Background

The safety and efficacy of aspirin for the primary prevention of cardiovascular disease in patients with diabetes mellitus remains controversial.

Design

A meta-analysis to investigate the effects of aspirin for the prevention of cardiovascular disease in diabetes mellitus.

Methods

Ten randomized controlled trials were selected using MEDLINE, EMBASE and CENTRAL databases until 27 September 2018. Risk ratios (RRs) with 95% confidence intervals (CIs) and risk differences (RDs) reported as incident events per 1000 person-years were calculated.

Results

In 33,679 patients, aspirin did not significantly reduce the risk of major adverse cardiovascular outcomes (RR 0.93, 95% CI 0.87–1.00, P = 0.06; RD −0.68 incident cases per 1000 person-years (95% CI −1.54, 0.17)), cardiovascular mortality (RR 0.95, 95% CI 0.83–1.09, P = 0.49; RD 0.11 incident cases per 1000 person-years (95% CI −0.80, 1.02)), myocardial infarction (RR 0.91, 95% CI 0.75–1.11, P = 0.36; RD −0.66 incident cases per 1000 person-years (95% CI −2.07, 0.75)), or stroke (RR 0.91, 95% C, 0.76–1.10, P = 0.33; RD −0.55 incident cases per 1000 person-years (95% CI −1.57, 0.47)). There was a significantly higher risk of total bleeding associated with aspirin (RR 1.29, 95% CI 1.07–1.55, P = 0.01; RD 1.49 incident cases per 1000 person-years (95% CI 0.36, 2.61)).

Conclusion

The use of aspirin for primary prevention of cardiovascular disease in patients with diabetes mellitus increases the risk of total bleeding without reducing the risk of major adverse cardiovascular outcomes.