AIM: To determine whether alpha-tocopherol or beta-carotene supplementation 
affects diabetic macrovascular complications and total mortality.
METHODS: This study was carried out as part of the Alpha-Tocopherol, 
Beta-Carotene Cancer Prevention Study, a double-blind, randomized trial with a 
2x2 factorial design. A total of 29,133 middle-aged male smokers received either 
vitamin E 50 mg/day or beta-carotene 20 mg/day, or both, or placebo for a median 
of 6.1 years. At base-line, 1700 men had type 2 diabetes. Of these men, 662 were 
diagnosed with first-ever macrovascular complication, and 1142 died during the 
19-year follow-up.
RESULTS: Neither supplementation affected the risk of macrovascular complication 
or total mortality during the intervention period. For the 
alpha-tocopherol-supplemented versus no alpha-tocopherol-supplemented, and 
beta-carotene-supplemented versus no beta-carotene-supplemented we found 
relative risk (RR) 0.84 (95% confidence interval (CI) 0.65-1.10) and RR 1.15 
(95% CI 0.89-1.50) for macrovascular complication, respectively, and RR 1.00 
(95% CI 0.80-1.25) and RR 1.06 (95% CI 0.85-1.33) for total mortality, 
respectively. No essential changes were found in these effects when the 
follow-up was extended up to 19 years.
CONCLUSION: Alpha-tocopherol or beta-carotene supplementation has no protective 
effect on macrovascular outcomes or total mortality of diabetic male smokers.