{"title":"Risk of New-Onset Atrial Fibrillation in Opioid Users: A Systematic Review and Meta-Analysis on 24,006,367 Participants.","authors":"Danilo Menichelli, Gianluca Gazzaniga, Arianna Pannunzio, Ilaria Maria Palumbo, Arianna Pani, Pasquale Pignatelli, Emanuele Valeriani, Daniele Pastori","doi":"10.1007/s40264-025-01555-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Despite ongoing efforts, the prescription of opioids is still common. Long-term opioid use has been associated with an increased risk of adverse cardiovascular outcomes.</p><p><strong>Objective: </strong>We aimed to evaluate the association between opioid use and the risk of new-onset atrial fibrillation.</p><p><strong>Methods: </strong>We performed a systematic review and meta-analysis of studies retrieved from MEDLINE and EMBASE databases according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines from inception to 29 January, 2024. The protocol was registered at PROSPERO (CRD42024512500). Two authors independently screened and extracted data from included studies. The quantitative analysis included only observational studies and results were synthesised by a pooled hazard ratio. Risk of bias was performed according to the ROBINS-I Cochrane tool, and the summary of evidence according to GRADE (Grading of Recommendations, Assessment, Development and Evaluations).</p><p><strong>Results: </strong>Four out of 782 studies met the inclusion criteria for a quantitative analysis with 24,006,367 participants. Overall, 153,734 were opioid users. The proportion of women ranged from 13.2 to 100% and the median age ranged from 34 to 65 years. Studies reported 991,263 cases of new-onset atrial fibrillation. The pooled analysis showed a significant association between use of opioids and new-onset atrial fibrillation (hazard ratio 1.96, 95% confidence interval 1.43-2.69 with high heterogeneity). A sensitivity analysis by removing the study with the largest cohort showed similar results to the main analysis. In the summary of findings, the certainty of the evidence according to GRADE was moderate.</p><p><strong>Conclusions: </strong>We found a significant association between opioid use and the risk of new-onset atrial fibrillation. When prescribing opioids, the risk of new-onset atrial fibrillation should be considered, especially in the presence of other risk factors for atrial fibrillation.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-05-18","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/s40264-025-01555-4","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
Background: Despite ongoing efforts, the prescription of opioids is still common. Long-term opioid use has been associated with an increased risk of adverse cardiovascular outcomes.
Objective: We aimed to evaluate the association between opioid use and the risk of new-onset atrial fibrillation.
Methods: We performed a systematic review and meta-analysis of studies retrieved from MEDLINE and EMBASE databases according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines from inception to 29 January, 2024. The protocol was registered at PROSPERO (CRD42024512500). Two authors independently screened and extracted data from included studies. The quantitative analysis included only observational studies and results were synthesised by a pooled hazard ratio. Risk of bias was performed according to the ROBINS-I Cochrane tool, and the summary of evidence according to GRADE (Grading of Recommendations, Assessment, Development and Evaluations).
Results: Four out of 782 studies met the inclusion criteria for a quantitative analysis with 24,006,367 participants. Overall, 153,734 were opioid users. The proportion of women ranged from 13.2 to 100% and the median age ranged from 34 to 65 years. Studies reported 991,263 cases of new-onset atrial fibrillation. The pooled analysis showed a significant association between use of opioids and new-onset atrial fibrillation (hazard ratio 1.96, 95% confidence interval 1.43-2.69 with high heterogeneity). A sensitivity analysis by removing the study with the largest cohort showed similar results to the main analysis. In the summary of findings, the certainty of the evidence according to GRADE was moderate.
Conclusions: We found a significant association between opioid use and the risk of new-onset atrial fibrillation. When prescribing opioids, the risk of new-onset atrial fibrillation should be considered, especially in the presence of other risk factors for atrial fibrillation.
背景:尽管不断努力,阿片类药物的处方仍然很普遍。长期使用阿片类药物与心血管不良后果的风险增加有关。目的:我们旨在评估阿片类药物使用与新发心房颤动风险之间的关系。方法:我们根据PRISMA(首选系统评价和meta分析报告项目)指南,对从MEDLINE和EMBASE数据库检索的研究进行了系统评价和荟萃分析,时间为2024年1月29日。该协议在PROSPERO注册(CRD42024512500)。两位作者从纳入的研究中独立筛选和提取数据。定量分析仅包括观察性研究,结果由合并风险比综合得出。偏倚风险评估采用ROBINS-I Cochrane工具,证据总结采用GRADE (Grading of Recommendations, Assessment, Development and evaluation)。结果:782项研究中有4项符合定量分析的纳入标准,共有24,006,367名参与者。总体而言,153,734人是阿片类药物使用者。女性比例为13.2 ~ 100%,中位年龄为34 ~ 65岁。研究报告了991,263例新发心房颤动。合并分析显示阿片类药物使用与新发房颤之间存在显著关联(风险比1.96,95%置信区间1.43-2.69,异质性高)。通过删除最大队列的研究进行敏感性分析,结果与主要分析相似。在研究结果总结中,根据GRADE,证据的确定性为中等。结论:我们发现阿片类药物使用与新发房颤风险之间存在显著关联。当处方阿片类药物时,应考虑新发房颤的风险,特别是在房颤存在其他危险因素的情况下。
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.