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Completely steroid-free immunosuppression in liver transplantation: a randomized study.

By Carlo B. MD Ramirez, Cataldo PhD MD Doria, Adam M. MD Frank, Stephen T. Armenti and Ignazio R. MD Marino

Abstract

INTRODUCTION: Corticosteroids (CS) have been standard immunosuppression to prevent and treat rejection. However, CS are associated with increased risk of infection, obesity, hypertension, hyperlipidemia, diabetes, and accelerated hepatitis C virus (HCV) recurrence post-orthotopic liver transplantation (OLT). This study assesses the safety and efficacy of CS-free immunosuppressive regimen in adult OLT. METHODS: A two-yr, prospective, randomized study of CS with delayed withdrawal (CS) or CS-free regimen with basiliximab, tacrolimus, and enteric-coated mycophenolate sodium (EC-MPS) was performed in 39 patients (CS=20; CS-free=19). CS group received intra-operative methylprednisolone weaned by six months. HCV patients had HCV PCR pre-OLT and 0.5, one, three, and six months post-OLT. Protocol liver biopsies were performed at OLT, 2 and 24 wk post-OLT or when indicated. RESULTS: Rejection occurred in two patients. Patient survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (80% vs. 63%) post-OLT were similar between CS and CS-free group, respectively. Death-censored graft survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (75% vs. 63%) were also similar. The risk of new-onset DM, hypertension, hypercholesterolemia, and weight gain was similar between groups. CONCLUSION: CS avoidance with basiliximab, calcineurin inhibitor, and EC-MPS is safe and effective as CS- containing immunosuppression in adult OLT

Topics: Adolescent, Adrenal Cortex Hormones, Adult, Aged, Antibodies, Monoclonal, Female, Follow-Up Studies, Graft Rejection, Humans, Immunosuppression, Immunosuppressive Agents, Liver Diseases, Liver Transplantation, Male, Methylprednisolone, Middle Aged, Pilot Projects, Prognosis, Prospective Studies, Recombinant Fusion Proteins, Survival Rate, Tacrolimus, Young Adult, Antibodies, Monoclonal, Surgery
Publisher: Jefferson Digital Commons
Year: 2013
OAI identifier: oai:jdc.jefferson.edu:surgeryfp-1192

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