n-3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia
n-3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia
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DOI：
10.1056/nejmoa1203859
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发表时间：
2012-07-26
影响因子：
158.5
通讯作者：
Yusuf, Salim
中科院分区：
文献类型：
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作者：
Bosch, Jackie;Gerstein, Hertzel C.;Yusuf, Salim
研究背景使用n-3脂肪酸可以预防近期心肌梗死或心力衰竭患者的心血管事件。它们对患有方法在这项2 × 2析因设计的双盲研究中，我们随机分配了12,536例心血管事件高危患者，这些患者有空腹血糖受损，糖耐量受损，或糖尿病患者接受1 g胶囊，每日至少含900 mg（90%或更多）n-3脂肪酸乙酯或安慰剂，并接受甘精胰岛素或标准治疗。主要结局是心血管原因导致的死亡。本文报告了n-3脂肪酸和安慰剂的比较结果。在6.2年的中位随访期间，与接受安慰剂的患者相比，接受n-3脂肪酸的患者的主要结局发生率没有显著降低（574例患者[9.1%] vs. 581例患者[9.3%];风险比，0.98; 95%置信区间[CI]，0.87 - 1.10; P = 0.72）。使用n-3脂肪酸对主要血管事件的发生率也没有显著影响（1034例患者[16.5%] vs. 1017例患者[16.3%];风险比，1.01; 95% CI，0.93 - 1.10; P = 0.81），全因死亡（951 [15.1%] vs. 964 [15.4%];风险比，0.98; 95% CI，0.89 - 1.07; P = 0.63），或心律失常导致的死亡（288 [4.6%] vs. 259 [4.1%];风险比，1.10; 95% CI，0.93 - 1.30; P = 0.26）。与接受安慰剂的患者相比，接受n-3脂肪酸的患者的甘油三酯水平降低了14.5 mg/dl（0.16 mmol/L）（P
BACKGROUNDThe use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown.METHODSIn this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here.RESULTSDuring a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P