Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3‐year progression of carotid atherosclerosis
Citations:353
Influential Citations:16
Interventional (Human) Studies
90
Enhanced Details
Methods
Adults aged 45–69 with hypercholesterolemia (serum cholesterol ≥5.0 mmol/L) were randomized in a 2×2 factorial, double-masked trial to four strata by smoking status and gender (smoking men, non-smoking men, smoking postmenopausal women, non-smoking postmenopausal women); 520 participants (256 men and 264 postmenopausal women) were enrolled.
Intervention
Four-arm regimen over 3 years, taken as tablets twice daily: (1) 91 mg d-alpha-tocopherol (vitamin E) alone; (2) 250 mg slow-release ascorbic acid (vitamin C) alone; (3) both vitamins in a single tablet (CellaVie1); (4) placebo.
Results
In men, combined vitamin E and slow-release vitamin C for 3 years slowed progression of common carotid artery IMT. Covariate-adjusted mean IMT increase was 0.009 mm/year in the combination group vs 0.018 mm/year in other men (50.9% less; P=0.044). The proportion with progression was reduced by 74% in men receiving both vitamins versus placebo (P=0.003). No significant effect in women. Implication: the regimen may reduce atherosclerosis progression and potentially related events in men, particularly smokers; the combination was safe and adherence was high; effects in women were not evident, warranting further research.
Limitations
Effect observed in men only; insufficient power to detect effects in women; baseline vitamin levels were high in some groups (notably vitamin C in women), which may attenuate observed effects; not powered to assess cardiovascular events or mortality; 3-year duration; generalizability limited to middle-aged adults with hypercholesterolemia; dropout rate ~12%.
Abstract
Abstract. Salonen JT, Nyyssönen K, Salonen R, Lakka H‐M, Kaikkonen J, Porkkala‐Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, tuomainen T‐P, Valkonen V‐P, Ristonmaa U (University of Kuopio, Finland), Poulsen HE (University of Copenhagen...
Abstract. Salonen JT, Nyyssönen K, Salonen R, Lakka H‐M, Kaikkonen J, Porkkala‐Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, tuomainen T‐P, Valkonen V‐P, Ristonmaa U (University of Kuopio, Finland), Poulsen HE (University of Copenhagen, Copenhagen, Denmark). Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3‐year progression of carotid atherosclerosis. J Intern Med 2000; 248: 377–386.