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

Abstract

BackgroundThe 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.MethodsThirty 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.DiscussionRecipient, 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.

Immunosuppressive therapies after heart transplantation — The balance between under- and over-immunosuppression

“…Moreover, three randomized trials [34][35][36] and three retrospective studies [37][38][39], have compared HT patients treated with ATG and HT patients treated with IL-2 receptor antagonists. Although more trials are needed, especially with regard to the comparison of ATG vs. no induction, it appears from the above reports as if both drugs could have benefits in terms of preventing ACR, and that ACR could be somewhat better prevented with ATG than with IL-2 receptor antagonists.…”

Induction Therapy in the Current Immunosuppressive Therapy

“…Although two randomized controlled trials demonstrated that the IL-2RA, daculizmab, effectively reduced the rate of moderate and severe rejections within first year after HTx [12,23,24], such effect could not be observed in trials for ATG. Previous systematic review which evaluated four randomized trials comparing of ATG with IL-2RA [28][29][30][31] showed that the use of IL-2RA was associated with significantly higher risk of moderate-to-severe rejection than ATG, but similar risk of death, infections, and malignancy [15]. In the retrospective analyses using large registry or cohort data in HTx, Nozohoor et al [11] suggested that the recipients receiving ATG showed the better survival as compared with those receiving IL-2RA, however, found more malignancy post-HTx with ATG compared with basiliximab.…”

Outcomes of Induction Therapy with Rabbit Anti-Thymocyte Globulin in Heart Transplant Recipients: A Single Center Retrospective Cohort Study

“…Two randomized trials have compared the use of rATG versus IL-2 receptor antagonist as induction agents in heart transplantations, their results demonstrated a controversial rate of biopsy-proven acute rejection and no long-term survival data were provided [ 9 , 10 ]. Meanwhile, 3 retrospective studies have observed a lower incidence or severity of acute rejection using rATG versus IL-2 receptor antagonist induction [ 11 – 13 ]. These studies had limitations of using fewer than 50 patients and had short-term follow-up periods with no long-term survival data.…”