EFFECTS OF ALPHA-TOCOPHEROL AND BETA-CAROTENE SUPPLEMENTS ON SYMPTOMS, PROGRESSION, AND PROGNOSIS OF ANGINA-PECTORIS

Objective-To evaluate the effects of alpha tocopherol and beta caroten e supplements on recurrence and progression of angina symptoms, and in cidence of major coronary events in men with angina pectoris. Design-P lacebo controlled clinical trial. Setting-The Finnish alpha tocopherol beta carotene cancer prevention study primarily undertaken to examine the effects of a tocopherol and beta carotene on cancer. Subjects-Mal e smokers aged 50-69 years who had angina pectoris in the Rose chest p airs questionnaire at baseline (n = 1795). Interventions-alpha tocophe rol (vitamin E) 50 mg/day, beta carotene 20 mg/day or both, or placebo in 2 x 2 factorial design. Main outcome measures-Recurrence of angina pectoris at annual follow up visits when the questionnaire was readmi nistered; progression from mild to severe angina; incidence of major c oronary events (non-fatal myocardial infarction and fatal coronary hea rt disease). Results-There were 2513 recurrences of angina pectoris du ring follow up (median 4 years). Compared to placebo, the odds ratios for recurrence in the active treatment groups were: alpha tocopherol o nly 1.06 (95% confidence interval (CI) 0.85 to 1.33), alpha tocopherol and beta carotene 1.02 (0.82 to 1.27), beta carotene only 1.06 (0.84 to 1.33). There were no significant differences in progression to seve re angina among the groups given supplements or placebo. Altogether 31 4 major coronary events were observed during follow up (median 5.5 yea rs) and the risk for them did not differ significantly among the group s given supplements or placebo. Conclusions-There was no evidence of b eneficial effects for a tocopherol or beta carotene supplements in mal e smokers with angina pectoris, indicating no basis for therapeutic or preventive use of these agents in such patients.