Long-Term, Low-Dose Aspirin May Not Prevent Type 2 Diabetes in Healthy Women

Laurie Barclay, MD

December 31, 2008

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December 31, 2008 — Long-term, low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women, according to the results of a randomized controlled trial reported in the January 2009 issue of Diabetes Care.

"Subclinical inflammation is linked with the development of type 2 diabetes, and epidemiologic data suggest that this association may be stronger in women," write Aruna D. Pradhan, MD, from Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts, and colleagues. "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."

The Women's Health Study was a 10-year, randomized, double-blind, placebo-controlled trial of aspirin and vitamin E for primary prevention of cardiovascular disease and cancer in women who were at least 45 years old at study entry from 1992 to 1995. There were 38,716 participants free of clinical diabetes at baseline who were randomly assigned to receive either low-dose aspirin (n = 19,326) or placebo (n = 19,390).

During follow-up (median duration, 10.2 years), there were 849 cases of documented clinical type 2 diabetes in the aspirin group and 847 cases in the placebo group (rate ratio, 1.01; 95% confidence interval, 0.91 - 1.11; P = NS). Stratification by diabetes risk factors including age, body mass index, family history of diabetes, physical activity, hemoglobin A1c levels, and high-sensitivity C-reactive protein levels did not change this finding, nor did treatment duration or adherence.

"These data suggest that long-term low-dose aspirin does not prevent the development of clinical type 2 diabetes in initially healthy women," the study authors write.

Limitations of this study include the lack of systematic screening for more sensitive measures of glucose intolerance and insulin resistance during follow-up.

"Aspirin at a dose of 100 mg on alternate days is not effective for the prevention of clinical type 2 diabetes among otherwise healthy women at generally low risk for this disease," the study authors conclude. "Our data do not pertain to other salicylate agents currently being evaluated for diabetes treatment or to intermediate or high doses of long-term aspirin in primary prevention. However, even at the low dose evaluated in this trial, the use of aspirin was associated with a significant increase in clinically important bleeding events and any potential benefit at higher doses, if found, must take into account this potential for excess risk."

The National Heart, Lung, and Blood Institute and the National Cancer Institute (Bethesda, Maryland) supported this study. Bayer HealthCare provided aspirin and aspirin placebo. The Natural Source Vitamin E Association provided vitamin E and vitamin E placebo. The study authors have disclosed no relevant financial relationships. The costs of publication of this article were defrayed in part by the payment of page charges, mandating that it must therefore be marked "advertisement" solely to indicate this fact.

Diabetes Care. 2009;32:3-8.

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