EFFECT OF ALPHA-TOCOPHEROL (VITAMIN-E) AND BETA-CAROTENE SUPPLEMENTATION ON THE INCIDENCE OF INTERMITTENT CLAUDICATION IN MALE SMOKERS

We examined the primary preventive effect of vitamin E (alpha-tocopher ol) and beta-carotene supplementation on intermittent claudication. Th e subjects-participants in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study-were male smokers aged 50 to 69 years who were random ly assigned to receive 50 mg of alpha-tocopherol daily, 20 mg of beta- carotene daily, both, or placebo. At baseline, there were 26289 men wi th no history or symptoms of intermittent claudication. The Rose quest ionnaire on intermittent claudication was administered annually to dis cover incident cases. We observed 2704 cases of first occurrence of ty pical intermittent claudication during a median follow-up time of 4.0 years. Compared with placebo, the adjusted relative risk for typical i ntermittent claudication among those who received alpha-tocopherol tho se who received alpha-tocopherol and beta-carotene, 1.02 (0.91-1.13); and among those who received beta-carotene only, 1.02 (0.92-1.14). Whe n we compared the alpha-tocopherol-supple mented subjects with those w ho received no alpha-tocopherol, the adjusted relative risk for typica l intermittent claudication was 1.05 (0.98-1.14), and for beta-caroten e-supplemented subjects compared with those who did not receive beta-c arotene, the relative risk was 0.96 (0.89-1.04). In conclusion, no pri mary preventive effect on intermittent claudication was observed among middle-aged male smokers who were supplemented with alpha-tocopherol, beta-carotene, or both.