Phase 3 Study of Xarelto for Treatment and Secondary Prevention of Venous Blood Clots

Janssen Research & Development announced results of the EINSTEIN-PE study showing that Xarelto (rivaroxaban) was comparable to today's standard of care in treating patients with acute symptomatic pulmonary embolism (PE) and in preventing development of a secondary venous blood clot (known as venous thromboembolism or VTE). The study also found rivaroxaban had a similar safety profile and significantly lower risk of major bleeding versus the current standard regimen.

The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial that compared oral rivaroxaban –15mg twice daily for three weeks, followed by 20mg once daily – with the current standard of care of enoxaparin (Lovenox; Sanofi Aventis) followed by a vitamin K antagonist (VKA) in the treatment of 4,833 patients with acute symptomatic PE with or without symptomatic DVT for the prevention of recurrent VTE. Patients received treatment for three, six or 12 months. In the study, rivaroxaban succeeded in demonstrating non-inferiority to standard therapy for the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE [2.1% vs. 1.8%, respectively (P=0.003 for non-inferiority)]. Rivaroxaban also demonstrated similar results compared to standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [10.3% vs. 11.4% (P=0.23), respectively].  Rivaroxaban treatment also resulted in a significant reduction in major bleeding events [1.1% vs. 2.2% (P=0.003), respectively] compared to standard therapy.

EINSTEIN-PE is one of three Phase 3 studies in the global EINSTEIN program, evaluating the safety and efficacy of rivaroxaban in the treatment and prevention of a recurrent, symptomatic VTE in patients with acute symptomatic DVT or PE. Combined, these trials have enrolled more than 9,400 patients.

Xarelto is a factor Xa inhibitor, oral anticoagulant. It is currently indicated for the prophylaxis of deep vein thrombosis in people undergoing knee- or hip-replacement surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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