已确诊的动脉样性心血管疾病患者的长期使用
Michelle L O'Donoghue1, Robert P Giugliano1, Stephen D Wiviott1
1TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.L.O., R.P.G., S.D.W., J.F.K., K.I., S.A.M., M.S.S.).
Circulation
|August 29, 2022
概括
在高风险患者中,长期使用evolcumab显著降低了心血管事件和死亡. 与安慰剂相比,这种PCSK9抑制剂在8年内表现出持续的安全性和有效性,没有增加不良事件.
科学领域:
- 心血管医学
- 药理学
- 临床试验
背景情况:
- 在FOURIER试验中,evolocumab降低了LDL- C和心血管事件.
- 关于evolcumab安全性和有效性的长期数据是有限的.
研究的目的:
- 评估埃沃洛库马布在患有动脉样硬化心血管疾病的患者的长期安全性和疗效.
- 在长时间内评估心血管结果和不良事件.
主要方法:
- 来自FOURIER试验的患者被纳入了开放式扩展研究 (FOURIER- OLE).
- 从美国和欧洲的扩展研究中汇总了数据,主要分析侧重于不良事件发生率.
- 血脂值和主要心血管不良事件在平均5. 0年的随访期间被前性收集.
主要成果:
- 治疗Evolocumab导致LDL- C的中位数为30 mg/ dL,其中63. 2%的LDL- C达到< 40 mg/ dL.
- 长期不良事件的发生率 (严重的副作用,肌肉事件,新的糖尿病,中风,神经认知事件) 不超过安慰剂,并且没有随着时间的推移而增加.
- 与安慰剂相比,接受evolcumab治疗的患者心血管重大不良事件的风险降低了15%,心血管死亡的风险降低了23%.
结论:
- 长期使用埃沃洛库马布降低LDL-C是安全的,并且可以耐受超过8年.
- 与延迟开始治疗相比,Evolocumab显示持续降低心血管风险.
- 这项研究支持evolocumab在高风险心血管患者的长期益处.
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