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Cardiol Ther. 2019 Jun;8(1):43-54. doi: 10.1007/s40119-019-0129-2. Epub 2019 Feb 11.

Characteristics of Japanese Patients with Nonvalvular Atrial Fibrillation on Anticoagulant Treatment: A Descriptive Analysis of J-dabigatran Surveillance and JAPAF Study.

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National Hospital Organization Osaka National Hospital, Osaka, Japan.
Department of Health and Environmental Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan.
Minamihachioji Hospital, Tokyo, Japan.
Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
Department of Cerebrovascular Disease, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.
Medicine Division, Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.
Saiseikai Toyama Hospital, Toyama, Japan.



Following approval of dabigatran and other antithrombotics in Japan, few studies have specifically evaluated the clinical characteristics of patients prescribed these antithrombotics for nonvalvular atrial fibrillation (NVAF) in real-world practice.


We conducted a descriptive analysis of data from two real-world studies [J-dabigatran surveillance and Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation (JAPAF); conducted at sites common to both studies] to determine the characteristics of patients with NVAF initiated on dabigatran etexilate [110 mg twice daily (BID; DE110) or 150 mg BID (DE150)], warfarin, rivaroxaban, or antiplatelets as their first antithrombotic treatment. Inferential statistical analyses were not performed, and no statistical hypothesis was tested.


Data for 1270 and 3011 eligible patients from the J-dabigatran surveillance (DE110, 976; DE150, 273) and JAPAF study (warfarin, 82.5%; rivaroxaban, 10.3%; antiplatelets, 21%), respectively, were extracted. In the J-dabigatran surveillance, 31.8% (full cohort, 28.1%) of patients had been switched from warfarin to dabigatran. Among patients prescribed DE110/DE150, 41.4%/57.5% and 41.5%/18.7% of patients had low-to-intermediate risk for ischemic stroke (CHADS2 score of 0 or 1) and high risk for bleeding (HAS-BLED score ≥ 3), respectively. Similarly, 33.7%/41.3%/40.2% and 48.7%/42.6%/75.7% of patients taking warfarin/rivaroxaban/antiplatelets had a CHADS2 score of 0 or 1 and HAS-BLED score ≥ 3, respectively. Dabigatran was favored in patients with creatinine clearance > 50 ml/min.


In Japan, physicians who attempt stroke prevention in patients with atrial fibrillation choose appropriate anticoagulant treatment, taking into consideration the individual patient backgrounds as well as the features of each antithrombotic agent.

TRIAL REGISTRATION: Identifier, NCT01491178 and University Hospital Medical Information Network (UMIN) Clinical Trial Registry Identifier, UMIN000009644.


Nippon Boehringer Ingelheim Co., Ltd. Plain language summary available for this article.


Anticoagulant; Dabigatran; Japan; Nonvalvular atrial fibrillation; Postmarketing surveillance

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