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Ongoing trials for new oral anticoagulant
 

Study shows dabigatran etexilate, a new oral anticoagulant, is effective and safe in preventing thromboembolic disease after orthopaedic surgery

In future, the prevention of venous thromboembolism (VTE) in patients after knee-replacement surgery might become much easier with a new agent in capsule form, called dabigatran etexilate. Dabigatran etexilate is an oral direct thrombin inhibitor, a new oral anticoagulant in advanced development.

Results from the RE-MODELTM trial demonstrate that dabigatran etexilate is as effective as the low molecular-weight heparin, enoxaparin, in the primary prevention of VTE in patients undergoing elective knee replacement surgery. No difference in bleeding rates was observed between dabigatran etexilate and enoxaparin in the RE-MODEL trial.

In contrast to standard clot-preventing therapies like low molecular weight heparin, which are given as a series of subcutaneous injections, dabigatran etexilate is given orally from early in the postoperative period, needs no coagulation monitoring and no weight-adjusted dosing and therefore could offer greater convenience. These data were presented at the 48th Annual Meeting of the American Society of Haematology, in Orlando, Florida in December 2006.

People undergoing hip and knee replacement surgery are at particularly high risk of developing VTE. VTE is one of the most common causes of hospital readmission following orthopaedic surgery. Without preventive treatment many orthopaedic surgery patients could develop deep vein thrombosis (DVT) (including asymptomatic thrombi), and risk developing pulmonary emboli (PE). The late consequences of DVT could also represent a serious clinical problem as some patients who have a DVT can develop chronic venous insufficiency (post-thrombotic syndrome) - symptoms of which can range from oedema and pain to chronic leg ulcers and leg deformity.

Trials are ongoing and dabigatran etexilate is not available yet.