A Randomized Trial of Low-Dose Aspirin in the Prevention of Clinical Type 2 Diabetes in Women
- Aruna D. Pradhan, MD1234,
- Nancy R. Cook, SCD123,
- JoAnn E. Manson, MD3,
- Paul M. Ridker, MD12356 and
- Julie E. Buring, SCD13
- 1Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- 2Donald W. Reynolds Center for Cardiovascular Research, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- 3Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- 4Division of Cardiology, VA Boston Medical Center, Boston, Massachusetts
- 5Leducq Center for Molecular and Genetic Epidemiology of Cardiovascular Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- 6Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- Corresponding author: Aruna D. Pradhan, apradhan{at}partners.org
Abstract
OBJECTIVE—Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women. Although small clinical studies have shown a prominent hypoglycemic effect of short-term high-dose aspirin, no randomized trials have directly evaluated the efficacy of aspirin in diabetes prevention at doses acceptable for use in routine clinical practice. We evaluated whether chronic low-dose aspirin prevents the development of clinical diabetes among initially healthy American women.
RESEARCH DESIGN AND METHODS—Subjects were enrolled in the Women's Health Study, a 10-year randomized double-blind, placebo-controlled trial of aspirin and vitamin E for primary prevention of cardiovascular disease and cancer. Between 1992 and 1995, 38,716 women aged ≥45 years and free of clinical diabetes were randomly assigned to either low-dose aspirin or placebo (median follow-up 10.2 years). Documented clinical type 2 diabetes was prospectively evaluated throughout the trial.
RESULTS—Among women randomly assigned to receive aspirin (n = 19,326) or placebo (n = 19,390), there was no statistically significant difference in the incidence of type 2 diabetes. There were 849 cases of diabetes in the aspirin group and 847 in the placebo group (rate ratio 1.01 [95% CI 0.91–1.11]). Stratification by diabetes risk factors including age, BMI, family history of diabetes, physical activity, A1C, and high-sensitivity C-reactive protein did not support a modulating effect of these variables. Analyses accounting for treatment duration and adherence similarly found no beneficial effects.
CONCLUSIONS—These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women.
Footnotes
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Published ahead of print at http://care.diabetesjournals.org on 3 October 2008.
Clinical trial reg. no. NCT00000479, clinicaltrials.gov.
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- Accepted September 18, 2008.
- Received July 1, 2008.
- DIABETES CARE
