariate model, hypothyroidism (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.027 to 2.085, p=0.035), female gender (HR 0.64, 95% CI 0.428 to 0.963, p=0.032), and creatinine (HR 1.26, 95% CI 1.145 to 1.382, phypothyroidism at baseline developed the composite end point compared with 39.8% of those with euthyroidism (p=0.02). In conclusion, hypothyroidism is associated with a worse prognosis after CRT implantation.

  1. 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

  2. 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

  3. 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

  4. Functional status decline as a measure of adverse events in home health care: an observational study

    Directory of Open Access Journals (Sweden)

    Feldman Penny H

    2006-12-01

    Full Text Available Abstract Background Research that examines the quality of home health care is complex because no gold standard exists for measuring adverse outcomes, and because the patient and clinician populations are highly heterogeneous. The objectives in this study are to develop models to predict functional decline for three indices of functional status as measures of adverse events in home health care and determine which index is most appropriate for risk-adjusting for future quality research. Methods Data come from the Outcomes and Assessment Information Set (OASIS from a large urban home health care agency and other agency data. Prognostic data yields 49,437 episodes, while follow-up data yields 47,684 episodes. We tested three indices defined as substantial decline in three or more (gt3_ADLs, two or more (gt2_ADLs, and one or more (gt1_ADLs ADLs. Multivariate logistic regression determines the performance of the models for each index as measured by the c-statistic and Hosmer-Lemeshow chi square (χ2. Results Frequencies for gt3_ADLs, gt2_ADLs, and gt1_ADLs are 212 (0.43%, 783 (1.58%, and 4,271 (8.64% respectively. Follow-up results are comparable with frequencies of 218 (0.46%, 763 (1.60%, and 3,949 (8.28% for each index. Gt3_ADLs does not produce valid models. The model for gt2_ADLs consistently yields a higher c-statistic compared to gt1_ADLs (0.754 vs. 0.679, respectively. Both indices' models yield non-significant Hosmer-Lemeshow chi square indicating reasonable model fit. Findings for gt2_ADLs and gt1_ADLs are consistent over time as indicated by follow-up data results. Conclusion Gt2_ADLs yields the best models as indicated by a high c-statistic and a non-significant Hosmer-Lemeshow χ2, both of which exhibit exceptional consistency. We conclude that gt2_ADLs may be preferable in defining ADL adverse events in the context of home health care.

  5. Post-operative serious adverse events in a mixed surgical population - a retrospective register study

    DEFF Research Database (Denmark)

    Hansen, M S; Petersen, E E; Dahl, J B;

    2016-01-01

    .9% (5.4-6.5), respectively. Mortality within longest follow-up as well as 90 and 180 days post-operatively was 3.6% (3.1-4.0), 1.7% (1.4-2.0), and 2.2% (1.9-2.6), respectively. CONCLUSION: We found a risk of one or more events in the composite outcome within 342 days after inclusion of the last patients......BACKGROUND: The number of surgical procedures is increasing, and knowledge of surgical risk factors, post-operative mortality and serious adverse events (SAE) is essential. The aim with our study was to determine the risk of a composite outcome of post-operative: death; myocardial infarction...... a follow-up until 342 days after inclusion of the last patient was estimated to 8.3%, 95% Confidence Intervals (CI) (7.8-9.0), with a median observation time of 437 days (IQR 387-485, range 0-522). The risk of the composite outcome within 90- and 180-day follow-up of each patient was 4.8% (4.4-5.3) and 5...

  6. 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.

  7. 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

  8. 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

  9. Association between serum resistin level and cardiovascular events in postmenopausal women with acute coronary syndrome undergoing percutaneous coronary intervention

    Institute of Scientific and Technical Information of China (English)

    LI Lei; HAN Jiang-li; MAO Jie-ming; GUO Li-jun; GAO Wei

    2013-01-01

    Background As an adipocytokine,resistin has been proposed as a link between inflammation,metabolic disorder and atherosclerosis.The aim of the study is to evaluate whether serum resistin is associated with acute coronary syndrome (ACS) and major adverse cardiovascular events (MACEs) among postmenopausal women with ACS undergoing percutaneous coronary intervention (PCI).Methods A total of 106 consecutive postmenopausal women who underwent coronary angiography for evaluation of suspected myocardial ischemia were enrolled.Pre-procedure serum resistin,inflammatory and metabolic biomarkers were measured.All participants were followed for seven years for MACEs,including cardiovascular death,recurrent nonfatal myocardial infarction,and re-PCI.Results Patients with ACS (n=69) had significantly higher resistin levels than those without coronary artery disease (CAD) (n=37) (4.61 (1.79-10.80) ng/ml vs.2.36 (0.85-4.15) ng/ml,P=0.002).Correlation analysis revealed positive correlations between resistin levels and inflammatory and metabolic factors (P <0.05).A follow-up of a mean of 83.4months showed that patients with ACS suffered more MACEs than those without (13.0% vs.2.7%,P=0.05).Adjusted for cardiovascular risks,inflammatory and metabolic factors,multiple Logistic regression analysis indicated that an elevated resistin level was an independent predictor of ACS onset (OR=1.139,95% CI 1.024-1.268,P=0.017) and of MACEs after PCI (OR=1.099,95% CI 1.015-1.189,P=0.019).To clarify the association between resistin levels and MACEs,ACS patients were divided into two subgroups on the basis of resistin levels.Compared with the low resistin subgroup (≤4.35ng/ml,n=32),patients in the high resistin subgroup (>4.35 ng/ml,n=37) were more prone to suffer MACEs (21.6% vs.3.1%,P=0.015).Kaplan-Meier analysis showed a significantly lower event-free survival rate in ACS patients with high resistin levels than in the low resistin subgroup (78.4% vs.96.9%,Log rank 5.594,P=0

  10. 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...

  11. 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

  12. Hospitalizations Due to Adverse Drug Events in the Elderly—A Retrospective Register Study

    Science.gov (United States)

    Laatikainen, Outi; Sneck, Sami; Bloigu, Risto; Lahtinen, Minna; Lauri, Timo; Turpeinen, Miia

    2016-01-01

    Adverse drug events (ADEs) are more likely to affect geriatric patients due to physiological changes occurring with aging. Even though this is an internationally recognized problem, similar research data in Finland is still lacking. The aim of this study was to determine the number of geriatric medication-related hospitalizations in the Finnish patient population and to discover the potential means of recognizing patients particularly at risk of ADEs. The study was conducted retrospectively from the 2014 emergency department patient records in Oulu University Hospital. A total number of 290 admissions were screened for ADEs, adverse drug reactions (ADRs) and drug-drug interactions (DDIs) by a multi-disciplinary research team. Customized Naranjo scale was used as a control method. All admissions were categorized into “probable,” “possible,” or “doubtful” by both assessment methods. In total, 23.1% of admissions were categorized as “probably” or “possibly” medication-related. Vertigo, falling, and fractures formed the largest group of ADEs. The most common ADEs were related to medicines from N class of the ATC-code system. Age, sex, residence, or specialty did not increase the risk for medication-related admission significantly (min p = 0.077). Polypharmacy was, however, found to increase the risk (OR 3.3; 95% CI, 1.5–6.9; p = 0.01). In conclusion, screening patients for specific demographics or symptoms would not significantly improve the recognition of ADEs. In addition, as ADE detection today is largely based on voluntary reporting systems and retrospective manual tracking of errors, it is evident that more effective methods for ADE detection are needed in the future. PMID:27761112

  13. 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...

  14. 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. ...

  15. 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

  16. 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

  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. 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

    and severe disease, respectively. In patients with psoriasis but without a family history of CVD, there was no increased risk of MACE. LIMITATIONS: Results may not apply to late-onset psoriasis. CONCLUSIONS: A family history of CVD predicted the risk of first-time MACE in young adults with psoriasis...

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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...

  4. Cardiovascular risk factors and estimated 10-year risk of fatal cardiovascular events using various equations in Greeks with metabolic syndrome.

    Science.gov (United States)

    Chimonas, Theodoros; Athyros, Vassilios G; Ganotakis, Emmanouel; Nicolaou, Vassilios; Panagiotakos, Demosthenes B; Mikhailidis, Dimitri P; Elisaf, Moses

    2010-01-01

    We investigated cardiovascular disease (CVD) risk factors in 1501 Greeks (613 men and 888 women, aged 40-65 years) referred to outpatients with metabolic syndrome (MetS) and without diabetes mellitus or CVD. The 10-year risk of fatal CVD events was calculated using European Society of Cardiology Systematic Coronary Risk Estimation (ESC SCORE), Hellenic-SCORE, and Framingham equations. Raised blood pressure (BP) and hypertriglyceridemia were more common in men (89.6% vs 84.2% and 86.8% vs 74.2%, respectively; P < .001). Low high-density lipoprotein cholesterol (HDL-C) and abdominal obesity were more common in women (58.2% vs 66.2% and 85.8% vs 97.1%, respectively; P < .001). The 10-year risk of fatal CVD events using HellenicSCORE was higher in men (6.3% +/- 4.3% vs 2.7% +/- 2.1%; P < .001). European Society of Cardiology Systematic Coronary Risk Estimation and Framingham yielded similar results. The risk equations gave similar assessments in a European Mediterranean population except for HellenicSCORE that calculated more MetS women requiring risk modification. This might justify local risk engine evaluation in event-based studies. (Clinical-Trials.gov ID: NCT00416741).

  5. 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.

