EFFECT OF VITAMIN-E AND BETA-CAROTENE ON THE INCIDENCE OF ANGINA-PECTORIS - A RANDOMIZED, DOUBLE-BLIND, CONTROLLED TRIAL

Objective.-To examine the effect of supplementation with vitamin E (al pha tocopherol), beta carotene, or both on the incidence of angina pec toris in men without known previous coronary heart disease. Design.-Ra ndomized, double-blind, placebo-controlled trial. Setting and Particip ants.-Participants in the Alpha Tocopherol, Beta Carotene Cancer Preve ntion Study (N=29 133) were male smokers aged 50 through 69 years who were living in southern and western Finland. Of these men, 22 269 were considered free of coronary heart disease at baseline and were follow ed up for the incidence of angina pectoris. Intervention.-Participants were randomized to receive 50 mg/d of alpha tocopherol, 20 mg/d of be ta carotene, both, or placebo in a 2x2 design. Outcome Measures.-An in cident case was defined as the first occurrence of typical angina pect oris identified in administering the annually repeated World Health Or ganization (Rose) Chest Pain Questionnaire. Results.-During a median f ollow-up time of 4.7 years (96 427 person-years), 1983 new cases of an gina pectoris were detected. Comparing alpha tocopherol-supplemented s ubjects with non-alpha tocopherol-supplemented subjects showed a relat ive risk (RR) of angina pectoris incidence of 0.91 (95% confidence int erval [CI], 0.83 to 0.99; P=.04). The RR for incidence of angina pecto ris for the beta carotene-supplemented subjects compared with those no t receiving beta carotene was 1.06 (95% CI, 0.97 to 1.16; P=.19). Comp ared with those receiving placebo, the RRs for incidence of angina pec toris were 0.97 (95% CI, 0.85 to 1.10) and 0.96 (95% CI, 0.85 to 1.09) in the alpha tocopherol and alpha tocopherol plus beta carotene group s respectively, and 1.13 (95% CI, 1.00 to 1.27) in the beta carotene g roup (P=.06). Baseline dietary intakes and serum levels of alpha tocop herol and beta carotene did not predict incidence of angina pectoris. Conclusions.-Supplementation with alpha tocopherol was associated with only a minor decrease in the incidence of angina pectoris. Beta carot ene had no preventive effect and was associated with a slight increase in the incidence of angina.