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Published on 1 September 2010

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Rivaroxaban demonstrates non-inferiority compared to the standard of care for DVT

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The Phase III EINSTEIN-DVT clinical trial of the oral anticoagulant rivaroxaban demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile. The data were presented today during a Hot Line session at the European Society of Cardiology (ESC) Congress.

“Results from EINSTEIN-DVT could transform the way physicians treat deep vein thrombosis,” said lead investigator Harry R Büller, MD, Academic Medical Center in Amsterdam, Netherlands, who presented the results. “While the current standard of care is effective when well-controlled, it is often associated with significant drawbacks for patients and physicians. A novel single-drug approach such as oral rivaroxaban could potentially provide an effective and well-tolerated, simple, fixed-dose regimen for the treatment of deep vein thrombosis as a replacement for current standard therapy.”

In the study, oral rivaroxaban demonstrated non-inferiority for the primary efficacy outcome, defined as the cumulative incidence of symptomatic recurrent DVT and non-fatal or fatal PE, in patients with acute symptomatic DVT compared with the current standard of care of enoxaparin followed by a vitamin K antagonist (VKA) [2.1% vs. 3.0%, respectively (p <0.0001 for non-inferiority)]. Rivaroxaban also demonstrated similar results compared to the standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [8.1% in both treatment groups, (p=0.77)]. Monthly liver function tests did not reveal a signal for impaired liver safety. Rivaroxaban was well tolerated in the study, and discontinuation rates related to adverse events were low and similar in both treatment groups.

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