Data from the RE-NOVATE® II study presented today at the 15th Annual Congress of the European Hematology Association (EHA) have shown that dabigatran etexilate 220mg once daily is as effective and safe as enoxaparin 40mg in preventing venous thromboembolism (VTE) after total hip replacement surgery. The results also showed that dabigatran etexilate significantly reduced the combined endpoint of major VTE and VTE-related death compared to enoxaparin.
The double-blind non-inferiority trial randomized 2,055 patients and was designed to investigate whether treatment with 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 profiles of the two treatments.
Currently, existing treatments such as heparins (like enoxaparin) require regular injections for the prevention of VTE following total hip replacement surgery. However, this can be inconvenient for patients outside of the hospital setting especially when extended prophylaxis is carried out, which significantly reduces the number of VTE events. Oral anticoagulants such as dabigatran etexilate are therefore seen as a development in facilitating improved patient care.
In detail, the results showed:
- Dabigatran etexilate is as effective as enoxaparin in preventing total VTE (venographic or symptomatic) and death from all causes. The outcome occurred in 7.7% of patients taking dabigatran etexilate and 8.8% of patients taking enoxaparin (absolute risk difference -1.1% (95% CI, -3.8% to 1.6%); p<0.0001 for non-inferiority)
- Dabigatran etexilate significantly reduced the combined endpoint of major VTE (proximal deep-vein thrombosis, nonfatal pulmonary embolism) and VTE-related mortality compared with enoxaparin. The outcome occurred in 2.2% of patients taking dabigatran etexilate and 4.2% of patients taking enoxaparin (absolute risk difference -1.9%, relative risk reduction - 46% (95% CI -3.6% to -0.2%);>
- Major bleeding events were comparable between both treatments with 1.4% of patients reported in the dabigatran etexilate group and 0.9% patients taking enoxaparin>
Michael Huo, MD, Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center said, "These positive findings, together with the results of RE-NOVATE®, a study of analogous design with the combined data of 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 bleeding risk and 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 mortality."
VTE, comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major public health problem in Europe with nearly 750,000 VTE events taking place each year and approximately 300,000 of these being fatal. Three out of five patients develop DVT after major orthopaedic surgery without anticoagulant treatment, with one in five patients undergoing total hip replacement surgery developing DVT despite five-11 days of anticoagulant treatment. New anticoagulants are therefore needed to improve patient care and aid the prevention of thromboembolic disease.
Michael Huo continued, "As dabigatran etexilate is administered orally, it is more convenient than injectable anticoagulants such as enoxaparin for patients outside of the hospital setting. 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 an attractive treatment option in this clinical setting."
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs) targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.5 Dabigatran etexilate is currently being investigated in a number of other therapy areas including stroke prevention in atrial fibrillation.