Abstract:
PURPOSE:Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identify values inferred from a population that predict a stronger potential for TdP. METHODS:Prolongation data of 30 non-antiarrhythmic QT prolonging drugs were analysed. Depending on how strong the drugs were associated with TdP, they were categorized as strong or borderline torsadogens. The differences in mean QTc increases between the two groups were compared and cut-off values that distinguished strong from borderline drugs were searched for. RESULTS:The average QTc increase of 19.3 millisecond of strong torsadogens was significantly greater than the 8.0 millisecond of borderline torsadogens. Prolongation greater than 12 millisecond in the context of monotherapy or 25 millisecond in the presence of metabolic inhibition and an upper bound of 95% confidence interval (CI) for the mean QTc increase greater than 14 millisecond in monotherapy or 30.1 millisecond in combination therapy with metabolic inhibitors favoured a stronger association with TdP. CONCLUSIONS:Drugs strongly associated with TdP have greater QTc increases than those with less concern. Several cut-off values have been noted to distinguish between them. These values may be helpful for evaluation of TdP risk for future QT prolonging drugs.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Lin YL,Kung MFdoi
10.1002/pds.1707subject
Has Abstractpub_date
2009-03-01 00:00:00pages
235-9issue
3eissn
1053-8569issn
1099-1557journal_volume
18pub_type
杂志文章abstract:PURPOSE:We discuss the practical advantages and challenges of sharing controls among two or more concurrently conducted case-control studies. METHODS:We conducted two case-control studies, one of breast cancer and the other of endometrial cancer, with overlapping, shared control groups. The studies had overlapping geo...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1130
更新日期:2005-08-01 00:00:00
abstract:PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1328
更新日期:2007-01-01 00:00:00
abstract:PURPOSE:Longitudinal data on prescriptions of antidepressants (AD) in children and adolescents depression are scarce. This study aimed to examine AD prescription trends in children and adolescents in Germany. METHODS:Data of a large statutory health insurance company were analyzed for the period 2005-2012, and outpati...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 历史文章,杂志文章
doi:10.1002/pds.3649
更新日期:2014-12-01 00:00:00
abstract::Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial inf...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199707)6:4<283::AID-PDS270
更新日期:1997-07-01 00:00:00
abstract:PURPOSE:To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1991
更新日期:2010-09-01 00:00:00
abstract:PURPOSE:To examine the association between the use of psychotropic drugs and fatal pulmonary embolism. METHODS:We conducted a national case-control study of fatal pulmonary embolism. Cases were 75 New Zealand men and women aged 15-59 years who died between 1 January 1990 and 31 December 1998, where the underlying caus...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.841
更新日期:2003-12-01 00:00:00
abstract::Purpose - The objective of this study was an evaluation of the sensitivity of findings of the relationship between oral corticosteroid use and the risk of fracture. We found in earlier work that the risk of fracture was significantly higher during oral corticosteroid treatment, with increases of 61% in hip and 160% in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/1099-1557(200009/10)9:5<359::AID-PDS507>3.
更新日期:2000-09-01 00:00:00
abstract:BACKGROUND:High-grade cervical dysplasia or cervical intraepithelial neoplasia grade 2 or worse has been widely used as a surrogate endpoint in cervical cancer screening or prevention trials. METHODS:To identify high-grade cervical dysplasia and cervical cancer, we developed claims-based algorithms that incorporated a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3520
更新日期:2013-11-01 00:00:00
abstract:PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5188
更新日期:2020-12-27 00:00:00
abstract:BACKGROUND:Laboratory technicians, laboratory supervisors, decontamination/remediation workers, and environmental investigators are at increased risk for repeated occupational exposure to Bacillus anthracis. In 2002, the Advisory Committee on Immunization Practices (ACIP) recommended pre-exposure vaccination for these ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1302
更新日期:2006-12-01 00:00:00
abstract:PURPOSE:Breast cancer is the most common cancer in women worldwide. We attempted to investigate the association between the risk of breast cancer and use of captopril and other antihypertensive medication. METHODS:We performed a cohort study with a nested case-control analysis using the General Practitioner Research D...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.910
更新日期:2004-08-01 00:00:00
abstract:PURPOSE:Multimorbidity (MM) (presence of more than one chronic condition within a same patient) imposes a heavy burden on patients and health care systems. In contrast to high-income countries, the epidemiology of this phenomenon is unclear in low- and middle-income countries, particularly among Iranian population. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4925
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:To evaluate whether the risk of coronary heart disease (CHD) differs among adult diabetic patients treated with thiazolidinediones (TZDs) and similar patients treated with combined oral metformin and sulfonylurea (M + S) therapy. METHODS:We conducted a retrospective cohort study involving 25 140 diabetic patie...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1356
更新日期:2007-05-01 00:00:00