  6. Venous thromboembolism and subsequent hospitalisation due to acute arterial cardiovascular events: a 20-year cohort study

    DEFF Research Database (Denmark)

    Sørensen, Henrik Toft; Horvath-Puho, Erzsebet; Pedersen, Lars;

    2007-01-01

    of myocardial infarction and stroke in 25,199 patients with deep venous thrombosis, 16,925 patients with pulmonary embolism, and 163,566 population controls. FINDINGS: For patients with deep venous thrombosis, the relative risks varied from 1.60 for myocardial infarction (95% CI 1.35-1.91) to 2.19 (1......-up, with 20-40% increases in risk for arterial cardiovascular events. Relative risks were similar for those with provoked and unprovoked deep venous thrombosis and pulmonary embolism. INTERPRETATION: Patients with venous thromboembolism have a substantially increased long-term risk of subsequent arterial......BACKGROUND: In some studies, venous thromboembolism has been associated with atherosclerosis and with the risk of arterial cardiovascular events such as myocardial infarction and stroke. Other studies, however, do not show this association. To help clarify these discrepant findings, we aimed...

  7. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    Directory of Open Access Journals (Sweden)

    Judith U. Cope

    2015-01-01

    Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

  8. On the dark side of therapies with immunoglobulin concentrates. The adverse events

    Directory of Open Access Journals (Sweden)

    Peter J. Spaeth

    2015-02-01

    Full Text Available Abstract to the dark side of therapies with human immunoglobulin G concentratesTherapy 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, even at life-long need for therapy, is 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.

  9. 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

  10. 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

  11. Refractory Pulmonary Edema Caused by Late Pulmonary Vein Thrombosis After Lung Transplantation: A Rare Adverse Event.

    Science.gov (United States)

    Denton, Eve J; Rischin, Adam; McGiffin, David; Williams, Trevor J; Paraskeva, Miranda A; Westall, Glen P; Snell, Greg

    2016-09-01

    After lung transplantation, pulmonary vein thrombosis is a rare, potentially life-threatening adverse event arising at the pulmonary venous anastomosis that typically occurs early and presents as graft failure and hemodynamic compromise with an associated mortality of up to 40%. The incidence, presentation, outcomes, and treatment of late pulmonary vein thrombosis remain poorly defined. Management options include anticoagulant agents for asymptomatic clots, and thrombolytic agents or surgical thrombectomy for hemodynamically significant clots. We present a rare case highlighting a delayed presentation of pulmonary vein thrombosis occurring longer than 2 weeks after lung transplantation and manifesting clinically as graft failure secondary to refractory pulmonary edema. The patient was treated successfully with surgical thrombectomy and remains well. We recommend a high index of suspicion of pulmonary vein thrombosis when graft failure after lung transplantation occurs and is not responsive to conventional therapy, and consideration of investigation with transesophageal echocardiography or computed tomography with venous phase contrast in such patients even more than 2 weeks after lung transplantation.

  12. WHO efforts to promote reporting of adverse events and global learning

    Directory of Open Access Journals (Sweden)

    Itziar Larizgoitia

    2013-12-01

    Full Text Available Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents.

  13. Cognitive adverse events of topiramate in patients with epilepsy and intellectual disability.

    Science.gov (United States)

    Brandt, Christian; Lahr, Denise; May, Theodor W

    2015-04-01

    Topiramate (TPM) is an effective antiepileptic drug (AED). A high proportion of patients, however, experiences cognitive adverse events (CAEs), especially in verbal fluency, memory spans, and working memory. To our knowledge, CAEs of TPM have not been studied systematically in patients with intellectual disability (ID). This may be due to the fact that many of those patients are not able to follow test instructions properly and that neuropsychological instruments are not validated for that group. Cognitive deterioration in patients with ID may thus easily be overlooked. Topiramate is in frequent use in persons with ID. We included 26 consecutive patients with epilepsy and ID in this observational study who had undergone neuropsychological examinations as part of clinical routine before and after the introduction of TPM into the therapeutic regimen (n=4) or before and after the withdrawal of TPM (n=22). Examinations under TPM showed reduced cognitive speed, reduced verbal memory, reduced verbal fluency, and reduced flexibility compared to examinations without TPM. Despite some limitations (especially small sample size, high interindividual variation of the results dependent on the degree of ID, effects of other - limited - changes in the therapeutic regimen), our study indicates that TPM in persons with epilepsy and ID may lead to CAEs comparable to those in persons with normal intelligence. Neuropsychological testing is mandatory in order not to miss CAEs that might severely impair quality of life.

  14. Adverse Event Management of Oral Mucositis in Patients with Breast Cancer

    Science.gov (United States)

    Seiler, Sabine; Kosse, Jens; Loibl, Sibylle; Jackisch, Christian

    2014-01-01

    Summary Oral mucositis (OM) is a clinically important and frequent adverse event (AE) associated with cancer treatment with conventional chemotherapy as well as new targeted agents. Incidence and severity of OM vary from treatment to treatment and from patient to patient. The pathogenesis of chemotherapy-induced OM can be divided into 5 phases. OM induced by targeted therapies differs among other things in appearance, course, concomitant AEs and toxicity, and thus could be perceived as an entity distinct from chemotherapy-induced OM with an innate pathogenic mechanism. OM has a severe impact on a patient's quality of life (QoL) by causing complications such as pain and discomfort. Even more important are associated restrictions in nutrition and hydration. Thus, the efficacy of cancer therapy might be impaired due to the necessity of dose delays and dose reductions. Numerous preventive and therapeutic approaches have been evaluated, but currently no single agent has changed the standard of care in preventing and treating OM. Thus, the current management has evolved from clinical experience rather than clinical evidence. This article will review the AE ‘OM’ induced by breast cancer treatment with chemotherapy and targeted agents in order to provide practical guidance for management and prevention. PMID:25404881

  15. 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

  16. 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.

  17. 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

  18. DNA bar coding and pyrosequencing to analyze adverse events in therapeutic gene transfer.

    Science.gov (United States)

    Wang, Gary P; Garrigue, Alexandrine; Ciuffi, Angela; Ronen, Keshet; Leipzig, Jeremy; Berry, Charles; Lagresle-Peyrou, Chantal; Benjelloun, Fatine; Hacein-Bey-Abina, Salima; Fischer, Alain; Cavazzana-Calvo, Marina; Bushman, Frederic D

    2008-05-01

    Gene transfer has been used to correct inherited immunodeficiencies, but in several patients integration of therapeutic retroviral vectors activated proto-oncogenes and caused leukemia. Here, we describe improved methods for characterizing integration site populations from gene transfer studies using DNA bar coding and pyrosequencing. We characterized 160,232 integration site sequences in 28 tissue samples from eight mice, where Rag1 or Artemis deficiencies were corrected by introducing the missing gene with gamma-retroviral or lentiviral vectors. The integration sites were characterized for their genomic distributions, including proximity to proto-oncogenes. Several mice harbored abnormal lymphoproliferations following therapy--in these cases, comparison of the location and frequency of isolation of integration sites across multiple tissues helped clarify the contribution of specific proviruses to the adverse events. We also took advantage of the large number of pyrosequencing reads to show that recovery of integration sites can be highly biased by the use of restriction enzyme cleavage of genomic DNA, which is a limitation in all widely used methods, but describe improved approaches that take advantage of the power of pyrosequencing to overcome this problem. The methods described here should allow integration site populations from human gene therapy to be deeply characterized with spatial and temporal resolution.

  19. 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...

  20. 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...

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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: ...

  6. 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…

  7. "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

  8. Relatie tussen dalspiegels van tacrolimus in bloed en adverse events bij kinderen die een levertransplantatie hebben ondergaan

    NARCIS (Netherlands)

    Sportel, Esther; Scheenstra, R.; Uges, D.R.A.; Kosterink, J.G.W.

    2013-01-01

    OBJECTIVE: To determine the relation between tacrolimus trough levels in blood and adverse events in paediatric liver transplantation. Although therapeutic drug monitoring plays an important role in daily practice, there is no general agreement on the therapeutic window in children. DESIGN AND METHO

  9. Relation between change in blood pressure in acute stroke and risk of early adverse events and poor outcome

    DEFF Research Database (Denmark)

    Sandset, Else C; Murray, Gordon D; Bath, Philip M W;

    2012-01-01

    The Scandinavian Candesartan Acute Stroke Trial (SCAST) found no benefits of candesartan in acute stroke. In the present analysis we aim to investigate the effect of change in blood pressure during the first 2 days of stroke on the risk of early adverse events and poor outcome....

  10. 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

  11. The incidence, root-causes, and outcomes of adverse events in surgical units: implications for potential prevention strategies.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Keizer, B. de; Merten, H.; Groenewegen, P.P.; Wal, G. van der

    2011-01-01

    Background: We need to know the scale and underlying causes of surgical adverse events (AEs) in order to improve the safety of care in surgical units. However, there is little recent data. Previous record review studies that reported on surgical AEs in detail are now more than ten years old. Since t

  12. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Keizer, B. de; Merten, H.; Groenewegen, P.P.; Wal, G. van der; Wagner, C.

    2011-01-01

    Background: We need to know the scale and underlying causes of surgical adverse events (AEs) in order to improve the safety of care in surgical units. However, there is little recent data. Previous record review studies that reported on surgical AEs in detail are now more than ten years old. Since t

  13. 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)

  14. Construct and concurrent validity of a patient-reported adverse drug event questionnaire : a cross-sectional study

    NARCIS (Netherlands)

    de Vries, Sieta T.; Haaijer-Ruskamp, Flora M.; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    Background: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is

  15. Practitioner Review: Current Best Practice in the Management of Adverse Events during Treatment with ADHD Medications in Children and Adolescents

    Science.gov (United States)

    Cortese, Samuele; Holtmann, Martin; Banaschewski, Tobias; Buitelaar, Jan; Coghill, David; Danckaerts, Marina; Dittmann, Ralf W.; Graham, John; Taylor, Eric; Sergeant, Joseph

    2013-01-01

    Background: Medication is an important element of therapeutic strategies for ADHD. While medications for ADHD are generally well-tolerated, there are common, although less severe, as well as rare but severe adverse events AEs during treatment with ADHD drugs. The aim of this review is to provide

  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. 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.

