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Abstract BACKGROUND: There is conflicting evidence on the benefits of foods rich in vitamin E (alpha-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 (< or = 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 (relative-risk 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 statistically significant benefit. Vitamin E had no benefit. Its effects on fatal cardiovascular events require further exploration.
This article was published in Lancet
and referenced in Journal of Diabetes & Metabolism