Aspirin Use May Increase Risk of Major Bleeding


Aspirin use among patients without diabetes was significantly associated with a higher risk of major gastrointestinal or cerebral bleeding, according to a study published in the June 6 JAMA. Aspirin use did not augment the risk of bleeding among patients with diabetes, but diabetes was independently associated with an increased risk of major bleeding.

Giorgia De Berardis of Consorzio Mario Negri Sud in Santa Maria Imbaro, Italy, and her colleagues studied 186,425 patients treated with aspirin and 186,425 controls to determine the incidence of major gastrointestinal and intracranial bleeding in individuals with and without diabetes. Over the median follow-up of 5.7 years, the incidence rate of hemorrhagic events was 5.58 per 1,000 person-years for patients taking aspirin, compared with 3.60 per 1,000 person-years for controls.

“The excess number of major bleeding events associated with … aspirin is of the same magnitude of the number of major cardiovascular events avoided in the primary prevention setting for individuals with a 10-year risk of between 10% and 20%,” said Ms. De Berardis.

“Findings from the study by De Berardis et al reinforce the European recommendations for aspirin use,” said Jolanta M. Siller-Matula, MD, PhD, Junior Professor of Cardiology at the Medical University of Vienna, in an accompanying editorial. “Perhaps the most important contribution of the study by De Berardis et al is the addition of a large number of patients … and especially of patients with diabetes … that far exceed the numbers included in previous analyses ... Moreover, the report is important because the risk of bleeding associated with aspirin use was assessed in real-world patients.”

De Berardis G, Lucisano G, D’Ettorre A, et al. Association of aspirin use with major bleeding in patients with and without diabetes. JAMA. 2012;307(21):2286-2294.
Siller-Matula JM. Hemorrhagic complications associated with aspirin: an underestimated hazard in clinical practice? JAMA. 2012;307(21):2318-2320.

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