title: Present profiles of novel anticoagulant use in Japanese patients with atrial fibrillation: insights from the Rivaroxaban Postmarketing Surveillance Registry.
abstract: BACKGROUND
  The postmarketing surveillance registry evaluated the safety and efficacy of rivaroxaban in Japanese patients with atrial fibrillation (AF) treated with rivaroxaban.
  
  
  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.
  
  
  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.
  
  
  CONCLUSIONS
  This registry will continue to provide insights into the safety and efficacy of rivaroxaban in real-world practice.
authors.affiliation: International University of Health and Welfare Mita Hospital, Tokyo, Japan. Electronic address: sogawa@juhw.ac.jp.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ogawa
authors.affiliation: Department of Cardiovascular Medicine, Toho University Medical Center, Tokyo, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Ikeda
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Takanari
authors.initials: T
authors.lastname: Kitazono
authors.affiliation: Integrative Stroke Imaging Center, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
authors.forename: Jyoji
authors.initials: J
authors.lastname: Nakagawara
authors.affiliation: National Cerebral and Cardiovascular Center Hospital, Suita, Osaka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.affiliation: Department of Neurosurgery, Kyoto University, Kyoto, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Miyamoto
authors.affiliation: The Fourth Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Kawasaki, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Murakawa
authors.affiliation: Department of Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Kazuma
authors.initials: K
authors.lastname: Iekushi
authors.affiliation: Department of Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamanaka
authors.affiliation: Department of Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Lyo
authors.initials: L
authors.lastname: Inuyama
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D044466:Asian People; D001281:Atrial Fibrillation / Q000150:complications*; D004617:Embolism / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D007668:Kidney / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012042:Registries; D012307:Risk Factors; D000069552:Rivaroxaban; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D009025:Morpholines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D000069552:Rivaroxaban
keywords: Atrial fibrillation; Japanese; multicenter registry; oral anticoagulation