Safety and effectiveness of dabigatran at 2 years: Final outcomes from Phase II of the GLORIA-AF registry program

Am Heart J. 2019 Dec:218:123-127. doi: 10.1016/j.ahj.2019.08.012.

Abstract

GLORIA-AF is a large, ongoing, prospective, global registry program run in 3 phases, assessing long-term safety and effectiveness of dabigatran etexilate (dabigatran) in patients with newly diagnosed atrial fibrillation (AF) in clinical practice. This report provides the final analysis of 2-year clinical outcomes of the full cohort of 4873 patients prescribed dabigatran and followed for a mean of 18.0 +/- 9.4 months out of the 15,308 eligible patients enrolled in Phase II (2011-2014). The overall incidence rates per 100 person-years were: stroke 0.65 (95% CI 0.48-0.87), major bleeding 0.97 (0.76-1.23) and myocardial infarction (MI) 0.50 (0.35-0.69), with observed event rates broadly consistent in all study regions, which confirms the sustained safety and effectiveness of dabigatran over 2 years of observation in clinical practice.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antithrombins / administration & dosage
  • Antithrombins / adverse effects*
  • Atrial Fibrillation / complications*
  • Cause of Death
  • Cohort Studies
  • Dabigatran / administration & dosage
  • Dabigatran / adverse effects*
  • Follow-Up Studies
  • Hemorrhage / chemically induced
  • Hemorrhage / epidemiology
  • Humans
  • Incidence
  • Myocardial Infarction / epidemiology
  • Prospective Studies
  • Registries / statistics & numerical data*
  • Stroke / epidemiology
  • Stroke / etiology
  • Stroke / prevention & control*
  • Time Factors
  • Treatment Outcome

Substances

  • Antithrombins
  • Dabigatran