Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: A retrospective cohort study

Julie C. Lauffenburger, Joel F. Farley, Anil K. Gehi, Denise H. Rhoney, M. Alan Brookhart, Gang Fang

Research output: Contribution to journalArticlepeer-review

142 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-12
Number of pages12
JournalJournal of the American Heart Association
Volume4
Issue number4
DOIs
StatePublished - 2015

Bibliographical note

Publisher Copyright:
© 2015 The Authors.

Keywords

  • Anticoagulants
  • Atrial fibrillation
  • Dabigatran
  • Novel oral anticoagulants
  • Warfarin

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