Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised openlabel, blinded endpoint analysis
Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised openlabel, blinded endpoint analysis
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DOI：
10.1016/s0140-6736(07)60527-3
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发表时间：
2007-03-01
期刊：
影响因子：
168.9
通讯作者：
Shirato, Kunio
中科院分区：
文献类型：
--
作者：
Yokoyama, Mitsuhiro;Origasa, Hideki;Shirato, Kunio
流行病学和临床证据表明，增加长链n-3脂肪酸的摄入可以预防冠状动脉疾病的死亡。我们的目的是测试的假设，即长期使用二十碳五烯酸（EPA）是有效的预防主要的冠状动脉事件在高胆固醇血症患者在日本谁消耗了大量的fish.Methods 18645例总胆固醇为6.5 mmol/L或更高的患者在1996年和1999年之间从日本各地的医生招募。患者被随机分配接受1800 mg EPA每日与他汀类药物（EPA组; n=9326）或他汀类药物（对照组; n=9319），随访5年。主要终点是任何主要冠状动脉事件，包括心源性猝死、致死性和非致死性心肌梗死，以及其他非致死性事件，包括不稳定型心绞痛、血管成形术、支架植入术或冠状动脉旁路移植术。clinicaltrials.gov在平均4.6年的随访中，我们在EPA组262例（2.8%）和对照组324例（3.5%）患者中检测到主要终点-主要冠状动脉事件相对减少19%（p=0.011）。两组治疗后LDL胆固醇浓度均从4.7 mmol/L降低25%。血清低密度脂蛋白胆固醇不是降低主要冠状动脉事件风险的重要因素。EPA组的不稳定型心绞痛和非致命性冠状动脉事件也显著减少。心脏性猝死和冠状动脉死亡在两组之间没有差异。在接受EPA治疗的有冠状动脉疾病史的患者中，主要冠状动脉事件减少了19%（二级预防亚组：EPA组158例[8.7%] vs对照组197例[10.7%]; p=0.048）。在没有冠状动脉疾病史的患者中，EPA治疗使主要冠状动脉事件减少了18%，但这一发现并不显著（EPA组104例[1.4%] vs对照组127例[1.7%];解释EPA是预防主要冠状动脉事件，特别是非致命性冠状动脉事件的有希望的治疗，在日本高胆固醇血症患者中。
Background Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish.Methods 18645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting. Analysis was by intention-to-treat. The study was registered at clinicaltrials.gov, number NCT00231738.Findings At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011). Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group vs 197 [10.7%] in the control group; p=0.048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132).Interpretation EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients.