基于FDA不良事件报告系统 (FAERS) 数据库,对阿米万塔相关心血管不良事件的现实世界药监测研究
Rui Sun1, Zhen Ning2, Henan Qin1
1Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.
Scientific reports
|April 25, 2024
概括
这项研究发现了与肺癌药物amivantamab相关的新的心血管风险. 现实世界的数据显示,血栓,血压问题和心律失常的风险增加,强调需要对患者进行警监测.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 心脏病学 心脏病学
背景情况:
- 阿米万塔马布是一种针对特定突变的非小细胞肺癌 (NSCLC) 的EGFR和MET的新型抗体.
- 虽然临床试验报告没有心血管毒性,但现实世界的安全数据有限.
- 了解amivantamab的心血管安全概况对于患者管理至关重要.
研究的目的:
- 调查与amivantamab相关的心血管不良事件 (AE) 的临床特征,发病时间和结果.
- 为了确定amivantamab心血管毒性的潜在新安全信号.
- 为临床实践提供有关接受amivantamab.com的患者监测和管理的信息.
主要方法:
- 食品和药物管理局不良事件报告系统 (FAERS) 数据库的回顾性分析 (2019年第一季度2023年第二季度).
- 使用报告概率比率 (ROR) 和信息组件 (IC) 来检测安全信号的不成比例分析.
- 计算心血管事件发病的中位时间 (TTO) 和累计发病率.
主要成果:
- 在与amivantamab相关的20,270,918个记录中,发现了98个心血管AE.
- 对静脉血栓性疾病,血压异常,心律失常和心周溢出观察到积极的安全信号.
- 心血管AE的TTO中位数为33天;90天内的累积发病率达到心力衰竭的100%和中风的75%.
- 16.3%的心血管不良事件导致死亡,主要心血管不良事件 (MACE) 的死亡率高达60%.
结论:
- 这项药物监测研究揭示了在现实环境中对amivantamab的显著心血管安全信号.
- 静脉血栓栓塞和异常血压是需要早期检测和干预的关键问题.
- 对心血管毒性进行密集监测对于用amivantamab治疗的患者至关重要.
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