title: Risk of Gastrointestinal Bleeding Among Dabigatran Users - A Self Controlled Case Series Analysis.
abstract: This article aims to evaluate the real world risk of gastrointestinal bleeding among users naïve 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 naïve 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.
authors.affiliation: Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, District of Columbia, USA.
authors.forename: Wenze
authors.initials: W
authors.lastname: Tang
authors.affiliation: Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.|Department of Health Policy &Management, Bloomberg School of Public Health, Baltimore, USA.
authors.forename: Hsien-Yen
authors.initials: HY
authors.lastname: Chang
authors.affiliation: Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
authors.forename: Meijia
authors.initials: M
authors.lastname: Zhou
authors.affiliation: Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.|Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, Maryland, USA.|Department of Family Medicine and Community Health, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Sonal
authors.initials: S
authors.lastname: Singh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000009:adverse effects* / Q000627:therapeutic use; D000069604:Dabigatran / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D000991:Antithrombins; D000069604:Dabigatran