Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2025-01-27 DOI:10.1007/s40264-024-01512-7
Saad Hanif Abbasi, Lars Christian Lund, Jesper Hallas, Anton Pottegård
{"title":"Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example.","authors":"Saad Hanif Abbasi, Lars Christian Lund, Jesper Hallas, Anton Pottegård","doi":"10.1007/s40264-024-01512-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Large administrative healthcare databases can be used for near real-time sequential safety surveillance of drugs as an alternative approach to traditional reporting-based pharmacovigilance. The study aims to build and empirically test a prospective drug safety monitoring setup and perform a sequential safety monitoring of rofecoxib use and risk of cardiovascular outcomes.</p><p><strong>Methods: </strong>We used Danish population-based health registers and performed sequential analysis of rofecoxib use and cardiovascular outcomes using case-time-control and cohort study designs from January 2000 to September 2004. Each monitoring period added 6 months of data until the end of the study period. In the case-time-control study, incident cases of myocardial infarction (MI) and ischemic stroke were identified and matched with up to five time controls on age, sex, and calendar time. Exposure status on the date of diagnosis was assessed using a 60-day focal window, with reference windows 120, 180, and 240 days prior to the diagnoses. In the cohort study, incident users of rofecoxib were matched up to 1:4 with ibuprofen users (active comparators) using high-dimensional disease risk scores and were followed for 60 days.</p><p><strong>Results: </strong>The earliest association between rofecoxib use and the risk of MI was seen in study period 2 for case-time-control design (OR 1.42, 95% CI 1.04-1.93) and in study period 7 for the cohort study design (RR 1.22; 95% CI 1.02-1.47).</p><p><strong>Conclusions: </strong>Our prospective drug safety monitoring setup showed that the risk of MI could have been detected 3.5 years before the ultimate market withdrawal of rofecoxib. However, further research is needed to validate this approach.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40264-024-01512-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Large administrative healthcare databases can be used for near real-time sequential safety surveillance of drugs as an alternative approach to traditional reporting-based pharmacovigilance. The study aims to build and empirically test a prospective drug safety monitoring setup and perform a sequential safety monitoring of rofecoxib use and risk of cardiovascular outcomes.

Methods: We used Danish population-based health registers and performed sequential analysis of rofecoxib use and cardiovascular outcomes using case-time-control and cohort study designs from January 2000 to September 2004. Each monitoring period added 6 months of data until the end of the study period. In the case-time-control study, incident cases of myocardial infarction (MI) and ischemic stroke were identified and matched with up to five time controls on age, sex, and calendar time. Exposure status on the date of diagnosis was assessed using a 60-day focal window, with reference windows 120, 180, and 240 days prior to the diagnoses. In the cohort study, incident users of rofecoxib were matched up to 1:4 with ibuprofen users (active comparators) using high-dimensional disease risk scores and were followed for 60 days.

Results: The earliest association between rofecoxib use and the risk of MI was seen in study period 2 for case-time-control design (OR 1.42, 95% CI 1.04-1.93) and in study period 7 for the cohort study design (RR 1.22; 95% CI 1.02-1.47).

Conclusions: Our prospective drug safety monitoring setup showed that the risk of MI could have been detected 3.5 years before the ultimate market withdrawal of rofecoxib. However, further research is needed to validate this approach.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
求助全文
约1分钟内获得全文 去求助
来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
期刊最新文献
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database. Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study. Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database. Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments. Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS).
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1