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



Mazurek, Michał, Teutsch, Christine, Diener, Hans-Christoph, Dubner, Sergio J, Halperin, Jonathan L, Ma, Chang-Sheng, Rothman, Kenneth J, Paquette, Miney, Zint, Kristina, França, Lionel Riou
et al (show 5 more authors) (2019) Safety and effectiveness of dabigatran at 2 years: Final outcomes from Phase II of the GLORIA-AF registry program. American heart journal, 218. 123 - 127.

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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.

Item Type: Article
Uncontrolled Keywords: GLORIA-AF Investigators
Depositing User: Symplectic Admin
Date Deposited: 12 Dec 2019 13:15
Last Modified: 09 Jan 2021 02:40
DOI: 10.1016/j.ahj.2019.08.012
URI: https://livrepository.liverpool.ac.uk/id/eprint/3066094