Boehringer Ingelheim will announce positive results from the landmark Re-Cover study at the 51st Annual Meeting of the American Society of Haematology on 6 December 2009. The Re-Cover study assessed dabigatran etexilate in a head-to-head comparison with the current standard in care, warfarin, for the treatment of acute venous thromboembolism (VTE), enabling healthcare professionals to make direct comparisons and care based value judgements.
VTE includes deep vein thrombosis (DVT) and its potentially fatal acute complication pulmonary embolism (PE) and affects around 1.5 million Europeans and 3 million Americans. It is the third most prevalent cardiovascular disease and places a significant burden on healthcare systems. Each year VTE kills around half a million people in the EU - more than double the total number of deaths from AIDS, breast cancer, prostate cancer and traffic accidents combined. Due to the many restrictions and complications of current therapy with warfarin there is a huge need for a better therapeutic alternative.
The Re-Cover study involved 2,539 pateints with acute VTE and investigated the effects of the oral direct thrombin inhibitor dabigatran etexilate (150 mg twice daily in a fixed dose) with warfarin (dose adjusted to an International Normalized Ratio, INR, of 2.0 and 3.0), each given for six months. Primary efficacy endpoints for the Re-Cover study included recurrent symptomatic VTE and deaths related to VTE. Safety endpoints included incidence of bleeding, acute cororonary syndrome, liver function tests and adverse events.
The data will be presented within the main plenary scientific sessions at 14:00 Central Standard Time on Sunday 6 December in Hall F, Ernest N Morial Convention Centre, New Orleans, Louisiana, USA.
The positive results from the Re-Cover study follow closely behind the groundbreaking results of the RE-LY study, which involved over 18,000 patients and demonstrated that dabigatran etexilate convincingly beat warfarin in the prevention of stroke in patients with atrial fibrillation. With existing results from the RE-LY study, the Re-Cover study further expands the growing body of evidence supporting the efficacy and safety of dabigatran etexilate.
Re-Cover is a global, phase III, randomized, double blind, parallel-group study evaluating whether oral dabigatran etexilate (150 mg BID) is as effective and safe (non-inferior to) warfarin (INR 2.0-3.0) for six months treatment of acute symptomatic venous thromboembolism, following initial treatment (5-11 days) with a parenteral anticoagulant.
Venous thromboembolism (VTE) refers to blood clots (thrombi) which originate in the veins, and includes deep vein thrombosis (DVT) and its potentially fatal acute complication pulmonary embolism (PE).
Pradaxa 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.