在没有先前心肌梗塞或中风的患者中使用Evolocumab
Erin A Bohula1, Nicholas A Marston1, Ajay K Bhatia2
1Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston.
The New England journal of medicine
|November 10, 2025
概括
作为PCSK9抑制剂的Evolocumab显著降低了动脉样硬化或糖尿病患者的心血管事件风险,但之前没有心脏病发作或中风. 这项研究证明了其在预防新的患者队列中重大心血管不良事件 (MACE) 的有效性.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 众所周知,与evolocumab一样的Proprotein转化酶亚素-kexin类型9 (PCSK9) 抑制剂可降低已确诊心血管疾病患者的重大心血管不良事件 (MACE).
- 埃沃洛库马布在没有心肌梗塞或中风病史的患者中对MACE风险的影响以前尚未确定.
研究的目的:
- 评估埃沃洛库马布在降低动脉样硬化或糖尿病但没有先前心肌梗塞或中风的患者心血管事件的疗效.
- 评估evolocumab在这个患者群体中的安全性.
主要方法:
- 一项国际双盲,随机,安慰剂对照试验,涉及12,257名动脉样硬化或糖尿病患者和低密度脂蛋白胆固醇≥90 mg/dL的患者.
- 患者接受了evolocumab (140毫克每2周) 或安慰剂在1:1的比例.
- 主要终点包括冠心病死亡,心肌梗塞或缺血性中风 (3点MACE) 的复合组合,以及包括这些加上缺血驱动的再血管化 (4点MACE) 的复合组合.
主要成果:
- 与安慰剂相比,Evolocumab在4.6年的中位随访期间显著降低了3点MACE的风险25% (HR,0.75;P<0.001) 和4点MACE的风险19% (HR,0.81;P<0.001).
- 卡普兰-梅尔对3点MACE的5年估计为6.2%与evolocumab对比8.0%与安慰剂.
- 在evolocumab和安慰剂组之间没有观察到安全事件发生率的显著差异.
结论:
- 使用evolocumab抑制PCSK9有效降低了在没有心肌梗塞或中风史的动脉样硬化或糖尿病患者中首次心血管事件的风险.
- 埃沃洛库马布代表了一种有价值的治疗选择,用于选择高风险患者的心血管事件的初级预防.
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