Abstract:
PURPOSE:Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS:The study was performed in three US managed care organizations and a US national health plan with chart access and complete electronic pharmacy data, with a covered population of 13.9 million. There were 47 cases of possible or definite CSS and 4700 asthma drug user controls identified between January 1, 1995 and December 31, 2002. We examined exposure to asthma drugs in cases and controls, including leukotriene modifiers (6 cases and 202 controls), in the two to 6 months prior to the onset of adjudicated CSS. RESULTS:While the crude association between use of leukotriene modifiers and CSS was strong (odds ratio (OR) 4.00, 95% confidence interval (CI): 1.49-10.60), in a multivariable analysis controlling for use of oral corticosteroids, inhaled corticosteroids, and number of categories of asthma drugs dispensed, there was no significant association (OR 1.32, 95% CI: 0.44-3.96). Use of inhaled and oral corticosteroids, evaluated as markers of asthma severity, were associated with CSS (OR 3.07, 95% CI: 1.34-7.03 and OR 5.36, 95% CI: 2.51-11.45, respectively). CONCLUSIONS:No association was found between CSS and leukotriene modifiers after controlling for asthma drug use However, it is not possible to rule out modest associations with asthma treatments given CSS is so rare and so highly correlated with asthma severity, suggesting further investigation is warranted.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Harrold LR,Patterson MK,Andrade SE,Dube T,Go AS,Buist AS,Chan KA,Weller PF,Wechsler ME,Yood RA,Davis KJ,Platt R,Walker AMdoi
10.1002/pds.1353subject
Has Abstractpub_date
2007-06-01 00:00:00pages
620-6issue
6eissn
1053-8569issn
1099-1557journal_volume
16pub_type
杂志文章abstract:PURPOSE:Proton pump inhibitor (PPI) may suppress adrenal cortical steroid synthesis and release, thereby leading to electrolyte disturbances. Both hyponatremia and hyperkalemia in the setting of PPI therapy have been documented in case reports. The objective of this study was to examine the association between serum po...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1795
更新日期:2009-09-01 00:00:00
abstract:PURPOSE:To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France. METHODS:A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1002/pds.3471
更新日期:2013-09-01 00:00:00
abstract:PURPOSE:To compare birth outcomes between women exposed and unexposed to the antiviral medications oseltamivir or zanamivir during pregnancy. METHODS:This was an observational cohort study including women who gave birth to singletons in Sweden 2005-2007 and their infants. We obtained information from the national heal...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2194
更新日期:2011-10-01 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:BACKGROUND:Current guidelines for the empiric treatment of uncomplicated urinary tract infection in women recommend that first-line trimethoprim-sulfamethoxazole (TMP-SMX) or ofloxacin be given for 3 days and nitrofurantoin for 5 days. Increasing the duration of treatment raises costs, and perhaps, the incidence of adv...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.862
更新日期:2004-04-01 00:00:00
abstract:PURPOSE:This paper introduces an improved tool for designing matched-pairs randomized trials. The tool allows the incorporation of clinical and other knowledge regarding the relative importance of variables used in matching and allows for multiple types of missing data. The method is illustrated in the context of a clu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3260
更新日期:2012-05-01 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:BACKGROUND AND AIMS:Epidemiologic studies on a potential chemopreventive effect of statin therapy have yielded conflicting results. We sought to clarify whether long-term statin therapy has a chemopreventive effect on the risk of colorectal cancer (CRC) in a large, population-representative cohort. METHODS:A nested ca...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1599
更新日期:2008-09-01 00:00:00
abstract:INTRODUCTION:The analgesic metamizole (dipyrone) is not recommended during pregnancy due to limited experience. In several countries, metamizole has no market authorization because of agranulocytosis as a rare but severe adverse effect. However, in others, metamizole is available and widely used as a pain reliever, and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4277
更新日期:2017-10-01 00:00:00
abstract:PURPOSE:Medicaid programs are concerned about inappropriate, potentially hazardous, and costly off-label use of second-generation antipsychotics (SGAs). Several states are exploring policies aimed at managing low-dose quetiapine, commonly prescribed for off-label conditions. This study aimed to characterize longitudina...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3538
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:Cause of death is often not available in administrative claims data. OBJECTIVE:To develop claims-based algorithms to identify deaths due to fatal cardiovascular disease (CVD; ie, fatal coronary heart disease [CHD] or stroke), CHD, and stroke. METHODS:Reasons for Geographic and Racial Differences in Stroke ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4421
