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

John C Mullen,Antigone Oreopoulos,Michael J Bentley,Emily J Kuurstra,Shaohua Wang

doi:10.1186/2047-1440-3-14

John C Mullen, Antigone Oreopoulos + Show 3 more

Open Access

https://doi.org/10.1186/2047-1440-3-14

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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.

Highlights

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
This study compared the results of using DZM versus ATG during induction therapy after heart transplantation
There were no differences in the incidence of rejection, steroidinduced diabetes or malignancy compared to patients who received ATG

Summary

Introduction

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. Progress in immunosuppression has been slower, partly because the heart is a fundamental organ and acute allograft rejection can include hemodynamic compromise, irreversible graft injury, and death. The immunosuppressive therapy used to prevent rejection increases the risk of infection, which continues to be a leading cause of death in the first year after cardiac transplantation [1,2]. A common immunosuppression protocol for cardiac transplantation includes cyclosporine, mycophenolate mofetil, and corticosteroids (triple therapy). An alternative to standard triple therapy at the time of cardiac transplantation has been the use of augmented immunosuppression, commonly termed ‘induction therapy’.

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