( ed patients thatwere included in the p...)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

ed patients that were included in the phase 3 primary VTE prevention program (RE-MODEL(TM), RE-MOBILIZE(TM) and RE-NOVATE studies).(ii) The pooled analysis concluded that dabigatran etexilate was non-inferior to enoxaparin in the prevention of major VTE and VTE-related mortality after both knee and hip replacement. Major VTE rates for both doses of dabigatran etexilate were similar to enoxaparin -- major VTE and VTE-related mortality occurred in 3.8% of the 150 mg dabigatran etexilate group and 3.0% of the 220 mg dabigatran etexilate group, versus 3.3% of the enoxaparin group. Major bleeding events were similar across all treatment groups (1.1%, 1.4% and 1.4% respectively). As part of the safety evaluation, patients were monitored frequently for liver enzyme elevations. Those patients with elevations of >3 x ULN (upper limit of normal) were infrequent and similar across all treatment groups. In addition, treatment emergent acute coronary syndrome (ACS) events were infrequent and similar across treatment groups.

Results from the European knee replacement trial (RE-MODEL) were previously presented in December 2006 (iii) at the Annual Meeting of the American Society of Hematology. The RE-MODEL study was a multi-national, randomized, double-blind, non-inferiority trial involving 2,076 patients comparing dabigatran etexilate with enoxaparin in the prevention of VTE in patients undergoing primary elective total knee replacement surgery. Patients were randomized to either oral dabigatran 150 mg or 220 mg once daily or 40 mg enoxaparin administered by subcutaneous injection once daily. In the U.S., the approved dose of enoxaparin for this indication is 30 mg, administered twice daily by subcutaneous injection.

Results from the North American knee replacement trial (RE-MOBILIZE) were also presented at ISTH.(iv) The RE-MOBILIZE study was a randomized, double- blind, non-inferiority trial involving 2,615 patients comparing 150 mg or 220 mg once-daily or 30 mg twi
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