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Randomized Trials of Vitamin E in the Treatment and Prevention of Cardiovascular Disease
Rachel S. Eidelman, MD;
Danielle Hollar, PhD;
Patricia R. Hebert, PhD;
Gervasio A. Lamas, MD;
Charles H. Hennekens, MD, DrPH
Arch Intern Med. 2004;164:1552-1556.
Background Observational epidemiological studies consistently show that individuals who choose to take high amounts of vitamin E through diet or supplements experience cardiovascular benefits, for which basic research provides plausible mechanisms. However, because the size of the postulated benefit is small to moderate, the confounding inherent in observational studies is as great as the effect size. Before the availability of randomized evidence, about 1 in 4 adults was taking vitamin E supplements in the United States.
Methods We conducted a computerized search of the English-language literature from 1990 to the present and found 7 large-scale randomized trials of the effectiveness vitamin E in the treatment and prevention of cardiovascular disease. Data were available on myocardial infarction, stroke, or cardiovascular death.
Results Six of the 7 trials showed no significant effect of vitamin E on cardiovascular disease. In an overview, vitamin E had neither a statistically significant nor a clinically important effect on any important cardiovascular event (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.94-1.03) or its components: nonfatal myocardial infarction (OR, 1.00; 95% CI, 0.92-1.09), nonfatal stroke (OR, 1.03; 95% CI, 0.93-1.14), or cardiovascular death (OR, 1.00; 95% CI, 0.94-1.05).
Conclusions The ORs and CIs provide strong support for a lack of statistically significant or clinically important effects of vitamin E on cardiovascular disease. The use of agents of proven lack of benefit, especially those easily available over the counter, may contribute to underuse of agents of proven benefit and failure to adopt healthy lifestyles.
From the Agatston Research Institute, Miami Beach, Fla (Drs Eidelman, Hollar, and Hennekens); Department of Cardiology, Mount Sinai Medical Center/Miami Heart Institute, Miami Beach, Fla (Dr Lamas); Departments of Medicine (Drs Hollar, Lamas, and Hennekens) and Epidemiology and Public Health (Dr Hennekens), University of Miami School of Medicine, Miami, Fla; and Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Conn (Dr Hebert). Dr Hennekens is funded by the Agatston Research Institute, a nonprofit foundation, as Director of Research. He serves as consultant, including as chairperson or member of data and safety monitoring boards, to AstraZeneca, Bayer, Bristol-Myers Squibb, Chattem, Delaco, the Food and Drug Administration, GlaxoSmithKline, McNeil, the National Institutes of Health, Novartis, Pfizer, Reliant, and TAP. He receives royalties for authorship or editorship of 3 textbooks and as coinventor, with Paul M. Ridker, MD, for patents concerning inflammatory markers and cardiovascular disease held by Brigham and Women's Hospital.
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