Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Centro Studi e Ricerche in Medicina Generale, Monza, Italy
N Engl J Med. 2013 May 9;368(19):1800-8. doi: 10.1056/NEJMoa1205409.
Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction.
In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes.
Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points.
In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. (Funded by Società Prodotti Antibiotici and others; ClinicalTrials.gov number, NCT00317707.).
试验表明 n-3 多不饱和脂肪酸对既往心肌梗死或心力衰竭患者有益。我们评估了这种治疗方法对有多种心血管危险因素或动脉粥样硬化性血管疾病但没有心肌梗死的患者的潜在益处。
在这项双盲、安慰剂对照的临床试验中，我们招募了一个由意大利 860 名全科医生组成的网络随访的患者队列。合格的患者为有多种心血管危险因素或动脉粥样硬化性血管疾病但没有心肌梗死的男性和女性。患者被随机分配接受 n-3 脂肪酸（每天 1 克）或安慰剂（橄榄油）治疗。最初指定的主要终点是死亡、非致死性心肌梗死和非致死性卒中的累积发生率。在 1 年时，由于事件发生率低于预期，主要终点修订为心血管原因导致的死亡时间或因心血管原因住院。
在纳入的 12513 名患者中，6244 名被随机分配接受 n-3 脂肪酸治疗，6269 名接受安慰剂治疗。中位随访 5 年后，分析纳入的 12505 名患者中有 1478 名（11.8%）发生了主要终点事件，其中 6239 名患者中有 733 名（11.7%）接受了 n-3 脂肪酸治疗，6266 名患者中有 745 名（11.9%）接受了安慰剂治疗（n-3 脂肪酸治疗的调整后危险比为 0.97；95%置信区间，0.88 至 1.08；P=0.58）。所有次要终点也观察到相同的无效结果。
在一个有多种心血管危险因素的大型普通实践队列中，每天用 n-3 脂肪酸治疗并未降低心血管死亡率和发病率。（由 Società Prodotti Antibiotici 等资助；ClinicalTrials.gov 编号，NCT00317707。）
