Menno V Huisman1, Kenneth J Rothman2, Miney Paquette3, Christine Teutsch4, Hans-Christoph Diener5, Sergio J Dubner6, Jonathan L Halperin7, Chang Sheng Ma8, Kristina Zint9, Amelie Elsaesser10, Shihai Lu11, Dorothee B Bartels12, Gregory Y H Lip13. 1. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. Electronic address: M.V.Huisman@lumc.nl. 2. RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC, USA. 3. Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, Boehringer Ingelheim Ltd., Burlington, Ontario, Canada. 4. Medical Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 5. Department of Neurology, University of Duisburg-, Essen, Germany. 6. Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina. 7. Icahn School of Medicine at Mount Sinai, New York, NY, USA. 8. Cardiology Department, Atrial Fibrillation Center, Beijing AnZhen Hospital, Capital Medical University, Beijing, China. 9. Global Epidemiology Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 10. Biostatistics and Data Sciences Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 11. Biostatistics and Data Sciences Department, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. 12. Global Epidemiology Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany. 13. Institute of Cardiovascular Sciences, University of Birmingham, UK and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: g.y.h.lip@bham.ac.uk.
Abstract
BACKGROUND AND PURPOSE: GLORIA-AF is a large, global, prospective registry program of newly diagnosed atrial fibrillation (AF) patients with ≥1 stroke risk factors. We describe the effectiveness and safety of dabigatran etexilate over 2 years from routine clinical practice in nearly 3000 patients from GLORIA-AF who are newly diagnosed with non-valvular AF and at risk of stroke. METHODS: Consecutive enrollment into phase II of GLORIA-AF was initiated following approval of dabigatran for stroke prevention in non-valvular AF. Within this Phase II, 2937 dabigatran patients completed 2-year follow-up by May 2016 and were eligible for analysis. Patients who took at least 1 dose of dabigatran (n=2932) were used to estimate incidence rates. RESULTS: Overall incidence rates per 100 person-years of 0.63 (95% confidence interval [CI], 0.42-0.92) for stroke, 1.12 (0.83-1.49) for major bleeding, 0.47 (0.29-0.72) for myocardial infarction, and 2.69 (2.22-3.23) for all-cause death were observed. For patients taking 150 mg dabigatran twice daily (BID), corresponding rates (95% CI) were 0.56 (0.30-0.94), 1.00 (0.64-1.47), 0.48 (0.25-0.83), and 2.07 (1.55-2.72), respectively. For patients taking 110 mg dabigatran BID, event rates (95% CI) were 0.67 (0.33-1.20), 1.16 (0.70-1.80), 0.43 (0.17-0.88), and 3.16 (2.36-4.15). CONCLUSIONS: These global data confirm the sustained safety and effectiveness of dabigatran over 2 years of follow-up, consistent with the results from clinical trials as well as contemporary real-world studies. WHAT IS KNOWN: • Non-vitamin K antagonist (VKA) anticoagulants (NOACs) are the preferred therapy for prevention of ischemic stroke based on phase 3 trials, but there is insufficient information on their efficacy and safety in daily practice, based on prospectively collected data. WHAT IS NEW: • This study shows that in non-valvular AF patient population, with up to 2 years of follow-up, the use of dabigatran led to a low incidence of ischemic stroke, major bleeding, and myocardial infarction in routine clinical care, confirming the sustained safety and effectiveness of dabigatran in clinical practice over 2 years of follow-up.
BACKGROUND AND PURPOSE: GLORIA-AF is a large, global, prospective registry program of newly diagnosed atrial fibrillation (AF) patients with ≥1 stroke risk factors. We describe the effectiveness and safety of dabigatran etexilate over 2 years from routine clinical practice in nearly 3000 patients from GLORIA-AF who are newly diagnosed with non-valvular AF and at risk of stroke. METHODS: Consecutive enrollment into phase II of GLORIA-AF was initiated following approval of dabigatran for stroke prevention in non-valvular AF. Within this Phase II, 2937 dabigatranpatients completed 2-year follow-up by May 2016 and were eligible for analysis. Patients who took at least 1 dose of dabigatran (n=2932) were used to estimate incidence rates. RESULTS: Overall incidence rates per 100 person-years of 0.63 (95% confidence interval [CI], 0.42-0.92) for stroke, 1.12 (0.83-1.49) for major bleeding, 0.47 (0.29-0.72) for myocardial infarction, and 2.69 (2.22-3.23) for all-cause death were observed. For patients taking 150 mg dabigatran twice daily (BID), corresponding rates (95% CI) were 0.56 (0.30-0.94), 1.00 (0.64-1.47), 0.48 (0.25-0.83), and 2.07 (1.55-2.72), respectively. For patients taking 110 mg dabigatranBID, event rates (95% CI) were 0.67 (0.33-1.20), 1.16 (0.70-1.80), 0.43 (0.17-0.88), and 3.16 (2.36-4.15). CONCLUSIONS: These global data confirm the sustained safety and effectiveness of dabigatran over 2 years of follow-up, consistent with the results from clinical trials as well as contemporary real-world studies. WHAT IS KNOWN: • Non-vitamin K antagonist (VKA) anticoagulants (NOACs) are the preferred therapy for prevention of ischemic stroke based on phase 3 trials, but there is insufficient information on their efficacy and safety in daily practice, based on prospectively collected data. WHAT IS NEW: • This study shows that in non-valvular AFpatient population, with up to 2 years of follow-up, the use of dabigatran led to a low incidence of ischemic stroke, major bleeding, and myocardial infarction in routine clinical care, confirming the sustained safety and effectiveness of dabigatran in clinical practice over 2 years of follow-up.
Authors: Jan Beyer-Westendorf; A John Camm; Keith A A Fox; Jean-Yves Le Heuzey; Sylvia Haas; Alexander G G Turpie; Saverio Virdone; Ajay K Kakkar Journal: Thromb J Date: 2019-04-25
Authors: Rabih R Azar; Hany I Ragy; Omer Kozan; Maurice El Khuri; Nooshin Bazergani; Sabrina Marler; Christine Teutsch; Mohamed Ibrahim; Gregory Y H Lip; Menno V Huisman Journal: Int J Cardiol Heart Vasc Date: 2021-04-10
Authors: Sergio Dubner; José Francisco Kerr Saraiva; Juan Carlos Nunez Fragoso; Gonzalo Barón-Esquivias; Christine Teutsch; Venkatesh Kumar Gurusamy; Sabrina Marler; Menno V Huisman; Gregory Y H Lip; Cecilia Zeballos Journal: Int J Cardiol Heart Vasc Date: 2020-11-03
Authors: Charles Hsu; Edward Hutt; Daniel M Bloomfield; David Gailani; Jeffrey I Weitz Journal: J Am Coll Cardiol Date: 2021-08-10 Impact factor: 27.203