1 / 8

Dabigatran etexilate has been shown to concurrently reduce both thrombotic and haemorrhagic events

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

hiero
Download Presentation

Dabigatran etexilate has been shown to concurrently reduce both thrombotic and haemorrhagic events

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 Subjects 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/ Time racio • JCS guideline for pharmacotherapy of atrial fibrillation2008: • 2.0~3.0 for <70 years • 1.6~2.6 for ≧70 years

  8. RE-LY® - Japanese Population 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.

More Related