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DU-176b equivalent to warfarin in non-valvular AF
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A once daily dose of DU-176b, a Factor Xa inhibitor, may be a safe alternative to treatment with warfarin in patients with atrial fibrillation, according to the results of a phase-2 study.
“DU-176b is a promising new oral anticoagulant. When used at doses of 30 mg or 60 mg per day DU-176b appears to have a safety profile similar to that of warfarin,” said Jeffrey I. Weitz, MD, Henderson Research Centre, Hamilton, Ontario.
Patients with non-valvular atrial fibrillation with a CHADS2 index >2 were enrolled in the study. Patients were assigned to warfarin or one of four doses of DU-176b: 30 mg once daily, 30 mg twice daily, 60 mg once daily or 60 mg twice daily.
An Independent Data Monitoring Committee prematurely terminated the 60 mg twice daily group. Patients in this group (10.6%) and in the 30 mg twice daily group (7.8%) had a significantly higher incidence of major and clinically relevant non-major bleeding events compared with the group assigned to warfarin (3.2%). However, patients assigned to the 30 mg once daily and the 60 mg once daily groups had a similar incidence of bleeding to that in patients assigned to warfarin. – by Leah Lawrence
For more information:
- Weitz JI. #33.
- Presented at: 50th Annual meeting of the American Society of Hematology; Dec. 5-9, 2008; San Francisco.
This study involves a newer inhibitor of Factor Xa in development, DU-176b, and it was carried out with the primary goal of safety assessment. The results suggest that DU-176b is safest when administered as a once daily drug. It is not possible to conclude much about its efficacy (i.e. in stroke prevention) relative to warfarin from this study.
– Nigel Key, MD
Harold Roberts Distinguished Professor,
University of North Carolina, Chapel Hill