Trial shows dabigatran non-inferior to Lovenox

Boehringer Ingelheim GmbH (Ingelheim, Germany) said dabigatran was non-inferior to Lovenox enoxaparin on the composite primary endpoint in the Phase III RE-NOVATE trial to prevent venous thromboembolism (VTE) following total hip replacement surgery. The direct oral thrombin inhibitor was non-inferior to Lovenox on the composite 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, dabigatran 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). The double-blind trial enrolled 2,055 patients. Data were presented at the European Hematology Association meeting in Barcelona. ...