替扎帕肽的安全性概况：对 EudraVigilance 数据库的实际药物警戒分析

IF 2.3 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Clinical Epidemiology and Global Health Pub Date : 2024-11-01 DOI:10.1016/j.cegh.2024.101805

Atul Khurana , Syed Arman Rabbani , Mohamed El-Tanani , Mandeep Kumar Arora , Shrestha Sharma , Harikesh Dubey , Alaa A. Aljabali , Murtaza M. Tambuwala

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引用次数: 0

摘要

背景与现有的 GLP-1 受体激动剂相比，替扎帕肽在控制血糖和减轻体重方面表现出更优越的疗效。然而，在现实世界中，其安全性仍有待充分阐明。本研究利用 EudraVigilance 数据库对其安全性进行了研究。方法我们利用 EudraVigilance 数据库对以替扎帕肽为可疑药物的单个病例安全报告 (ICSR) 进行了药物警戒分析。我们进行了描述性分析，以探讨这些 ICSR 的特征。结果我们评估了 2102 例以替瑞帕肽为可疑药物的 ICSR。大多数 ICSR 由医护人员报告（1299 例，占 61.8%）。共报告了 5774 例与替哌肽相关的不良反应，其中大多数被归类为严重不良反应（4914 例，占 85.1%）。大多数 AEs（2754 例，占 47.7%）的结果报告为未知，而 30.9%（1784 例）的结果报告为已恢复/解决。与 "胃肠功能紊乱 "SOC（1873 例，32.4%）相关的 AE 报告最多，其次是与 "损伤、中毒和手术并发症 "SOC（641 例）相关的 AE。胰腺炎（363 例）和呕吐（274 例）是最常报告的 AE。比例失调分析表明，与塞马鲁肽、度拉鲁肽、利拉鲁肽和艾塞那肽相比，替扎帕肽的胃肠道 AE 报告频率更高（ROR：1.35，95 % CI：1.47-1.23；PRR：1.16，95 % CI：1.26-1.06）。该研究强调了持续监测的必要性，特别是考虑到替哌肽刚上市不久。

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Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database

Background

Tirzepatide has demonstrated superior efficacy in glycemic control and weight reduction compared to existing GLP-1 receptor agonists. However, its safety profile remains to be fully elucidated in real-world settings. This study examines its safety profile using the EudraVigilance database.

Methods

We conducted a pharmacovigilance analysis of individual case safety reports (ICSRs) with tirzepatide as the suspected drug using EudraVigilance database. A descriptive analysis was carried out to explore the characteristics of these ICSRs. Disproportionality analysis was performed using reporting odds ratio (ROR) and proportional reporting ratio (PRR) metrics.

Results

We evaluated 2102 ICSRs where tirzepatide was implicated as the suspected drug. Majority of the ICSRs were reported by healthcare professionals (1299, 61.8 %). A total of 5774 AEs associated with tirzepatide were reported with majority being classified as serious (4914, 85.1 %). The outcome for most AEs (47.7 %, 2754 AEs) was reported as unknown, whereas 30.9 % (1784 AEs) were reported as recovered/resolved. AEs associated with the ‘Gastrointestinal Disorders’ SOC (1873, 32.4 %) were the most frequently reported, followed by those related to ‘Injury, poisoning and procedural complications’ SOC (641 AEs). Pancreatitis (363) and vomiting (274) emerged as the most commonly reported AEs. The disproportionality analysis indicated a higher reporting frequency of gastrointestinal AEs for tirzepatide (ROR: 1.35, 95 % CI: 1.47-1.23; PRR: 1.16, 95 % CI: 1.26-1.06) compared to semaglutide, dulaglutide, liraglutide and exenatide.

Conclusion

This study underscores tirzepatide's safety profile in real-world settings. It highlights the need for ongoing monitoring, especially considering tirzepatide's recent introduction to the market.

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来源期刊

Clinical Epidemiology and Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

4.60

自引率

7.70%

发文量

218

审稿时长

66 days

期刊介绍： Clinical Epidemiology and Global Health (CEGH) is a multidisciplinary journal and it is published four times (March, June, September, December) a year. The mandate of CEGH is to promote articles on clinical epidemiology with focus on developing countries in the context of global health. We also accept articles from other countries. It publishes original research work across all disciplines of medicine and allied sciences, related to clinical epidemiology and global health. The journal publishes Original articles, Review articles, Evidence Summaries, Letters to the Editor. All articles published in CEGH are peer-reviewed and published online for immediate access and citation.