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Present profiles of novel anticoagulant use in Japanese patients with atrial fibrillation: insights from the Rivaroxaban Postmarketing Surveillance Registry.

Authors :
Ogawa S
Ikeda T
Kitazono T
Nakagawara J
Minematsu K
Miyamoto S
Murakawa Y
Iekushi K
Yamanaka S
Yamada T
Inuyama L
Source :
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association [J Stroke Cerebrovasc Dis] 2014 Nov-Dec; Vol. 23 (10), pp. 2520-2526. Date of Electronic Publication: 2014 Sep 20.
Publication Year :
2014

Abstract

Background: The postmarketing surveillance registry evaluated the safety and efficacy of rivaroxaban in Japanese patients with atrial fibrillation (AF) treated with rivaroxaban.<br />Methods: A total of 10,038 patients with AF were enrolled between April 18, 2012 and December 16, 2013. Overall, 48.9% of the patients were of 75 years or older. The median CHADS2 score was 2 (interquartile range, 1-3). A total of 54.7% of patients had switched from an anticoagulant/antiplatelet drug, whereas 45.3% were treatment naive. Initial analysis was conducted for the 1039 patients who had completed the 6-month follow-up examinations by the end of June 2013. The low dose (10 mg/d) of rivaroxaban had been selected for approximately one quarter of the patients because of bleeding risks and advanced age in addition to renal impairment, although the high dose (15 mg/d) should have been selected.<br />Results: Major and nonmajor clinically relevant bleeding events were observed in 36 of 1035 patients. Five of 16 patients who concomitantly used 2 or more antiplatelet agents developed a bleeding event. Bleeding events were observed in 8 of 158 patients who were of 75 years or older and weighed 50 kg or less. The composite end point event of stroke, systemic embolism, or myocardial infarction was observed in 6 of 1034 patients.<br />Conclusions: This registry will continue to provide insights into the safety and efficacy of rivaroxaban in real-world practice.<br /> (Copyright © 2014. Published by Elsevier Inc.)

Details

Language :
English
ISSN :
1532-8511
Volume :
23
Issue :
10
Database :
MEDLINE
Journal :
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
Publication Type :
Academic Journal
Accession number :
25245483
Full Text :
https://doi.org/10.1016/j.jstrokecerebrovasdis.2014.03.006