AstraZeneca's novel anticoagulant Exanta shows promise in DVT trials

AstraZeneca's oral direct thrombin inhibitor Exanta (ximelegatran) hasbeen found to be equivalent to warfarin and Aventis' low-molecular weight heparin product Clexane/Lovenox (enoxaparin) in Phase III studies looking at the drug's activity in reducing the incidence of thromboses in patients undergoing orthopedic surgery, according to data presented at the Congress of the International Society on Thrombosis and Hemostasis in Paris, France.

A US study compared the efficacy and safety of Exanta 24mg bd with dose-adjusted warfarin, given for seven to 12 days starting on the morning after total knee replacement surgery, in 680 patients. The main endpoints in the trial were the incidence of deep vein thrombosis and pulmonary embolism, as well as bleeding rates. DVT/PE occurred in 19.2% of the Exanta group and 25.7% of warfarin-treated patients, and the incidence of major bleeding and total bleeding was 1.7% and 9%, respectively with Exanta, and 0.9% and 7% with warfarin.

There were no statistically-significant differences between the groups for any of these outcomes, but the key advantages of Exanta over warfarin, the most commonly-used drug for this indication in the USA, are its oral versus injectable route of administration, as well as the fact that it does not require routine blood coagulation monitoring.