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.
- Xarelto demonstrated superior efficacy with acceptable safety versus placebo in the prevention of recurrent venous thromboembolic events
- Xarelto demonstrated a significantly better net clinical benefit compared with placebo:
- To prevent one recurrent venous thromboembolic event, only 17 patients needed to be treated with Xarelto (number needed to treat =17)
- To incur one of major bleeding event, 150 patients needed to be treated (number needed to harm =150)
Key findings from EINSTEIN EXT
Xarelto demonstrated, in comparison with placebo:
- Superior efficacy:
- Reassuring safety:
- Rates of major bleeding were low, with non-significant (p=0.11) differences between Xarelto (0.7%; 4/598) and placebo (0%; 0/590)96
- Superior long-term net clinical benefit for the prevention of recurrent VTE:
- A 72% lower risk of recurrent VTE and major bleeding events (composite outcome) compared with placebo (2.0% [12/602] for Xarelto and 7.1% [42/594] for placebo; p<0.001)96
- To prevent one recurrent venous thromboembolic event; only 17 patients needed to be treated with Xarelto (number needed to treat = 17)
- To prevent one recurrent venous thromboembolic event; only 15 patients needed to be treated with Xarelto (number needed to treat = 15)
- To incur one major bleeding event, 150 patients needed to be treated with Xarelto (number needed to harm = 150)
- Overall, 34 recurrent events were prevented at the cost of four major bleeding events97
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- 96 - The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499–2510.
- 97 - Buller HR. Oral rivaroxaban for the acute and continued treatment of symptomatic venous thromboembolism: the EINSTEIN-DVT and EINSTEIN-Extension Study. Blood (ASH Annual Meeting Abstracts) 2010;116:86. Abstract 187.
- 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.
- Efficacy
- The ability of a drug to produce the desired effect.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