  18. [Analysis on 315 cases of clinical adverse drug reaction/event induced by gastrodin].

    Science.gov (United States)

    Zheng, Yang-yang; Dong, Zhi; Lu, Xiao-qin; Xia, Yong-peng; Zhu, Shu-bing

    2015-05-01

    With patients' general situation, medication use, occurrence time of adverse drug reaction/event (ADR/ADE), clinical manifestations and prognosis as reference items, a retrospective study was made for 315 cases with ADR/ADE induced by Gastrodin in Chongqing from January 2008 to June 2014, in order to analyze the characteristics of ADR/ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR/ADE, 143 cases (45.4%) were males and 172 cases (54.6%) were females, most of them (74.9%) were aged above 45; 60 cases (19.0%) with ADE were caused by off-label indications and 66 cases (21.0%) with ADE were caused by over dosage; ADR/ADE cases induced by intravenous drip mainly happened within 30 min (85.5%), ADR/ADE cases induced by oral administration mainly happened within 2 h (74.4%), and all of ADR/ ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR/ADE cases were reported, which were mainly damages in gastrointestinal system, skin and its adnexa; And 61.9% of ADR/ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR/ADE induced by gastrodin, apply it in clinic with standards, pay close attention to changes of patients' situations and attach importance to the monitoring of ADR/ADE, so as to enhance the safety of medication.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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...

  5. Could erlotinib treatment lead to acute cardiovascular events in patients with lung adenocarcinoma after chemotherapy failure?

    Directory of Open Access Journals (Sweden)

    Kus T

    2015-06-01

    Full Text Available Tulay Kus, Gokmen Aktas, Alper Sevinc, Mehmet Emin Kalender, Celaletdin Camci Department of Internal Medicine, Division of Medical Oncology, Gaziantep University, Gaziantep, Turkey Abstract: Erlotinib, an epidermal growth factor receptor and tyrosine kinase inhibitor, is a targeted drug that was approved for the treatment of non-small-cell lung cancers and pancreatic cancers. Targeted tyrosine kinase inhibitors are known to have cardiotoxic effects. However, erlotinib does not have a statistically proven effect of increasing acute cardiovascular event (ACE risk. Preclinical studies showed that beta agonist stimulation among rats that were administered erlotinib led to cardiovascular damage. Thus, there would be an aggregate effect of erlotinib on ACE, although it is not thought to be a cardiotoxic drug itself. In this paper, we present two non-small-cell lung cancer cases that developed ACE under erlotinib treatment. Keywords: erlotinib, lung cancer, myocardial infarction, EGFR

  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. 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.

  8. Assessment of Inflammatory and Cardiovascular Markers in Type 2 Diabetes without Clinical Evidence of Cardiac Events

    Directory of Open Access Journals (Sweden)

    Marwan Al-Nimer

    2014-09-01

    Full Text Available Purpose: There is no doubt that several inflammatory markers were detected in type 2 diabetes (T2D. Cardiovascular events were also associated with T2D or complicated T2D. Co-existence of cardiovascular and inflammatory biomarkers in T2D patients in the absence of cardiovascular morbidity have been mentioned in a few articles. This study aimed to assess the association of C-reactive protein as inflammatory marker with serum NT-proBNP (a diagnostic marker of heart failure with nitric oxide (a marker of vascular endothelial function in T2D patients without clinical evidence of heart failure. Material and Method: A total of 75 T2D patients recruited from the Center of Diabetes and 25 healthy subjects served as controls were enrolled in the study. Patients without clinical evidence of heart failure or recent infection were included in the study. Serum C- reactive protein, NT-proBNP, and nitric oxide were determined. Results: High serum NT-proBNP levels (≥600 pg/ml indicating the presence of moderate to severe heart failure was detected in 10.7% of subjects. Serum nitric oxide levels were significantly lower (60.98±30.75 µmol compared with those in healthy subjects (120.3±12.5 µmol. Serum nitric oxide significantly and inversely correlated with serum NT-proBNP level (r=-0.228, p<0.05. Seven out of 14 patients with positive C-reactive protein had significantly high serum NT-proBNP level (≥600 pg/ml. Patients with positive C-reactive protein significantly have low serum nitric oxide level compared with those expressed negative C-reactive protein reaction. Discussion: Biomarkers of cardiovascular events in T2D patients without clinical evidence of heart failure are detected in the presence of inflammatory process. Turk Jem 2014; 18: 75-78

  9. 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.

  10. 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.

  11. Trigger event – a key factor in adverse Aircraft/Rotorcraft Pilot Couplings

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    Achim IONITA

    2012-09-01

    Full Text Available An important element that interacts unfavorably with pilot and aircraft is the triggering event. Without a trigger event (or a chain of triggering events A/RPC does not appear. This study presents an overview of different classes of triggers that can initiate an A/RPC phenomenon. Based on extended analysis of triggering events a new definition is proposed.

  12. Ankle-Brachial Index and cardiovascular events in atrial fibrillation. The ARAPACIS Study.

    Science.gov (United States)

    Violi, Francesco; Davì, Giovanni; Proietti, Marco; Pastori, Daniele; Hiatt, William R; Corazza, Gino Roberto; Perticone, Francesco; Pignatelli, Pasquale; Farcomeni, Alessio; Vestri, Anna Rita; Lip, Gregory Y H; Basili, Stefania

    2016-04-01

    Atrial fibrillation (AF) patients are at high risk for thrombotic and vascular events related to their cardiac arrhythmia and underlying systemic atherosclerosis. Ankle-Brachial Index (ABI) is a non-invasive tool in evaluating systemic atherosclerosis, useful in predicting cardiovascular events in general population; no data are available in AF patients. ARAPACIS is a prospective multicentre observational study performed by the Italian Society of Internal Medicine, analysing association between low ABI (≤ 0.90) and vascular events in NVAF out- or in-patients, enrolled in 136 Italian centres. A total of 2,027 non-valvular AF (NVAF) patients aged > 18 years from both sexes followed for a median time of 34.7 (interquartile range: 22.0-36.0) months, yielding a total of 4,614 patient-years of observation. Mean age was 73 ± 10 years old with 55 % male patients. A total of 176 patients (8.7 %) experienced a vascular event, with a cumulative incidence of 3.81 %/patient-year. ABI≤ 0.90 was more prevalent in patients with a vascular event compared with patients free of vascular events (32.2 vs 20.2 %, p5.083; p=0.001). This latter association was also confirmed after excluding patients with previous MI (HR: 2.901, 95 % CI: 1.408-5.990, p=0.004). No association was observed between low ABI and stroke/transient ischaemic attack (p=0.91). In conclusion, low ABI is useful to predict MI and vascular death in NVAF patients and may independently facilitate cardiovascular risk assessment in NVAF patients.

  13. 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.)

  14. 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

    , 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......Epidermal growth factor receptor (EGFR) inhibitors are widely used in the treatment of cancer. EGFR-targeted treatment is known to be associated with a high incidence of dermatological adverse reactions, including papulopustular rash, which can be dose-limiting and may affect compliance...

  15. 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 ...

  16. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

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    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

  17. WHO Efforts to Promote Reporting of Adverse Events and Global Learning.

    Science.gov (United States)

    Larizgoitia, Itziar; Bouesseau, Marie-Charlotte; Kelley, Edward

    2013-12-01

    Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents. Significance for public healthUnderstanding the causes and consequences of incidents is cornerstone for patient safety improvement. Likewise, setting up systems to facilitate such understanding and communicate the learning across all healthcare actors is crucial. Over the past decade, the World Health

  18. Adverse events and retention of donors of double red cell units by apheresis

    Science.gov (United States)

    Keshelashvili, Ketevan; O’Meara, Alix; Stern, Martin; Jirout, Zuzana; Pehlic, Vildana; Holbro, Andreas; Buser, Andreas; Sigle, Jörg; Infanti, Laura

    2016-01-01

    Background Safety of double-erythrocyte (2RBC) collection and reasons for ceasing 2RBC donation were retrospectively analysed in the blood donor population of Basel, Switzerland. Methods Donors with at least 1 2RBC apheresis were included in the study. Minimal requirements were Hb ≥140 g/L and body weight ≥70 kg; serum ferritin (SF) values were measured routinely, but were not part of the selection criteria. 2RBC collections were performed with ALYX devices at 6-month intervals. Adverse events (AEs) were systematically recorded and classified according to the ISBT EHN 2008 criteria. Data of procedures were retrieved from the ALYX software. Demographics, apheresis data and AEs were analysed with descriptive statistics. Results Data of 4,377 2RBC aphereses performed in 793 donors (779 males) between 1st January 2003 and 31st May 2015 were evaluated. Mean donor age at first 2RBC donation was 44 years (standard deviation [SD] 21), median number of donations was 4 (interquartile range [IQR] 8); 32% of the donors underwent a single procedure. There were 161 AEs, mostly local haematomas (55%) and vasovagal reactions (20%); fatigue was reported in 6% of the cases and was more frequent than citrate toxicity. Two severe AEs were observed. The most frequent reasons for abandoning 2RBC donation were low SF levels and donor choice (both 11%), but most donors simply did not reply to invitations (16%). Overall, procedure-related causes (AEs, low SF levels, no time for apheresis, inadequate venous access) were observed in 14% of the cases. At the end of the observation period, 40% of the donors were still active blood donors, but only 20% were donating 2RBC. Discussion 2RBC donation is overall safe. Donor retention was low over a period of 11 years. An important reason for abandoning 2RBC was the detection of low SF levels. The impact of fatigue on donor retention and the course of iron stores after repeated 6-monthly 2RBC apheresis require further investigation. PMID:27136442

