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The Lancet Publishes Major Phase 3 Study on Novel Oral Direct Thrombin Inhibitor
Date:9/13/2007

ing showed that the frequency of increases in liver enzyme concentrations with dabigatran etexilate is low during the entire extended treatment period. Results showed that alanine aminotransferase (ALT) elevation greater than three times the upper limit of normal occurred in 5.3% enoxaparin group, as compared to 3.0% in the 150mg group and 3.0% in the 220mg group taking dabigatran etexilate. Similarly, the incidence of acute coronary events was low, with no significant differences between all groups.

Current treatment guidelines recommend that patients undergoing knee or hip replacement surgery receive thromboprophylaxis (treatment to prevent VTE) with low molecular weight heparin (LMWH), fondaparinux or warfarin for at least 10 days after surgery. For patients undergoing hip replacement surgery, extended thromboprophylaxis for up to 28-35 days is recommended.(3) The RE- NOVATE study was designed consistent with these guidelines.

About dabigatran etexilate

Dabigatran etexilate is an investigational oral direct thrombin inhibitor that specifically and reversibly inhibits thrombin, the key enzyme for blood clot formation, and is currently in phase 3 development. In the RE-NOVATE study, dabigatran etexilate was dosed once a day without routine coagulation monitoring. Patients in the study received a fixed dose of dabigatran etexilate and were not titrated during the duration of the study.

Further studies investigating dabigatran etexilate

Dabigatran etexilate is being investigated in multiple phase 3 trials that are designed to investigate the oral direct thrombin inhibitor as a potential treatment and prophylaxis for several thromboembolic disease conditions. The phase 3 clinical trial program is expected to involve more than 27,000 patients from Asia, Australia, Europe, the Americas, and South Africa.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest
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SOURCE Boehringer Ingelheim
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