Aspirin linked to high bleeding rate in diabetes

Jun 7 2012

By Piriya Mahendra

Diabetes may be associated with an increased risk for major bleeding irrespective of aspirin use, researchers say.

In the latest analysis of aspirin use for primary prevention, the drug was significantly associated with an increased risk for gastrointestinal or cerebral bleeding episodes. However, in patients with diabetes, the high rate of bleeding was not independently associated with aspirin use.

The population-based cohort study, published in JAMA, was conducted by Antonio Nicolucci (Consorzio Mario Negri Sud, Italy) and team. It included 186,425 patients who were treated with low-dose aspirin (≤300 mg) and 186,425 controls who did not use aspirin between January 2003 and December 2008.

During a median follow-up period of 5.7 years, the incidence of hemorrhagic events was 5.58 per 1000 person-years for aspirin users versus 3.60 per 1000 person-years for non-aspirin users, corresponding to an incidence rate ratio (IRR) of 1.55.

Aspirin use was associated with a significantly greater risk for major bleeding in most of the subgroups investigated, including gender, age, and hypertension. However, it was not associated with a significantly increased risk for bleeding in diabetes patients.

Moreover, the baseline risk for bleeding in the absence of aspirin therapy was higher among individuals with diabetes than those without diabetes, at 5.35 versus 3.32 events per 1000 person-years, whereas aspirin use was associated with a significantly higher bleeding risk in diabetes patients only (IR for gastrointestinal bleeding 1.08, intracranial bleeding 1.01).

The authors say that the lack of an excess bleeding risk in patients with diabetes "deserved additional consideration."

"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," they remark.

"Diabetes might represent a different population in terms of both expected benefits and risks associated with antiplatelet therapy," Nicolucci et al conclude.

In a related editorial, Jolanta Siller-Matula (Medical University of Vienna, Austria) states that Nicolucci and team's study reinforces European guidelines for aspirin use.

She adds: "Future studies investigating the risks and benefits for individual patients appear to be mandatory to help physicians appropriately make recommendations about aspirin use for primary prevention."

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