Results of the Phase III EINSTEIN-DVT study have shown that the oral anticoagulant Rivaroxaban ( Xarelto ) achieved the primary efficacy and safety outcomes in the treatment of patients with acute, symptomatic deep vein thrombosis ( DVT ).

Rivaroxaban has demonstrated non-inferior efficacy in the treatment of deep vein thrombosis compared with initial Enoxaparin ( Clexane, Lovenox ) treatment followed by a vitamin K antagonist, the current standard therapy for the treatment of deep vein thrombosis.
Recurrent symptomatic venous thromboembolism ( ie, the composite of recurrent deep vein thrombosis, non-fatal or fatal pulmonary embolism ) occurred in 2.1% of the Rivaroxaban recipients and 3.0% of the subjects receiving standard therapy ( p<0.0001 for non-inferiority ).

The EINSTEIN-DVT trial has also demonstrated similar rates of major and clinically relevant non-major bleeding, the principal safety outcome, for Rivaroxaban compared with the current standard therapy ( 8.1% vs. 8.1%, respectively ).
No liver signal attributable to Rivaroxaban was observed in the study.

The EINSTEIN-DVT trial was designed to investigate a new single-drug approach with Rivaroxaban in comparison to standard therapy in a randomised, open-label, non-inferiority study. The trial involved more than 3,400 patients with acute symptomatic deep vein thrombosis, but without any symptoms of pulmonary embolism, across 253 sites in 32 countries worldwide.
Patients received either oral Rivaroxaban ( 15 mg twice-daily for the first three weeks, followed by 20 mg once daily ) or body weight-adjusted subcutaneous Enoxaparin followed by Warfarin ( Coumadin ) or Acenocoumarol ( Sintrom ) ( dose adjusted to maintain a therapeutic normalised ratio ) for 3, 6 or 12 months, based on the attending physician’s assessment at baseline.

The primary efficacy outcome was the cumulative incidence of symptomatic recurrent venous thromboembolism ( non-fatal or fatal ). The principal safety outcome was the composite of major and clinically relevant non-major bleeding.

Source: European Society of Cardiology Meeting, 2010

XagenaMedicine2010


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