美国REDUCE-IT:美国3146名随机患者的结果
Deepak L Bhatt1, Michael Miller2, Eliot A Brinton3
1Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).
Circulation
|November 12, 2019
概括
在美国患者中,Icosapent ethyl显著降低了心血管事件,在REDUCE- IT试验中显示出强大的风险降低. 这一发现支持对高风险个体的使用,包括所有死亡原因的好处.
科学领域:
- 心血管医学
- 临床试验
- 药理学
背景情况:
- 之前的试验表明患者对治疗的反应因地域不同而有所不同.
- 在REDUCE- IT试验中,研究了icosapent乙烯对心血管风险的降低.
- 一个小组分析侧重于美国患者,以澄清这一群体中的治疗疗效.
研究的目的:
- 评估icosapent ethyl在美国患者中的特定益处.
- 在美国的REDUCE- IT试验中,将icosapent乙烯与安慰剂的疗效进行比较.
主要方法:
- 在REDUCE- IT试验中,随机选择了8179名患有高甘油和已确定的心血管风险因素的患者.
- 参与者接受了icosapent乙烯 (4 g/ d) 或安慰剂.
- 主要综合终点包括心血管死亡,心肌梗塞,中风,再血管或不稳定的心痛住院.
主要成果:
- 总共分析了3146名美国患者,占试验队列的38. 5%.
- 在美国患者中,icosapent ethyl显著降低了初级复合终点 (HR 0. 69) 和关键二次复合终点 (HR 0. 69).
- 对心血管死亡,心肌梗塞,中风和全因死亡的风险有显著降低,对全因死亡的相互作用是显著的 (P=0. 02).
结论:
- 美国患者在REDUCE- IT试验中经历了相当大的心血管风险降低.
- 调查结果显示,在美国小组中,包括所有原因死亡率在内的益处特别强大.
- 安全性和耐受性概况与整个研究群体一致.
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