Article Title

Risk of Major Gastrointestinal Bleeding Among Dabigatran Users: A Population-Based, New-User, Self-Controlled Study

Publication Date



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.




June 28th, 2017


August 10th, 2017