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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Sterneck, M; Kaiser, GM; Heyne, N; Richter, N; Rauchfuss, F; Pascher, A; Schemmer, P; Fischer, L; Klein, CG; Nadalin, S; Lehner, F; Settmacher, U; Neuhaus, P; Gotthardt, D; Loss, M; Ladenburger, S; Paulus, EM; Mertens, M; Schlitt, HJ.
Everolimus and early calcineurin inhibitor withdrawal: 3-year results from a randomized trial in liver transplantation.
Am J Transplant. 2014; 14(3):701-710
Doi: 10.1111/ajt.12615
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- Co-authors Med Uni Graz
- Schemmer Peter
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- Abstract:
- The feasibility of de novo everolimus without calcineurin inhibitor (CNI) therapy following liver transplantation was assessed in a multicenter, prospective, open-label trial. Liver transplant patients were randomized at 4 weeks to start everolimus and discontinue CNI, or continue their current CNI-based regimen. The primary endpoint was adjusted estimated GFR (eGFR; Cockcroft-Gault) at month 11 post randomization. A 24-month extension phase followed 81/114 (71.1%) of eligible patients to month 35 post randomization. The adjusted mean eGFR benefit from randomization to month 35 was 10.1 mL/min (95% confidence interval [CI] -1.3, 21.5 mL/min, p = 0.082) in favor of CNI-free versus CNI using Cockcroft-Gault, 9.4 mL/min/1.73 m(2) (95% CI -0.4, 18.9, p = 0.053) with Modification of Diet in Renal Disease (four-variable) and 9.5 mL/min/1.73 m(2) (95% CI -1.1, 17.9, p = 0.028) using Nankivell. The difference in favor of the CNI-free regimen increased gradually over time due to a small progressive decline in eGFR in the CNI cohort despite a reduction in CNI exposure. Biopsy-proven acute rejection, graft loss and death were similar between groups. Adverse events led to study drug discontinuation in five CNI-free patients and five CNI patients (12.2% vs. 12.5%, p = 1.000) during the extension phase. Everolimus-based CNI-free immunosuppression is feasible following liver transplantation and patients benefit from sustained preservation of renal function versus patients on CNI for at least 3 years. © 2014 The Authors. American Journal of Transplantation Published by Wiley Periodicals, Inc. on behalf of American Society of Transplant Surgeons.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Calcineurin Inhibitors -
- Cyclosporine - administration & dosage
- Cyclosporine - adverse effects
- Everolimus -
- Feasibility Studies -
- Female -
- Follow-Up Studies -
- Graft Rejection - drug therapy
- Graft Rejection - etiology
- Graft Survival - drug effects
- Humans -
- Immunosuppressive Agents - administration & dosage
- Immunosuppressive Agents - adverse effects
- Liver Diseases - surgery
- Liver Transplantation -
- Male -
- Middle Aged -
- Prognosis -
- Prospective Studies -
- Sirolimus - administration & dosage
- Sirolimus - analogs & derivatives
- Time Factors -
- Withholding Treatment -
- Young Adult -
- Find related publications in this database (Keywords)
- Calcineurin inhibitor
- everolimus
- liver transplantation
- long-term
- withdrawal