EINSTEIN PE
- Xarelto® demonstrated equivalent efficacy and overall safety with a lower rate of major bleeding compared with the current standard dual-drug therapy of enoxaparin plus a VKA in the treatment of patients with acute PE
- Xarelto demonstrated a similar net clinical benefit with a trend towards fewer events
- Xarelto provides a convenient, simple, single-drug approach for the treatment of acute PE without the need for routine coagulation monitoring
Key findings from EINSTEIN PE
Xarelto demonstrated, in comparison with enoxaparin plus a VKA:
- Equivalent efficacy with the built-in simplicity of a single-drug approach
- Xarelto was non-inferior to enoxaparin plus a VKA followed by the VKA alone for the primary efficacy endpoint (composite of recurrent DVT, non-fatal PE and fatal PE).121 The primary efficacy endpoint occurred in 2.1% (50/2419) of patients receiving Xarelto and in 1.8% (44/2413) of patients receiving enoxaparin/VKA (p=0.003 for non-inferiority)
- A reassuring and favourable safety profile:121
- The rates of major and non-major clinically relevant bleeding were similar for patients treated with Xarelto (10.3%; 249/2412) and for patients treated with enoxaparin/VKA (11.4%; 274/2405)
- The rate of major bleeding events was reduced by 51% with Xarelto (1.1%; 26/2412) compared with enoxaparin/VKA (2.2%; 52/2405)
- Similar net clinical benefit with a trend towards fewer events:
- Defined as symptomatic, recurrent VTE (composite of recurrent DVT, non-fatal PE and fatal PE) and major bleeding for Xarelto compared with enoxaparin/VKA121
- The net clinical benefit outcome occurred at a similar rate with Xarelto (3.4%; 83/2419 and enoxaparin/VKA (4.0%; 96/2413); (hazard ratio 0.85; 95% confidence interval 0.63–1.14; p=0.28)
- 121 - The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287–1297.
- 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.
- Efficacy
- The ability of a drug to produce the desired effect.
- 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.
- 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.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