更新日期:2018-07-01 00:00:00
abstract:PURPOSE:Clinical trials of olmesartan for prevention of progression of renal disease in patients with diabetes showed renal protection but an unexpected imbalance in cardiac deaths. The US Food and Drug Administration requested from the manufacturer a cohort study of olmesartan, other angiotensin-receptor blockers (ARB...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3558
更新日期:2014-04-01 00:00:00
abstract:PURPOSE:We conducted a nested case-control study to evaluate the association between risk of cancer and mirtazapine use in depression patients in Taiwan. METHODS:We obtained data from the Taiwan National Health Insurance Research Database to conduct a population-based nested case-control study. The study cohort includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3523
更新日期:2013-12-01 00:00:00
abstract:BACKGROUND:Recent evidence suggested that oral form of domperidone may possess pro-arrhythmic effects and increase the risk of ventricular arrhythmia. The concomitant use of cytochrome P450 (CYP) 3A4 isoenzyme inhibitors may further potentiate this association. Nevertheless, empirical data supporting these associations...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3814
更新日期:2015-08-01 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:OBJECTIVE:To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates. METHODS:A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health for antidepressants and lithium was carried out for the period ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1944
更新日期:2010-09-01 00:00:00
abstract:PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2155
更新日期:2011-07-01 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:The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS:Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate an...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3928
更新日期:2016-03-01 00:00:00
abstract:PURPOSE:Administrative claim databases are increasingly being used to study the safety of medication exposures during pregnancy. These studies are restricted to live births due to a reliance on algorithms for estimating gestational age that are based on codes associated with live delivery. Conditioning on live birth ma...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4387
更新日期:2018-03-01 00:00:00
abstract:PURPOSE:Ejection fraction (EF) is crucial information when studying the use and effectiveness of therapies in patients with heart failure (HF) and myocardial infarction (MI). We aimed to assess the validity of claims data-based definitions of systolic dysfunction (SD). METHODS:We identified 1072 patients with EF recor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2146
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:To describe published validation studies of administrative health care claims data in the Asia-Pacific region. METHODS:A comprehensive literature search was conducted in PubMed for English language articles published through 31-Oct-2017 in humans from 10 Asian-Pacific countries or regions (Japan, Australia, Ne...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4616
更新日期:2019-02-01 00:00:00
abstract:PURPOSE:To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS:We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of intere...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4285
更新日期:2017-10-01 00:00:00
abstract::Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199709/10)6:5<347::AID-PDS
更新日期:1997-09-01 00:00:00
abstract:PURPOSE:PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. METHODS:We adapted e...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4718
更新日期:2019-05-01 00:00:00
abstract:PURPOSE:To develop and test an algorithm that translates total dose and daily regimen, inputted as 'free text' on a prescription, into numerical values to calculate the prescribed treatment duration. METHOD:The algorithm was developed using antibiotic prescriptions (n = 711,714) from multiple primary care computer sys...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2012
更新日期:2010-09-01 00:00:00
abstract:PURPOSE:A recent regulatory warning and case reports have described the development of muscle complications with the use of 5-α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. METHODS:We used a matched cohort design and linked administrative data from the...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4383
更新日期:2018-03-01 00:00:00
abstract:PURPOSE:To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS:We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empiri...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3480
更新日期:2013-09-01 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:OBJECTIVE:To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN:Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS:There were 56.8 million prescriptions for oral contrace...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199605)5:3<141::AID-PDS221
更新日期:1996-05-01 00:00:00