Boehringer Ingelheim has unveiled positive Phase III data from a major study of its promising new oral direct thrombin inhibitor Rendix.
Results from the 2,076-patient RE-MODEL trial, presented at the American Society of Hematology meeting in Orlando, demonstrate that Rendix (dabigatran etexilate) is as effective as the low molecular-weight heparin, enoxaparin, in the primary prevention of venous thromboembolism in patients undergoing elective knee replacement surgery, and no difference in bleeding rates was observed between the two drugs.
The company believes that the main advantage of its drug is that, in contrast to standard clot-preventing therapies which are given as a series of subcutaneous injections, Rendix is given orally from early in the postoperative period, without the need for coagulation monitoring or weight-adjusted dosing, and therefore could offer greater convenience.
RE-MODEL forms part of RE-VOLUTION, a massive study that will involve 27,000 patients worldwide and investigate the use of Rendix to prevent strokes in patients with atrial fibrillation, as well as in the treatment of deep vein thrombosis after orthopaedic surgery. Enrollment in the stroke strand of the trial alone, called RE-LY, is targeted at 15,000 patients from almost 1,000 study centres.
If approval is achieved, competition will come from AstraZeneca's Exanta (ximelegatran), an orally-active direct thrombin inhibitor which was first launched in Europe last year for the short-term prevention of venous