European multi-centre trial demonstrates H 376/95 compares well with dalteparin in prevention of venous thromboembolism in orthopaedic surgery
The oral direct thrombin inhibitor H 376/95, the first new oral anticoagulant for 50 years, is effective in preventing venous thrombo-embolism in patients undergoing total hip or total knee replacement surgery, according to data presented for the first time at the 16th International Congress on Thrombosis in Porto, Portugal. The data were taken from the results of the Phase II study, known as METHRO II, which involved a total of 1916 patients in 13 European countries. A highly significant dose-dependent decrease in venous thrombo-embolism was observed with H 376/95 in both total hip (p<0.0001) and total knee replacement (p=0.0014) surgery. The incidence of venous thromboembolism was significantly lower with the highest dosage of H 376/95 compared with dalteparin (p<0.0001).
Dr Bengt Eriksson, Associate Professor of Orthopaedic Surgery, Sahlgrenska University Hospital, Östra, Gothenburg, Sweden, the METHRO II principal investigator who presented the findings, said: "The results of the METHRO II study have confirmed the promising preliminary findings of the Phase IIa study of H 376/95 in the prevention of venous thromboembolism in orthopaedic surgery. The prophylactic regimen used, starting with subcutaneous melagatran followed by oral H 376/95 (melagatran is the active form of H 376/95) seems to be superior to standard therapy, low molecular weight heparin. In addition to its proven efficacy, H 376/95 has a number of practical advantages, especially oral administration offering patients the possibility of taking tablets instead of having injections. The drug is well absorbed and has no known interactions with other drugs or food. There is no need for laboratory monitoring, which is a great relief for patients."