defined future standards for the treatment of DVT
- Xarelto® demonstrated equivalent efficacy and safety compared with the current standard dual-drug therapy of enoxaparin plus a VKA in the treatment of patients with acute DVT
- Xarelto demonstrated a superior net clinical benefit and confirmed the favourable benefit–risk profile seen in other phase III trials of rivaroxaban
- Xarelto provides a convenient, simple single-drug approach for the treatment of acute DVT without the need for routine coagulation monitoring
Key findings from EINSTEIN DVT
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 in preventing symptomatic recurrent VTE (composite of recurrent DVT, non-fatal PE and fatal PE).10 The primary efficacy endpoint occurred in 2.1% (36/1731) of patients receiving Xarelto and in 3.0% (51/1718) of patients receiving enoxaparin/VKA (p<0.001 for non-inferiority)
- A reassuring and favourable safety profile:
- The rates of major and non-major clinically relevant bleeding were similar for patients treated with Xarelto (8.1%; 139/1718) and for patients treated with enoxaparin/VKA (8.1%; 138/1711)
- The rate of major bleeding events was numerically lower for Xarelto (0.8%) compared with enoxaparin/VKA (1.2%)96
- Significantly improved net clinical benefit:
- Defined as symptomatic, recurrent VTE (composite of recurrent DVT, non-fatal PE and fatal PE) and major bleeding for Xarelto compared with enoxaparin/VKA96
- Net clinical benefit was significantly better with Xarelto (2.9%; 51/1731) compared with enoxaparin/VKA (4.2%; 73/1718)
for more information about the EINSTEIN DVT
- 96 - The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499–2510.
- 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.
- 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.
- 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.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.