与瘤坏死因子-α抑制剂相关的心血管不良事件:现实世界药监分析
Junlong Ma1,2, Jiangfan Cai2, Heng Chen3
1Center of Clinical Pharmacology, Th ird Xiangya Hospital, Central South University.
Journal of atherosclerosis and thrombosis
|June 12, 2024
概括
阿达利马布,但不是其他瘤亡因子-α抑制剂,在药监测研究中显示出血栓性心血管不良事件的风险. 需要进一步的研究来证实TNF-α疗法的这些发现.
科学领域:
- 药监和药物安全 药监和药物安全
- 免疫学和风湿病学
- 心血管医学 心血管医学
背景情况:
- 有限且相互矛盾的证据表明,与瘤亡因子α (TNF-α) 抑制剂相关的心血管风险是有限的.
- 了解这些关联对于治疗炎症疾病的患者安全至关重要.
研究的目的:
- 研究特定的TNF-α抑制剂与心血管不良事件 (AE) 之间的关联.
- 为了确定任何特定的TNF-α抑制剂是否会增加血栓性心血管事件的风险.
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 数据库进行的回顾性药监测研究.
- 不成比例性分析 (报告几率比率 - ROR) 应用于与阿达利木马布,因弗利西马布,乙坦塞普特,戈利木马布和克尔科利祖马布相关的心血管副作用.
- 进行了调整的ROR和子组分析,以控制混因素.
主要成果:
- 在9,817份心血管病报告中,只有阿达利马布与心肌梗塞 (ROR=1.58) 和动脉血栓形成 (ROR=1.54) 有显著关联.
- 对于其他四种TNF-α抑制剂,没有发现显著的风险相关性.
- 阿达利马布仍然与心血管事件有显著的关联,特别是在牛皮患者中 (调整后的ROR=2.16).
结论:
- 确定阿达利马布是唯一与血栓性心血管AE风险增加相关的TNF-α抑制剂.
- 其他评估的TNF-α抑制剂没有显示出类似的风险.
- 建议进行前性研究,以验证这些药监发现,因为研究固有的局限性.
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