The Unique Role of Low-Dose Aspirin in Diabetes: Evidence of Reduced TIA Without Increased Major Harm - A Systematic Review and Meta-Analysis of Trials Using Strict Low-Dose Aspirin Monotherapy

Introduction: Aspirin is established for secondary cardiovascular prevention, but its efficacy for primary prevention in diabetes mellitus (DM) is uncertain due to bleeding risks. This review aimed to determine if aspirin reduces cardiovascular events in adults with DM compared with placebo and to assess bleeding risks. Research Design and Methods: We searched PubMed, Google Scholar, and Cochrane Library (inception–Sep 30, 2025) for randomized clinical trials (RCTs) comparing aspirin with placebo for primary prevention in DM. RevMan 5.4 was used to calculate risk ratios (RRs) with 95% confidence intervals (CIs) using random-effects models. Primary outcomes were TIA, stroke, and MI; adverse events included gastrointestinal bleeding. Results: Five RCTs (45,286 patients) were included. Aspirin significantly reduced TIA (RR 0.84; 95% CI 0.71–0.99). Differences for nonfatal MI (RR 0.94; 95% CI 0.76–1.15) and combined stroke (RR 0.88; 95% CI 0.67–1.16) were non-significant. Aspirin was associated with increased gastrointestinal bleeding risk (RR 1.36; 95% CI 0.85–2.17). Conclusions: In this meta-analysis of 45,286 diabetic patients, aspirin reduced TIA but did not significantly affect nonfatal MI or stroke, while increasing gastrointestinal bleeding risk.