Details

Autor(en) / Beteiligte

• 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
• Lu, Shihai
• Bartels, Dorothee B.
• Huisman, Menno V.
• Lip, Gregory Y.H.

Titel

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

Ist Teil von

• The American heart journal, 2019-12, Vol.218, p.123-127

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2019

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.