Pradaxa dabigatran etexilate: Phase III data

In the double-blind Phase III RE-NOVATE II trial in 2,055 patients, Pradaxa was non-inferior to Lovenox enoxaparin on the composite primary endpoint of total venous thromboembolic events and all-cause mortality from days 28-35 after surgery (7.7% vs. 8.8%, p<0.0001 for non-inferiority). Additionally, Pradaxa was superior to Lovenox in reducing the combined occurrence of major VTE and VTE-related mortality (2.2% vs. 4.2, p=0.03 for superiority). There was no significant difference in the rates of major bleeding between treatment arms (1.4% vs. 0.9%, p=0.40).

Patients undergoing total hip replacement surgery received 220 mg once-daily oral Pradaxa or 40 mg once-daily subcutaneous Lovenox. Data were presented at the European Hematology Association meeting in Barcelona. ...