In a population-based cohort, aspirin use was significantly associated with an increased risk of major gastrointestinal or cerebral bleeding episodes, according to a study published June 5 in the Journal of the American Medical Association (JAMA). Patients with diabetes had a high rate of bleeding that was not independently associated with aspirin use.

The study, which looked at 186,425 patients being treated with low-dose aspirin and the same number of control patients not using aspirin, is thought to be the first longitudinal study specifically examining the role of diabetes in the incidence of major bleeding in a cohort of individuals, irrespective of the use of aspirin.

Results indicate that aspirin was associated with a 55 percent increase in major bleeding – a finding that suggests the incidence of major bleeding events is much higher than previously shown in other randomized, prospective clinical trials. There also was a higher risk of bleeding among aspirin users younger than 50, in those being treated for hypertension and those using aspirin to relieve pain.

Patients with diabetes who were not on aspirin therapy had a higher risk of baseline bleeding compared to patients without the disease. However, patients without diabetes who used aspirin had an increased risk of bleeding. "Diabetes might represent a different population in terms of both expected benefits and risk associated with antiplatelet therapy," the study authors said.

Based on these results, the study authors suggest that "weighing the benefits of aspirin therapy against the potential harms is of particular relevance in the primary prevention setting, in which benefits seem to be lower than expected based on results in high-risk populations."

Currently, low-dose aspirin therapy is recommended as a secondary prevention measure for patients with moderate to high risk of cardiovascular events. For patients with diabetes, the American Diabetes Association recommends low-dose aspirin use for those with no previous history of vascular disease, but who have a 10-year risk of cardiovascular events greater than 10 percent and who are not at increased risk for bleeding.

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