The endoxaban is an oral direct inhibitor of factor Xa with a rapid onset of action and a half-life of 8-10 hours. Endoxaban efficacy and safety for long-term versus warfarinin patients with atrial fibrillation was not studied. This was a randomized, double-blind study that compares two different regimes of endoxaban with warfarin in 21105 patients with moderate/high risk atrial fibrillation.
The primary efficacy end point was the incidence of stroke or systemic embolism and the safety major bleeding. Randomization was 1:1:1 to warfarin (adjusted the dose to obtain a RIN between 2 and 3), endoxaban high doses (60 mg) or endoxaban low dose (30 mg). The annual rate of the primary end point was 1.5 % for warfarin versus 1.18 % for endoxaban high doses (p < 0.001 for noninferiority) versus 1.61 % for endoxaban low doses (p = 0.005 for non-inferiority). The annual rate of major bleeding was 3.4 % with warfarin versus 2.75 % for endoxaban high doses ( p < 0.001 ) versus 1.61 % low doses ( p < 0.001) .
Conclusion:
Both schemes of endoxaban daily doses were not inferior to warfarin in regards to the prevention of stroke and systemic embolism, but with lower rates of bleeding and death for cardiovascular causes.
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Robert P. Giugliano
2013-11-19
Original title: ENGAGE AF-TIMI 48 Primary Results