Aspirin for primary prevention of cardiovascular outcomes in diabetes mellitus: An updated systematic review and meta-analysis.

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,  = 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,  = 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,  = 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,  = 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,  = 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.