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AHA2019丨ω-3脂肪酸再续“传奇”,降低心血管事件显获益

2019-11-20 国际循环编辑部 国际循环

AHA 2019大会的多项最新研究结果已陆续发布。其中,REDUCE-IT研究显示,在高甘油三酸酯(TGs)和已知心血管疾病或高发病风险以及已接受他汀类药物治疗低密度脂蛋白胆固醇(LDL-C)水平控制相对良好的患者中,使用一种高剂量纯化形式的ω-3脂肪酸(Icosapent Ethyl)可降低TGs,心血管事件和心血管死亡。REDUCE-IT研究的目的是评估在TGs患者中,与安慰剂相比,Icosa

AHA 2019大会的多项最新研究结果已陆续发布。其中,REDUCE-IT研究显示,在高甘油三酸酯(TGs)和已知心血管疾病或高发病风险以及已接受他汀类药物治疗低密度脂蛋白胆固醇(LDL-C)水平控制相对良好的患者中,使用一种高剂量纯化形式的ω-3脂肪酸(Icosapent Ethyl)可降低TGs,心血管事件和心血管死亡。

REDUCE-IT研究的目的是评估在TGs患者中,与安慰剂相比,Icosapent Ethyl 在减少心血管(CV)事件方面的安全性和获益。
 
研究共计纳入19 212例患者(28%为女性),平均年龄64.0岁,将患者以1:1的方式随机分配至Icosapent Ethyl 组(2 g,2/日)(n=4089)或相匹配的安慰剂组(n=4090)。主要研究终点为心血管死亡,非致死性心肌梗死,非致死性卒中,冠状动脉血运重建,因不稳定性心绞痛住院。主要次要终点为心血管死亡,非致死性心肌梗死,非致死性卒中。随访4.9年。
 
纳入标准:年龄大于45岁的已诊断心血管疾病患者(二级预防人群)或年龄大于50岁的糖尿病和≥1个其他危险因素(一级预防人群);空腹TG水平135~500 mg/dl;LDL-C水平为41~100 mg/dl;接受他汀稳定治疗≥4周。



其他显著特征/特性:二级预防人群70.7%;依泽替米贝用量6.4%;中度或高强度他汀类药物94%;糖尿病59%;基线平均TG水平216 mg/dl;LDL 75 mg/dl;高密度脂蛋白40 mg/dl;高敏C反应蛋白2.2。
 
主要研究终点:与安慰剂相比,Icosapent Ethyl 的心血管死亡,非致死性心肌梗死(MI),卒中,冠状动脉血运重建或不稳定性心绞痛的心血管事件较低(22.0% vs. 17.2%,HR=0.75,95%CI:0.68-0.83;P<0.0001)。
 



次要终点结果:Icosapent Ethyl 组与安慰剂组相比,心血管死亡或心肌梗死率较低(9.6% vs. 12.4%,P<0.001);血运重建率较低(5.3% vs. 7.8%,P<0.001);全因死亡率较低(6.7% vs. 7.6%,P不显著);心房颤动发生率较高(5.3%vs. 3.9%);严重不良出血事件较高(2.7% vs. 2.1%,P=0.06)。
 
与安慰剂组相比,Icosapent Ethyl 的主要终点事件发生率从每1000个患者年中的89个降至61个(RR=0.70,95%CI:0.62~0.78,P<0.0001)。Icosapent Ethyl可降低首发主要复合终点事件(HR=0.75,95%CI:0.68~0.83,P<0.0001)和再发不良事件(HR=0.68,95%CI:0.60~0.78,P<0.0001)。主要次要终点也得到类似结果。
 



亚组分析中(n=3146,38.5%),Icosapent Ethyl组与安慰剂组相比,主要终点事件发生率较低(18.2% vs. 24.7%,P=0.0001),即心血管死亡(4.7% vs. 6.7%,P=0.007)、心肌梗死(6.7%vs. 8.8%,P=0.01)、卒中(2.6% vs. 4.1%,P=0.02)和全因死亡率(7.2% vs. 9.8%,P=0.004)均较低。安全性终点与总体队列结果一致。
 
这项研究表明,在高TGs和已知心血管疾病或高风险以及已接受他汀类药物治疗LDL-C水平控制相对良好患者中,Icosapent Ethyl(2 g,2/日)在降低TGs,心血管事件和心血管死亡方面优于安慰剂。
 
与其他临床试验相比,Icosapent Ethyl这种药物是一种高剂量纯化形式的二十碳五烯酸(EPA)(4 g /日),目前正在进行中高剂量EPA的其他试验。这是最早显示具有心血管获益的非LDL靶向试验之一,并且会在未来指南中进行介绍。

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    2019-11-22 zhaohui6731
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