RANDOMIZED TRIAL OF ALPHA-TOCOPHEROL AND BETA-CAROTENE SUPPLEMENTS ONINCIDENCE OF MAJOR CORONARY EVENTS IN MEN WITH PREVIOUS MYOCARDIAL-INFARCTION

Background Epidemiological data suggest that the intake of antioxidant s such as alpha-tocopherol (vitamin E) and beta-carotene has an invers e correlation with the incidence of coronary heart disease. The result s from clinical of antioxidant supplementation in people with coronary heart disease are inconclusive.Methods We studied the frequency of ma jor coronary events in 1862 men enrolled in the Alpha-tocopherol Beta- carotene Cancer Prevention Study (smokers aged between 50 and 69 years ) who had a previous myocardial infarction. In this randomised, double -blind, placebo-controlled study, men had received dietary supplements of alpha-tocopherol (50 mg/day), beta-carotene (20 mg/day), both, or placebo. The median follow-up was 5.3 years. The endpoint of this subs tudy was the first major coronary event after randomisation. Analyses were by intention to treat. Findings 424 major coronary events (non-fa tal myocardial infarction and fatal coronary heart disease) occurred d uring follow-up. There were no significant differences in the number o f major coronary events between any supplementation group and the plac ebo group (alpha-tocopherol 94/466; beta-carotene 113/461; alpha-tocop herol and beta-carotene 123/497; placebo 94/438 [log-rank test, p=0.25 ]). There were significantly more deaths from fatal coronary heart dis ease in the beta-carotene (74/461, multivariate-adjusted relative risk 1.75 [95% CI 1.16-2.64], p=0.007) and combined alpha-tocopherol and b eta-carotene groups (67/497, relative risk 1.58 [1.05-2.40], p=0.03) t han in the placebo group (39/438), but there was no significant increa se in the alpha-tocopherol supplementation group (54/466, relative ris k 1.33 [0.86-2.05], p=0.20). Interpretation The proportion of major co ronary events in men with a previous myocardial infarction who smoke w as not decreased with either alpha-tocopherol or beta-carotene supplem ents. In fact, the risk of fatal coronary heart disease increased in t he groups that received either beta-carotene or the combination of alp ha-tocopherol and beta-carotene; there was a non-significant trend of increased deaths in the alpha-tocopherol group. We do not recommend th e use of alpha-tocopherol or beta-carotene supplements in this group o f patients.