First large-scale clinical study establishes the efficacy of the new oral anticoagulant H 376/95

at high risk of venous thrombosis (formation of a blood clot in a vein) which may result in pulmonary embolism leading to death. A common approach to prevention of venous thromboembolism is the use of anticoagulant prophylaxis e.g. injectable low molecular weight heparin or oral warfarin. Warfarin requires careful and regular coagulation monitoring i.e. taking blood samples. Warfarin has limitations because of a slow onset of effect over several days. Also, bleeding complications and drug interactions are common. There is, therefore, a need for an effective and well-tolerated oral alternative to warfarin. The data from the METHRO II study indicate that H 376/95 shows considerable promise as a replacement for low molecular weight heparin and warfarin in the prophylaxis of venous thromboembolism in orthopaedic surgery."

The METHRO II study was a double-blind, dose-finding study and a comparator agent was used. The primary purpose of the study was to determine the dose-response relationship with regard to efficacy for the oral direct thrombin inhibitor, H 376/95, preceded by subcutaneous administration of melagatran. The METHRO II study was also designed to compare the efficacy of the H 376/95 regimen with conventional prophylaxis using the injectable low molecular weight heparin agent, dalteparin.

Patients were randomised to one of four melagatran/H 376/95 regimens or dalteparin for 8-11 days. The regimens were: 1mg, 1.5mg, 2.25mg or 3mg melagatran subcutaneously twice daily followed by 8mg, 12mg, 18mg or 24mg oral H 376/95 twice daily respectively or dalteparin 5000 IU once daily subcutaneously. A diagnostic procedure, phlebography, was carried out on the final day of treatment. Patient follow-up was 4-6 weeks post-operatively. Two-thirds of the patients underwent hip replacement and one-third knee replacement surgery. The age range was 18-85 years.

There was a clear relationship between the dose regimen of H 376/95 and the occurrence of

Contact: Jonathan Wilson/Rebecca Hunt

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