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Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
Date:5/2/2012

symptomatic DVT. EINSTEIN-PE enrolled 4,833 patients, who received treatment for six or 12 months of therapy, making it the largest study ever conducted in the acute treatment of PE. Results from EINSTEIN-PE were presented at the American College of Cardiology Annual Scientific Sessions, and published in the New England Journal of Medicine in March 2012 (n engl j med 10.1056).

The EINSTEIN-DVT study compared the safety and efficacy of oral rivaroxaban – administered at 15 mg twice daily for three weeks followed by 20 mg once daily – to standard therapy of enoxaparin followed by VKA. More than 3,400 patients with acute symptomatic DVT in the deep veins of the knee or thigh, but without any symptoms of PE, were enrolled and received treatment for three, six or 12 months of therapy. Results from EINSTEIN-DVT were presented at the annual European Society of Cardiology Congress, in August 2010.

EINSTEIN-EXT evaluated 1,197 patients who had previously completed six to 12 months of treatment with a VKA for an acute episode of VTE or had participated in the Phase 3 EINSTEIN-DVT or EINSTEIN-PE trials, in which they were treated with either rivaroxaban or a VKA. Upon enrolling in EINSTEIN-EXT, patients were randomized to receive either 20 mg of rivaroxaban dosed once-daily or placebo and were evaluated for an additional six or 12 months. Results from EINSTEIN-EXT were presented at the annual meeting of the American Society of Hematology in December 2009. Data from EINSTEIN-DVT and EINSTEIN-EXT were published together in the New England Jo
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