Despite all the fuss about Xarelto being superior to Lovenox, Sanofi-Aventis has been lauding a new treatment which it hopes will become the next big thing for the prevention of venous thromboembolism.

Speaking at the American Society of Haematology meeting in Atlanta, the French drugmaker unveiled data from a Phase IIb study, called TREK, which showed its new injectable anticoagulant, AVE5026, demonstrated a 'highly statistically significant' dose response in prevention of VTE in patients undergoing elective total knee replacement surgery. AVE5026 is a new ultra low molecular weight heparin, with predominantly anti-Xa activity, administrated subcutaneously once daily

The TREK study involved 705 patients in 19 different countries and in the dose ranging study, AVE5026 was administered for up to ten days for primary prevention of VTE in patients undergoing elective total knee replacement surgery. Lovenox (enoxaparin) 40mg once-daily was used as the comparator. The data showed that AVE5026 20mg and 40mg showed a superior efficacy for confirmed adjudicated VTE (58% and 61% relative risk reduction respectively) over Lovenox and had a good safety profile.

Michael Rud Lassen from the Department of Orthopaedics at Hillerod Hospital in Denmark, and chairman of the steering committee of the TREK study, said the results are "very promising and AVE5026 has a potential to become the new gold standard injectable therapy for VTE prevention". Sanofi added that a large scale Phase III clinical trial programme is planned to start in 2008, involving more than 10,000 patients. Clinical studies will be conducted in VTE prevention in patients undergoing orthopaedic or abdominal surgery or receiving chemotherapy, with a submission planned in 2010.