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.

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.

• Authors: Masatsugu Hori, Masayasu Matsumoto, Norio Tanahashi, Shin-ichi Momomura, Shinichiro Uchiyama, Shinya Goto, Tohru Izumi, Yukihiro Koretsune, Mariko Kajikawa, Masaharu Kato, Hitoshi Ueda, Kazuya Iwamoto, Masahiro Tajiri, J-ROCKET AF study investigators
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 77 Issue 3 Pg. 632-8 ( 2013) ISSN: 1347-4820 [Electronic] Japan
• PMID: 23229461 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Morpholines
• Thiophenes
• Warfarin
• Rivaroxaban
• Creatinine

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Anticoagulants (adverse effects, pharmacology, therapeutic use)
• Asian People
• Atrial Fibrillation (drug therapy, physiopathology)
• Creatinine (metabolism)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Japan
• Kidney (drug effects, metabolism, physiopathology)
• Male
• Middle Aged
• Morpholines (adverse effects, pharmacology, therapeutic use)
• Renal Insufficiency (chemically induced, metabolism, physiopathology)
• Reproducibility of Results
• Risk Factors
• Rivaroxaban
• Stroke (prevention & control)
• Thiophenes (adverse effects, pharmacology, therapeutic use)
• Treatment Outcome
• Warfarin (adverse effects, therapeutic use)