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New Phase II Data Show Safety of Once-Daily Oral Factor Xa Inhibitor, DU-176b, Comparable to Warfarin in Patients With Non-Valvular Atrial Fibrillation
Date:12/7/2008

"Having clear results from a robust Phase II study among atrial fibrillation patients gives us confidence in evaluating the doses selected for our Phase III clinical trial," said Francis Plat, M.D., vice president, clinical development at Daiichi Sankyo Pharma Development. "We are hopeful that DU-176b may one day provide the community with a safe and convenient treatment for the prevention of stroke in patients with non-valvular atrial fibrillation."

About the DU-176b Phase II Safety Study

A total of 1,146 patients with atrial fibrillation with a CHADS2 index >/= 2 were enrolled in the study. Patients were randomly assigned to receive either one of the four fixed dose regimens of DU-176b (30mg/N=235 or 60mg/N=234 administered once daily; 30mg/N=244 or 60mg/N=180 administered twice daily), or warfarin (N=250) dose-adjusted locally to a target International Normalized Ratio (INR) of 2.0-3.0 for 12 weeks. The INR was determined weekly for four weeks and every two weeks thereafter. Investigators, sponsors and study subjects were blinded to the DU-176b dose; however, those taking warfarin were aware they were randomized to the warfarin arm.

The primary endpoints of the study were the incidence of bleeding events (major and clinically relevant non-major) and elevated liver enzymes and/or bilirubin. Secondary endpoints included major adverse cardiovascular events, stroke, systemic embolism, acute myocardial infarction, hospitalizations due to cardiovascular conditions or cardiovascular death.

The incidence of major and clinically relevant non-major bleeding events was significantly higher with the 30 mg and 60 mg twice-daily DU-176b regimens (7.8 percent, p = 0.029 and 10.6 percent, p = 0.002 respectively) than it was in patients given warfarin (3.2 percent). In contrast, the incidence of major and clinically relevant non-major bleeding events with the 30 mg and 60 mg once-dai
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SOURCE Daiichi Sankyo Company, Limited
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