Risk of Major Gastrointestinal Bleeding Among Dabigatran Users: A Population-Based, New-User, Self-Controlled Study
cardiovascular disease, observational studies, patient safety, epidemiology, pharmaceuticals, costs
Background: Dabigatran is an oral anticoagulant approved for stroke prevention among patients with atrial fibrillation. Our objective was to evaluate the real-world risk of major gastrointestinal bleeding among dabigatran users.
Methods: We adopted a new-user, self-controlled case series design to reduce confounding by indication. We sampled 1,215 eligible participants who were continuous adult commercial users in a large administrative claims database between July 1, 2010, and March 31, 2012, with use of dabigatran and at least one major gastrointestinal bleeding episode. We used a conditional Poisson regression to estimate incidence rate ratio (IRR) after adjusting for various confounders.
Results: The population consisted of 64.49% of male and 61.81% elderly patients (ie, age ≥ 65 years). After adjustment for time-variant confounders, including bleeding-related comorbidities and concomitant medication use, the incidence rate of major gastrointestinal bleeding was 13% higher during dabigatran risk period compared with the nonexposed period (95% confidence interval [CI]: 0.99–1.27). There was no significant difference between periods of dabigatran and warfarin use (IRR: 1.02, 95% CI: 0.77–1.34).
Conclusion: This study should help the clinicians prescribe the appropriate anticoagulant for patients together with other studies on the efficacy, effectiveness and safety of anticoagulant.
Tang W, Chang HY, Zhou M, Singh S. Risk of major gastrointestinal bleeding among dabigatran users: a population-based, new-user, self-controlled study. J Patient Cent Res Rev. 2017;4:181.