Xarelto® demonstrates an improved clinical benefit in the treatment of acute DVT and PE, and prevention of recurrent DVT and PE 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 either warfarin or acenocoumarol dose adjusted to an international normalized ratio
of 2.0–3.0) in patients with:
- 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
who had already been treated for 6–12 months with a VKA
- The ability of a drug to produce the desired effect.
- International Normalized Ratio
- A system for assessing the clotting tendency of blood in patients receiving anticoagulant therapy. For patients with atrial fibrillation, the recommended target INR range is between 2 and 3. If the INR is higher than 3, patients are at risk of serious bleeding. If the INR is less than 2, patients are at risk of a blood clotting event.
- 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.
- Vitamin K antagonist
- An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment is required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many patients are actually not treated and many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.