einstein dvt and einstein pe pooled analysis 'xarelto' for the treatment of symptomatic venous...

Download EINSTEIN DVT and EINSTEIN PE Pooled Analysis 'Xarelto' for the Treatment of Symptomatic Venous Thromboembolism

Post on 23-Dec-2015

217 views

Category:

Documents

2 download

Embed Size (px)

TRANSCRIPT

  • Slide 1
  • EINSTEIN DVT and EINSTEIN PE Pooled Analysis 'Xarelto' for the Treatment of Symptomatic Venous Thromboembolism
  • Slide 2
  • Effective and Safe Treatment of DVT and PE Across a Wide Range of Patients Effective and safe treatment of DVT and PE can be challenging, particularly in high-risk subgroups of patients, including: Frail and elderly patients 1 Patients with renal impairment 2 Patients with cancer 2 1. Silverstein et al, 2007; 2. Van Es et al, 2011 These patients may be at increased risk of bleeding and/or venous thromboembolism
  • Slide 3
  • EINSTEIN DVT and PE Pooled Analysis Two phase III studies with similar designs 1,2 1. The EINSTEIN Investigators, 2010; 2. The EINSTEINPE Investigators, 2012 Allowed prespecified pooling of >8000 patients, which provided robustness for: Subgroup analyses Evaluation of rare safety events Objectively confirmed DVT without symptomatic PE Objectively confirmed PE with or without symptomatic DVT 15 mg bid N=3449 'Xarelto' Day 1 Day 21 Enoxaparin (1.0 mg/kg) bid for at least 5 days, plus VKA target INR 2.5 (INR range 2.03.0) Predefined treatment period of 3, 6 or 12 months 20 mg od 'Xarelto' R 30-day observation period N=4832
  • Slide 4
  • Effective VTE Treatment Matters 0.5 3.0 2.5 2.0 1.5 1.0 0.0 'Xarelto' N=4150 Enoxaparin/VKA N=4131 0306090120150180210240270300330360 Time to event (days) Cumulative event rate (%) HR=0.89 (95% CI 0.661.19); p non-inferiority