Xarelto® demonstrates an improved clinical benefit in the treatment of DVT and prevention of recurrent DVT and PE following an acute DVT in adults
The phase III EINSTEIN DVT and EINSTEIN PE studies evaluated the efficacy and safety of the single-drug approach with Xarelto® 15 mg twice daily for 3 weeks then 20 mg once daily compared with the current standard dual-drug therapy (enoxaparin 1.0 mg/kg twice daily initially plus acenocoumarol dose adjusted to the international normalized ratio) in patients with:
The EINSTEIN EXT study compared the efficacy and safety of continued treatment with Xarelto® 20 mg once daily or placebo for an additional 6 or 12 months in patients with confirmed symptomatic DVT or PE who had already been treated for 6–12 months with a vitamin K antagonist (VKA) or Xarelto®.
The EINSTEIN DVT and EINSTEIN EXT studies have been completed and reported.96 EINSTEIN PE has been completed and the results will be reported in 2012.
- Acute symptomatic DVT without symptomatic PE (EINSTEIN DVT)
- Acute symptomatic PE with or without symptomatic DVT (EINSTEIN PE)
The EINSTEIN EXT study compared the efficacy and safety of continued treatment with Xarelto® 20 mg once daily or placebo for an additional 6 or 12 months in patients with confirmed symptomatic DVT or PE who had already been treated for 6–12 months with a vitamin K antagonist (VKA) or Xarelto®.
The EINSTEIN DVT and EINSTEIN EXT studies have been completed and reported.96 EINSTEIN PE has been completed and the results will be reported in 2012.
EINSTEIN DVT
EINSTEIN EXT
EINSTEIN EXT showed that extended (6–12 months) anticoagulation therapy with Xarelto® significantly reduced the incidence of recurrent DVT and PE, providing effective long-term protection from an enduring threat.
Read more
Read more
EINSTEIN PE
EINSTEIN PE is a unique trial evaluating the efficacy and safety of Xarelto® in a simple fixed-dose regimen for the initial and continued treatment of patients with acute symptomatic PE.
Read more
Read more
- 96 - The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499–2510.
- Efficacy
- The ability of a drug to produce the desired effect.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