  19. Adverse events post smallpox-vaccination: insights from tail scarification infection in mice with Vaccinia virus.

    Directory of Open Access Journals (Sweden)

    Bruno E F Mota

    Full Text Available Adverse events upon smallpox vaccination with fully-replicative strains of Vaccinia virus (VACV comprise an array of clinical manifestations that occur primarily in immunocompromised patients leading to significant host morbidity/mortality. The expansion of immune-suppressed populations and the possible release of Variola virus as a bioterrorist act have given rise to concerns over vaccination complications should more widespread vaccination be reinitiated. Our goal was to evaluate the components of the host immune system that are sufficient to prevent morbidity/mortality in a murine model of tail scarification, which mimics immunological and clinical features of smallpox vaccination in humans. Infection of C57BL/6 wild-type mice led to a strictly localized infection, with complete viral clearance by day 28 p.i. On the other hand, infection of T and B-cell deficient mice (Rag1(-/- produced a severe disease, with uncontrolled viral replication at the inoculation site and dissemination to internal organs. Infection of B-cell deficient animals (µMT produced no mortality. However, viral clearance in µMT animals was delayed compared to WT animals, with detectable viral titers in tail and internal organs late in infection. Treatment of Rag1(-/- with rabbit hyperimmune anti-vaccinia serum had a subtle effect on the morbidity/mortality of this strain, but it was effective in reduce viral titers in ovaries. Finally, NUDE athymic mice showed a similar outcome of infection as Rag1(-/-, and passive transfer of WT T cells to Rag1(-/- animals proved fully effective in preventing morbidity/mortality. These results strongly suggest that both T and B cells are important in the immune response to primary VACV infection in mice, and that T-cells are required to control the infection at the inoculation site and providing help for B-cells to produce antibodies, which help to prevent viral dissemination. These insights might prove helpful to better identify

  20. Association of variants in NEDD4L with blood pressure response and adverse cardiovascular outcomes in hypertensive patients treated with thiazide diuretics

    Science.gov (United States)

    McDonough, Caitrin W.; Burbage, Sarah E.; Duarte, Julio D.; Gong, Yan; Langaee, Taimour Y.; Turner, Stephen T.; Gums, John G.; Chapman, Arlene B.; Bailey, Kent R.; Beitelshees, Amber L.; Boerwinkle, Eric; Pepine, Carl J.; Cooper-DeHoff, Rhonda M.; Johnson, Julie A.

    2013-01-01

    Objective Single-nucleotide polymorphisms (SNPs) in NEDD4L may influence the ability of the NEDD4L protein to reduce epithelial sodium channel expression. A variant in NEDD4L, rs4149601, was associated with antihypertensive response and cardiovascular outcomes during treatment with thiazide diuretics and β-blockers in a Swedish population. We sought to further evaluate associations between NEDD4L polymorphisms, blood pressure response and cardiovascular outcomes with thiazide diuretics and β-blockers. Methods Four SNPs, rs4149601, rs292449, rs1008899 and rs75982813, were genotyped in 767 patients from the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) clinical trial and association was assessed with blood pressure response to hydrochlorothiazide and atenolol. One SNP, rs4149601, was also genotyped in 1345 patients from the International Verapmil SR Trandolapril Study (INVEST), and association was examined with adverse cardiovascular outcomes relative to hydrochlorothiazide treatment. Results Significant associations or trends were found between rs4149601, rs292449, rs75982813 and rs1008899 and decreases in blood pressure in whites on hydrochlorothiazide, and a significant association was observed with increasing copies of the GC rs4149601-rs292449 haplotype and greater blood pressure response to hydrochlorothiazide in whites (P = 0.0006 and 0.006, SBP and DBP, respectively). Significant associations were also seen with rs4149601 and an increased risk for adverse cardiovascular outcomes in whites not treated with hydrochlorothiazide [P = 0.022, odds ratio (95% confidence interval) = 10.65 (1.18–96.25)]. Conclusion NEDD4L rs4149601, rs292449 and rs75982813 may be predictors for blood pressure response to hydrochlorothiazide in whites, and NEDD4L rs4149601 may be a predictor for adverse cardiovascular outcomes in whites not treated with hydrochlorothiazide. PMID:23353631

  1. 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

  2. Automatic prediction of cardiovascular and cerebrovascular events using heart rate variability analysis.

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    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.

  3. 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

  4. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis.

    Science.gov (United States)

    Johansson, K; Neovius, K; DeSantis, S M; Rössner, S; Neovius, M

    2009-09-01

    The objective of this article was to estimate the risk of discontinuation due to adverse events in trials of orlistat, sibutramine and rimonabant. Medline, EMBASE, the Cochrane controlled trials register and reference lists of identified articles were searched from 1990 to May 2008. All randomized placebo-controlled trials of 12-24 months of duration on adults using licensed doses were included. Studies/study arms were excluded if they evaluated weight maintenance after weight loss. Trials were identified, subjected to inclusion and exclusion criteria and reviewed. Data on participants, interventions and discontinuation were extracted and trials rated for quality based on established criteria. A random effects model was used to estimate pooled risk ratios, risk differences and number needed to harm (NNH). A total of 28 trials met the inclusion criteria (16 orlistat, 7 sibutramine and 5 rimonabant). The risk ratios for discontinuation due to adverse events were significantly elevated for rimonabant (2.00; 1.66-2.41) and orlistat (1.59; 1.21-2.08), but not sibutramine (0.98, 0.68-1.41). Compared with placebo, the risk difference was the largest for rimonabant (7%, 5-9%; NNH 14, 11-19), followed by orlistat (3%, 1-4%; NNH 39, 25-83), while no significant difference was seen for sibutramine (0.2%, -3 to 4%; NNH 500). The most common adverse events leading to withdrawal were gastrointestinal for orlistat (40%) and psychiatric for rimonabant (47%). Corresponding information was unavailable for sibutramine. In conclusion, available weight loss drugs differ markedly regarding risk of discontinuation due to adverse events, as well as in underlying causes of these events. Given the large number of patients eligible for treatment, the low NNH for rimonabant is a concern.

  5. Psoriasis and the Risk of Major Cardiovascular Events: Cohort Study Using the Clinical Practice Research Datalink.

    Science.gov (United States)

    Parisi, Rosa; Rutter, Martin K; Lunt, Mark; Young, Helen S; Symmons, Deborah P M; Griffiths, Christopher E M; Ashcroft, Darren M

    2015-09-01

    The association between psoriasis and risk of major cardiovascular (CV) events (myocardial infarction, acute coronary syndrome, unstable angina, and stroke) is unclear. A cohort study with 48,523 patients with psoriasis and 208,187 controls was conducted. During a median follow-up of 5.2 years, 1,257 patients with psoriasis (2.59%) had a major CV event, compared with 4,784 controls (2.30%). In the multivariable analysis, inflammatory arthritis hazard ratio (HR) 1.36 (1.18-1.58), diabetes HR 1.18 (1.06-1.31), chronic kidney disease HR 1.18 (1.07-1.31), hypertension HR 1.37 (1.29-1.45), transient ischemic attack HR 2.74 (2.41-3.12), atrial fibrillation HR 1.54 (1.36-1.73), valvular heart disease HR 1.23 (1.05-1.44), thromboembolism 1.32 (1.17-1.49), congestive heart failure HR 1.57 (1.39-1.78), depression HR 1.16 (1.01-1.34), current smoker HR 2.18 (2.03-2.33), age (year) HR 1.07 (1.07-1.07), and male gender HR 1.83 (1.69-1.98) were statistically significant for the risk of major CV events. The age- and gender-adjusted HRs of a major CV event for psoriasis were 1.10 (1.04-1.17) and for severe psoriasis 1.40 (1.07-1.84), whereas the fully adjusted HRs were attenuated to 1.02 (0.95-1.08) and 1.28 (0.96-1.69). In conclusion, neither psoriasis nor severe psoriasis were associated with the short-to-medium term (over 3-5 years) risk of major CV events after adjusting for known cardiovascular disease risk factors.

  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. Intravenous iron supplementation practices and short-term risk of cardiovascular events in hemodialysis patients.

    Directory of Open Access Journals (Sweden)

    Abhijit V Kshirsagar

    Full Text Available BACKGROUND & OBJECTIVES: Intravenous iron supplementation is widespread in the hemodialysis population, but there is uncertainty about the safest dosing strategy. We compared the safety of different intravenous iron dosing practices on the risk of adverse cardiovascular outcomes in a large population of hemodialysis patients. DESIGN SETTINGS PARTICIPANTS & MEASUREMENTS: A retrospective cohort was created from the clinical database of a large dialysis provider (years 2004-2008 merged with administrative data from the United States Renal Data System. Dosing comparisons were (1 bolus (consecutive doses ≥ 100 mg exceeding 600 mg during one month versus maintenance (all other iron doses during the month; and (2 high (> 200 mg over 1 month versus low dose (≤ 200 mg over 1 month. We established a 6-month baseline period (to identify potential confounders and effect modifiers, a one-month iron exposure period, and a three-month follow-up period. Outcomes were myocardial infarction, stroke, and death from cardiovascular disease. RESULTS: 117,050 patients contributed 776,203 unique iron exposure/follow-up periods. After adjustment, we found no significant associations of bolus dose versus maintenance, hazards ratio for composite outcome, 1.03 (95% C.I. 0.99, 1.07, or high dose versus low dose intravenous iron, hazards ratio for composite outcome, 0.99 (95% C.I. 0.96, 1.03. There were no consistent associations of either high or bolus dose versus low or maintenance respectively among pre-specified subgroups. CONCLUSIONS: Strategies favoring large doses of intravenous iron were not associated with increased short-term cardiovascular morbidity and mortality. Investigation of the long-term safety of the various intravenous iron supplementation strategies may still be warranted.

