Adverse drug reaction patterns of GLP-1 receptor agonists approved for obesity treatment: Disproportionality analysis from global pharmacovigilance database

IF 5.7 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2025-04-02 DOI:10.1111/dom.16376

Tae Hyeon Kim MD, Kyeongmin Lee MS, Seoyoung Park MS, Jiyeon Oh MD, Jaeyu Park PhD, Hyesu Jo MS, Hayeon Lee PhD, Jaehyeong Cho MD, Xuerong Wen PhD, Hanseul Cho MD, Sunyoung Kim MD, Dong Keon Yon MD

{"title":"Adverse drug reaction patterns of GLP-1 receptor agonists approved for obesity treatment: Disproportionality analysis from global pharmacovigilance database","authors":"Tae Hyeon Kim MD, Kyeongmin Lee MS, Seoyoung Park MS, Jiyeon Oh MD, Jaeyu Park PhD, Hyesu Jo MS, Hayeon Lee PhD, Jaehyeong Cho MD, Xuerong Wen PhD, Hanseul Cho MD, Sunyoung Kim MD, Dong Keon Yon MD","doi":"10.1111/dom.16376","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>This study aims to compare adverse drug reaction patterns of liraglutide, semaglutide and tirzepatide—glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for anti-obesity medications—to evaluate their real-world safety.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>This disproportionality analysis utilized a case–control design with VigiBase. The study focused on reports of adverse events associated with liraglutide, semaglutide and tirzepatide, selected based on warnings in the US Food and Drug Administration approval labels for each drug. Data were restructured using unique identifiers to differentiate individuals affected by adverse drug reactions. Multivariable logistic regression models estimated adjusted reporting odds ratios (aRORs) with 95% confidence intervals (CIs) to assess the association between various adverse events and GLP-1 RAs, adjusting for age, sex, region, reporter qualification, reporting year and concomitant medication. The information component (IC) was analysed, and signals of adverse drug reactions were considered significant only when both aROR and IC were statistically significant.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Our analysis of targeted adverse drug reactions included 24 725 individuals using liraglutide, 21 454 using semaglutide and 11 538 using tirzepatide. Tirzepatide had fewer reports of adverse drug reactions compared with the other two drugs, and its pharmacovigilance association strength was the lowest. Semaglutide, however, was significantly associated with several unusual adverse events, including suicidal ideation and behaviour (IC, 1.53 [IC<sub>025</sub>, 1.28]; aROR, 2.52 [95% CI, 2.18–2.93]), hair loss (IC, 0.78 [IC<sub>025</sub>, 0.63]; aROR, 1.42 [95% CI, 1.30–1.55]) and vision loss (IC, 1.27 [IC<sub>025</sub>, 1.13]; aROR, 1.80 [95% CI, 1.66–1.97]).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Our findings emphasize the need for cautious prescribing and further research to ensure the safe use of these medications.</p>\n </section>\n </div>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":"27 6","pages":"3490-3502"},"PeriodicalIF":5.7000,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes, Obesity & Metabolism","FirstCategoryId":"3","ListUrlMain":"https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16376","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Aims

This study aims to compare adverse drug reaction patterns of liraglutide, semaglutide and tirzepatide—glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for anti-obesity medications—to evaluate their real-world safety.

Materials and Methods

This disproportionality analysis utilized a case–control design with VigiBase. The study focused on reports of adverse events associated with liraglutide, semaglutide and tirzepatide, selected based on warnings in the US Food and Drug Administration approval labels for each drug. Data were restructured using unique identifiers to differentiate individuals affected by adverse drug reactions. Multivariable logistic regression models estimated adjusted reporting odds ratios (aRORs) with 95% confidence intervals (CIs) to assess the association between various adverse events and GLP-1 RAs, adjusting for age, sex, region, reporter qualification, reporting year and concomitant medication. The information component (IC) was analysed, and signals of adverse drug reactions were considered significant only when both aROR and IC were statistically significant.

Results

Our analysis of targeted adverse drug reactions included 24 725 individuals using liraglutide, 21 454 using semaglutide and 11 538 using tirzepatide. Tirzepatide had fewer reports of adverse drug reactions compared with the other two drugs, and its pharmacovigilance association strength was the lowest. Semaglutide, however, was significantly associated with several unusual adverse events, including suicidal ideation and behaviour (IC, 1.53 [IC₀₂₅, 1.28]; aROR, 2.52 [95% CI, 2.18–2.93]), hair loss (IC, 0.78 [IC₀₂₅, 0.63]; aROR, 1.42 [95% CI, 1.30–1.55]) and vision loss (IC, 1.27 [IC₀₂₅, 1.13]; aROR, 1.80 [95% CI, 1.66–1.97]).

Conclusions

Our findings emphasize the need for cautious prescribing and further research to ensure the safe use of these medications.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

批准用于肥胖治疗的GLP-1受体激动剂的不良反应模式：来自全球药物警戒数据库的歧化分析

目的：本研究旨在比较利拉鲁肽、西马鲁肽和替西帕肽-胰高血糖素样肽-1受体激动剂（GLP-1 RAs）被批准用于抗肥胖药物的不良反应模式，以评估其实际安全性。材料和方法：歧化分析采用VigiBase的病例对照设计。这项研究的重点是利拉鲁肽、西马鲁肽和替西帕肽相关的不良事件报告，这些报告是根据美国食品和药物管理局（fda）每种药物批准标签上的警告来选择的。数据使用唯一标识符进行重组，以区分受药物不良反应影响的个体。多变量logistic回归模型估计调整后的报告优势比（aRORs）， 95%置信区间（CIs），以评估各种不良事件与GLP-1 RAs之间的关系，调整年龄、性别、地区、报告资格、报告年份和伴随用药。分析信息成分（IC），只有当aROR和IC均具有统计学意义时，才认为药物不良反应信号显著。结果：我们的药物不良反应分析包括利拉鲁肽24 725例，西马鲁肽21 454例，替西帕肽11 538例。与其他两种药物相比，替西帕肽的药物不良反应报告较少，其药物警戒关联强度最低。然而，Semaglutide与一些不寻常的不良事件显著相关，包括自杀意念和行为(IC, 1.53 [IC025, 1.28]；aROR, 2.52 [95% CI, 2.18-2.93])，脱发(IC, 0.78 [IC025, 0.63]；aROR, 1.42 [95% CI, 1.30-1.55])和视力丧失(IC, 1.27 [IC025, 1.13]；aROR, 1.80 [95% CI, 1.66-1.97])。结论：我们的研究结果强调需要谨慎的处方和进一步的研究，以确保这些药物的安全使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.