Completely steroid-free immunosuppression in liver transplantation: a randomized study.
Ramirez CB, Doria C, et al.Clinical Transplantation 2013; 27(3):463-71.
Aims
To evaluate the efficacy and safety of a corticosteroid (CS) free immunosuppressive regimen in orthotopic liver transplantation.
Interventions
Patients were randomised to receive either standard immunosuppression of basiliximab, tacrolimus, and enteric-coated mycophenolate sodium (EC-MPS) with basiliximab, tacrolimus, and enteric-coated mycophenolate sodium (EC-MPS) CS and delayed CS withdrawal or complete CS avoidance.
Participants
40 adult recipients of deceased donor primary orthotopic liver transplantation.
Outcomes
The outcomes included graft and patient survival rates and incidence and treatment of acute cellular rejection. The secondary outcomes included metabolic complications (aspartate aminotransferase, alanine aminotransferase, total bilirubin and international normalized ratio levels) and hepatitis C virus.
Follow-up
5 years.
CET Conclusions
This study, limited perhaps by a relatively small sample size, suggests that corticosteroid avoidance in adult recipients of a liver transplant who have been induced with basiliximab and maintained with CNI and enteric coated MPS is as safe and effective as a more standard protocol with corticosteroids. Although there was no difference in graft function or patient and graft survival contrary to other studies there was not a significant difference in the incidence of hypertension, hypercholesterolemia, new onset diabetes mellitus and weight gain in the corticosteroid free group, nor was there any difference in the incidence, severity or degree of progression of HCV recurrence after liver transplantation.
Data analysis
Available case analysis
Trial registration
Not reported.