  8. The role of nonverbal cognitive ability in the association of adverse life events with dysfunctional attitudes and hopelessness in adolescence.

    Science.gov (United States)

    Flouri, Eirini; Panourgia, Constantina

    2012-10-01

    The aim of this study was to test whether nonverbal cognitive ability buffers the effect of life stress (number of adverse life events in the last year) on diatheses for depression. It was expected that, as problem-solving aptitude, nonverbal cognitive ability would moderate the effect of life stress on those diatheses (such as dysfunctional attitudes) that are depressogenic because they represent deficits in information-processing or problem-solving skills, but not on diatheses (such as hopelessness) that are depressogenic because they represent deficits in motivation or effort to apply problem-solving skills. The sample included 558 10- to 19-year-olds from a state secondary school in London. Nonverbal cognitive ability was negatively associated with both dysfunctional attitudes and hopelessness. As expected, nonverbal cognitive ability moderated the association between life adversity and dysfunctional attitudes. However, hopelessness was not related to life stress, and therefore, there was no life stress effect for nonverbal cognitive ability to moderate. This study adds to knowledge about the association between problem-solving ability and depressogenic diatheses. By identifying life stress as a risk factor for dysfunctional attitudes but not hopelessness, it highlights the importance of considering outcome specificity in models predicting adolescent outcomes from adverse life events. Importantly for practice, it suggests that an emphasis on recent life adversity will likely underestimate the true level of hopelessness among adolescents.

  9. 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...

  10. 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.

  11. 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...

  12. Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children.

    Science.gov (United States)

    Tseng, Hung Fu; Sy, Lina S; Liu, In-Lu Amy; Qian, Lei; Marcy, S Michael; Weintraub, Eric; Yih, Katherine; Baxter, Roger; Glanz, Jason M; Donahue, James; Naleway, Allison; Nordin, James; Jacobsen, Steven J

    2013-05-24

    Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13(®) (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7(®) (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0-28 days following vaccination was 1.94 (95% confidence interval: 0.79-4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.

  13. 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...

  14. 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

  15. Hospital Readmissions Following Endovascular Therapy for Critical Limb Ischemia: Associations With Wound Healing, Major Adverse Limb Events, and Mortality

    OpenAIRE

    Reed, Grant W.; Raeisi‐Giglou, Pejman; Kafa, Rami; Malik, Umair; Salehi, Negar; Mehdi H Shishehbor

    2016-01-01

    Background The significance of hospital readmission after endovascular therapy for critical limb ischemia (CLI) is not well established. We sought to investigate the incidence, timing, and causes of readmissions after endovascular therapy for CLI and whether readmission is associated with major adverse limb events (MALE) or mortality. Methods and Results This was a retrospective study of 252 patients treated with endovascular therapy for CLI. During median follow‐up of 381 days (interquartile...

  16. 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...

  17. 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...

  18. 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 ...

  19. 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...

  20. Effect of endotracheal intubation and laryngeal mask airway on perioperative respiratory adverse events in children with upper airway infections

    Institute of Scientific and Technical Information of China (English)

    黄华君

    2014-01-01

    Objective To investigate the effect of endotracheal intubation(TT)or the laryngeal mask airway(LMA)on the incidence of perioperative respiratory adverse events in children with upper respiratory tract infection undergoing general anesthesia.Methods From November,2006to October,2012 in the Zhuji People’s Hospital,76 children with upper respiratory tract infection approved by hospital ethic committee were randomly divided into 2groups:group I(n=36),

  1. 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 ...

  2. The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients.

    Directory of Open Access Journals (Sweden)

    Tomoya Tachi

    Full Text Available 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 Anticancer Drugs before and after 1 course of outpatient chemotherapy. European Quality of Life 5 Dimensions utility value and Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs total score decreased significantly after chemotherapy (p<0.001 and p = 0.018, respectively. The mean scores for the activity, physical condition, and psychological condition subscales of the Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs decreased significantly after chemotherapy (p = 0.003, p<0.001, and p = 0.032, respectively, whereas the social relationships score increased significantly (p<0.001. Furthermore, in the evaluation of quality of life according to individual adverse events, the decrease in quality of life after chemotherapy in terms of the European Quality of Life 5 Dimensions utility value and the Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs total score was greater in anorexic patients than in non-anorexic patients (p = 0.009 and p<0.001, respectively. This suggests that anorexia greatly reduces quality of life. Our findings reveal that anticancer drug-related adverse events, particularly anorexia, reduce overall quality of life following the first course of outpatient chemotherapy in current breast cancer patients. These findings are extremely useful and important in understanding the impact of anticancer drug-related adverse events on quality of life.

  3. 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...

  4. 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

  5. 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

  6. The association of visceral adiposity with cardiovascular events in patients with peripheral artery disease.

    Directory of Open Access Journals (Sweden)

    Oliver Cronin

    Full Text Available BACKGROUND: Previous studies have suggested that patients with peripheral artery disease (PAD suffer from a high incidence of cardiovascular events (CVE. Visceral adiposity has been implicated in promoting CVEs. This study aimed to assess the association of relative visceral adipose volume with incident cardiovascular events in patients with peripheral artery disease. METHODS: This was a prospective cohort study including 260 patients with PAD who presented between 2003 and 2012. Cases were patients with diagnosed PAD including symptomatic lower limb athero-thrombosis and asymptomatic abdominal aortic aneurysm. All patients underwent computed tomography angiography (CTA. Abdominal visceral to total adipose volume ratio (relative visceral adipose volume was estimated from CTAs using a previously validated workstation protocol. Cardiovascular risk factors were recorded at entry. The association of visceral adiposity with major CVEs (death, non-fatal myocardial infarction or stroke was examined using Kaplan Meier and Cox proportional hazard analyses. RESULTS: A total of 92 major CVEs were recorded in 76 patients during a median follow-up of 2.8 (IQR 1.2 to 4.8 years, including myocardial infarction (n = 26, stroke (n = 10 and death (n = 56. At 3 years the incidence of major CVEs stratified by relative visceral adipose volume quartiles were 15% [Quartile (Q 1], 17% (Q2, 11% (Q3 and 15% (Q4 (P = 0.517. Relative visceral adipose volume was not associated with major CVEs after adjustment for other risk factors. CONCLUSION: This study suggests that visceral adiposity does not play a central role in the predisposition for major CVEs in patients with PAD.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Gene polymorphisms in APOE, NOS3, and LIPC genes may be risk factors for cardiac adverse events after primary CABG

    Directory of Open Access Journals (Sweden)

    Nollert Georg

    2009-08-01

    Full Text Available Abstract Introduction Coronary artery disease progression after primary coronary artery bypass grafting may, beside classical atherosclerosis risk factors, be depending on genetic predisposition. Methods We investigated 192 CABG patients (18% female, age: 60.9 ± 7.4 years. Clinically cardiac adverse events were defined as need for reoperation (n = 88; 46%, reintervention (n = 58; 30%, or angina (n = 89; 46%. Mean follow-up time measured 10.1 ± 5.1 years. Gene polymorphisms (ApoE, NOS3, LIPC, CETP, SERPINE-1, Prothrombin were investigated separately and combined (gene risk profile. Results Among classical risk factors, arterial hypertension and hypercholesterinemia significantly influenced CAD progression. Single ApoE, NOS3 and LIPC polymorphisms provided limited information. Patients missing the most common ApoE ε3 allele (5,2%, showed recurrent symptoms (p = 0,077 and had more frequently reintervention (p = 0,001. NOS3 a allele was associated with a significant increase for reintervention (p = 0,041 and recurrent symptoms (p = 0,042. Homozygous LIPC patients had a higher reoperation rate (p = 0.049. A gene risk profile enabled us to discriminate between faster and slower occurrence of cardiac adverse events (p = 0.0012. Conclusion Single APOE, LIPC and NOS3 polymorphisms permitted limited prognosis of cardiac adverse events in patients after CABG. Risk profile, in contrast, allowed for risk stratification.

  12. 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.

  13. 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

    - and 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...

  14. Testosterone and Cardiovascular Disease.

    Science.gov (United States)

    Kloner, Robert A; Carson, Culley; Dobs, Adrian; Kopecky, Stephen; Mohler, Emile R

    2016-02-01

    Testosterone (T) is the principal male sex hormone. As men age, T levels typically fall. Symptoms of low T include decreased libido, vasomotor instability, and decreased bone mineral density. Other symptoms may include depression, fatigue, erectile dysfunction, and reduced muscle strength/mass. Epidemiology studies show that low levels of T are associated with more atherosclerosis, coronary artery disease, and cardiovascular events. However, treating hypogonadism in the aging male has resulted in discrepant results in regard to its effect on cardiovascular events. Emerging studies suggest that T may have a future role in treating heart failure, angina, and myocardial ischemia. A large, prospective, long-term study of T replacement, with a primary endpoint of a composite of adverse cardiovascular events including myocardial infarction, stroke, and/or cardiovascular death, is needed. The Food and Drug Administration recently put additional restrictions on T replacement therapy labeling and called for additional studies to determine its cardiac safety. PMID:26846952

  15. 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

  16. 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.

