Milestone Results Assessing Novel Anticoagulant Dabigatran Etexilate versus Warfarin in the Treatment of Acute Deep Vein Thrombosis and Pulmonary Embolism to be Presented at ASH 2009

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim will announce positive results from the landmark RE-COVER™ study at the 51st Annual Meeting of the American Society of Hematology 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.^1

VTE includes deep vein thrombosis (DVT) and its potentially fatal acute complication pulmonary embolism (PE) and affects around 1.5 million Europeans^2 and 3 million Americans^3. It is the third most prevalent cardiovascular disease and places a significant burden on healthcare systems.^4,5 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.^2 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 patients 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 6 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 coronary syndrome, liver function tests and adverse events.^1

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.^6 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.^1,6,7,8

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This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.

For further information please visit

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2009/02_december_2009.html

References

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^1 Schulman S, Eriksson H, Goldhaber SZ, et al. Dabigatran etexilate versus warfarin in the treatment of venous thromboembolism. Oral presentation, ASH Annual Meeting 2009, Abstract number 19394, 6 December 2009 ^2 Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007;98:756-64 ^3 White RH. The epidemiology of venous thromboembolism. Circulation 2003;107[23 suppl 1]:I4-I8 ^4 Hawkins D. The role of oral direct thrombin inhibitors in the prophylaxis of venous thromboembolism. Pharmacotherapy 2004;24:179S–183S ^5 Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy 2009;29:943-53 ^6 Connolly S, Ezekowitz D, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Eng J Med 2009;361:1139-51 ^7 Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007;370:949–56 ^8 Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178–85