title: 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.
abstract: 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 15 mg once daily was given to patients with creatinine clearance (CrCl) ≥ 50 ml/min (preserved renal function), and was reduced to 10mg once daily in patients with CrCl 30-49 ml/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.
  
  
  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.
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. hori-ma@mc.pref.osaka.jp
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Hori
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
authors.forename: Norio
authors.initials: N
authors.lastname: Tanahashi
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Momomura
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.forename: Shinya
authors.initials: S
authors.lastname: Goto
authors.forename: Tohru
authors.initials: T
authors.lastname: Izumi
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Koretsune
authors.forename: Mariko
authors.initials: M
authors.lastname: Kajikawa
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kato
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ueda
authors.forename: Kazuya
authors.initials: K
authors.lastname: Iwamoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tajiri
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D044466:Asian People; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000503:physiopathology; D003404:Creatinine / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D007668:Kidney / Q000187:drug effects / Q000378:metabolism / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D051437:Renal Insufficiency / Q000139:chemically induced* / Q000378:metabolism / Q000503:physiopathology; D015203:Reproducibility of Results; D012307:Risk Factors; D000069552:Rivaroxaban; D020521:Stroke / Q000517:prevention & control*; D013876:Thiophenes / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D009025:Morpholines; D013876:Thiophenes; D014859:Warfarin; D000069552:Rivaroxaban; D003404:Creatinine