Effect of alpha-tocopherol and beta-carotene supplementation on macrovascular complications and total mortality from diabetes: results of the ATBC Study.
OBJECTIVE
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.


CONCLUSIONS
Alpha-tocopherol or beta-carotene supplementation has no protective effect on macrovascular outcomes or total mortality of diabetic male smokers.
Kataja-Tuomola
Merja K
MK
National Institute for Health and Welfare, Mannerheimintie 166, Helsinki, Finland. merja.kataja-tuomola@thl.fi
Kontto
Jukka P
JP
Männistö
Satu
S
Albanes
Demetrius
D
Virtamo
Jarmo R
JR
D000368:Aged; D003327:Coronary Disease / Q000401:mortality / Q000517:prevention & control; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000401:mortality; D003925:Diabetic Angiopathies / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D005387:Finland / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000401:mortality / Q000517:prevention & control; D012907:Smoking / Q000401:mortality; D020521:Stroke / Q000401:mortality / Q000517:prevention & control; D015996:Survival Rate; D016896:Treatment Outcome; D014815:Vitamins / Q000097:blood / Q000627:therapeutic use*; D024502:alpha-Tocopherol / Q000097:blood / Q000627:therapeutic use*; D019207:beta Carotene / Q000097:blood / Q000627:therapeutic use*
D014815:Vitamins; D019207:beta Carotene; D024502:alpha-Tocopherol