abstract:PURPOSE:Concomitant use of anti-dementia drugs with psychotropic drugs is potentially problematic in patients with dementia. The aim of this study was to investigate how frequently patients in Norway use anti-dementia drugs concomitantly with psychotropic drugs. METHODS:Analyses are based on data from the Norwegian Pr...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2211
更新日期:2011-12-01 00:00:00
abstract:PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2030
更新日期:2010-11-01 00:00:00
abstract:PURPOSE:Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. METHODS:A MEDLINE search of English language literature was performed to identify studies published between Janua...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1230
更新日期:2006-08-01 00:00:00
abstract:OBJECTIVE:Outcome misclassification may occur in observational studies using administrative databases. We evaluated a two-step multiple imputation approach based on complementary internal validation data obtained from two subsamples of study participants to reduce bias in hazard ratio (HR) estimates in Cox regressions....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4223
更新日期:2017-08-01 00:00:00
abstract:PURPOSE:Our study addresses how the information in the labels differed between United States (US) and Japan, what factors were associated with the decision to place the boxed warning on the label, and the relation of both countries in terms of drug label policy. METHODS:We investigated adverse drug reactions (ADRs) in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4111
更新日期:2017-02-01 00:00:00
abstract:PURPOSE:Complex medication management in older people with multiple chronic conditions can introduce practice variation in polypharmacy prevalence. This study aimed to determine the inter-practice variation in polypharmacy prevalence and examine how this variation was influenced by patient and practice characteristics....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4016
更新日期:2016-09-01 00:00:00
abstract:PURPOSES:The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4991
更新日期:2020-09-01 00:00:00
abstract:PURPOSE:To optimize the efficiency of signal detection by maximizing the proportion of true positive (TP) signals among signals detected by a disproportionality algorithm. METHODS:We compared 176 different combinations of stratification factors, sex (S), age (A), region (R) and year of report (Y), and cut-off values o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3392
更新日期:2013-05-01 00:00:00
abstract:PURPOSE:This study aimed to examine the effect of antidepressant use on persistence with newly initiated oral antidiabetic medicines in older people. METHODS:A retrospective study of administrative claims data from the Australian Government Department of Veterans' Affairs, from 1 July 2000 to 30 June 2008 of new users...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3424
更新日期:2013-06-01 00:00:00
abstract:PURPOSE:Residual confounding is a potential limitation of pharmacoepidemiologic studies, and in particular, studies based on administrative claims data that do not capture lifestyle and clinical confounders. We describe an application of the case-cohort design to assess residual confounding by thromboembolic risk facto...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1554
更新日期:2008-03-01 00:00:00
abstract:PURPOSE:In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out. METHODS:A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monoth...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.554
更新日期:2000-12-01 00:00:00
abstract:BACKGROUND:Various strategies have been studied in the literature to address the significant underreporting of adverse drug reactions (ADRs) in healthcare systems worldwide. OBJECTIVES:We conducted a systematic review of the literature that assessed the impact of various strategies to improve ADR reporting published i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4906
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:To determine patterns of United Arab Emirates (UAE) citizen herbal medicine taking. METHODS:Questionnaire survey of UAE citizens attending a primary healthcare clinic in Abu Dhabi. RESULTS:Three hundred and thirty surveys were analysed. Seventy-six per cent (250/330) had previously used herbal products, and o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1591
更新日期:2008-07-01 00:00:00
abstract:PURPOSE:We review statistical methods for assessing the possible impact of bias due to unmeasured confounding in real world data analysis and provide detailed recommendations for choosing among the methods. METHODS:By updating an earlier systematic review, we summarize modern statistical best practices for evaluating ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.5117
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailored to the different roles and responsibilities of the various st...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1153
更新日期:2006-03-01 00:00:00
abstract:PURPOSE:UK primary care databases are frequently used in observational studies with cancer outcomes. We aimed to systematically review methods used by such studies to identify and validate incident cancers of the breast, colorectum, and prostate. METHODS:Medline and Embase (1980-2013) were searched for UK primary care...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3729
更新日期:2015-01-01 00:00:00
abstract:PURPOSE:We aimed to describe time-trends in the use of NOACs among a group of ambulatory patients with nonvalvular atrial fibrillation (NVAF) in Colombia and to describe treatment patterns and user characteristics. METHODS:Using the Audifarma S.A administrative healthcare database in Colombia, we identified 10 528 pat...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5124
更新日期:2020-10-15 00:00:00