Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial

医学 心肌梗塞 多不饱和脂肪酸 维生素E 内科学 维生素 心脏病学 随机对照试验 脂肪酸 生物化学 生物 抗氧化剂
作者
Roberto Marchioli
出处
期刊:The Lancet [Elsevier BV]
卷期号:354 (9177): 447-455 被引量:3802
标识
DOI:10.1016/s0140-6736(99)07072-5
摘要

Summary Background There is conflicting evidence on the benefits of foods rich in vitamin E (α-tocopherol), n-3 polyunsaturated fatty acids (PUFA), and their pharmacological substitutes. We investigated the effects of these substances as supplements in patients who had myocardial infarction. Methods From October, 1993, to September, 1995, 11 324 patients surviving recent (≤3 months) myocardial infarction were randomly assigned supplements of n-3 PUFA (1 g daily, n=2836), vitamin E (300 mg daily, n=2830), both (n=2830), or none (control, n=2828) for 3·5 years. The primary combined efficacy endpoint was death, non-fatal myocardial infarction, and stroke. Intention-to-treat analyses were done according to a factorial design (two-way) and by treatment group (four-way). Findings Treatment with n-3 PUFA, but not vitamin E, significantly lowered the risk of the primary endpoint (relativerisk decrease 10% [95% CI 1–18] by two-way analysis, 15% [2–26] by four-way analysis). Benefit was attributable to a decrease in the risk of death (14% [3–24] two-way, 20% [6–33] four-way) and cardiovascular death (17% [3–29] two-way, 30% [13–44] four-way). The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint (14% [1–26]) and for fatal events (20% [5–33]). Interpretation Dietary supplementation with n-3 PUFA led to a clinically important and satistically significant benefit. Vitamin E had no benefit. Its effects on fatal cardiovascular events require further exploration.
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