A randomized controlled trial of daclizumab versus anti-thymocyte globulin induction for heart transplantation

Background: The purpose of this study was to test the efficacy and safety of daclizumab (DZM) versus anti-thymocyte globulin (ATG) as a component of induction therapy in heart transplant recipients. Methods: Thirty heart transplant patients were randomized to receive either ATG or DZM during induction therapy. Patients in the DZM group received an initial dose of 2 mg/kg intravenous (IV) at the time of transplant and 1 mg/kg IV on postoperative day 4. Discussion: Recipient, donor, and intraoperative variables did not differ significantly between groups. The cost of induction therapy, total drug cost, and hospital ward costs were significantly less for the DZM group. Average absolute lymphocyte and platelet counts were significantly higher in the DZM group. There were no significant differences in the incidence of rejection, infection, malignancy, or steroid-induced diabetes. One year survival was excellent in both groups (87%, P = 0.1). Daclizumab is a safe component of induction therapy in heart transplantation.