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The investigational oral anticoagulant dabigatran etexilate is noninferior to enoxaparin in preventing venous thromboembolism (VTE) and all-cause mortality after total hip replacement surgery, when given for an extended average period of 33 days, a study has found.
Phase III data on the dabigatran were presented at the 21st Congress of the International Society on Thrombosis and Haemostasis, held in Geneva on 7-13 July.
The drug is a direct thrombin inhibitor that specifically and reversibly inhibits thrombin, the key enzyme involved in clotting. It is administered as a once-daily dose and does not require titration or coagulation monitoring.
The RE-NOVATE trial involved more than 3,000 patients who had undergone total hip replacement surgery, randomised to once-daily dabigatran etexilate (220mg or 150mg) or enoxaparin 40mg. Treatment was administered for an average of 33 days.
Incidences for the primary efficacy composite endpoint of total VTE and all-cause mortality were 6.0% for dabigatran 220mg, 8.6% for dabigatran 150mg and 6.7% for enoxaparin 40mg. This endpoint was within the pre-specified noninferiority margin of 7.7% in both dabigatran dose groups.
Safety was evaluated for 3,463 patients receiving study treatment: the incidences of major bleeding events were similar in all treatment groups, 2.0%, 1.3% and 1.6% for dabigatran 220mg and 150mg and enoxaparin 40mg, respectively. The incidence of liver enzyme elevations and acute coronary events during the treatment or during the follow-up period did not differ significantly between the treatment groups.
National Electronic Library for Medicines 12/7/2007