  17. Impact of Cardiovascular Events on Change in Quality of Life and Utilities in Patients After Myocardial Infarction

    DEFF Research Database (Denmark)

    Lewis, Eldrin F; Li, Yanhong; Pfeffer, Marc A;

    2014-01-01

    OBJECTIVES: The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL). BACKGROUND: There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial in...

  18. Uric Acid as a Risk Factor for Cardiovascular Disease and Mortality in Overweight/Obese Individuals

    DEFF Research Database (Denmark)

    Skak-Nielsen, Helle; Torp-Pedersen, Christian; Finer, Nick;

    2013-01-01

    The predictive value of serum uric acid (SUA) for adverse cardiovascular events among obese and overweight patients is not known, but potentially important because of the relation between hyperuricaemia and obesity.......The predictive value of serum uric acid (SUA) for adverse cardiovascular events among obese and overweight patients is not known, but potentially important because of the relation between hyperuricaemia and obesity....

  19. Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz

    Science.gov (United States)

    Abah, Isaac Okoh; Akanbi, Maxwell; Abah, Mercy Enuwa; Finangwai, Amos Istifanus; Dady, Christy W; Falang, Kakjing Dadul; Ebonyi, Augustine Odoh; Okopi, Joseph Anejo; Agbaji, Oche Ochai; Sagay, Altiene Solomon; Okonkwo, Prosper; Idoko, John A; Kanki, Phyllis J

    2015-01-01

    Introduction Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART). Methods This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. Results A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. Conclusion Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up. PMID:26405676

  20. 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.

  1. 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

  2. Dopamine D4 receptor exon III polymorphism, adverse life events and personality traits in a nonclinical German adult sample.

    Science.gov (United States)

    Reiner, Iris; Spangler, Gottfried

    2011-01-01

    Personality and temperament embrace a wide area of both psychological and behavioral processes which are also based on disposition. A functional polymorphism in exon III of the dopamine D4 receptor gene (DRD4) has been a highly suspect genetic marker for personality in spite of ambiguous results. The present study aimed to further elucidate the relationship between DRD4, negative life events and personality in a representative nonclinical sample. Hundred sixty-seven Germans completed the NEO Five-Factor Inventory, the Tridimensional Personality Questionnaire and the California Adult Q-Sort. A factor analysis revealed 3 factors: emotional stability, social orientation and impulsivity. DNA from buccal cells was genotyped for the DRD4 variable-number tandem-repeat exon III polymorphism with respect to presence versus absence of the DRD4 7-repeat allele. Adverse life events were assessed by means of the Adverse Life Events Scale. Men carrying the DRD4 7-repeat allele were more impulsive than those without. Male 7-repeat carriers were more emotionally instable than others, but only when they experienced a large amount of negative life events. No genotype-personality relationships were found for women. The results indicate gender-specific influences of the DRD4 gene on human behavior and invite researchers to further investigate gene-environment correlations on personality traits.

  3. Healthy Lifestyle Factors and Risk of Cardiovascular Events and Mortality in Treatment-Resistant Hypertension: The Regards Study

    OpenAIRE

    Diaz, Keith M; Booth, John N.; Calhoun, David A.; Irvin, Marguerite R.; Howard, George; Safford, Monika M.; Muntner, Paul; Shimbo, Daichi

    2014-01-01

    Few data exist regarding whether healthy lifestyle factors are associated with better prognosis among individuals with apparent treatment-resistant hypertension, a high-risk phenotype of hypertension. The purpose of this study was to assess the association of healthy lifestyle factors with cardiovascular events, all-cause mortality, and cardiovascular mortality among individuals with apparent treatment-resistant hypertension. We studied participants (n=2,043) from the population-based REasons...

  4. A prospective study of risk factors for cardiovascular events among the elderly

    Directory of Open Access Journals (Sweden)

    Cabrera MA

    2012-11-01

    Full Text Available Marcos Aparecido Sarria Cabrera,1 Selma Maffei de Andrade,2 Arthur Eumann Mesas21Discipline of Geriatrics, Postgraduate Program in Public Health, 2Department of Public Health, Postgraduate Program in Public Health, Universidade Estadual de Londrina, Paraná, BrazilObjective: To analyze the impact of cardiovascular (CV risk factors on the occurrence of fatal and non-fatal CV events in elderly individuals.Methods: The present research was a prospective cohort study of 800 elderly Brazilian outpatients (60 to 85 years old with a 12-year follow-up period (baseline: 1997–1998. The outcome variable was CV mortality or non-fatal CV events (stroke, infarction, angina, heart failure. Hypertension, diabetes, global and abdominal obesity, dyslipidemias, and metabolic syndrome were analyzed as independent variables. The analyses were based on Cox proportional hazard models and adjusted for gender, age range, smoking, regular physical activity, and previous cardiovascular disease.Results: A total of 233 fatal and non-fatal CV events were observed (29.1%. In the adjusted analysis, the following variables were associated with CV risk: hypertension hazard ratio (HR: 1.69; confidence interval (CI 95%: 1.28–2.24, diabetes (HR: 2.67; CI 95%: 1.98–3.61, metabolic syndrome (HR: 1.61; CI 95%: 1.24–2.09, abdominal obesity (HR: 1.36; CI 95%: 1.03–1.79, hypertriglyceridemia (HR: 1.67; CI 95%: 1.22–2.30 and high triglyceride/HDL-c ratio (HR: 1.73; CI 95%: 1.31–2.84. Hypertension, diabetes, and dyslipidemia remained associated with CV risk regardless of abdominal obesity.Conclusion: In this prospective study, hypertension, diabetes, metabolic syndrome, abdominal obesity, and hypertriglyceridemia were predictors of CV risk in elderly individuals. These results confirm the relevance of controlling these CV risk factors in this age group.Keywords: aged, cardiovascular diseases, risk factors, epidemiology

  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. 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

  7. The Role of Personal Goals in Depressive Reaction to Adverse Life Events: A Cross-Sectional Study

    Directory of Open Access Journals (Sweden)

    Alessandro Couyoumdjian

    2012-01-01

    Full Text Available Consistent with cognitive views of depression, we aimed to investigate the mediating role of personal goals in the relationship between stressful events and distinct patterns of depressive symptoms in a nonclinical sample. Participants identified a dysphoric episode that occurred in the previous year by reporting the severity of 12 depressive symptoms and their plausible cause. A goal taxonomy was used to determine how much the event interfered with the achievement of a series of personal goals. After controlling for age and current level of depression, the patterns of symptoms differed based on the triggering events. The relationship between sadness and affective losses was partially mediated by the personal goal of lovableness, and success was a partial mediator in the association between an event of failure and symptoms of worthlessness and anhedonia. Although the cross-sectional design of the study does not allow for conclusions on the direction of effects, findings suggest the importance of motivational factors in the development of specific patterns of depressive symptoms to adverse events. Assuming a continuum from low mood to clinical depression, treatment models could benefit from a precise identification of the specific stressors that initiate depressive behaviour and the personal meaning assigned to those events.

  8. Usefulness of Beta2-Microglobulin as a Predictor of All-Cause and Nonculprit Lesion-Related Cardiovascular Events in Acute Coronary Syndromes (from the PROSPECT Study).

    Science.gov (United States)

    Möckel, Martin; Muller, Reinhold; Searle, Julia; Slagman, Anna; De Bruyne, Bernard; Serruys, Patrick; Weisz, Giora; Xu, Ke; Holert, Fabian; Müller, Christian; Maehara, Akiko; Stone, Gregg W

    2015-10-01

    In the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study, plaque burden, plaque composition, and minimal luminal area were associated with an increased risk of adverse cardiovascular events arising from untreated atherosclerotic lesions (vulnerable plaques) in patients with acute coronary syndromes (ACS). We sought to evaluate the utility of biomarker profiling and clinical risk factors to predict 3-year all-cause and nonculprit lesion-related major adverse cardiac events (MACEs). Of 697 patients who underwent successful percutaneous coronary intervention (PCI) for ACS, an array of 28 baseline biomarkers was analyzed. Median follow-up was 3.4 years. Beta2-microglobulin displayed the strongest predictive power of all variables assessed for all-cause and nonculprit lesion-related MACE. In a classification and regression tree analysis, patients with beta2-microglobulin >1.92 mg/L had an estimated 28.7% 3-year incidence of all-cause MACE; C-peptide 1.92 mg/L identified a cohort with a 3-year rate of 18.5%, and C-peptide PROSPECT study, beta2-microglobulin strongly predicted all-cause and nonculprit lesion-related MACE within 3 years after PCI in ACS. C-peptide and HDL provided further risk stratification to identify angiographically mild nonculprit lesions prone to future MACE.

  9. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study

    DEFF Research Database (Denmark)

    Friis-Møller, Nina; Thiébaut, Rodolphe; Reiss, Peter;

    2010-01-01

    AIMS: HIV-infected patients receiving combination antiretroviral therapy may experience metabolic complications, potentially increasing their risk of cardiovascular diseases (CVDs). Furthermore, exposures to some antiretroviral drugs seem to be independently associated with increased CVD risk. We...... on Adverse Effects of Anti-HIV Drugs Study. Using cross-validation methods, separate models were developed to predict the risk of myocardial infarction, coronary heart disease, and a composite CVD endpoint. Model performance was compared with the Framingham score.The models included age, sex, systolic blood.......670-0.818) for coronary heart disease and 0.769 (0.695-0.824) for CVD. The models estimated more accurately the outcomes in the subgroups than the Framingham score. CONCLUSION: Risk equations developed from a population of HIV-infected patients, incorporating routinely collected cardiovascular risk parameters...

