Dabigatran etexilate offers effective therapy to prevent recurrent VTE

Boehringer IngelheimDec 6 2009

Results from RE-COVER(TM) study published online in the New England Journal of Medicine

Results from the landmark RE-COVER(TM) study were presented today at the American Society of Hematology Annual Meeting and published online in the New England Journal of Medicine. The results showed dabigatran etexilate 150 mg twice-daily (BID) was equally as effective as well-controlled warfarin at preventing recurrent venous thromboembolism (VTE) (p(less than)0.001 for prespecified non-inferiority margin). VTE refers to blood clots (thrombi) which originate in the veins, and includes deep vein thrombosis (DVT), which can lead to a potentially fatal acute complication pulmonary embolism (PE).

For safety, dabigatran etexilate demonstrated a significant 37 per cent reduction in major or clinically relevant non-major bleeding>

"The results of RE-COVER(TM) are a long-awaited breakthrough in the treatment of VTE; not only does dabigatran etexilate offer an effective therapy to prevent recurrent VTE, it does so with less bleeding than warfarin," commented Dr. Sam Schulman, Principle Investigator, Department of Medicine, McMaster University, Hamilton, Ontario. "Warfarin is a highly effective therapy when well-controlled within its narrow therapeutic range, as in clinical trials, but in the real world sufficient control is rarely achieved and maintained, leaving patients poorly protected from VTE or at-risk of bleeding. With dabigatran etexilate, we have a therapy that protects our patients effectively and safely, without need for frequent laboratory monitoring and dose changes."

Dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug interactions and no known food interactions, without the need for routine coagulation monitoring or dose adjustment. In contrast to VKAs, which variably act via different coagulation factors, direct thrombin inhibitors achieve potent anthrombotic effects by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation.

Earlier this year, the RE-LY(R) study (18,113 patients in 44 countries worldwide) showed groundbreaking results for dabigatran etexilate convincingly beating warfarin in stroke prevention in atrial fibrillation.

As such, dabigatran etexilate has the protential to benefit even more patients and replace warfarin as the treatment of choice.

In total, four trials involving 8,900 patients are exploring dabigatran etexilate in VTE treatment: RE-COVER(TM) and RE-COVER(TM) II in acute VTE and RE-MEDY(TM) and RE-SONATE(TM) in prevention of secondary VTE. The results of RE-COVER(TM) and the very favourable results of RE-LY add to the growing database of evidence supporting the efficacy and safety of dabigatran etexilate across a wide range of acute and chronic thromboembolic disorders from the RE-VOLUTION(R) clinical development program involving over 38,000 patients.