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Age-Related Maculopathy in a Randomized Trial of Low-Dose Aspirin Among US Physicians
William G. Christen, ScD;
Robert J. Glynn, ScD;
Umed A. Ajani, MBBS;
Debra A. Schaumberg, ScD;
Emily Y. Chew, MD;
Julie E. Buring, ScD;
JoAnn E. Manson, MD;
Charles H. Hennekens, MD
Arch Ophthalmol. 2001;119:1143-1149.
Objective To examine the development of age-related maculopathy (ARM) in a large-scale
trial of low-dose aspirin treatment.
Methods The Physicians' Health Study I was a randomized, double-masked, placebo-controlled
trial of low-dose aspirin (325 mg every other day) and beta carotene (50 mg
every other day) in the prevention of cardiovascular disease and cancer conducted
among 22 071 US male physicians aged 40 to 84 years in 1982. A total
of 21 216 participants did not report ARM at baseline, were followed
up for at least 7 years, and are included in this analysis.
Main Outcome Measures Total ARM, defined as a self-report confirmed by medical record evidence
of an initial diagnosis subsequent to randomization, and ARM with vision loss,
defined as total ARM but with vision loss to 20/30 or worse attributable to
ARM.
Results Early termination of the randomized aspirin component of the Physicians'
Health Study I, after an average of 60.2 months of treatment and follow-up
due to a statistically extreme 44% reduced risk of first myocardial infarction,
resulted in a far lower number of incident cases of ARM during the aspirin
treatment period than would have accrued without early termination. Thus,
during an average of 60.2 months of follow-up, a total of 117 cases of ARM
were confirmed, including 57 cases responsible for vision loss to 20/30 or
worse. There were 51 cases of ARM in the aspirin group and 66 in the placebo
group (relative risk, 0.77; 95% confidence interval, 0.54-1.11). For ARM with
vision loss, there were 25 cases in the aspirin group and 32 in the placebo
group (relative risk, 0.78; 95% confidence interval, 0.46-1.32).
Conclusions These randomized trial data tend to exclude any large beneficial effect
of 5 years of low-dose aspirin treatment on ARM. However, a smaller, but potentially
important, beneficial effect cannot be ruled out and would require testing
in randomized trials of adequate size and duration.
From the Division of Preventive Medicine, Department of Medicine (Drs
Christen, Glynn, Ajani, Schaumberg, Buring, and Manson), the Department of
Ambulatory Care and Prevention (Dr Buring), and Channing Laboratory, Department
of Medicine (Dr Manson), Harvard Medical School and Brigham and Women's Hospital,
Boston, Mass; the Departments of Biostatistics (Dr Glynn) and Epidemiology
(Drs Buring and Manson), Harvard School of Public Health, Boston; and the
National Eye Institute, Bethesda, Md (Dr Chew). Dr Hennekens is a Visiting
Professor of Medicine and of Epidemiology and Public Health, University of
Miami School of Medicine, Miami, Fla.
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