Leiden University Scholarly Publications

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Mazurek, M.; Teutsch, C.; Diener, H.C.; Dubner, S.J.; Halperin, J.L.; Ma, C.S.; ... ; GLORIA-AF Investigators (2019)

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

Article / Letter to editor
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.
All authors
Mazurek, M.; Teutsch, C.; Diener, H.C.; Dubner, S.J.; Halperin, J.L.; Ma, C.S.; Rothman, K.J.; Paquette, M.; Zint, K.; Franca, L.R.; Lu, S.H.; Bartels, D.B.; Huisman, M.V.; Lip, G.Y.H.; GLORIA-AF Investigators
Date
2019-12-01
Journal
American Heart Journal
Volume
218
Pages
123 - 127
DOI
doi:10.1016/j.ahj.2019.08.012