Portola Pharmaceuticals and Merck achieved positive results from EXPLORE-Xa, a Phase II dose finding study of investigational oral direct Factor Xa inhibitor betrixaban. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non-major (CRNM) bleeds compared to dose-adjusted warfarin.

The multinational study of 508 patients with non-valvular atrial fibrillation or atrial flutter with at least one risk factor for stroke, showed that a once daily dose of betrixaban 40 mg demonstrated significantly less major and CRNM bleeding than open label warfarin. The risk of major and CRNM bleeding for the 60 mg and 80 mg doses of betrixaban was similar to warfarin. The primary study endpoint was the time to occurrence of major or CRNM bleeding. The incidence of major or CRNM bleeding was 0.8%, 3.9%, 3.9% and 5.5% for the betrixaban 40 mg, 60 mg, and 80 mg and warfarin groups, respectively.

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