Hokusai-VTE: Endoxaban shows solid results versus warfarin in venous thromboembolism .

The venous thromboembolism is the third most common cardiovascular disease after acute myocardial infarction and stroke . Usual treatment is to use low molecular weight heparin followed by vitamin K antagonists Other studies have shown that the new oral anticoagulants with or without initial heparin are effective alternatives. The endoxaban is a direct Factor Xa inhibitor with a rapid onset of action and a half-life of 10 to 14 hours orally administered .

This trial is randomized , double-blind , non-inferiority  to test the usefulness of endoxaban in patients with venous thromboembolism versus warfarin . All patients had acute thromboembolism ( pulmonary thromboembolism 40 % and 60 % deep vein thrombosis) and initially received heparin. Endoxaban dose was 60 mg once a day or 30 mg once per day in case of reduced kidney function or low weight for 3 to 12 months. Primary efficacy endpoint was recurrence of venous thromboembolism and major and minor bleeding safety . We included a total of 4921 patients diagnosed with deep vein thrombosis and 3319 evolving pulmonary embolism  . Endoxaban was non-inferior to warfarin with respect to the primary end point occurred in 3.2 % endoxaban group versus 3.5 % in the warfarin group ( p < 0.001 for noninferiority ) . The safety end point occurred in 8.5 % endoxaban group versus 10.3 % in the warfarin group ( p = 0.004 for superiority ) .

Conclusion:

Endoxaban administered once per day after initial treatment with heparin was non-inferior to conventional therapy with warfarin and has a lower rate of bleeding in a broad spectrum of patients with venous thromboembolism .

Editorial comment:

The rapid onset of action of endoxaban has an important advantage of not requiring treatment overlap when pass from heparin to oral anticoagulant . Keep better security effectively make this drug to be a promising option for these patients.

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Harry Buller
2013-09-02

Original title: Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism.The Hokusai-VTE Investigators.