小柯机器人

美国克利夫兰诊所心脏和血管中心Steven E. Nissen团队比较了大剂量ω-3脂肪酸和玉米油辅助治疗心血管高危患者对重大心血管不良事件的影响。2020年11月15日，该研究发表在《美国医学会杂志》上。

ω-3脂肪酸二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）是否会降低心血管疾病的风险尚不确定。为了确定EPA和DHA羧酸制剂（ω-3 CA）对心血管结局的影响，并证明其对动脉粥样硬化血脂异常和高心血管风险患者的脂质和炎性标志物有益，研究组进行了一项比较ω-3 CA与玉米油的双盲、随机、多中心试验。

2014年10月30日至2017年6月14日，研究组在北美、欧洲、南美、亚洲、澳大利亚、新西兰和南非的22个国家的675家学术和社区医院中共招募了13078名具有较高心血管风险、高甘油三酯血症和低水平的高密度脂蛋白胆固醇（HDL-C）、接受他汀类药物治疗的患者。

将参与者随机分组，除继续接受他汀类药物治疗外，6539名接受ω-3 CA治疗，6539名接受玉米油治疗。主要终点是心血管死亡、非致命性心肌梗塞、非致命性中风、冠状动脉血运重建或需要住院的不稳定型心绞痛的综合指标。当1384例患者经历了主要终点事件（原计划为1600例）时，中期分析表明该试验相对于玉米油而言具有较低的临床获益可能，试验提前中止。

13078名患者的平均年龄为62.5岁， 35％为女性，70％患有糖尿病，低密度脂蛋白（LDL）胆固醇的平均水平为75.0 mg/dL；甘油三酯的平均水平为240 mg/dL；HDL-C的平均水平为36 mg/dL；高敏C反应蛋白的平均水平为2.1 mg/L，共有12633名（96.6％）完成试验。ω-3 CA组中有785名患者（12.0％）发生主要终点，玉米油组中有795名（12.2％），风险比为0.99。ω-3 CA组中有24.7%的患者发生胃肠道不良事件，显著高于玉米油组（14.7％）。

总之，对于接受他汀类药物治疗的高心血管风险患者，与玉米油相比，添加ω-3 CA并不能显著降低重大不良心血管事件的综合结局。

附：英文原文

Title: Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial

Author: Stephen J. Nicholls, A. Michael Lincoff, Michelle Garcia, Dianna Bash, Christie M. Ballantyne, Philip J. Barter, Michael H. Davidson, John J. P. Kastelein, Wolfgang Koenig, Darren K. McGuire, Dariush Mozaffarian, Paul M Ridker, Kausik K. Ray, Brian G. Katona, Anders Himmelmann, Larrye E. Loss, Martin Rensfeldt, Torbjrn Lundstrm, Rahul Agrawal, Venu Menon, Kathy Wolski, Steven E. Nissen

Issue&Volume: 2020-11-15

Abstract:

Importance  It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.

Objective  To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.

Design, Setting, and Participants  A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.

Interventions  Participants were randomized to receive 4 g/d of omega-3 CA (n=6539) or corn oil, which was intended to serve as an inert comparator (n=6539), in addition to usual background therapies, including statins.

Main Outcomes and Measures  The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

Results  When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P=.84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil–treated patients (14.7%).

Conclusions and Relevance  Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.

DOI: 10.1001/jama.2020.22258

Source: https://jamanetwork.com/journals/jama/fullarticle/2773120

JAMA-Journal of The American Medical Association：《美国医学会杂志》，创刊于1883年。隶属于美国医学协会，最新IF：157.335
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