Edoxaban versus Warfarin in Patients with Atrial Fibrillation

Edoxaban, an oral factor Xa inhibitor, was noninferior to warfarin in the prevention of stroke or systemic embolism in patients with atrial fibrillation. There was less bleeding with edoxaban than with warfarin. Edoxaban is an oral, reversible, direct factor Xa inhibitor with a linear and predictable pharmacokinetic profile and 62% oral bioavailability. 1 It achieves maximum concentrations within 1 to 2 hours, and 50% is excreted by the kidney. 2 A randomized, dose-ranging, warfarin-controlled, phase 2 study involving 1146 patients with atrial fibrillation showed that once-daily doses of edoxaban (60 mg or 30 mg) were safer than twice-daily doses. 3 Pharmacokinetic modeling and simulation showed that patients with low body weight, moderate-to-severe renal dysfunction, or concomitant use of a potent P-glycoprotein inhibitor should have the edoxaban dose reduced by 50%. 4 A phase 3 study involving . . .