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Clinical Trial
. 1999 Aug 7;354(9177):447-55.

Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico

No authors listed
  • PMID: 10465168
Clinical Trial

Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico

No authors listed. Lancet. .

Erratum in

  • Lancet 2001 Feb 24;357(9256):642
  • Lancet. 2007 Jan 13;369(9556):106

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.

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Comment in

  • ACP J Club. 2000 Jan-Feb;132(1):6
  • Do vitamin E and fish oil protect against ischaemic heart disease?
    Brown M. Brown M. Lancet. 1999 Aug 7;354(9177):441-2. doi: 10.1016/S0140-6736(99)00253-6. Lancet. 1999. PMID: 10465163 Clinical Trial. No abstract available.
  • GISSI-Prevenzione trial.
    Jialal I, Devaraj S, Huet BA, Traber M. Jialal I, et al. Lancet. 1999 Oct 30;354(9189):1554; author reply 1556-7. doi: 10.1016/s0140-6736(99)90191-5. Lancet. 1999. PMID: 10551518 No abstract available.
  • GISSI-Prevenzione trial.
    Harrison R, Burr M, Elton P. Harrison R, et al. Lancet. 1999 Oct 30;354(9189):1554-5; author reply 1556-7. doi: 10.1016/S0140-6736(05)76582-X. Lancet. 1999. PMID: 10551519 No abstract available.
  • GISSI-Prevenzione trial.
    Salen P, de Lorgeril M. Salen P, et al. Lancet. 1999 Oct 30;354(9189):1555; author reply 1556-7. doi: 10.1016/S0140-6736(05)76583-1. Lancet. 1999. PMID: 10551520 No abstract available.
  • GISSI-Prevenzione trial.
    Ng W, Tse HF, Lau CP. Ng W, et al. Lancet. 1999 Oct 30;354(9189):1555-6; author reply 1556-7. doi: 10.1016/S0140-6736(05)76584-3. Lancet. 1999. PMID: 10551521 No abstract available.
  • GISSI-Prevenzione trial.
    Singh RB. Singh RB. Lancet. 1999 Oct 30;354(9189):1556-7. doi: 10.1016/s0140-6736(05)76585-5. Lancet. 1999. PMID: 10551522 No abstract available.
  • GISSI-Prevenzione trial.
    Hopper L, Ness A, Higgins JP, Moore T, Ebrahim S. Hopper L, et al. Lancet. 1999 Oct 30;354(9189):1557. doi: 10.1016/s0140-6736(05)76587-9. Lancet. 1999. PMID: 10551523 No abstract available.

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