Risk of gastrointestinal bleeding with dabigatran: a head-to-head comparative study with rivaroxaban

Digestion. 2014;90(2):137-46. doi: 10.1159/000365967. Epub 2014 Oct 1.

Abstract

Introduction: 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).

Conclusion: Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antithrombins / adverse effects*
  • Benzimidazoles / adverse effects*
  • Dabigatran
  • Factor Xa Inhibitors / adverse effects*
  • Female
  • Gastrointestinal Hemorrhage / chemically induced*
  • Gastrointestinal Hemorrhage / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Morpholines / adverse effects*
  • Retrospective Studies
  • Risk Factors
  • Rivaroxaban
  • Thiophenes / adverse effects*
  • beta-Alanine / adverse effects
  • beta-Alanine / analogs & derivatives*

Substances

  • Antithrombins
  • Benzimidazoles
  • Factor Xa Inhibitors
  • Morpholines
  • Thiophenes
  • beta-Alanine
  • Rivaroxaban
  • Dabigatran