Huo Yan, Ma Minghua, Liao Xiaolan
Department of Pharmacy, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, China.
Expert Opin Drug Saf. 2025 Jun;24(6):675-683. doi: 10.1080/14740338.2024.2376686. Epub 2024 Jul 15.
Tirzepatide is a novel dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) for type 2 diabetes or obesity. To explore the safety profile of tirzepatide in real-world clinical applications.
A retrospective analysis of adverse events (AEs) reports associated with tirzepatide was conducted from the second quarter of 2022 through the fourth quarter of 2023, utilizing the FDA Adverse Event Reporting System (FAERS) database. Signal mining utilized the reporting odds ratio (ROR) method, and onset time was analyzed utilizing the Weibull Shape Parameter (WSP).
We identified 25,215 AE reports related to tirzepatide, predominantly in the 65 to 85 age group. Four positive signals were found at the system organ classes level. Additionally,109 AEs at the preferred terms level with positive signals were indicated. Included among these are novel signals, such as the presence of thyroid mass, medullary thyroid carcinoma, and conditions affecting the reproductive system and breast. Most AEs occurred within the first 30 days. The WSP was 0.66, indicating a propensity for early failure type.
This study identified several novel AE signals for tirzepatide, highlighting the need for careful monitoring, especially in the early stages of treatment.
替尔泊肽是一种新型的双重胃抑制多肽（GIP）和胰高血糖素样肽-1受体激动剂（GLP-1 RA），用于治疗2型糖尿病或肥胖症。旨在探索替尔泊肽在实际临床应用中的安全性。
利用美国食品药品监督管理局不良事件报告系统（FAERS）数据库，对2022年第二季度至2023年第四季度与替尔泊肽相关的不良事件（AE）报告进行回顾性分析。信号挖掘采用报告比值比（ROR）方法，发病时间采用威布尔形状参数（WSP）进行分析。
我们识别出25215份与替尔泊肽相关的AE报告，主要集中在65至85岁年龄组。在系统器官分类水平上发现了四个阳性信号。此外，还指出了109个在首选术语水平上具有阳性信号的AE。其中包括新出现的信号，如甲状腺肿物、甲状腺髓样癌以及影响生殖系统和乳房的病症。大多数AE发生在开始治疗的前30天内。WSP为0.66，表明具有早期失效类型的倾向。
本研究识别出替尔泊肽的几个新的AE信号，强调了仔细监测的必要性，尤其是在治疗早期。
