Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study

Background: In “real-world” practice, anticoagulant therapy is indicated for patients whose clinical profiles are not addressed in randomized clinical trials. We assessed the effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with non-valvular atrial fibrillatio...

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Main Authors: Miyoko Naganuma, PhD, Tsuyoshi Shiga, MD, Takehiko Nagao, MD, Atsushi Suzuki, MD, Kagari Murasaki, MD, Nobuhisa Hagiwara, MD
Format: Article
Language:English
Published: Wiley 2017-04-01
Series:Journal of Arrhythmia
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1880427616300813
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author Miyoko Naganuma, PhD
Tsuyoshi Shiga, MD
Takehiko Nagao, MD
Atsushi Suzuki, MD
Kagari Murasaki, MD
Nobuhisa Hagiwara, MD
author_facet Miyoko Naganuma, PhD
Tsuyoshi Shiga, MD
Takehiko Nagao, MD
Atsushi Suzuki, MD
Kagari Murasaki, MD
Nobuhisa Hagiwara, MD
author_sort Miyoko Naganuma, PhD
collection DOAJ
description Background: In “real-world” practice, anticoagulant therapy is indicated for patients whose clinical profiles are not addressed in randomized clinical trials. We assessed the effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with non-valvular atrial fibrillation (NVAF). Methods: Among 613 NVAF patients who initiated dabigatran or warfarin therapy during the period between 2011 and 2013, 362 patients were included in the study after propensity score adjustment. The median follow-up period was 1.3 years. The effectiveness and safety outcomes were thromboembolism and major bleeding, respectively. Results: The propensity-matched hazard ratios of thromboembolism and major bleeding with dabigatran were 1.03 (95% CI: 0.12-8.04, p=0.971) and 0.15 (95% CI: 0.01–0.90, p=0.037), respectively. Conclusions: The ability of dabigatran to prevent thromboembolism is comparable to that of warfarin; however, the major bleeding rate is lower with dabigatran in “real-world” NVAF patients.
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spelling doaj.art-69db48a36c234e4f87342bb2dbf467012022-12-21T19:13:06ZengWileyJournal of Arrhythmia1880-42762017-04-0133210711010.1016/j.joa.2016.07.007Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational studyMiyoko Naganuma, PhD0Tsuyoshi Shiga, MD1Takehiko Nagao, MD2Atsushi Suzuki, MD3Kagari Murasaki, MD4Nobuhisa Hagiwara, MD5Intelligent Clinical Research and Innovation Center, Tokyo Women׳s Medical University Hospital, Tokyo, JapanIntelligent Clinical Research and Innovation Center, Tokyo Women׳s Medical University Hospital, Tokyo, JapanDepartment of Neurology, Tokyo Women׳s Medical University, Tokyo, JapanDepartment of Cardiology, Tokyo Women׳s Medical University, Tokyo, JapanDepartment of Cardiology, Tokyo Women׳s Medical University, Tokyo, JapanIntelligent Clinical Research and Innovation Center, Tokyo Women׳s Medical University Hospital, Tokyo, JapanBackground: In “real-world” practice, anticoagulant therapy is indicated for patients whose clinical profiles are not addressed in randomized clinical trials. We assessed the effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with non-valvular atrial fibrillation (NVAF). Methods: Among 613 NVAF patients who initiated dabigatran or warfarin therapy during the period between 2011 and 2013, 362 patients were included in the study after propensity score adjustment. The median follow-up period was 1.3 years. The effectiveness and safety outcomes were thromboembolism and major bleeding, respectively. Results: The propensity-matched hazard ratios of thromboembolism and major bleeding with dabigatran were 1.03 (95% CI: 0.12-8.04, p=0.971) and 0.15 (95% CI: 0.01–0.90, p=0.037), respectively. Conclusions: The ability of dabigatran to prevent thromboembolism is comparable to that of warfarin; however, the major bleeding rate is lower with dabigatran in “real-world” NVAF patients.http://www.sciencedirect.com/science/article/pii/S1880427616300813Atrial fibrillationDabigatranJapaneseStrokeWarfarin
spellingShingle Miyoko Naganuma, PhD
Tsuyoshi Shiga, MD
Takehiko Nagao, MD
Atsushi Suzuki, MD
Kagari Murasaki, MD
Nobuhisa Hagiwara, MD
Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
Journal of Arrhythmia
Atrial fibrillation
Dabigatran
Japanese
Stroke
Warfarin
title Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
title_full Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
title_fullStr Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
title_full_unstemmed Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
title_short Effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with atrial fibrillation: A single-center observational study
title_sort effectiveness and safety of dabigatran versus warfarin in real world japanese patients with atrial fibrillation a single center observational study
topic Atrial fibrillation
Dabigatran
Japanese
Stroke
Warfarin
url http://www.sciencedirect.com/science/article/pii/S1880427616300813
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