Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS.
<h4>Background</h4>The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global...
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Public Library of Science (PLoS)
2021-01-01
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| author | Takanori Ikeda Satoshi Ogawa Takanari Kitazono Jyoji Nakagawara Kazuo Minematsu Susumu Miyamoto Yuji Murakawa Sanghun Iwashiro Yutaka Okayama Toshiyuki Sunaya Kazufumi Hirano Takanori Hayasaki |
| author_facet | Takanori Ikeda Satoshi Ogawa Takanari Kitazono Jyoji Nakagawara Kazuo Minematsu Susumu Miyamoto Yuji Murakawa Sanghun Iwashiro Yutaka Okayama Toshiyuki Sunaya Kazufumi Hirano Takanori Hayasaki |
| author_sort | Takanori Ikeda |
| collection | DOAJ |
| description | <h4>Background</h4>The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global regions, in Japanese patients with non-valvular atrial fibrillation in real-world clinical practice.<h4>Methods</h4>In this prospective, open-label, single-arm, observational study, 11,308 patients with non-valvular atrial fibrillation newly prescribed rivaroxaban (15/10 mg once daily) at 1416 sites across Japan were enrolled and followed for a mean of 2.5 years.<h4>Results</h4>In total, 10,664 and 10,628 patients were included in the safety and effectiveness analyses, respectively. In the safety population, mean (standard deviation) age was 73.1 (9.8) years and Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, previous Stroke/TIA (2 points) (CHADS2) score was 2.2 (1.3). Incidences (95% confidence intervals) of any and major bleeding were 3.77 (3.53-4.01) and 1.16 (1.03-1.29) events per 100 patient-years, respectively. Age ≥75 years, creatinine clearance <50 mL/min, diabetes mellitus, and vascular disease were independently associated with incidence of major bleeding. The primary composite effectiveness outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction occurred at an incidence (95% confidence interval) of 1.32 (1.18-1.46) events per 100 patient-years. Age ≥75 years, hypertension, prior ischemic stroke/transient ischemic attack, and concomitant use of antiplatelets were independently associated with incidence of the composite outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction.<h4>Conclusion</h4>In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up. |
| format | Article |
| id | doaj-art-b4c49a7ceb404b83a60b6d9e87b35dea |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-b4c49a7ceb404b83a60b6d9e87b35dea2025-08-20T02:54:33ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01166e025132510.1371/journal.pone.0251325Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS.Takanori IkedaSatoshi OgawaTakanari KitazonoJyoji NakagawaraKazuo MinematsuSusumu MiyamotoYuji MurakawaSanghun IwashiroYutaka OkayamaToshiyuki SunayaKazufumi HiranoTakanori Hayasaki<h4>Background</h4>The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global regions, in Japanese patients with non-valvular atrial fibrillation in real-world clinical practice.<h4>Methods</h4>In this prospective, open-label, single-arm, observational study, 11,308 patients with non-valvular atrial fibrillation newly prescribed rivaroxaban (15/10 mg once daily) at 1416 sites across Japan were enrolled and followed for a mean of 2.5 years.<h4>Results</h4>In total, 10,664 and 10,628 patients were included in the safety and effectiveness analyses, respectively. In the safety population, mean (standard deviation) age was 73.1 (9.8) years and Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, previous Stroke/TIA (2 points) (CHADS2) score was 2.2 (1.3). Incidences (95% confidence intervals) of any and major bleeding were 3.77 (3.53-4.01) and 1.16 (1.03-1.29) events per 100 patient-years, respectively. Age ≥75 years, creatinine clearance <50 mL/min, diabetes mellitus, and vascular disease were independently associated with incidence of major bleeding. The primary composite effectiveness outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction occurred at an incidence (95% confidence interval) of 1.32 (1.18-1.46) events per 100 patient-years. Age ≥75 years, hypertension, prior ischemic stroke/transient ischemic attack, and concomitant use of antiplatelets were independently associated with incidence of the composite outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction.<h4>Conclusion</h4>In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0251325&type=printable |
| spellingShingle | Takanori Ikeda Satoshi Ogawa Takanari Kitazono Jyoji Nakagawara Kazuo Minematsu Susumu Miyamoto Yuji Murakawa Sanghun Iwashiro Yutaka Okayama Toshiyuki Sunaya Kazufumi Hirano Takanori Hayasaki Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. PLoS ONE |
| title | Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. |
| title_full | Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. |
| title_fullStr | Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. |
| title_full_unstemmed | Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. |
| title_short | Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. |
| title_sort | real world safety and effectiveness of rivaroxaban using japan specific dosage during long term follow up in patients with atrial fibrillation xapass |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0251325&type=printable |
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