TY - JOUR
T1 - Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation
T2 - A retrospective cohort study
AU - Lauffenburger, Julie C.
AU - Farley, Joel F.
AU - Gehi, Anil K.
AU - Rhoney, Denise H.
AU - Brookhart, M. Alan
AU - Fang, Gang
N1 - Publisher Copyright:
© 2015 The Authors.
PY - 2015
Y1 - 2015
N2 - Background-The recent availability of dabigatran, a novel oral anticoagulant, provided a new treatment option for stroke prevention in atrial fibrillation beyond warfarin, the main therapy for years. Little is known about their real-world comparative effectiveness and safety, even less among patient demographic and clinical subgroups. Methods and Results-Using a cohort of non-valvular AF patients initiating anticoagulation from October 2010 to December 2012 drawn from a large US database of commercial and Medicare supplement claims, we applied propensity score weights to Cox proportional hazards regression to assess the comparative effectiveness and safety of dabigatran versus warfarin. Analyses were repeated among clinical and demographic subgroups using stratum-specific propensity scores as an exploratory analysis. Of the 64 935 patients initiating anticoagulation, 32.5% used dabigatran. Compared with warfarin, dabigatran was associated with a lower risk of ischemic stroke or systemic embolism (composite adjusted Hazard Ratio [aHR], 95% CI: 0.86, 95% CI: 0.79 to 0.93), hemorrhagic stroke (aHR: 0.51, 0.40 to 0.65), and acute myocardial infarction (aHR: 0.88, 95% CI: 0.77 to 0.99), and no relation was seen between dabigatran and the composite harm outcome (aHR: 0.94, 95% CI: 0.87 to 1.01). However, dabigatran was associated with a higher risk of gastrointestinal bleeding (aHR: 1.11, 95% CI: 1.02 to 1.22). Estimates of effectiveness and safety appeared to be mostly similar across subgroups. Conclusions-Dabigatran could be a safe and potentially more effective alternative to warfarin in patients with atrial fibrillation managed in routine practice settings.
AB - Background-The recent availability of dabigatran, a novel oral anticoagulant, provided a new treatment option for stroke prevention in atrial fibrillation beyond warfarin, the main therapy for years. Little is known about their real-world comparative effectiveness and safety, even less among patient demographic and clinical subgroups. Methods and Results-Using a cohort of non-valvular AF patients initiating anticoagulation from October 2010 to December 2012 drawn from a large US database of commercial and Medicare supplement claims, we applied propensity score weights to Cox proportional hazards regression to assess the comparative effectiveness and safety of dabigatran versus warfarin. Analyses were repeated among clinical and demographic subgroups using stratum-specific propensity scores as an exploratory analysis. Of the 64 935 patients initiating anticoagulation, 32.5% used dabigatran. Compared with warfarin, dabigatran was associated with a lower risk of ischemic stroke or systemic embolism (composite adjusted Hazard Ratio [aHR], 95% CI: 0.86, 95% CI: 0.79 to 0.93), hemorrhagic stroke (aHR: 0.51, 0.40 to 0.65), and acute myocardial infarction (aHR: 0.88, 95% CI: 0.77 to 0.99), and no relation was seen between dabigatran and the composite harm outcome (aHR: 0.94, 95% CI: 0.87 to 1.01). However, dabigatran was associated with a higher risk of gastrointestinal bleeding (aHR: 1.11, 95% CI: 1.02 to 1.22). Estimates of effectiveness and safety appeared to be mostly similar across subgroups. Conclusions-Dabigatran could be a safe and potentially more effective alternative to warfarin in patients with atrial fibrillation managed in routine practice settings.
KW - Anticoagulants
KW - Atrial fibrillation
KW - Dabigatran
KW - Novel oral anticoagulants
KW - Warfarin
UR - http://www.scopus.com/inward/record.url?scp=85012241679&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85012241679&partnerID=8YFLogxK
U2 - 10.1161/JAHA.115.001798
DO - 10.1161/JAHA.115.001798
M3 - Article
C2 - 25862791
AN - SCOPUS:85012241679
SN - 2047-9980
VL - 4
SP - 1
EP - 12
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 4
ER -