大劑量ω-3脂肪酸不能降低心血管高危患者的重大心血管不良事件風險
作者：
小柯機器人發布時間：2020/11/17 11:19:47
美國克利夫蘭診所心臟和血管中心Steven E. Nissen團隊比較了大劑量ω-3脂肪酸和玉米油輔助治療心血管高危患者對重大心血管不良事件的影響。2020年11月15日，該研究發表在《美國醫學會雜誌》上。
ω-3脂肪酸二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）是否會降低心血管疾病的風險尚不確定。為了確定EPA和DHA羧酸製劑（ω-3 CA）對心血管結局的影響，並證明其對動脈粥樣硬化血脂異常和高心血管風險患者的脂質和炎性標誌物有益，研究組進行了一項比較ω-3 CA與玉米油的雙盲、隨機、多中心試驗。
2014年10月30日至2017年6月14日，研究組在北美、歐洲、南美、亞洲、澳大利亞、紐西蘭和南非的22個國家的675家學術和社區醫院中共招募了13078名具有較高心血管風險、高甘油三酯血症和低水平的高密度脂蛋白膽固醇（HDL-C）、接受他汀類藥物治療的患者。
將參與者隨機分組，除繼續接受他汀類藥物治療外，6539名接受ω-3 CA治療，6539名接受玉米油治療。主要終點是心血管死亡、非致命性心肌梗塞、非致命性中風、冠狀動脈血運重建或需要住院的不穩定型心絞痛的綜合指標。當1384例患者經歷了主要終點事件（原計劃為1600例）時，中期分析表明該試驗相對於玉米油而言具有較低的臨床獲益可能，試驗提前中止。
13078名患者的平均年齡為62.5歲， 35％為女性，70％患有糖尿病，低密度脂蛋白（LDL）膽固醇的平均水平為75.0 mg/dL；甘油三酯的平均水平為240 mg/dL；HDL-C的平均水平為36 mg/dL；高敏C反應蛋白的平均水平為2.1 mg/L，共有12633名（96.6％）完成試驗。ω-3 CA組中有785名患者（12.0％）發生主要終點，玉米油組中有795名（12.2％），風險比為0.99。ω-3 CA組中有24.7%的患者發生胃腸道不良事件，顯著高於玉米油組（14.7％）。
總之，對於接受他汀類藥物治療的高心血管風險患者，與玉米油相比，添加ω-3 CA並不能顯著降低重大不良心血管事件的綜合結局。
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