使用FAERS和JADER数据库对与伊尔贝沙坦相关的不良事件进行现实世界药监分析
Qian Liu1, Zhiwei Cui2, Chao Deng1
1Department of Cardiovascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Frontiers in pharmacology
|December 5, 2024
概括
这项研究分析了伊尔贝萨坦的安全性数据,确定了新的不良药物事件,如急性胰腺炎和狂肠分裂. 持续监测对于管理高血压药物风险至关重要.
科学领域:
- 药监和药物安全 药监和药物安全
- 心血管药理学心血管药理学
- 现实世界的证据研究研究.
背景情况:
- 高血压是全球主要的健康风险.
- 伊尔贝沙坦是一种血管激素II受体抑制剂,需要持续进行安全评估.
- 与伊尔贝萨坦相关的不良药物事件 (ADEs) 需要彻底调查.
研究的目的:
- 进行与伊尔贝萨坦相关的ADEs的不成比例分析.
- 为了确定伊尔贝沙坦的潜在新安全信号.
- 评估与伊尔贝萨坦相关的ADEs发生的时间.
主要方法:
- 使用FDA FAERS和日本JADER数据库进行ADE报告.
- 采用统计方法,包括ROR,PRR,BCPNN和EBGM用于信号检测.
- 进行了灵敏度和子组分析,并使用韦布尔分布和卡普兰-梅尔曲线评估发病时间.
主要成果:
- 分析了5,816份 (FAERS) 和366份 (JADER) 报告,分别发现了219个和20个积极信号.
- 已确认已知的信号 (高血,低血压,急性损伤) 和确定新的信号 (急性胰腺炎,体溶解,呼吸衰竭).
- 亚组分析显示出根据性别和年龄的差异;ADEs发生在1个月内和1年后,平均发病时间为107天.
结论:
- 这项研究提供了对伊尔贝沙坦安全性概况的真实证据.
- 新发现的安全信号需要药物标签更新和专注的患者管理.
- 时间到发病分析强调需要对伊尔贝萨坦的不良事件保持持续警.
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