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 language | English (US) |
|---|---|
| Pages (from-to) | 1-12 |
| Number of pages | 12 |
| Journal | Journal of the American Heart Association |
| Volume | 4 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2015 |
Bibliographical note
Funding Information:The database infrastructure used for this project was funded by the Department of Epidemiology, UNC Gillings School of Global Public Health; the Cecil G. Sheps Center for Health Services Research, UNC; the CER Strategic Initiative of UNC's Clinical Translational Science Award (1 UL RR025747); and the UNC School of Medicine. At the time of the research, Dr Lauffenburger received support from the National Institute of Nursing Research (T32NR008856) and was at the University of North Carolina at Chapel Hill. Dr Fang receives investigatorinitiated research finding from the National Institutes of Health (R21 AG043668, R01 AG046267) and through contracts with the Agency for Healthcare Research and Quality's Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program and the Patient Centered Outcomes Research Institute (PCORI). Dr Brookhart receives investigator-initiated research funding from the National Institutes of Health (R01 AG042845, R21 HD080214, R01 AG023178) and through contracts with the Agency for Healthcare Research and Quality's DEcIDE program and the PCORI. Dr Farley received investigator-initiated research funding from the Agency for Healthcare Research and Quality (R01 HS023099).
Funding Information:
funding from the Agency for Healthcare Research and Quality (R01 HS023099).
Funding Information:
The database infrastructure used for this project was funded by the Department of Epidemiology, UNC Gillings School of Global Public Health; the Cecil G. Sheps Center for Health Services Research, UNC; the CER Strategic Initiative of UNC’s Clinical Translational Science Award (1 UL RR025747); and the UNC School of Medicine. At the time of the research, Dr Lauffenburger received support from the National Institute of Nursing Research (T32NR008856) and was at the University of North Carolina at Chapel Hill. Dr Fang receives investigator- initiated research finding from the National Institutes of Health (R21 AG043668, R01 AG046267) and through contracts with the Agency for Healthcare Research and Quality’s Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program and the Patient Centered Outcomes Research Institute (PCORI). Dr Brookhart receives investigator-initiated research funding from the National Institutes of Health (R01 AG042845, R21 HD080214, R01 AG023178) and through contracts with the Agency for Healthcare Research and Quality’s DEcIDE program and the PCORI. Dr Farley received investigator-initiated research
Publisher Copyright:
© 2015 The Authors.
Keywords
- Anticoagulants
- Atrial fibrillation
- Dabigatran
- Novel oral anticoagulants
- Warfarin