Everolimus and early calcineurin inhibitor withdrawal: 3-year results from a randomized trial in liver transplantation.
Sterneck M, Kaiser GM, Heyne N, et al.American Journal of Transplantation. 2014; 14: 701-710.
Aims
To investigate long-term feasibility of calcineurin free everolimus based immunosuppression in liver transplant recipients from the PROTECT trial data.
Interventions
All patients received basiliximab induction and were randomised to receive everolimus and discontinue calcineurin inhibitor (CNI) therapy (tacrolimus or cyclosporine with or without corticosteroids depending on local practice) or to continue their current CNI-based regime.
Participants
203 living or deceased donor de novo liver transplant recipients.
Outcomes
The primary outcome included renal function measured by estimated glomerular filtration rate.
Follow-up
3 years.
CET Conclusions
This report of the three year results from the PROTECT study does suggest that patients with a liver transplant who were converted to everolimus in a CNI free regimen had better renal function than those patients who continued on cyclosporine. However the large number of discontinuations meant that the long term follow up was not powered to detect a significant difference in renal function (despite using 3 methods of calculating the GFR!) as the extension study population represented only a selected cohort of patients. Nevertheless it is a promising approach that needs further evaluation.
Data analysis
Available case analysis
Quality notes
Previously assessed in Fischer L, et al. A randomised controlled study to assess the conversion from calcineurin inhibitors to everolimus after transplantation – PROTECT. American Journal of Transplantation. 2012; 12: 1855-1865.
Trial registration
NCT00378014