TY - JOUR
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
N1 - Funding Information:
TI received research grants from Daiichi Sankyo, Bristol-Myers Squibb, Medtronic Japan, St. Jude Medical, and Bayer Yakuhin Ltd. and honoraria from Daiichi Sankyo, Ono Pharma, Bayer Yakuhin Ltd., Bristol-Myers Squibb, and Pfizer and was a member of advisory board for Bayer Yakuhin Ltd. and Bristol-Myers Squibb. SO was a member of advisory board for Bayer Yakuhin Ltd. TK received research grant from Bayer Yakuhin Ltd. and was a member of advisory board for Bayer Yakuhin Ltd. JN received research grant from Nihon Medi-Physics and was a member of advisory board for Bayer Yakuhin Ltd. KM received honoraria form Bayer Yakuhin Ltd., Otsuka Pharmaceutical, Boehringer-Ingelheim, AstraZeneca, Pfizer, Mitsubishi Tanabe Pharma Cooperation, Japan Stryker, Kowa, Nihon Medi-Physics Co, BMS, Sawai Pharmaceutical Co., Sumitomo Dainippon Pharma Co Ltd, Dai-ichi Sankyo, Asteras Pharma, and Nippon Chemiphar and was a member of advisory board for CSL Behring, Medico's Hirata, and Bayer Yakuhin, Ltd. SM received research grant from Takeda Pharma, CSL Behring, Meiji Seika Pharma, MSD, Astellas Pharma, Eisai, Otsuka Pharma, Carl Zeiss Meditec, Philips Electronics Japan, Sanofi, Siemens Healthcare, Daiichi Sankyo, Mitsubishi-Tanabe Pharma, Chugai Pharma, Nihon Medi-Physics, Pfizer, Bristol-Myers Squibb, Brainlab, Mizuho, and Medtronic and was a member of advisory board for Bayer Yakuhin Ltd. YM received research grant from Bayer Yakuhin Ltd., Daiichi Sankyo, and Boehringer-Ingelheim and honoraria from Bayer Yakuhin Ltd., Daiichi Sankyo, Boehringer-Ingelheim, and Bristol-Myers Szuibb and was a member of advisory board for Bayer Yakuhin Ltd. Y. Ohashi was an employee of Bayer Yakuhin, Ltd. and is an employeee of Novartis Pharma K.K. MT, Y. Okayama, TS, and SY are employees of Bayer Yakuhin, Ltd.
Funding Information:
This research was supported by Bayer Yakuhin, Ltd. (Osaka, Japan). The authors acknowledge EPS Corporation for data management and analysis. The authors also thank Angela Morben, DVM, ELS, from Edanz Group (www.edanzediting.com/ac), for editing a draft of this manuscript.
Publisher Copyright:
© 2019 Japanese College of Cardiology
PY - 2019/7
Y1 - 2019/7
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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U2 - 10.1016/j.jjcc.2019.01.001
DO - 10.1016/j.jjcc.2019.01.001
M3 - Article
C2 - 30745002
AN - SCOPUS:85061089677
VL - 74
SP - 60
EP - 66
JO - Journal of Cardiology
JF - Journal of Cardiology
SN - 0914-5087
IS - 1
ER -