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Phase 3 Results for Dabigatran Etexilate, an Investigational Oral,Anticoagulant, Presented Today at the XXIst Congress of the,International Society on Thrombosis and Haemostasis

RIDGEFIELD, Conn., July 11, 2007 /PRNewswire/ -- Phase 3 results from the RE-NOVATE(TM) trial demonstrated that oral dabigatran etexilate once daily, administered for an average of 33 days, was non-inferior to enoxaparin, also administered for an average of 33 days, in preventing venous thromboembolism (VTE) and all-cause mortality after total hip replacement surgery. In this trial, the rate of major bleeding associated with dabigatran etexilate was similar to enoxaparin. The incidence of liver enzyme elevations and acute coronary events during the treatment or during the follow-up period did not differ significantly between the treatment groups. These data were presented at the XXIst Congress of the International Society on Thrombosis and Haemostasis (ISTH) today.(i) In clinical trials, dabigatran etexilate is given orally once daily and does not require titration or coagulation monitoring.

Results of the RE-NOVATE trial showed that both oral doses (220mg; 150 mg) of dabigatran etexilate were non-inferior to injected enoxaparin at reducing the risk of thromboembolic disease after primary elective total hip replacement surgery when given for the extended average time period of 33 days. The incidences for the primary efficacy composite endpoint of total VTE and all-cause mortality were 6.0% (dabigatran 220 mg), 8.6% (dabigatran 150 mg), and 6.7% (enoxaparin 40 mg). The incidences of total VTE and all-cause mortality in both dabigatran dose groups were within the pre-specified non- inferiority margin of 7.7%. Safety was evaluated for 3,463 patients receiving study treatment. The incidences of major bleeding events were similar in all treatment groups, 2.0% (dabigatran 220 mg), 1.3% (dabigatran 150 mg), and 1.6% (enoxaparin 40 mg).

Also presented at ISTH was a pooled analysis of major VTE and VTE-related mortality after primary elective knee and hip replacement surgery across more than 8,000 randomiz
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