inhibitor (DTI),(15) in a class of oral anticoagulants being studied in the prevention and treatment of acute and chronic thromboembolic diseases.(1),(4),(5),(6),(7),(8),(9) Direct thrombin inhibitors provide an anticoagulant effect by specifically and selectively blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation - conversion of fibrinogen to fibrin.(15)
Dabigatran etexilate is not approved by the FDA. Dabigatran etexilate is approved and marketed as Pradaxa(R) in 40 countries for the primary prevention of venous thromboembolic events (blood clots) in patients who have undergone elective total hip or elective total knee replacement surgery.
RE-LY(R) is part of Boehringer Ingelheim's extensive RE-VOLUTION clinical trial program - evaluating the efficacy and safety of dabigatran etexilate against current standard therapy in more than 38,000 patients. (1),(4),(5),(6),(7),(8),(9),(16),(17) In addition to RE-LY, the development program encompasses studies in:
- Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgeries(5),(6),(7)
- Treatment of acute VTE(9)
- Secondary prevention of VTE(8)
- Prevention of atherothrombotic events in patients with acute coronary syndrome(4)
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47
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