Safety and Efficacy of Adjusted Dose of Rivaroxaban in Japanese Patients With Non-Valvular Atrial Fibrillation : – Subanalysis of J-ROCKET AF for Patients With Moderate Renal Impairment –
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概要
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Background: In the Japanese Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (J-ROCKET AF) study, rivaroxaban 15mg once daily was given to patients with creatinine clearance (CrCl) ≥50ml/min (preserved renal function), and was reduced to 10mg once daily in patients with CrCl 30–49ml/min (moderate renal impairment). The aim of this subanalysis was to assess the safety and efficacy of the adjusted dose of rivaroxaban compared with warfarin in a cohort with moderate renal impairment. Methods and Results: Compared with patients with preserved renal function, those with moderate renal impairment (22.2% of all randomized patients) had higher rates of bleeding and stroke events irrespective of study treatment. Among those with moderate renal impairment, the principal safety endpoint occurred at 27.76%/year with rivaroxaban vs. 22.85%/year with warfarin (hazard ratio [HR], 1.22; 95% confidence interval [CI]: 0.78–1.91) and the rate of the primary efficacy endpoint was 2.77%/year vs. 3.34%/year (HR, 0.82; 95% CI: 0.25–2.69), respectively. There were no significant interactions between renal function and study treatment in the principal safety and the primary efficacy endpoints (P=0.628, 0.279 for both interactions, respectively). Conclusions: The safety and efficacy of rivaroxaban vs. warfarin were consistent in patients with moderate renal impairment and preserved renal function.
著者
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HORI Masatsugu
Osaka Medical Center for Cancer and Cardiovascular Disease
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Koretsune Yukihiro
Institute For Clinical Research Osaka National Hospital
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Tanahashi Norio
Department Of Anesthesiology Osaka University Medical School
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Momomura Shin-ichi
Division Of Cardiovascular Medicine Department Of Integrated Medicine I Jichi Medical University Sai
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Izumi Tohru
Department Of Angio-cardiology Kitasato University School Of Medicine
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KAJIKAWA Mariko
Bayer Yakuhin Ltd
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KATO Masaharu
Bayer Yakuhin Ltd
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UEDA Hitoshi
Bayer Yakuhin Ltd
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IWAMOTO Kazuya
Bayer Yakuhin Ltd
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TAJIRI Masahiro
Bayer Yakuhin Ltd
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Goto Shinya
Department Of Cardiology Tokai University
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Matsumoto Masayasu
Department Of Clinical Neuroscience And Therapeutics Graduate School Of Biomedical Science Hiroshima University
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Uchiyama Shinichiro
Department of Health Chemistry, School of Pharmaceutical Sciences, Showa University
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Tanahashi Norio
Department of Neurology, Saitama Medical University International Medical Center
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Matsumoto Masayasu
Department of Clinical Neuroscience and Therapeutics Division of Integrated Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
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Tajiri Masahiro
Bayer Yakuhin
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Ueda Hitoshi
Bayer Yakuhin
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Iwamoto Kazuya
Bayer Yakuhin
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Kato Masaharu
Bayer Yakuhin
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Momomura Shin-ichi
Division of Cardiology, Department of Integrated Medicine I, Saitama Medical Center, Jichi Medical University School of Medicine
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Kajikawa Mariko
Bayer Yakuhin
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