title: Risk of gastrointestinal bleeding with dabigatran: a head-to-head comparative study with rivaroxaban.
abstract: BACKGROUND
  The risk of gastrointestinal (GI) bleeding of dabigatran and rivaroxaban is relatively unexplored. The aim of our study was to compare this risk in both drugs.
  
  
  METHODS
  We examined the medical records of patients on either dabigatran or rivaroxaban from October 2010 to April 2013 in two hospitals.
  
  
  RESULTS
  A total of 374 patients (147 rivaroxaban vs. 227 dabigatran) were identified. GI bleeding occurred in 5.3% in the dabigatran when compared to 4.8% in the rivaroxaban group (p = 0.8215). Multivariate analysis showed that the odds of GI bleeding while on dabigatran for ≤40 days when compared to ≥40 days was 8.3 (p < 0.0001). In the rivaroxaban group, patients who were on the drug for ≤40 days had a higher incidence of bleeding when compared to those >40 days (OR = 2.8, p = 0.023). Concomitant use of antiplatelets (single or dual) or non-steroidal anti-inflammatory drugs was not associated with increased bleeding in the dabigatran group; however, the use of dual antiplatelet agents with rivaroxaban was associated with an increased risk of GI bleeding (OR = 7.4, p = 0.0378). Prior GI bleeding had a higher risk of bleeding in the rivaroxaban group (OR = 15.5, p = 0.0002).
  
  
  CONCLUSIONS
  Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.
authors.affiliation: Section of Gastroenterology and Hepatology, Georgia Regents University, Augusta, Ga., USA.
authors.forename: Muhammed
authors.initials: M
authors.lastname: Sherid
authors.forename: Humberto
authors.initials: H
authors.lastname: Sifuentes
authors.forename: Samian
authors.initials: S
authors.lastname: Sulaiman
authors.forename: Salih
authors.initials: S
authors.lastname: Samo
authors.forename: Husein
authors.initials: H
authors.lastname: Husein
authors.forename: Ruth
authors.initials: R
authors.lastname: Tupper
authors.forename: Dharma
authors.initials: D
authors.lastname: Thiruvaiyaru
authors.forename: Charles
authors.initials: C
authors.lastname: Spurr
authors.forename: Subbaramiah
authors.initials: S
authors.lastname: Sridhar
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000009:adverse effects*; D001562:Benzimidazoles / Q000009:adverse effects*; D000069604:Dabigatran; D065427:Factor Xa Inhibitors / Q000009:adverse effects*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects*; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D000069552:Rivaroxaban; D000069604:Dabigatran