title: Issues in the early termination of the aspirin component of the Physicians' Health Study. Data Monitoring Board of the Physicians' Health Study.
abstract: The Physicians' Health Study is a randomized, double-blind, placebo-controlled prevention trial of 22,071 US physicians, using a factorial design to evaluate the role of aspirin in the prevention of cardiovascular mortality and beta carotene in the reduction of cancer incidence. After approximately 5 years of follow-up, the aspirin component was terminated, 3 years ahead of schedule. Several factors were considered in the decision to terminate, including a cardiovascular mortality rate markedly lower than expected in both aspirin and placebo subjects, precluding the evaluation of the primary aspirin hypothesis, and a highly significant (P < .00001) and impressive (44%) reduction in the risk of first myocardial infarction in the aspirin group. Issues in the decision to terminate are described in this report.
authors.affiliation: Harvard School of Public Health, Boston, MA.
authors.forename: J
authors.initials: J
authors.lastname: Cairns
authors.forename: L
authors.initials: L
authors.lastname: Cohen
authors.forename: T
authors.initials: T
authors.lastname: Colton
authors.forename: D L
authors.initials: DL
authors.lastname: DeMets
authors.forename: D
authors.initials: D
authors.lastname: Deykin
authors.forename: L
authors.initials: L
authors.lastname: Friedman
authors.forename: P
authors.initials: P
authors.lastname: Greenwald
authors.forename: G B
authors.initials: GB
authors.lastname: Hutchison
authors.forename: B
authors.initials: B
authors.lastname: Rosner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D002338:Carotenoids / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000401:mortality / Q000517:prevention & control*; D010820:Physicians; D019207:beta Carotene
chemical_list: D019207:beta Carotene; D002338:Carotenoids; D001241:Aspirin