New England Journal of Medicine · 1988 · 520 citations · 5 references
MedicinePharmacologyPreventive MedicineCancer PreventionCardiovascular PharmacotherapyClinical PharmacologyBenefit-risk AssessmentClinical TrialsEfficacy EvaluationPharmacoepidemiologyStudy DesignAspirin ChemopreventionAspirin Prevention TherapyCardiovascular Disease IncidenceCardiovascular Disease MortalityClinical Pharmacology EvidenceData MonitoringEarly Trial TerminationPlacebo-controlled Efficacy Assessment
The Physicians' Health Study is a randomized, double-blind, placebo-controlled trial testing two primary-prevention hypotheses: (1) whether 325 mg of aspirin (as Bufferin, supplied by Bristol-Myers Products) taken every other day reduces mortality from cardiovascular disease, and (2) whether 50 mg of beta carotene (as Lurotin, supplied by BASF) taken on alternate days decreases the incidence of cancer.1 At a special meeting on December 18, 1987, the external Data Monitoring Board of the Physicians' Health Study took the unusual step of recommending the early termination of the randomized aspirin component of the trial, primarily because a statistically extreme beneficial effect on . . .
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