Arixtra studies support superiority to LMWH

Results of two major clinical trials of Sanofi-Synthelabo and AkzoNobel's pentasaccharide drug Arixtra (fondaparinux sodium), just published in the New England Journal of Medicine (November 1), have confirmed the superiority of the drug over a low-molecular weight heparin (Aventis' Clexane/Lovenox [enoxaparin]) in the prevention of venous thromboembolism in patients undergoing hip and knee surgery. Preliminary results from the PENTHIFRA and PENTAMAKS trials were reported earlier this year (Marketletter July 16).

In the 1,711-patient hip surgery study (PENTHIFRA), Arixtra was associated with an incidence of VTE at day 11 of 8.3%, compared to 19.1% in the enoxaparin arm (a 56% reduction in risk). The same risk-reduction was seen in the knee surgery (PENTAMAKS) study, with VTE seen in 12.5% of the Arixtra group and 27.8% of the Lovenox-treated arm. There were no significant differences between the groups in terms of bleeding complications. Arixtra has been submitted for approval in the European Union and USA, and was recently deemed approvable in the latter market (Marketletter August 16).