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Previous Volume 342:154-160 January 20, 2000 Number 3 Next

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ABSTRACT

Background Observational and experimental studies suggest that the amount of vitamin E ingested in food and in supplements is associated with a lower risk of coronary heart disease and atherosclerosis.

Methods We enrolled a total of 2545 women and 6996 men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor. These patients were randomly assigned according to a two-by-two factorial design to receive either 400 IU of vitamin E daily from natural sources or matching placebo and either an angiotensin-converting–enzyme inhibitor (ramipril) or matching placebo for a mean of 4.5 years (the results of the comparison of ramipril and placebo are reported in a companion article). The primary outcome was a composite of myocardial infarction, stroke, and death from cardiovascular causes. The secondary outcomes included unstable angina, congestive heart failure, revascularization or amputation, death from any cause, complications of diabetes, and cancer.

Results A total of 772 of the 4761 patients assigned to vitamin E (16.2 percent) and 739 of the 4780 assigned to placebo (15.5 percent) had a primary outcome event (relative risk, 1.05; 95 percent confidence interval, 0.95 to 1.16; P=0.33). There were no significant differences in the numbers of deaths from cardiovascular causes (342 of those assigned to vitamin E vs. 328 of those assigned to placebo; relative risk, 1.05; 95 percent confidence interval, 0.90 to 1.22), myocardial infarction (532 vs. 524; relative risk, 1.02; 95 percent confidence interval, 0.90 to 1.15), or stroke (209 vs. 180; relative risk, 1.17; 95 percent confidence interval, 0.95 to 1.42). There were also no significant differences in the incidence of secondary cardiovascular outcomes or in death from any cause. There were no significant adverse effects of vitamin E.

Conclusions In patients at high risk for cardiovascular events, treatment with vitamin E for a mean of 4.5 years has no apparent effect on cardiovascular outcomes.

Source Information

The writing group (Salim Yusuf, D.Phil., Gilles Dagenais, M.D., Janice Pogue, M.Sc., Jackie Bosch, M.Sc., and Peter Sleight, D.M.) assumes responsibility for the overall content and integrity of the manuscript.

Address reprint requests to Dr. Salim Yusuf at the Canadian Cardiovascular Collaboration Project Office, Hamilton General Hospital, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada, or at yusufs{at}fhs.mcmaster.ca.

Full Text of this Article

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Vitamin E Supplementation and Cardiovascular Events in High-Risk Patients
Jialal I., Devaraj S., Yusuf S.
Extract | Full Text  
N Engl J Med 2000; 342:1917-1918, Jun 22, 2000. Correspondence

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