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(Circulation. 1999;100:e126.)
© 1999 American Heart Association, Inc.
Circulation Electronic Pages |
From St Lukes Episcopal Hospital, Texas Heart Institute, Baylor College of Medicine, The University of Texas Health Science Center at Houston.
| Introduction |
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| Vascular Disease |
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The study: A large-scale multicenter (267 hospitals in 19 countries), randomized, placebo-controlled trial of ACE-inhibitor therapy and vitamin E supplementation in patients at high risk for vascular events. Inclusion criteria included age >55 years and evidence of vascular disease (coronary heart disease, stroke, and peripheral vascular disease, or diabetes and 1 other cardiovascular risk factor). Patients with heart failure, a low ejection fraction, current ACE-inhibitor or vitamin E therapy, or acute events within the previous 4 weeks were excluded. A total of 9541 qualifying patients were randomized in a 2x2 factorial design to ramipril (up to 10 mg/d) or placebo and vitamin E (400 IU/d) or placebo and were followed up for 4 to 6 years. The primary end point of the study was the composite of cardiovascular death, myocardial infarction (MI), and stroke. Secondary end points included revascularization and the development of congestive heart failure (CHF), unstable angina, or complications of diabetes. The study was terminated at 4.5 years because of convincing benefit in the ramipril group.
The results: Vitamin E therapy was not associated with any
significant clinical benefit. Composite primary outcome events occurred
in 16% of the vitamin E group and 15.4% of the placebo
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