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Risks cancel benefits of aspirin in diabetes

By Colin Kenny, Editor – Diabetes Distilled

Investigators examined whether aspirin reduced the risk of a first serious vascular event in people living with diabetes who did not have established atherosclerotic cardiovascular disease. The trial showed that although aspirin reduced serious vascular events in people with diabetes and no evidence of cardiovascular disease at trial entry, it also caused major bleeding events. The absolute benefits were counterbalanced by the bleeding hazard. 

A Study of Cardiovascular Events iN Diabetes (ASCEND) examined whether aspirin reduced the risk of a first cardiovascular event in people living with diabetes. This UK study randomly assigned 15,480 patients with diabetes and no evident or manifest history of cardiovascular disease to aspirin (100 mg daily) or placebo between 2005 and 2011. Investigators matched the placebo group for length of diabetes, smoking status, treatment of hypertension and statin use. 

Participants were followed for an average of 7.4 years, during which 685 (8.5%) participants allocated aspirin and 743 (9.6%) allocated placebo experienced a first serious vascular event. There was a 12% proportional reduction in the risk of serious vascular events.

Despite the positive impact of aspirin on vascular events, a first major bleed occurred in 314 (4.1%) participants allocated aspirin compared to 245 (3.2%) participants allocated placebo. This meant nine out of every 1,000 participants suffered a first major bleed during the trial as a result of allocation to aspirin. This represented a 29% proportional increase in the risk, most of which was gastrointestinal bleeding or other extracranial bleeding.

Over 7.4 years, 91 people needed to be treated with aspirin to avoid one serious vascular event. When offset against the increased risk of major bleeding, there were no absolute benefits associated with taking aspirin.

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