Paul G. Shekelle, MD
In men with a lower risk for cardiovascular disease, do vitamin E and vitamin C supplements reduce major cardiovascular (CV) events?
Randomized placebo-controlled trial (Physicians’ Health Study II). ClinicalTrials.gov NCT00270647.
Unclear allocation concealment.*
Blinded (patients, clinicians, and outcome assessors).*
Up to 10 years (mean 8 y).
14 641 male physicians ≥ 50 years (mean age 64 y). Men with a history of myocardial infarction (MI), stroke, or cancer were included. Exclusion criteria were history of cirrhosis, active liver disease, anticoagulant use, or serious illness. 5.1% of men had prevalent CV disease (CVD).
After stratification for age, previous cancer or CV disease diagnosis, and original β-carotene assignment, men were allocated to vitamin E, 400 IU every other day (n = 3659); vitamin C, 500 mg/d (n = 3673); vitamin E plus C (n = 3656); or placebo (n = 3653). Matching placebos were used. In addition, men were randomized to a daily multivitamin or placebo as well as to β-carotene or placebo (results pending).
A composite end point of nonfatal MI, nonfatal stroke, and CV mortality. Secondary outcomes included all-cause mortality, total MI, and total stroke. The study had 80% power to detect a 16% relative reduction in the primary outcome at the 5% significance level.
95% for morbidity; 98% for mortality.
Vitamin E and vitamin C did not differ from placebo for major CV events, all-cause mortality, total MI, total stroke, or CV death (Table).
Supplementation with vitamin E or vitamin C did not differ from placebo for major cardiovascular events and mortality.
Vitamin E or vitamin C vs placebo in male physicians†
†CV = cardiovascular; MI = myocardial infarction; NS = not significant; other abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
‡Adjusted for age, Physicians’ Health study cohort, randomized β-carotene assignment, randomized multivitamin assignment, and either randomized vitamin E or vitamin C assignment, and stratified on baseline cardiovascular disease.
§A composite outcome of nonfatal MI, nonfatal stroke, and CV death.
Shekelle PG. Supplementation with vitamin E or vitamin C did not differ from placebo for major cardiovascular events and mortality. Ann Intern Med. ;150:JC4–12. doi: 10.7326/0003-4819-150-8-200904210-02012
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Published: Ann Intern Med. 2009;150(8):JC4-12.
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