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QUESTION: In patients with ≥1 cardiovascular risk factor but no history of cardiovascular disease, how effective is treatment with aspirin and vitamin E in preventing cardiovascular events?
Design
Randomised (allocation concealed*), unblinded,* 2 × 2 factorial trial with mean 3.6 years of follow up.
Setting
315 general practices and 15 hospital hypertension units in Italy.
Patients
4495 patients who were ≥50 years of age (mean age 64 y, 58% women) and had ≥1 major cardiovascular risk factor: age ≥65 years, hypertension, hypercholesterolaemia, diabetes mellitus, obesity, and family history of myocardial infarction (MI) before 55 years of age in ≥1 parent or sibling. Exclusion criteria were treatment with antiplatelet drugs, chronic use of anti-inflammatory agents or anticoagulants, contraindication to aspirin, disease with …
Footnotes
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Sources of funding: Medical Department of Bayer Italy; aspirin preparation supplied by Bayer; vitamin E capsules supplied by Bracco SpA.
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For correspondence: Dr M C Roncaglioni, Istituto di Ricerche Farmacologiche “Mario Negri,” Via Eritrea 62, 20157 Milan, Italy. Fax +39 02 39001916.
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A modified version of this abstract also appears in Evidence-Based Nursing.