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Research highlights new approaches to prevent blood clots
Date:12/6/2008

h Centre, Hamilton, Canada

The primary objective of this study was to evaluate the safety of four dosing regimens of DU-176b in patients with non-valvular atrial fibrillation. This phase II study found that two regimens (30 mg and 60 mg once-daily) of an investigational oral Factor Xa inhibitor, DU-176b, are safe in patients with non-valvular atrial fibrillation, making the drug a potential substitute for warfarin, the conventional blood-thinning agent used in such patients to prevent stroke.

Dosing of warfarin is complicated because it interacts with many commonly-used medications and even certain foods. For that reason, patients receiving warfarin require regular blood testing to monitor the international normalized ratio (INR) to ensure that an adequate yet safe dose of warfarin is given.

A total of 1,146 patients with atrial fibrillation were randomized to receive either one of four fixed-dose regimens of DU-176b (30 mg once-daily, 30 mg twice-daily, 60 mg once-daily, 60 mg twice-daily) or warfarin (dose-adjusted to a target INR of 2.0 to 3.0) for 12 weeks. 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, which might be indicative of hepatic toxicity. 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 in the 30 mg and 60 mg twice-daily DU-176b regimens than it was in patients given warfarin (7.8 percent, 10.6 percent and 3.2 percent, respectively). In contrast, the incidence of major and clinically relevant non-major bleeding events with the 30 and 60 mg once-daily DU-176b regimens was comparable to that with warfarin (3.0 percent, 3.8 percent, and 3.2 percent, re
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Contact: Laura Stark
lstark@hematology.org
415-978-3505
American Society of Hematology
Source:Eurekalert

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