ENGAGE AF TIMI 48 results for edoxaban (Daiichi Sankyo) in Stroke Prevention

Daiichi Sankyo Company, Limited announced results from the phase III ENGAGE AF-TIMI 48 study. This clinical trial found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the Prevention of Stroke or Systemic Embolic Events (SEE) in patients with Non-Valvular Atrial Fibrillation (NVAF). Once-daily edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint. Results from ENGAGE AF-TIMI 48 were presented today as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas and published online in the New England Journal of Medicine.

The edoxaban 60 mg treatment arm had an annual incidence of stroke or SEE of 1.18% versus 1.50% for warfarin (hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001 for non-inferiority), and significantly reduced major bleeding by 20% (2.75% vs. 3.43% per year, respectively) (hr, 0.80; 95% ci, 0.71 to 0.91; p><0.001 for superiority).>

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"Edoxaban versus Warfarin in Atrial Fibrillation"-November 19, 2013 | R.P. Giugliano and Others(DOI: 10.1056/NEJMoa1310907.