Satoshi Ogawa1, Takanori Ikeda2, Takanari Kitazono3, Jyoji Nakagawara4, Kazuo Minematsu5, Susumu Miyamoto6, Yuji Murakawa7, Kazuma Iekushi8, Satoshi Yamanaka8, Takashi Yamada8, Lyo Inuyama8. 1. International University of Health and Welfare Mita Hospital, Tokyo, Japan. Electronic address: sogawa@juhw.ac.jp. 2. Department of Cardiovascular Medicine, Toho University Medical Center, Tokyo, Japan. 3. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 4. Integrative Stroke Imaging Center, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan. 5. National Cerebral and Cardiovascular Center Hospital, Suita, Osaka, Japan. 6. Department of Neurosurgery, Kyoto University, Kyoto, Japan. 7. The Fourth Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Kawasaki, Japan. 8. Department of Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.
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.
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.