Gregory Y H Lip1, Allison V Keshishian2, Amiee L Kang3, Xiaoyan Li3, Amol D Dhamane4, Xuemei Luo5, Neeraja Balachander6, Lisa Rosenblatt6, Jack Mardekian7, Anagha Nadkarni4, Xianying Pan8, Manuela Di Fusco9, Alessandra B Garcia Reeves10, Huseyin Yuce11, Steven B Deitelzweig12. 1. Liverpool Centre for Cardiovascular Science, at the Liverpool Heart & Chest Hospital, University of Liverpool, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: Gregory.Lip@liverpool.ac.uk. 2. Health Economics and Outcomes Research, SIMR, LLC, Ann Arbor, MI; Department of Mathematics, New York City College of Technology, City University of New York, New York. 3. Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Company, Lawrenceville, NJ. 4. Health Economics & Outcomes Research, Bristol-Myers Squibb Company, Lawrenceville, NJ. 5. Global Research and Development, Pfizer Inc., Groton, CT. 6. Worldwide Cardiovascular Department, Bristol-Myers Squibb Company, Lawrenceville, NJ. 7. Statistics Department, Pfizer Inc., New York, NY. 8. Center for Observational Research & Data Sciences, Bristol-Myers Squibb Company, Lawrenceville, NJ. 9. Patient and Health Impact, Pfizer Inc., New York, NY. 10. Gillings School of Global Public Health, University of North Carolina, Chapel Hill; Department of Hospital Medicine, Ochsner Clinic Foundation, New Orleans, LA. 11. Department of Mathematics, New York City College of Technology, City University of New York, New York. 12. Department of Hospital Medicine, Ochsner Clinic Foundation, New Orleans, LA; Queensland School of Medicine, University of Queensland School of Medicine, New Orleans, LA.
Abstract
OBJECTIVE: To address gaps in the data comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among patients with nonvalvular atrial fibrillation (NVAF) and diabetes. PATIENTS AND METHODS: A retrospective study was conducted on patients with NVAF and diabetes newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, through September 30, 2015, with Medicare data from the US Centers for Medicare & Medicaid Services and 4 other US commercial claims databases. One-to-one propensity score matching was completed between NOACs and warfarin and between NOACs in each database, and the results were pooled. Cox proportional hazards models were used to evaluate the risk of stroke/systemic embolism (SE) and major bleeding (MB). RESULTS: A total of 154,324 patients were included in the 6 matched cohorts, with a mean follow-up time of 6 to 8 months. Compared with warfarin, apixaban (hazard ratio [HR], 0.67; 95% CI, 0.57-0.77) and rivaroxaban (HR, 0.79; 95% CI, 0.71-0.89) were associated with a lower risk of stroke/SE; dabigatran (HR, 0.84; 95% CI, 0.67-1.07) was associated with a similar risk of stroke/SE. Apixaban (HR, 0.60; 95% CI, 0.56-0.65) and dabigatran (HR, 0.78; 95% CI, 0.69-0.88) were associated with a lower risk of MB; rivaroxaban (HR, 1.02; 95% CI, 0.94-1.10) was associated with a similar risk of MB compared with warfarin. Compared with dabigatran and rivaroxaban, apixaban was associated with a lower risk of MB. Compared with rivaroxaban, dabigatran was associated with a lower risk of MB. CONCLUSION: This study-the largest observational study to date of patients with NVAF and diabetes taking anticoagulants-found that NOACs were associated with variable rates of stroke/SE and MB compared with warfarin. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03087487.
OBJECTIVE: To address gaps in the data comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among patients with nonvalvular atrial fibrillation (NVAF) and diabetes. PATIENTS AND METHODS: A retrospective study was conducted on patients with NVAF and diabetes newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, through September 30, 2015, with Medicare data from the US Centers for Medicare & Medicaid Services and 4 other US commercial claims databases. One-to-one propensity score matching was completed between NOACs and warfarin and between NOACs in each database, and the results were pooled. Cox proportional hazards models were used to evaluate the risk of stroke/systemic embolism (SE) and major bleeding (MB). RESULTS: A total of 154,324 patients were included in the 6 matched cohorts, with a mean follow-up time of 6 to 8 months. Compared with warfarin, apixaban (hazard ratio [HR], 0.67; 95% CI, 0.57-0.77) and rivaroxaban (HR, 0.79; 95% CI, 0.71-0.89) were associated with a lower risk of stroke/SE; dabigatran (HR, 0.84; 95% CI, 0.67-1.07) was associated with a similar risk of stroke/SE. Apixaban (HR, 0.60; 95% CI, 0.56-0.65) and dabigatran (HR, 0.78; 95% CI, 0.69-0.88) were associated with a lower risk of MB; rivaroxaban (HR, 1.02; 95% CI, 0.94-1.10) was associated with a similar risk of MB compared with warfarin. Compared with dabigatran and rivaroxaban, apixaban was associated with a lower risk of MB. Compared with rivaroxaban, dabigatran was associated with a lower risk of MB. CONCLUSION: This study-the largest observational study to date of patients with NVAF and diabetes taking anticoagulants-found that NOACs were associated with variable rates of stroke/SE and MB compared with warfarin. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03087487.
Authors: Fatma Rustem Gulluoglu; Patrick C Souverein; Hendrika A van den Ham; Anthonius de Boer; Joris Komen Journal: Pharmacoepidemiol Drug Saf Date: 2020-12-24 Impact factor: 2.890