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Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer
Date:12/7/2008

nous thromboemolism at the end of six months of therapy.

A final objective included the reversal of the anticoagulant effect of idrabiotaparinux, as there are medically relevant instances, such as prior to surgery, when there is the need to reverse the effects of an anticoagulant. The reversal of the anticoagulant effect was measured after a 30-minute intravenous infusion of avidin (100 mg), a hen egg protein that binds with biotin to reverse the Factor Xa inhibiting activity of idrabiotaparinux. At the end of the initial six-month treatment with idrabiotaparinux, a subset of patients was re-randomized to receive avidin (those in the idrabiotaparinux arm) or placebo (those in both the idrabiotaparinux and idraparinux arms to preserve blinding). Avidin or placebo was infused between two and five hours after the last injection of idrabiotaparinux or idraparinux. Anti-Factor Xa activity was measured just prior to the infusion, just after the infusion, and then every day for five days to ensure that the reversibility remained unchanged.

The study found that there was less clinically relevant bleeding (5.2 percent versus 7.3 percent) and less major bleeding (0.8 percent versus 3.8 percent) in those treated with idrabiotaparinux as compared with idraparinux. Rates of recurrent venous thromboembolism (2.3 percent versus 3.2 percent) and fatal or non-fatal pulmonary embolism (1.6 percent versus 1.8 percent) were similar with both idrabiotaparinux and idraparinux.

Levels of Factor Xa activity were identical in both treatment groups throughout the six-month study. Of the 52 idrabiotaparinux patients re-randomized to receive avadin or placebo, 41 were analyzed for reversal of Factor Xa activity (23 received avidin and 18 received placebo). At the end of the 30- minute infusion of avidin, mean anti-Factor Xa activity was reduced by 77.8 percent and was sustained for at least five days as compared with 2.4 percent fo
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SOURCE American Society of Hematology
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