  10. 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

    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......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...... range, 2.9-10.9) a total of 793 (18.4%) patients developed CVD. The final prediction model included age, sex, diabetes duration, systolic blood pressure, low-density lipoprotein cholesterol, hemoglobin A1c, albuminuria, glomerular filtration rate, smoking, and exercise. Discrimination was excellent...

  11. 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...... 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...... cholesterol level from baseline to week 24. RESULTS: At week 24, the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points (P

  12. 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.)

  13. Risk of cardiovascular thrombotic events after surgical castration versus gonadotropin-releasing hormone agonists in Chinese men with prostate cancer

    Directory of Open Access Journals (Sweden)

    Jeremy YC Teoh

    2015-06-01

    Full Text Available We investigated the cardiovascular thrombotic risk after surgical castration (SC versus gonadotropin-releasing hormone agonists (GnRHa in Chinese men with prostate cancer. All Chinese prostate cancer patients who were treated with SC or GnRHa from year 2000 to 2009 were reviewed and compared. The primary outcome was any new-onset of cardiovascular thrombotic events after SC or GnRHa, which was defined as any event of acute myocardial infarction or ischemic stroke. The risk of new-onset cardiovascular thrombotic event was compared between the SC group and the GnRHa group using Kaplan-Meier method. Multivariate Cox regression analysis was performed to adjust for other potential confounding factors. A total of 684 Chinese patients was included in our study, including 387 patients in the SC group and 297 patients in the GnRHa group. The mean age in the SC group (75.3 ± 7.5 years was significantly higher than the GnRHa group (71.8 ± 8.3 years (P < 0.001. There was increased risk of new cardiovascular thrombotic events in the SC group when compared to the GnRHa group upon Kaplan-Meier analysis (P = 0.014. Upon multivariate Cox regression analysis, age (hazard ratio [HR] 1.072, 95% confidence interval [CI] 1.04-1.11, P< 0.001, hyperlipidemia (HR 2.455, 95% CI 1.53-3.93, P< 0.001, and SC (HR 1.648, 95% CI 1.05-2.59, P= 0.031 were significant risk factors of cardiovascular thrombotic events. In conclusion, SC was associated with increased risk of cardiovascular thrombotic events when compared to GnRHa. This is an important aspect to consider while deciding on the method of androgen deprivation therapy, especially in elderly men with known history of hyperlipidemia.

  14. 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.

  15. A study of adverse events associated with the use of Immunosuppressive agents in kidney transplanted Patients

    Directory of Open Access Journals (Sweden)

    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.

  16. PCSK9 Plasma Concentrations Are Independent of GFR and Do Not Predict Cardiovascular Events in Patients with Decreased GFR.

    Directory of Open Access Journals (Sweden)

    Kyrill S Rogacev

    Full Text Available Impaired renal function causes dyslipidemia that contributes to elevated cardiovascular risk in patients with chronic kidney disease (CKD. The proprotein convertase subtilisin/kexin type 9 (PCSK9 is a regulator of the LDL receptor and plasma cholesterol concentrations. Its relationship to kidney function and cardiovascular events in patients with reduced glomerular filtration rate (GFR has not been explored.Lipid parameters including PCSK9 were measured in two independent cohorts. CARE FOR HOMe (Cardiovascular and Renal Outcome in CKD 2-4 Patients-The Forth Homburg evaluation enrolled 443 patients with reduced GFR (between 90 and 15 ml/min/1.73 m2 referred for nephrological care that were prospectively followed for the occurrence of a composite cardiovascular endpoint. As a replication cohort, PCSK9 was quantitated in 1450 patients with GFR between 90 and 15 ml/min/1.73 m2 enrolled in the Ludwigshafen Risk and Cardiovascular Health Study (LURIC that were prospectively followed for cardiovascular deaths.PCSK9 concentrations did not correlate with baseline GFR (CARE FOR HOMe: r = -0.034; p = 0.479; LURIC: r = -0.017; p = 0.512. 91 patients in CARE FOR HOMe and 335 patients in LURIC reached an endpoint during a median follow-up of 3.0 [1.8-4.1] years and 10.0 [7.3-10.6] years, respectively. Kaplan-Meier analyses showed that PCSK9 concentrations did not predict cardiovascular events in either cohort [CARE FOR HOMe (p = 0.622; LURIC (p = 0.729]. Sensitivity analyses according to statin intake yielded similar results.In two well characterized independent cohort studies, PCSK9 plasma levels did not correlate with kidney function. Furthermore, PCSK9 plasma concentrations were not associated with cardiovascular events in patients with reduced renal function.

  17. 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...

  18. Pembrolizumab in a BRAF-mutant metastatic melanoma patient following a severe immune-related adverse event with ipilimumab.

    Science.gov (United States)

    Aya, Francisco; Fernández-Martínez, Aranzazu; Gaba, Lydia; Victoria, Iván; Tosca, Mónica; Carrera, Cristina; Prat, Aleix; Arance, Ana

    2016-06-01

    Currently, limited data exist on the safety of pembrolizumab in patients with metastatic melanoma who have developed severe immune-related adverse events following treatment with ipilimumab. We report a 45-year-old male patient with BRAF-mutant metastatic melanoma who discontinued treatment with ipilimumab due to treatment-related grade 3 colitis and was subsequently treated with the anti-programmed cell death 1 protein (PD-1) antibody pembrolizumab. He has been on treatment with pembrolizumab for more than 20 months with no major toxicities and has achieved an objective partial response, which is ongoing.

  19. 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...

  20. 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

  1. Genome-wide study of gene variants associated with differential cardiovascular event reduction by pravastatin therapy.

    Directory of Open Access Journals (Sweden)

    Dov Shiffman

    Full Text Available Statin therapy reduces the risk of coronary heart disease (CHD, however, the person-to-person variability in response to statin therapy is not well understood. We have investigated the effect of genetic variation on the reduction of CHD events by pravastatin. First, we conducted a genome-wide association study of 682 CHD cases from the Cholesterol and Recurrent Events (CARE trial and 383 CHD cases from the West of Scotland Coronary Prevention Study (WOSCOPS, two randomized, placebo-controlled studies of pravastatin. In a combined case-only analysis, 79 single nucleotide polymorphisms (SNPs were associated with differential CHD event reduction by pravastatin according to genotype (P<0.0001, and these SNPs were analyzed in a second stage that included cases as well as non-cases from CARE and WOSCOPS and patients from the PROspective Study of Pravastatin in the Elderly at Risk/PHArmacogenomic study of Statins in the Elderly at risk for cardiovascular disease (PROSPER/PHASE, a randomized placebo controlled study of pravastatin in the elderly. We found that one of these SNPs (rs13279522 was associated with differential CHD event reduction by pravastatin therapy in all 3 studies: P = 0.002 in CARE, P = 0.01 in WOSCOPS, P = 0.002 in PROSPER/PHASE. In a combined analysis of CARE, WOSCOPS, and PROSPER/PHASE, the hazard ratio for CHD when comparing pravastatin with placebo decreased by a factor of 0.63 (95% CI: 0.52 to 0.75 for each extra copy of the minor allele (P = 4.8 × 10(-7. This SNP is located in DnaJ homolog subfamily C member 5B (DNAJC5B and merits investigation in additional randomized studies of pravastatin and other statins.

  2. Elevation of urinary liver-type fatty acid binding protein after cardiac catheterization related to cardiovascular events

    Directory of Open Access Journals (Sweden)

    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

  3. 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

  4. Scintigraphic calf perfusion symmetry after exercise and prediction of cardiovascular events: One stone to kill two birds?

    Energy Technology Data Exchange (ETDEWEB)

    Tellier, Philippe [Centre de Medecine Nucleaire de l' Artois, Clinique Sainte Catherine, 62 223 Sainte Catherine Les Arras (France)]. E-mail: phtellier2@wanadoo.fr; Lecouffe, Pascal [Centre de Medecine Nucleaire de l' Artois, Clinique Sainte Catherine, 62 223 Sainte Catherine Les Arras (France); Zureik, Mahmoud [National Institute of Health and Medical Research (INSERM), Unit 508, Institut Pasteur de Lille (France)

    2007-02-01

    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.

  5. Predictors of cardiovascular events in a contemporary population with impaired glucose tolerance : an observational analysis of the Nateglinide and Valsartan in impaired glucose tolerance outcomes research (NAVIGATOR) trial

    NARCIS (Netherlands)

    Preiss, David; Thomas, Laine E.; Sun, Jie-Lena; Haffner, Steven M.; Holman, Rury R.; Standl, Eberhard; Leiter, Lawrence A.; Mazzone, Theodore; Rutten, Guy E.; Tognoni, Gianni; Martinez, Felipe A.; Chiang, Fu-Tien; Califf, Robert M.; McMurray, John J.

    2012-01-01

    Objectives: Risk factors for cardiovascular events are well established in general populations and those with diabetes but have been sparsely studied in impaired glucose tolerance (IGT). We sought to identify predictors of (1) a composite cardiovascular outcome (cardiovascular death, non-fatal myoca

  6. 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

  7. 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.

  8. 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.

  9. 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

    -months, and the pADE incidence was 5.6 per 1000 person-months (1.1-10.1). The median ADE preventability rate was 21% (11-38%). The median incidence of ADEs requiring hospital admission was 0.45 (0.10-13.1) per 1000 person-months, and the median incidence of pADEs requiring hospital admission was 4.5 per 1000 person....../pADE incidence, (2) clinical outcomes, (3) associated drug groups, and/or (4) underlying medication errors were included. Study country, year and design, sample size, follow-up time, ADE/pADE identification method, proportion of ADEs/pADEs and ADEs/pADEs requiring hospital admission, and frequency distribution...... of adverse outcome, associated drug groups, or medication errors were extracted. DATA SYNTHESIS: Twenty-nine studies met inclusion criteria: 14 were ambulatory-based and 15 were hospital-based. Seven studies enrolled only elderly patients. The median ADE incidence was 14.9 (range 4.0-91.3) per 1000 person...

