Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

Takanori Ikeda, Satoshi Ogawa, Takanari Kitazono, Jyoji Nakagawara, Kazuo Minematsu, Susumu Miyamoto, Yuji Murakawa, Makiko Takeichi, Yohei Ohashi, Yutaka Okayama, Toshiyuki Sunaya, Satoshi Yamanaka

研究成果: ジャーナルへの寄稿記事

4 引用 (Scopus)

抄録

Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance. In total, 11,308 patients with NVAF who began treatment with rivaroxaban were enrolled from April 2012 to June 2014, and 9578 patients were analyzed to examine the one-year outcomes. Results: The mean treatment duration was 300 ± 119 days. The patients’ age was 73.2 ± 9.8 years, and their CHADS2 score was 2.2 ± 1.3. Any bleeding and major bleeding occurred in 602 patients (7.6 events per 100 patient-years) and 143 patients (1.8 events per 100 patient-years), respectively. Stroke/non-central nervous system systemic embolism/myocardial infarction was observed in 144 patients (1.8 events per 100 patient-years). Conclusions: Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials.gov: NCT01582737).

元の言語英語
ページ(範囲)60-66
ページ数7
ジャーナルJournal of Cardiology
74
発行部数1
DOI
出版物ステータス出版済み - 7 1 2019

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Atrial Fibrillation
Safety
Hemorrhage
Embolism
Rivaroxaban
Stroke
Phase III Clinical Trials
Marketing
Nervous System
Observational Studies
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

これを引用

Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). / Ikeda, Takanori; Ogawa, Satoshi; Kitazono, Takanari; Nakagawara, Jyoji; Minematsu, Kazuo; Miyamoto, Susumu; Murakawa, Yuji; Takeichi, Makiko; Ohashi, Yohei; Okayama, Yutaka; Sunaya, Toshiyuki; Yamanaka, Satoshi.

:: Journal of Cardiology, 巻 74, 番号 1, 01.07.2019, p. 60-66.

研究成果: ジャーナルへの寄稿記事

Ikeda, T, Ogawa, S, Kitazono, T, Nakagawara, J, Minematsu, K, Miyamoto, S, Murakawa, Y, Takeichi, M, Ohashi, Y, Okayama, Y, Sunaya, T & Yamanaka, S 2019, 'Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)', Journal of Cardiology, 巻. 74, 番号 1, pp. 60-66. https://doi.org/10.1016/j.jjcc.2019.01.001
Ikeda, Takanori ; Ogawa, Satoshi ; Kitazono, Takanari ; Nakagawara, Jyoji ; Minematsu, Kazuo ; Miyamoto, Susumu ; Murakawa, Yuji ; Takeichi, Makiko ; Ohashi, Yohei ; Okayama, Yutaka ; Sunaya, Toshiyuki ; Yamanaka, Satoshi. / Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). :: Journal of Cardiology. 2019 ; 巻 74, 番号 1. pp. 60-66.
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abstract = "Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance. In total, 11,308 patients with NVAF who began treatment with rivaroxaban were enrolled from April 2012 to June 2014, and 9578 patients were analyzed to examine the one-year outcomes. Results: The mean treatment duration was 300 ± 119 days. The patients’ age was 73.2 ± 9.8 years, and their CHADS2 score was 2.2 ± 1.3. Any bleeding and major bleeding occurred in 602 patients (7.6 events per 100 patient-years) and 143 patients (1.8 events per 100 patient-years), respectively. Stroke/non-central nervous system systemic embolism/myocardial infarction was observed in 144 patients (1.8 events per 100 patient-years). Conclusions: Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials.gov: NCT01582737).",
author = "Takanori Ikeda and Satoshi Ogawa and Takanari Kitazono and Jyoji Nakagawara and Kazuo Minematsu and Susumu Miyamoto and Yuji Murakawa and Makiko Takeichi and Yohei Ohashi and Yutaka Okayama and Toshiyuki Sunaya and Satoshi Yamanaka",
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T1 - Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

AU - Ikeda, Takanori

AU - Ogawa, Satoshi

AU - Kitazono, Takanari

AU - Nakagawara, Jyoji

AU - Minematsu, Kazuo

AU - Miyamoto, Susumu

AU - Murakawa, Yuji

AU - Takeichi, Makiko

AU - Ohashi, Yohei

AU - Okayama, Yutaka

AU - Sunaya, Toshiyuki

AU - Yamanaka, Satoshi

PY - 2019/7/1

Y1 - 2019/7/1

N2 - Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance. In total, 11,308 patients with NVAF who began treatment with rivaroxaban were enrolled from April 2012 to June 2014, and 9578 patients were analyzed to examine the one-year outcomes. Results: The mean treatment duration was 300 ± 119 days. The patients’ age was 73.2 ± 9.8 years, and their CHADS2 score was 2.2 ± 1.3. Any bleeding and major bleeding occurred in 602 patients (7.6 events per 100 patient-years) and 143 patients (1.8 events per 100 patient-years), respectively. Stroke/non-central nervous system systemic embolism/myocardial infarction was observed in 144 patients (1.8 events per 100 patient-years). Conclusions: Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials.gov: NCT01582737).

AB - Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance. In total, 11,308 patients with NVAF who began treatment with rivaroxaban were enrolled from April 2012 to June 2014, and 9578 patients were analyzed to examine the one-year outcomes. Results: The mean treatment duration was 300 ± 119 days. The patients’ age was 73.2 ± 9.8 years, and their CHADS2 score was 2.2 ± 1.3. Any bleeding and major bleeding occurred in 602 patients (7.6 events per 100 patient-years) and 143 patients (1.8 events per 100 patient-years), respectively. Stroke/non-central nervous system systemic embolism/myocardial infarction was observed in 144 patients (1.8 events per 100 patient-years). Conclusions: Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials.gov: NCT01582737).

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