结合SGLT2抑制剂和GLP1受体激动剂的不良事件报告:FAERS的一项现实研究
Chunyan Tian1, Zheng Yang1, Subei Zhao1
1Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Nutrition, metabolism, and cardiovascular diseases : NMCD
|November 21, 2024
概括
-葡萄糖携带载体-2 抑制剂 (SGLT2i) 和类似葡萄糖-1 受体激动剂 (GLP1RA) 的组合不会不成比例地增加不良事件报告. 对FDA FAERS数据的分析显示,许多与SGLT2i和GLP1RA相关的不良事件在组合治疗中报告率下降.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 糖尿病治疗方法 糖尿病治疗方法 治疗方法
背景情况:
- -葡萄糖共传输体-2 抑制剂 (SGLT2i) 和类似葡萄糖-1 受体激动剂 (GLP1RA) 常用于2型糖尿病的治疗.
- 越来越多地使用SGLT2i和GLP1RA进行组合治疗.
- 这种组合的安全性概况与不良事件有关,需要彻底调查.
研究的目的:
- 评估SGLT2i和GLP1RA的组合是否导致与单一治疗相比,不良事件报告的不成比例增加.
- 分析SGLT2i和GLP1RA使用的FDA不良事件报告系统 (FAERS) 的不良事件数据.
主要方法:
- 利用FDA的FAERS数据库进行不良事件报告.
- 对SGLT2i和GLP1RA进行了不成比例分析,将组合疗法与单一疗法进行比较.
- 计算了比例报告率 (PRR),以评估不良事件报告的可能性.
主要成果:
- 与SGLT2i相关的不良事件的PRR,包括糖尿病酸症 (DKA) 和尿路感染,在组合治疗下降.
- 与GLP1RA相关的不良事件的PRR,如胃肠道问题和胰腺炎,也在组合治疗下降.
- 随着联合治疗,观察到高脂血和高胺血的PRR增加;没有发现抑郁或自杀行为的信号.
结论:
- 当SGLT2i和GLP1RA结合使用时,相比于各自的单一疗法,不良事件报告率并非不成比例地高.
- 在FAERS数据库中分析的大多数不良事件报告方面,组合治疗似乎是安全的.
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