  10. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Science.gov (United States)

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  11. Statistical and Ontological Analysis of Adverse Events Associated with Monovalent and Combination Vaccines against Hepatitis A and B Diseases

    Science.gov (United States)

    Xie, Jiangan; Zhao, Lili; Zhou, Shangbo; He, Yongqun

    2016-01-01

    Vaccinations often induce various adverse events (AEs), and sometimes serious AEs (SAEs). While many vaccines are used in combination, the effects of vaccine-vaccine interactions (VVIs) on vaccine AEs are rarely studied. In this study, AE profiles induced by hepatitis A vaccine (Havrix), hepatitis B vaccine (Engerix-B), and hepatitis A and B combination vaccine (Twinrix) were studied using the VAERS data. From May 2001 to January 2015, VAERS recorded 941, 3,885, and 1,624 AE case reports where patients aged at least 18 years old were vaccinated with only Havrix, Engerix-B, and Twinrix, respectively. Using these data, our statistical analysis identified 46, 69, and 82 AEs significantly associated with Havrix, Engerix-B, and Twinrix, respectively. Based on the Ontology of Adverse Events (OAE) hierarchical classification, these AEs were enriched in the AEs related to behavioral and neurological conditions, immune system, and investigation results. Twenty-nine AEs were classified as SAEs and mainly related to immune conditions. Using a logistic regression model accompanied with MCMC sampling, 13 AEs (e.g., hepatosplenomegaly) were identified to result from VVI synergistic effects. Classifications of these 13 AEs using OAE and MedDRA hierarchies confirmed the advantages of the OAE-based method over MedDRA in AE term hierarchical analysis. PMID:27694888

  12. Left Atrial Volume as Predictor of Valve Replacement and Cardiovascular Events in Patients with Asymptomatic Mild to Moderate Aortic Stenosis

    DEFF Research Database (Denmark)

    Dalsgaard, Morten; Egstrup, Kenneth; Wachtell, Kristian;

    2013-01-01

    Left atrial (LA) size is known to increase with chronically increased left ventricular (LV) filling pressure. We hypothesized that LA volume was predictive of aortic valve replacement (AVR) and cardiovascular events in a large cohort of patients with asymptomatic mild to moderate aortic valve ste...

  13. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe;

    2010-01-01

    In the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, combined ezetimibe (10 mg) and simvastatin (40 mg) decreased low-density lipoprotein cholesterol levels by 50% and ischemic cardiovascular event (ICE) risk by 22% compared to placebo. A larger decrease in ICE risk might have been...

  14. Ankle-Brachial Index Is a Powerful Predictor of Renal Outcome and Cardiovascular Events in Patients with Chronic Kidney Disease

    Directory of Open Access Journals (Sweden)

    Fu-An Chen

    2012-01-01

    Full Text Available Ankle-brachial index (ABI is an accurate tool to diagnose peripheral arterial disease. The aim of this study was to evaluate whether ABI is also a good predictor of renal outcome and cardiovascular events in patients with chronic kidney disease (CKD. We enrolled 436 patients with stage 3–5 CKD who had not been undergoing dialysis. Patients were stratified into two groups according to the ABI value with a cut point of 0.9. The composite renal outcome, including doubling of serum creatinine level and commencement of dialysis, and the incidence of cardiovascular events were compared between the two groups. After a median follow-up period of 13 months, the lower ABI group had a poorer composite renal outcome (OR=2.719, P=0.015 and a higher incidence of cardiovascular events (OR=3.260, P=0.001. Our findings illustrated that ABI is a powerful predictor of cardiovascular events and renal outcome in patients with CKD.

  15. Milano summer particulate matter (PM10 triggers lung inflammation and extra pulmonary adverse events in mice.

    Directory of Open Access Journals (Sweden)

    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

  16. Thiazolidinediones and Cardiovascular Events In High-Risk Patients with Type-2 Diabetes Mellitus

    Science.gov (United States)

    Shaya, Fadia T.; Lu, Zhiqiang; Sohn, Kyongsei; Weir, Matthew R.

    2009-01-01

    Context. The use of thiazolidinediones (TZDs) in patients with type-2 diabetes mellitus appears to be associated with an increased risk of myocardial infarction (MI) compared with placebo or other oral antidiabetic drug regimens. Objective. We conducted a study to investigate whether there was a difference in the risk of acute MI and hemorrhagic and non-hemorrhagic stroke between specific TZDs, namely rosiglitazone maleate (Avandia) and pioglitazone (Actos), and other oral antidiabetic agents in a high-risk, largely underrepresented and largely minority Medicaid population. Study Design, Setting, and Patients. We analyzed patient encounter data using propensity-scoring methods and logistic regression to compare the risk of cardiovascular (CV) events in patients with type-2 diabetes in a high-risk population. Main Outcome Measures. Outcomes were identified through International Classification of Disease (ICD-9) codes 410–411 for acute MI; 430–438 for stroke; and revenue (emergency department) codes 450–459 in the case of MI. Results. Using retrospective medical encounter and prescription data analyses, we found that rosiglitazone, compared with other oral antidiabetic agents, was associated with an increased rate of CV events by 20% in a high-risk cohort of diabetic patients. Neither pioglitazone nor the TZD drug class as a whole was associated with an increased CV risk. Conclusion. Rosiglitazone was associated with a significant increase in CV events (MI and stroke) among high-risk patients with type-2 diabetes, whereas pioglitazone was not. We recommend further research to capture risk factors that were not observed in our encounter data. PMID:20140111

  17. Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

    Directory of Open Access Journals (Sweden)

    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

  18. 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...

  19. Syntax Score and Major Adverse Cardiac Events in Patients with Suspected Coronary Artery Disease: Results from a Cohort Study in a University-Affiliated Hospital in Southern Brazil

    Science.gov (United States)

    Fuchs, Felipe C.; Ribeiro, Jorge P.; Fuchs, Flávio D.; Wainstein, Marco V.; Bergoli, Luis C.; Wainstein, Rodrigo V.; Zen, Vanessa; Kerkhoff, Alessandra C.; Moreira, Leila B.; Fuchs, Sandra C.

    2016-01-01

    Background: The importance of coronary anatomy in predicting cardiovascular events is well known. The use of traditional anatomical scores in routine angiography, however, has not been incorporated to clinical practice. SYNTAX score (SXscore) is a scoring system that estimates the anatomical extent of coronary artery disease (CAD). Its ability to predict outcomes based on a baseline diagnostic angiography has not been tested to date. Objective: To evaluate the performance of the SXscore in predicting major adverse cardiac events (MACE) in patients referred for diagnostic angiography. Methods: Prospective cohort of 895 patients with suspected CAD referred for elective diagnostic coronary angiography from 2008 to 2011, at a university-affiliated hospital in Brazil. They had their SXscores calculated and were stratified in three categories: no significant CAD (n = 495), SXscoreLOW-INTERMEDIATE: < 23 (n = 346), and SXscoreHIGH: ≥ 23 (n = 54). Primary outcome was a composite of cardiac death, myocardial infarction, and late revascularization. Secondary endpoints were the components of MACE and death from any cause. Results: On average, patients were followed up for 1.8 ± 1.4 years. The primary outcome occurred in 2.2%, 15.3%, and 20.4% in groups with no significant CAD, SXscoreLOW-INTERMEDIATE, and SXscoreHIGH, respectively (p < 0.001). All-cause death was significantly higher in the SXscoreHIGH compared with the 'no significant CAD' group, 16.7% and 3.8% (p < 0.001), respectively. After adjustment for confounding factors, all outcomes remained associated with the SXscore. Conclusions: SXscore independently predicts MACE in patients submitted to diagnostic coronary angiography. Its routine use in this setting could identify patients with worse prognosis. PMID:27509092

  20. Can exercise capacity assessed by the 6 minute walk test predict the development of major adverse cardiac events in patients with STEMI after fibrinolysis?

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    Ayman K M Hassan

    Full Text Available BACKGROUND: To assess the added value of the 6 minute walk test distance (6MWTD in the risk-stratification methods for patients with ST -segment elevation myocardial infarction (STEMI treated with fibrinolysis. METHODOLOGY/PRINCIPAL FINDINGS: This is a prospective cohort study of one hundred consecutive patients with STEMI, who had received fibrinolysis, at Assuit University Hospital. All patients underwent 6MWT pre- discharge and were followed up for 3 months to monitor the incidence of major adverse cardiac events (MACE. Patients were divided into 3 groups according to the level of 6MWTD (level I>450 m, level II = 300-450 m and level III450 m, patients in level III (<300 m were more likely to have clinical risk factors as hypertension, diabetes and impaired renal function. The patient's mean TIMI score was 3.4±2.2, the mean GRACE score was 150.5±27.7. There was a significant negative correlation between the 6 MWTD and GRACE risk score (r = -0.80, p<0.001. At 3 months of follow-up, 51% had MACE including 16% were dead. Multivariate logistic regression analysis identified that the GRACE risk score and 6MWT distance levels were the best predictors of the MACE at 3 month of follow up. The incidence of MACE was 4 times higher in patients with high GRACE risk score who couldn't walk more than 300 meters (OR = 4.66, 95% CI = 1.1-14.5, p = 0.006. CONCLUSIONS/SIGNIFICANCE: In patients with STEMI treated with fibrinolysis, the addition of 6MWTD assessment pre-discharge to the traditional GRACE risk score improved the risk prediction of cardiovascular events at 3 month follow up.