Edoxaban — Another Warfarin Alternative for Patients with Atrial Fibrillation

Edoxaban is an oral factor Xa inhibitor that is not yet FDA-approved for use in the U.S. In an industry-sponsored international trial, researchers randomized 21,000 patients with atrial fibrillation to receive daily edoxaban (30 mg or 60 mg) or placebo.

During a median follow-up of 2.8 years, annualized rates of various outcomes were as follows:

• Primary efficacy endpoint (stroke or systemic embolism): 1.50% with warfarin, 1.61% with low-dose edoxaban, and 1.18% with high-dose edoxaban; low-dose edoxaban was noninferior to warfarin, and high-dose edoxaban was superior to warfarin.

• Major bleeding: 3.43% with warfarin, 2.75% with high-dose edoxaban, and 1.61% with low-dose edoxaban; rates with both edoxaban doses were significantly lower than that with warfarin.

• All-cause mortality: 4.35% with warfarin, 3.99% with high-dose edoxaban, and 3.80% with low-dose edoxaban.

• Several “net clinical outcome” endpoints (which combined stroke, major bleeding, and death) favored edoxaban over warfarin, with little difference between the two edoxaban doses.