UMMS Affiliation

Department of Family Medicine and Community Health

Publication Date


Document Type



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.


Gastrointestinal Bleeding, Dabigatran

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Copyright © 2017, The Author(s).

DOI of Published Version



Sci Rep. 2017 Jan 20;7:40120. doi: 10.1038/srep40120. Link to article on publisher's site

Journal/Book/Conference Title

Scientific reports

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Link to Article in PubMed

PubMed ID


Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.



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