Myocardial Infarction: polyunsaturated fatty acids decreased death, MI and stroke.

Clinical bottom line (level 1b)

  1. Patients who had a myocardial infarction and are given n-3 polyunsaturated fatty acids, were less likely to die or have an MI or stroke than those not given supplements (NNT = 48 at 42 months) .
  2. Vitamin E did not clearly improve outcome, in terms of death, MI or stroke.
GISSI-Prevenzione Investigators : Lancet 1999; 354: 447-455
Expires March 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 130 cardiology departments and 42 rehabilitation centres, Italy

11324 patients (aged ?, 85% male) recent (3 months or less) myocardial infarction

Excluded if
  • contraindication to dietary supplements
  • unable to provide informed consent
  • unfavourable short-term outlook


    • Control Group: (n = 2828, 2828 analysed): no supplements
    Experimental Group: (n = 2836, 2836 analysed): n-3 polyunsaturated fatty acids, as daily doses of 1 gelatin capsule containing 850-882 mg eicosapentaenoic acid and docosahexanoic acid as ethyl esters
    Experimental Group: (n = 2830, 2830 analysed): vitamin E, given a s a300 mg capsule of synthetic gamma-tocopherol
    Experimental Group: (n = 2830, 2830 analysed): n-3 polyunsaturated fatty acids plus vitamin E

    100% followed for 42 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death, MI or stroke (n-3 polyunsaturated fatty acids vs control) 42 months 414
    (14.6%)    		 356
    (12.6%)    		 14.0%
    (2.00% to 25.0%)    		 2.09%
    (0.30% to 3.87%)    		 48
    (26 to 331)
    death, MI or stroke (combined vs control) 42 months 414
    (14.6%)    		 359
    (12.7%)    		 13.0%
    (1.00% to 24.0%)    		 1.95%
    (0.16% to 3.74%)    		 51
    (27 to 607)
    death, MI or stroke (vitamin E vs control) 42 months 414
    (14.6%)    		 371
    (13.1%)    		 10.0%
    (-2.00% to 21.0%)    		 1.53%
    (-0.27% to 3.33%)    		 65
    (NNT = 30 to infinity;
    NNH = 369 to infinity)

    Comments

    1. The findings of this study are consistent with the results of smaller studies of the effects of fish oil supplementation on serum lipids, vascular biology, and clinical events.
    2. Compliance was measured by refilling drug supplies every 3 months.

    Citation

    1. GISSI-Prevenzione Investigators , : Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet 1999; 354: 447-455
    Contributor: Clare Wotton and Musab Hayatli, February 2000
    Reviewer: Edward Havranek

    Clinical Question.
    Patient myocardial infarction
    Intervention or Exposure supplements of n-3 polyunsaturated fatty acids, vitamin E or both
    Comparison control
    Outcome death, MI or stroke