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

doi:10.1161/JAHA.115.001798

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

Pharmaceutical Care and Health Systems

Research output: Contribution to journal › Article › peer-review

117 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 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	https://doi.org/10.1161/JAHA.115.001798
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

Keywords

Anticoagulants
Atrial fibrillation
Dabigatran
Novel oral anticoagulants
Warfarin

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Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation : A retrospective cohort study. / Lauffenburger, Julie C.; Farley, Joel F.; Gehi, Anil K.; Rhoney, Denise H.; Brookhart, M. Alan; Fang, Gang.

In: Journal of the American Heart Association, Vol. 4, No. 4, 2015, p. 1-12.

Research output: Contribution to journal › Article › peer-review

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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.",

keywords = "Anticoagulants, Atrial fibrillation, Dabigatran, Novel oral anticoagulants, Warfarin",

author = "Lauffenburger, {Julie C.} and Farley, {Joel F.} and Gehi, {Anil K.} and Rhoney, {Denise H.} and Brookhart, {M. Alan} and Gang Fang",

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{\textquoteright}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{\textquoteright}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{\textquoteright}s DEcIDE program and the PCORI. Dr Farley received investigator-initiated research",

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T1 - Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation

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AU - Farley, Joel F.

AU - Gehi, Anil K.

AU - Rhoney, Denise H.

AU - Brookhart, M. Alan

AU - Fang, Gang

N1 - 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

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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.

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KW - Atrial fibrillation

KW - Dabigatran

KW - Novel oral anticoagulants

KW - Warfarin

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