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Edoxaban Found Safer Than and as Effective as Warfarin

Positive results announced from a phase III trial (November 19)

Encouraging results have been announced from the phase III ENGAGE AF-TIMI 48 study. In this clinical trial, edoxaban (Daiichi Sankyo), an investigational, oral, once-daily direct factor Xa-inhibitor, met the study’s primary efficacy endpoint of non-inferiority compared with warfarin for the prevention of stroke or systemic embolic events in patients with nonvalvular atrial fibrillation (AF). Once-daily edoxaban also demonstrated significant reductions in major bleeding compared with warfarin, achieving superiority for the principal safety endpoint. The results were presented November 19 at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas and were published online in the New England Journal of Medicine.

ENGAGE AF-TIMI 48 compared two treatment arms, receiving edoxaban 60 mg and 30 mg, with warfarin in 21,105 patients with nonvalvular AF for a median of 2.8 years. This represents the largest and longest trial with a novel anticoagulant in patients with AF performed to date. Patients receiving edoxaban 60 mg had an annual incidence of stroke or systemic embolic events of 1.18% versus 1.50% for warfarin and significantly reduced major bleeding by 20%.

Patients receiving edoxaban 30 mg had an annual incidence of stroke or systemic embolic events of 1.61% versus 1.50% for warfarin and a significantly reduced rate of major bleeding by 53% (1.61% vs. 3.43% per year, respectively).

Annualized rates for the key secondary composite endpoint of stroke, systemic embolic events, and cardiovascular death were 4.43% with warfarin, 3.85% with edoxaban 60 mg and 4.23% with edoxaban 30 mg.

Edoxaban was also associated with reduced annualized cardiovascular mortality rates versus warfarin: the incidence was 3.17% for warfarin, 2.74% with edoxaban 60 mg and 2.71% with edoxaban 30 mg. The primary net clinical outcome (defined in the study protocol as the composite of death, stroke, systemic embolic events, or major bleeding) was 8.11% per year for warfarin, 7.26% per year for edoxaban 60 mg and 6.79% per year for edoxaban 30 mg.

[Source: Daiichi Sankyo; November 19, 2013.]

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