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Completely steroid‐free immunosuppression in liver transplantation: a randomized study
Author(s) -
Ramirez Carlo B.,
Doria Cataldo,
Frank Adam M.,
Armenti Stephen T.,
Marino Ignazio R.
Publication year - 2013
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12119
Subject(s) - medicine , basiliximab , immunosuppression , regimen , liver transplantation , tacrolimus , methylprednisolone , gastroenterology , transplantation , calcineurin , surgery , hepatitis c
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 .