Results from the RE-NOVATE? II clinical trial presented today at the 15th Congress of the European Hematology Association (EHA) taking place from June 10 to 13 at the Fira Barcelona Gran Via in Barcelona, Spain, have shown that the drug dabigatran etexilate 220mg taken once daily is as effective and safe as enoxaparin 40mg in preventing venous thromboembolism (VTE) (blood clots in the leg veins) after total hip replacement surgery. The results also showed that the drug dabigatran etexilate significantly reduced the number of major blood clots and deaths from blood clots when compared to enoxaparin.

VTE, comprising deep-vein thrombosis (DVT) (blood clots in veins) and pulmonary embolism (PE) (blood clots in lungs which can cause sudden death), are major public health problem with nearly 750,000 VTE events taking place each year and approximately 300,000 of these being fatal. One in five patients undergoing total hip replacement surgery develops DVT despite 5-11 days of anticoagulant treatment. New anticoagulants are therefore needed to improve patient care and aid the prevention of blood clots.

The randomized trial with 2,055 patients was designed to investigate whether treatment with the drug dabigatran etexilate 220mg once daily was as effective as enoxaparin over 28-35 days in patients undergoing total hip replacement surgery and to compare the safety of the two treatments.
Existing treatments such as heparins (like enoxaparin) require daily injections under the skin for the prevention of VTE following total hip replacement surgery. Drugs taken by mouth such as dabigatran etexilate are therefore more acceptable to patients.

Michael Huo, MD, Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center said, ?These positive findings, together with the results of RE-NOVATE?, trial combining the results from more than 5,000 patients, confirm that dabigatran etexilate once daily is as effective as enoxaparin in patients following total hip replacement surgery for the prevention of VTE, with a similar safety profile. The additional and encouraging finding from this trial is that dabigatran etexilate was associated with significantly lower rates of major VTE and VTE-related death.?

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Michael Huo continued, ?As dabigatran etexilate is taken by mouth, it is more convenient than injectable anticoagulants such as enoxaparin. This advantage can also provide cost-saving benefits for national healthcare systems, as shown in the United Kingdom where the extended use of dabigatran etexilate was shown to provide a significant reduction in costs due to its oral administration when compared with enoxaparin. Dabigatran etexilate should therefore be considered as a treatment option in this clinical setting.?

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Dabigatran etexilate is part of a new generation of oral anticoagulants which are effective in the prevention of venous and lung blood clots. Dabigatran may also have a role in stroke prevention and the treatment of atrial fibrillation.

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