与CDK4/6抑制剂相关的新兴心血管毒性:来自FDA不良事件报告系统的现实洞察
Wensheng Liu1,2, Feifei Gao1,2, Xue Song3
1Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
Frontiers in pharmacology
|June 16, 2025
概括
循环素依赖性激酶4和6抑制剂 (CDK4/6i) 与心血管不良事件 (CVAE) 相关,包括严重和致命的病例. 高龄和特定的CDK4/6i类型增加了这些事件的风险.
科学领域:
- 心脏病学 心脏病学
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
背景情况:
- 循环素依赖性激酶4和6抑制剂 (CDK4/6i) 在治疗激素依赖性乳腺癌方面至关重要.
- 与CDK4/6i一起报告了心血管不良事件 (CVAE),在临床实践中引发了担忧.
- 现实世界的数据表明,需要进一步调查与CDK4/6i治疗相关的CVAE.
研究的目的:
- 在接受CDK4/6i的患者中描述CVAE的发病率和临床特征.
- 在CDK4/6i治疗期间识别与CVAE相关的风险因素.
- 提供关于CDK4/6i相关CVAE的警癌症管理的参考.
主要方法:
- 一项使用FDA不良事件报告系统 (FAERS) 数据从2015年1月到2024年9月的全球不成比例性研究.
- 报告几率比率 (ROR) 用于检测与CDK4/6i相关的新出现的CVAE.
- 使用多变量后勤回归和时间到发病分析来确定风险因素和模式.
主要成果:
- 确定了4709份与CDK4/6i相关的CVAE报告;90.5%是严重的,12%是致命的.
- 阿贝马西克利布显示静脉血栓栓塞的风险增加 (ROR = 2.57),而里博西克利布与心律失常 (ROR = 2.51) 和QT延长 (ROR = 5.7) 有关.
- 65岁以上的年龄和特定的CDK4/6i药物是CVAE的重要风险因素.
结论:
- 与CDK4/6i相比,CVAE可能会比以前认为的更频繁地发生.
- 本研究提供了与CDK4/6i相关的CVAE的全面概述,包括发病率,特征和风险因素.
- 在临床试验中未发现的潜在CVAE被发现,这突显了持续药物监测的重要性.
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