( ce-daily enoxaparin administered by sub...)Phase 3 Results for Dabigatran Etexilate, an Investigational Oral,Anticoagulant, Presented Today at the XXIst Congress of the,International Society on Thrombosis and Haemostasis,Health

ce-daily enoxaparin administered by subcutaneous injection. The primary endpoint of a composite of total VTE, and all-cause mortality was not achieved (33.7% and 31.1% for 150 mg and 220 mg dabigatran etexilate respectively, versus 25.3% enoxaparin). The difference in these results was primarily due to the incidence of asymptomatic deep vein thrombosis (DVT) detected by protocol required venography at the end of therapy. Major VTE occurred at similar rates across all treatment groups (3.0% and 3.4% for 150 mg and 220 mg dabigatran etexilate respectively, versus 2.2% enoxaparin). Although major bleeding events were more common in the enoxaparin group (1.4%) compared to the dabigatran 220 mg group (0.6%) and the dabigatran 150 mg group (0.6%), these differences were not statistically significant.

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. It is administered as a once daily oral dose that does not require titration or coagulation monitoring.

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 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,
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