Department of Family Medicine and Community Health
Chemicals and Drugs | Clinical Epidemiology | Digestive System Diseases | Epidemiology | Pathological Conditions, Signs and Symptoms
This article aims to evaluate the real world risk of gastrointestinal bleeding among users naive to dabigatran. We adopted a self-controlled case series design. We sampled 1215 eligible adult participants who were continuous insured users between July 1, 2010 and March 31, 2012 with use of dabigatran and at least one gastrointestinal bleeding episode. We used a conditional Poisson regression to estimate incidence rate ratios. The population consisted of 64.69% of male and 60.25% patients equal to or greater than age 65 at start of observation. After adjustment for time-variant confounders, the incidence rate of gastrointestinal bleeding was similar during dabigatran risk period and non-exposed period (incidence rate ratio [IRR] = 1.01, 95% confidence interval [CI] 0.90, 1.15). There was no significant difference in GI incidence rate between periods of dabigatran and warfarin (IRR = 0.99, 95% CI 0.75-1.31). Among this database of young and healthy participants, dabigatran was not associated with increased incidence rate of GI bleeding compared with non-exposed period among naive dabigatran users. We did not detect an increased risk of GI bleeding over dabigatran vs warfarin risk period. Along with other studies on safety and effectiveness, this study should help clinicians choose the appropriate anticoagulant for their patients.
Rights and Permissions
Copyright © 2017, The Author(s). Citation: Sci Rep. 2017 Jan 20;7:40120. doi: 10.1038/srep40120. Link to article on publisher's site
DOI of Published Version
Gastrointestinal Bleeding, Dabigatran
Tang, Wenze; Chang, Hsien-Yen; Zhou, Meijia; and Singh, Sonal, "Risk of Gastrointestinal Bleeding Among Dabigatran Users - A Self Controlled Case Series Analysis" (2017). Open Access Articles. 3063.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.