Abstract 3503: Low Dose Aspirin and Incident Diabetes Mellitus in Apparently Healthy Middle-Aged American Women - the Women’s Health Study
Introduction: Inflammation is linked with the development of type 2 diabetes. Epidemiologic data suggest this association may be stronger in women and clinical studies demonstrate that short-term high-dose aspirin has a prominent hypoglycemic effect. However, to date, no randomized trials have directly evaluated the efficacy of aspirin in the prevention of type 2 diabetes at doses acceptable for use in routine clinical practice.
Hypothesis: We assessed the hypothesis that treatment with low-dose aspirin reduces the incidence of type 2 diabetes among initially healthy middle-aged American women.
Methods: Subjects were enrolled in the Women’s Health Study, a randomized clinical trial of aspirin and vitamin E for primary prevention of cardiovascular disease and cancer in which subjects were also monitored for the clinical occurrence of type 2 diabetes. Between 1992 and 1995, 38,716 women aged ≥ 45 years and free of diabetes, cancer, and cardiovascular disease were randomized to either low-dose aspirin (100 mg on alternate days) or placebo. During the randomized treatment period (median follow-up = 10 years), 1,696 cases of confirmed clinical type 2 diabetes accrued.
Results: There were 849 cases in the aspirin group and 847 in the placebo group (HR 1.01; CI 1.00 to 1.02). Stratification of the population by diabetes risk factors including age, BMI, physical activity, postmenopausal hormone use, family history of diabetes, and high-sensitivity C-reactive protein levels (n = 27,167) had no effect on this main finding. Analyses accounting for adherence to randomized treatment also failed to show a beneficial effect.
Conclusions: Chronic low-dose aspirin does not prevent the development of type 2 diabetes in apparently healthy middle-aged and older American women.