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Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing
Date:7/15/2009

BOSTON and EDISON, N.J., July 15 /PRNewswire/ -- A sub-analysis of a Phase IIb multinational study(1) with edoxaban(2) - an investigational oral Factor Xa inhibitor - provides insights into why patients with non-valvular atrial fibrillation (AF) receiving edoxaban once daily (QD) experienced fewer bleeding events than patients given edoxaban twice a day (BID). The analysis finds that bleeding associated with edoxaban is most closely correlated with minimum concentration levels of the drug in the blood, and that these trough levels may best predict bleeding events, rather than total exposure or maximum concentration levels.

These findings were presented today at the XXII International Society on Thrombosis and Haemostasis Congress in Boston. Edoxaban is being developed solely by Daiichi Sankyo Company, Limited (TSE: 4568) as a potential treatment for the prevention of both arterial and venous thromboembolism; a Phase III trial is underway among patients with AF.

This pharmacokinetic (PK) analysis of the Phase IIb study examined the relationship between bleeding events reported in patients taking 30 or 60 mg edoxaban given either QD or BID and the concentration of edoxaban in their blood. The analysis examined overall bleeding rates when drug concentration levels reached the highest points (known as Cmax), lowest points (known as Cmin) as well as overall edoxaban exposure (measured by area under the curve or AUC). Delivering a compound twice per day generally allows for more consistent concentration levels in the blood. With twice-daily dosing, the Cmin levels (troughs) do not dip as low, and the Cmax levels (peaks) do not reach as high as when the compound is delivered once per day.

"When we assessed the pharmacokinetics in patients taking edoxaban once a day, lower minimum concentrations and fewer bleeding events were observed, compared to the same total daily dosage give
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SOURCE Daiichi Sankyo, Inc.
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