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

• Published in: Circulation Journal Vol. 77; no. 3; pp. 632 - 638
• Main Authors: Hori, Masatsugu, Matsumoto, Masayasu, Tanahashi, Norio, Momomura, Shin-ichi, Uchiyama, Shinichiro, Goto, Shinya, Izumi, Tohru, Koretsune, Yukihiro, Kajikawa, Mariko, Kato, Masaharu, Ueda, Hitoshi, Iwamoto, Kazuya, Tajiri, Masahiro, on behalf of the J-ROCKET AF study investigators
• Format: Journal Article
• Language: English
• Published: Japan The Japanese Circulation Society 2013
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants - adverse effects; Anticoagulants - pharmacology; Anticoagulants - therapeutic use; Asian Continental Ancestry Group; Atrial fibrillation; Atrial Fibrillation - drug therapy; Atrial Fibrillation - physiopathology; Creatinine - metabolism; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Japan; Kidney - drug effects; Kidney - metabolism; Kidney - physiopathology; Male; Middle Aged; Morpholines - adverse effects; Morpholines - pharmacology; Morpholines - therapeutic use; Renal impairment; Renal Insufficiency - chemically induced; Renal Insufficiency - metabolism; Renal Insufficiency - physiopathology; Reproducibility of Results; Risk Factors; Rivaroxaban; Stroke; Stroke - prevention & control; Thiophenes - adverse effects; Thiophenes - pharmacology; Thiophenes - therapeutic use; Treatment Outcome; Warfarin; Warfarin - adverse effects; Warfarin - therapeutic use; Japan
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-12-0899

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.  (Circ J 2013; 77: 632–638)