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基于FAERS数据库的tirzepatide不良事件的数据挖掘研究

Yan Huo¹, Minghua Ma¹, Xiaolan Liao¹

¹Department of Pharmacy, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, China.

Expert opinion on drug safety

|July 15, 2024

概括

双重GIP和GLP-1RA的蒂尔泽帕提德在现实世界的安全分析中显示了新的不良事件信号,包括甲状腺和生殖问题. 监测至关重要,特别是在治疗的早期.

科学领域:

药物监督药物监督药物监督
内分泌学在内分泌学.
临床安全临床安全

背景情况:

蒂尔泽帕提德是一种新型的双双依赖葡萄糖的胰岛素型多 (GIP) 和类似葡萄糖素的-1受体激动剂 (GLP-1 RA).
它适用于2型糖尿病和肥胖管理.
了解其现实世界的安全概况是必不可少的.

研究的目的:

在现实世界的临床环境中调查蒂尔泽帕提德的安全性.
为了识别与tirezepatide使用相关的潜在不良事件 (AE).
分析这些AE的发病模式.

主要方法:

从FDA不良事件报告系统 (FAERS) 数据库 (第2季度2022 - 第4季度2023) 中对AE报告的回顾性分析.
使用报告几率比率 (ROR) 方法进行信号挖掘.
使用韦布尔形状参数 (WSP) 分析AE发病时间.

主要成果:

鉴定出了25215起对提尔泽帕提德的副作用报告,主要是65-85岁的个人.
在系统器官类别层面检测到4个积极的安全信号,在首选术语层面检测到109个.
新的信号包括甲状腺质量,骨髓甲状腺癌和生殖/乳腺疾病. 大多数AE发生在30天内,WSP为0.66,表明早期发病.

结论:

这项研究确定了tirezepatide的新型不良事件信号.
这些发现强调了对泽帕提德的警监测的重要性.
应特别注意早期治疗阶段和特定的AE配置文件.

关键词:

在FAERS数据库中,我们可以找到FAERS数据库.蒂尔泽帕提德是什么意思不良事件不良事件不良事件数据挖掘是数据挖掘的一个方法.药物监督和药物监督

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