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QUESTION: In patients with recent myocardial infarction (MI), are n-3 polyunsaturated fatty acids (PUFAs) and vitamin E, singly or in combination, effective for reducing morbidity and mortality?
Design
Randomised (allocation concealed*), blinded (outcome assessors),* controlled trial with 42 month follow-up.
Setting
Centres in Italy.
Patients
11 324 patients (51% ⩽60 y of age, 85% men) with recent MI (within previous 3 mo) who had no contraindications to the study dietary supplements and no conditions with unfavorable short-term prognoses. Follow-up was 99.9%.
Intervention
Patients were allocated to n-3 PUFAs (n=2836), vitamin E (n=2830), n-3 PUFAs and vitamin E (n=2830), or no supplement (n=2828). n-3 PUFA was given in 1 gelatin capsule containing eicosa-pentaenoic acid, 850–882 …
Footnotes
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Sources of funding: Bristol-Myers Squibb; Pfizer; Pharmacia-Upjohn; Società Proditti Antibiotici.
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For correspondence: Dr R Marchioli, GISSI-Prevenzione Coordinating Centre, Consorzio Mario Negri Sud, Via Nazionale, 66030 Santa Maria Imbaro, Italy. FAX +39-0872-578240.
↵† p value calculated from data in article.