Refludan lepirudin direct thrombin inhibitor: Phase III data; marketed to treat heparin-induced thrombocytopenia

Hoechst Marion Roussel presented results from its 10,141-patient OASIS-2 study comparing a 72-hour infusion of Refludan to heparin. Refludan reduced the rate of death or heart attack by 24 percent at 3 days (2 percent versus 2.6 percent with heparin, p=0.036). However, the trial did not achieve significance with the primary end point of death and heart attack at 7 days (3.6 percent with Refludan and 4.2 percent with heparin, p=0.069). A significant increase in minor to moderate bleeding also was seen in the Refludan group. ...