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Efficacy and Safety of Dabigatran vs. Warfarin in Patients with Atrial Fibrillation - Japanese population in the RE-L

Efficacy and Safety of Dabigatran vs. Warfarin in Patients with Atrial Fibrillation - Japanese population in the RE-LY ® -.

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Efficacy and Safety of Dabigatran vs. Warfarin in Patients with Atrial Fibrillation - Japanese population in the RE-L

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  1. Efficacy and Safety of Dabigatran vs. Warfarin in Patients with Atrial Fibrillation - Japanese population in the RE-LY ® - Shinya Goto , MD., PhD.Tokai University School of Medicine C. Michael Gibson, M.S., M.D. Beth Israel Deaconess Medical Center, Harvard Medical School,Duke Clinical Research Institute

  2. RE-LY® - Overall Summary • Dabigatran etexilate has been shown to concurrently reduce both thrombotic and haemorrhagic events • Both doses of dabigatran provide different and complementary advantages over warfarin • 150 mg BID showed 35% statistically significant reduction in stroke/systemic embolism with similar bleeding • 110 mg BID showed comparable rates of stroke/systemic embolism has significantly less bleedings with similar efficacy

  3. RE-LY® - Baseline Characteristics in Japanese Population Hori M, et al: Circ J 2011; 75: 800 - 805, 2011

  4. RE-LY® - Stroke or Systemic Embolism Overall Japan RR 0.65 (95% CI: 0.52-0.81) RR 0.25 RR 0.90 (95% CI: 0.74-1.10) RR 0.52 % per year % per year 150mg bid 110mg bid (n=134/6,076) (n=183/6,015) (n=202/6,022) 150mg bid 110mg bid (n=1/111) (n=12/107) (n=4/108) Connolly SJ, et al.: N Engl J Med 363, 1875-1876, 2010 Hori M, et al: Circ J 2011; 75: 800 - 805, 2011

  5. RE-LY® - Plasma Concentration of Dabigatranin Overall and Japanese Overall Japanese Overall Japanese Cpre,ss: Pre dose plasma concentrations at steady state C2,ss : Plasma concentration at 2 hours after drug administration at steady state (approximate maximum plasma concentration) Hori M, et al: Circ J 2011; 75: 800 - 805, 2011

  6. Country Distribution of Mean Time in Therapeutic Range (TTR) in the RE-LY® Wallentin L, et al.: Lancet, 376: 975-83, 2010

  7. RE-LY® - INR Control/ TTR RE-LY in Japanese subgroup adapts INR 2.0-3.0 for <70 years and INR 2.0-2.6 for ≧70 years • JCS guideline for pharmacotherapy of atrial fibrillation 2008: • 2.0~3.0 for <70 years • 1.6~2.6 for ≧70 years

  8. RE-LY® - Conclusions • The result of Japanese subgroup is basically consistent with overall results of RE-LY®. • The demographics of the Japanese subgroup differ from the overall population in prior stroke and MI of RE-LY but the overall risk score is similar. • PK profile between Japanese subgroup and overall is similar. • Based on the Japanese guideline criteria, the INR control of warfarin was well-controlled.

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