Abstract
This review examines ulcers and gastrointestinal bleeding with low‐dose aspirin, focusing on randomized placebo‐controlled trials. The single endoscopic trial assessing ulcers showed no significant difference in 12‐week ulcer incidence: 6% of 381 given placebo vs. 7% of 387 given 81 mg enteric‐coated aspirin. The relative risk of major gastrointestinal bleeding with low‐dose aspirin in a meta‐analysis of placebo‐controlled trials of vascular protection was 2.07 (95% CI: 1.61–2.66). The absolute rate increase with aspirin above placebo was 0.12% per year (95% CI: 0.07–0.19%) with a number‐needed‐to‐harm of 833 patients (95% CI: 526–1429). A meta‐analysis of aspirin 50–1500 mg daily reported an odds ratio for any gastrointestinal bleeding of 1.68 (95% CI: 1.51–1.88) with an number‐needed‐to‐harm at 1 year of 247. The relative risk of hospitalization for upper gastrointestinal bleeding with low‐dose aspirin in a large Danish cohort study was 2.6 (95% CI: 2.2–2.9) with an absolute annual incidence of 0.6%. Factors that may increase the risk of gastrointestinal bleeding include prior history of ulcers or gastrointestinal bleeding, corticosteroid use, anticoagulant therapy and addition of a non‐aspirin non‐steroidal anti‐inflammatory drug. When determining whether low‐dose aspirin is appropriate for an individual patient, the cardiovascular benefit must be weighed against the potential for clinical events such as gastrointestinal bleeding.