Xarelto rivaroxaban: Phase III data

The open-label, international Phase III EINSTEIN-DVT trial in >3,400 patients showed that oral rivaroxaban was non-inferior to current standard therapy (initial Lovenox enoxaparin followed by a vitamin K antagonist) on the primary endpoint of the cumulative incidence of symptomatic recurrent VTE. Additionally, rivaroxaban significantly improved net clinical benefit, a pre-specified secondary endpoint defined as the composite of the primary endpoint plus major bleeding, vs. standard therapy. Rivaroxaban was well tolerated, and the composite rate of major and clinically relevant non-major bleeding was similar between treatment groups. Patients received 15 mg twice-daily oral rivaroxaban for 3 weeks, followed by 20 mg once-daily rivaroxaban for 3, 6 or 12 months, or standard therapy. Data will be presented at the European Society of Cardiology meeting in Stockholm later this month. ...