Present profiles of novel anticoagulant use in japanese patients with atrial fibrillation: Insights from the rivaroxaban postmarketing surveillance registry

Satoshi Ogawa, Takanori Ikeda, Takanari Kitazono, Jyoji Nakagawara, Kazuo Minematsu, Susumu Miyamoto, Yuji Murakawa, Kazuma Iekushi, Satoshi Yamanaka, Takashi Yamada, Lyo Inuyama

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2520-2526
Number of pages7
JournalJournal of Stroke and Cerebrovascular Diseases
Volume23
Issue number10
DOIs
Publication statusPublished - Jan 1 2014

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Anticoagulants
Atrial Fibrillation
Registries
Hemorrhage
Platelet Aggregation Inhibitors
Rivaroxaban
Safety
Embolism
Stroke
Myocardial Infarction
Kidney

All Science Journal Classification (ASJC) codes

  • Surgery
  • Rehabilitation
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

Cite this

Present profiles of novel anticoagulant use in japanese patients with atrial fibrillation : Insights from the rivaroxaban postmarketing surveillance registry. / Ogawa, Satoshi; Ikeda, Takanori; Kitazono, Takanari; Nakagawara, Jyoji; Minematsu, Kazuo; Miyamoto, Susumu; Murakawa, Yuji; Iekushi, Kazuma; Yamanaka, Satoshi; Yamada, Takashi; Inuyama, Lyo.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 23, No. 10, 01.01.2014, p. 2520-2526.

Research output: Contribution to journalArticle

Ogawa, Satoshi ; Ikeda, Takanori ; Kitazono, Takanari ; Nakagawara, Jyoji ; Minematsu, Kazuo ; Miyamoto, Susumu ; Murakawa, Yuji ; Iekushi, Kazuma ; Yamanaka, Satoshi ; Yamada, Takashi ; Inuyama, Lyo. / Present profiles of novel anticoagulant use in japanese patients with atrial fibrillation : Insights from the rivaroxaban postmarketing surveillance registry. In: Journal of Stroke and Cerebrovascular Diseases. 2014 ; Vol. 23, No. 10. pp. 2520-2526.
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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.",
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AU - Kitazono, Takanari

AU - Nakagawara, Jyoji

AU - Minematsu, Kazuo

AU - Miyamoto, Susumu

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AU - Yamada, Takashi

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