August 09, 2012
2 min read

Aspirin use and risk for bleeding in primary prevention

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As I’m sure you are aware, the American Diabetes Association offers some recommendations on aspirin use in patients with diabetes. Aspirin has been shown to reduce cardiovascular events and death in high-risk patients with previous myocardial infarction or stroke, so its use in these patients is pretty straight forward.

In primary prevention they recommend low-dose aspirin therapy be considered in those with type 1 or type 2 diabetes at increased CV risk (10-year risk >10%). This includes most men aged older than 50 years or women aged older than 60 years who have at least one additional major risk factor (family history of CVD, hypertension, smoking, dyslipidemia or albuminuria). They go on to state that aspirin should not be recommended for CVD prevention for adults with diabetes at low CVD risk (10-year CVD risk <5%, such as in men aged younger than 50 years and women aged younger than 60 years with no major additional CVD risk factors), since the potential adverse effects from bleeding likely offset the potential benefits. In patients in these age groups with multiple other risk factors (those with 10-year risk between 5% and 10%), clinical judgment is required.

James R. Taylor

Consider risks, benefits

It’s in the primary prevention group where clinicians must really weigh the potential benefits (CVD prevention) and risks (bleeding complications). The ADA clinical practice recommendations go on to state that the excess risk for gastrointestinal bleeding with aspirin use may be as high as one to five cases per 1,000 per year in real-world settings. Finally, they state that in adults with CVD risk >1% per year, the number of CVD events prevented will be similar to or greater than the number of episodes of bleeding induced, although these complications do not have equal effects on long-term health.

De Berardis and colleagues recently published the results of a population-based cohort study in Italy. They identified more than 186,000 new users of low-dose aspiring (<300 mg/day) and followed them during an average of almost 6 years to track hospital admissions for gastrointestinal bleeding or cerebral hemorrhage. They also followed 186,000 similarly matched individuals who were not prescribed long-term aspirin therapy to serve as a control group. The results showed that the overall incidence rate of hemorrhagic events was 5.58 (95% CI, 5.39-5.77) per 1,000 person-years for aspirin users and 3.60 (95% CI, 3.48-3.72) per 1,000 person-years for those without aspirin use (incidence rate ratio [IRR]=1.55; 95% CI, 1.48-1.63).

Aspirin’s efficacy

In the subgroup analysis, the use of aspirin was associated with a greater risk for major bleeding in most of the subgroups investigated but not in individuals with diabetes (IRR=1.09; 95% CI, 0.97-1.22). In those with diabetes, the incident rate for those taking aspirin was 5.83 (95% CI, 5.36-6.33) vs. 5.35 (95% CI, 4.97-5.76) in those not on long-term aspirin. Thus, while bleeding complications were relatively high in those who had diabetes, the addition of low-dose aspirin did not significantly increase the risk for bleeds.


The fact that bleeding did not increase in this population with the addition of aspirin may be explained by a reduced efficacy (reduced platelet inhibition) of aspirin in those with diabetes. Thus, while aspirin may be less likely to cause bleeds in patients with diabetes, it may be less effective in preventing CVD events, especially in primary prevention.

  • De Berardis G. JAMA. 2012;307:2286-2294.
  • The researchers report no relevant financial disclosures.

For more information:
  • James R. Taylor, PharmD, CDE, is a clinical associate professor in the department of pharmacy practice at the University of Florida, Gainesville.