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Self-Selected Posttrial Aspirin Use and Subsequent Cardiovascular Disease and Mortality in the Physicians' Health Study
Nancy R. Cook, ScD;
Patricia R. Hebert, PhD;
JoAnn E. Manson, MD;
Julie E. Buring, ScD;
Charles H. Hennekens, MD
Arch Intern Med. 2000;160:921-928.
Background The randomized aspirin component of the Physicians' Health Study (PHS) was terminated early, after 5 years, primarily because of the emergence of a statistically extreme (P<.00001) 44% reduction of first myocardial infarction (MI) among those assigned to aspirin. As a result, there were insufficient numbers of strokes or cardiovascular disease (CVD)–related deaths to evaluate these end points definitively.
Methods Data on self-selected aspirin use were collected until the beta carotene component ended as scheduled after 12 years. Posttrial use of aspirin was assessed at the 7-year follow-up among 18 496 participants with no previous reported CVD. Randomized and posttrial observational results in the PHS were compared, and differences between those self-selecting aspirin and those not were examined.
Results At 7 years, 59.5% of participants without CVD reported self-selected aspirin use for at least 180 d/y, and 20.8% for 0 to 13 d/y. Use was significantly associated with family history of MI, hypertension, elevated cholesterol levels, body mass index, alcohol consumption, exercise, and use of vitamin E supplements. In multivariate analyses, self-selected aspirin use for at least 180 vs 0 to 13 d/y was associated with lower risk for subsequent MI (relative risk [RR], 0.72; 95% confidence interval [CI], 0.55-0.95), no relation with stroke (RR, 1.02; 95% CI, 0.74-1.39), and significant reductions in CVD-related (RR, 0.65; CI, 0.47-0.89) and total mortality (RR, 0.64; CI, 0.54-0.77).
Conclusion These associations between self-selected aspirin use and CVD risk factors increase the likelihood of residual confounding and emphasize the need for large-scale randomized trials, such as the ongoing Women's Health Study, to detect reliably the most plausible small to moderate effects of aspirin in the primary prevention of stroke and CVD-related death.
From the Division of Preventive Medicine, Department of Medicine (Drs Cook, Manson, and Buring), and the Department of Ambulatory Care and Prevention (Dr Buring), Brigham and Women's Hospital, Harvard Medical School, and the Department of Epidemiology, Harvard School of Public Health (Drs Manson and Buring), Boston, Mass; and the Departments of Preventive Medicine and Medicine, Vanderbilt University School of Medicine, Nashville, Tenn (Dr Hebert). Dr Hennekens is now Visiting Professor of Medicine, and Epidemiology and Public Health at the University of Miami School of Medicine, Miami, Fla.
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