Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation

Background: There is little evidence of the efficacy and safety of dabigatran in Japanese patients with non-valvular atrial fibrillation (NVAF). Methods and Results: We evaluated 300 consecutive patients with NVAF (68±11 years old, 209 men, 180 paroxysmal) who received 220 mg/day (203 patients) or 3...

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Main Authors: Koji Miyamoto, Takeshi Aiba, Ikutaro Nakajima, Yuko Yamada, Hideo Okamura, Takashi Noda, Kazuhiro Satomi, Masaharu Ishihara, Toshihisa Anzai, Satoshi Yasuda, Hisao Ogawa, Shiro Kamakura, Wataru Shimizu
Format: Article
Language:English
Published: Wiley 2014-02-01
Series:Journal of Arrhythmia
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S188042761300094X
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author Koji Miyamoto
Takeshi Aiba
Ikutaro Nakajima
Yuko Yamada
Hideo Okamura
Takashi Noda
Kazuhiro Satomi
Masaharu Ishihara
Toshihisa Anzai
Satoshi Yasuda
Hisao Ogawa
Shiro Kamakura
Wataru Shimizu
author_facet Koji Miyamoto
Takeshi Aiba
Ikutaro Nakajima
Yuko Yamada
Hideo Okamura
Takashi Noda
Kazuhiro Satomi
Masaharu Ishihara
Toshihisa Anzai
Satoshi Yasuda
Hisao Ogawa
Shiro Kamakura
Wataru Shimizu
author_sort Koji Miyamoto
collection DOAJ
description Background: There is little evidence of the efficacy and safety of dabigatran in Japanese patients with non-valvular atrial fibrillation (NVAF). Methods and Results: We evaluated 300 consecutive patients with NVAF (68±11 years old, 209 men, 180 paroxysmal) who received 220 mg/day (203 patients) or 300 mg/day dabigatran (97 patients) at our hospital. Most patients (84%) had lower CHADS2 (congestive heart failure, hypertension, age>75 years, diabetes, stroke/transient ischemic attack) scores of 0 (n=60), 1 (n=114), or 2 (n=78) and lower HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition) scores of 0 (n=39), 1 (n=114), or 2 (n=103). The estimated creatinine clearance was 77±24 mL/min, which was inversely correlated to age (r2=0.48, p<0.0001). Activated partial thromboplastin time was 42±9 s but was not dependent on sampling time. During follow-up of 263±160 days, an ischemic stroke occurred in 1 patient (0.3%), but no systemic embolism was observed. Some adverse events were reported for 70 (23%) patients, such as dyspepsia (n=42, 14%) or minor bleeding complications (n=11, 4%) resulting in discontinuation of dabigatran for 39 patients. However, no major complications were observed, and no patient died from adverse events or because of cardiovascular or stroke events. Conclusions: Dabigatran is safe and useful for the prevention of ischemic strokes in Japanese NVAF patients, but additional care should be taken for elderly patients.
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spelling doaj.art-2afa811ec6454d78a37d86d6b9ddee272022-12-21T19:02:50ZengWileyJournal of Arrhythmia1880-42762014-02-01301586410.1016/j.joa.2013.04.010Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillationKoji Miyamoto0Takeshi Aiba1Ikutaro Nakajima2Yuko Yamada3Hideo Okamura4Takashi Noda5Kazuhiro Satomi6Masaharu Ishihara7Toshihisa Anzai8Satoshi Yasuda9Hisao Ogawa10Shiro Kamakura11Wataru Shimizu12Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, JapanBackground: There is little evidence of the efficacy and safety of dabigatran in Japanese patients with non-valvular atrial fibrillation (NVAF). Methods and Results: We evaluated 300 consecutive patients with NVAF (68±11 years old, 209 men, 180 paroxysmal) who received 220 mg/day (203 patients) or 300 mg/day dabigatran (97 patients) at our hospital. Most patients (84%) had lower CHADS2 (congestive heart failure, hypertension, age>75 years, diabetes, stroke/transient ischemic attack) scores of 0 (n=60), 1 (n=114), or 2 (n=78) and lower HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition) scores of 0 (n=39), 1 (n=114), or 2 (n=103). The estimated creatinine clearance was 77±24 mL/min, which was inversely correlated to age (r2=0.48, p<0.0001). Activated partial thromboplastin time was 42±9 s but was not dependent on sampling time. During follow-up of 263±160 days, an ischemic stroke occurred in 1 patient (0.3%), but no systemic embolism was observed. Some adverse events were reported for 70 (23%) patients, such as dyspepsia (n=42, 14%) or minor bleeding complications (n=11, 4%) resulting in discontinuation of dabigatran for 39 patients. However, no major complications were observed, and no patient died from adverse events or because of cardiovascular or stroke events. Conclusions: Dabigatran is safe and useful for the prevention of ischemic strokes in Japanese NVAF patients, but additional care should be taken for elderly patients.http://www.sciencedirect.com/science/article/pii/S188042761300094XDabigatranAtrial fibrillationEfficacySafetyJapanese
spellingShingle Koji Miyamoto
Takeshi Aiba
Ikutaro Nakajima
Yuko Yamada
Hideo Okamura
Takashi Noda
Kazuhiro Satomi
Masaharu Ishihara
Toshihisa Anzai
Satoshi Yasuda
Hisao Ogawa
Shiro Kamakura
Wataru Shimizu
Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
Journal of Arrhythmia
Dabigatran
Atrial fibrillation
Efficacy
Safety
Japanese
title Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
title_full Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
title_fullStr Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
title_full_unstemmed Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
title_short Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation
title_sort efficacy and safety of novel anticoagulant dabigatran in clinical practice for japanese patients with non valvular atrial fibrillation
topic Dabigatran
Atrial fibrillation
Efficacy
Safety
Japanese
url http://www.sciencedirect.com/science/article/pii/S188042761300094X
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