Statin Use and Gastrointestinal Hemorrhage: A Large Retrospective Cohort Study

Background: Nearly 70% of Americans with cardiovascular disease use statins, which have documented bleeding effects independent of their cholesterol-lowering activities. However, the literature is conflicting regarding the association between statin use and gastrointestinal hemorrhage. Objectives: The aim of this study was to investigate the risk of gastrointestinal hemorrhage in statin users. Methods: In this retrospective cohort study, data from the Truven Health MarketScan ^® Research Database (2009–2015) were used to investigate the risk of gastrointestinal hemorrhage amongst statin users aged 30–65 years at the initial prescription claim. Statin users and a group of negative controls (i.e. other chronic medication users) were followed until first gastrointestinal hemorrhage event (both inpatient and outpatient, as well as restricted to inpatient), and were censored at treatment discontinuation, disenrollment from coverage, or the end of the study period. Results: Statin users had an elevated risk of gastrointestinal hemorrhage, which was especially apparent in the first year of treatment (1-year adjusted hazard ratio 1.19; 95% confidence interval (CI) 1.15–1.23). The risk of gastrointestinal hemorrhage leading to hospitalization was even higher (1-year adjusted hazard ratio 1.38; 95% CI 1.30–1.69). High-intensity statin users had a greater rate of gastrointestinal hemorrhage than moderate-intensity users (incidence rates per 1000 subject-years 22.2 (95% CI 21.9–22.8) vs. 21.5 (95% CI 21.3–21.8), respectively). Conclusions: In a population of commercially insured subjects aged 30–65 years, statin users had a higher risk for gastrointestinal hemorrhage than other chronic medication users. These findings are important when treating patients at a high risk for bleeding events.