Sterneck, M. and Kaiser, G. M. and Heyne, N. and Richter, N. and Rauchfuss, F. and Pascher, A. and Schemmer, P. and Fischer, L. and Klein, C. G. and Nadalin, S. and Lehner, F. and Settmacher, U. and Neuhaus, P. and Gotthardt, D. and Loss, M. and Ladenburger, S. and Paulus, E. M. and Mertens, M. and Schlitt, H. J. (2014) Everolimus and Early Calcineurin Inhibitor Withdrawal: 3-Year Results From a Randomized Trial in Liver Transplantation. AMERICAN JOURNAL OF TRANSPLANTATION, 14 (3). pp. 701-710. ISSN 1600-6135, 1600-6143
Full text not available from this repository. (Request a copy)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 postrandomization. A 24-month extension phase followed 81/114 (71.1%) of eligible patients to month 35 postrandomization. The adjusted mean eGFR benefit from randomization to month 35 was 10.1mL/min (95% confidence interval [CI] -1.3, 21.5mL/min, p=0.082) in favor of CNI-free versus CNI using Cockcroft-Gault, 9.4mL/min/1.73m(2) (95% CI -0.4, 18.9, p=0.053) with Modification of Diet in Renal Disease (four-variable) and 9.5mL/min/1.73m(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. The beneficial effect on renal function achieved by early CNI withdrawal and treatment with everolimus after liver transplantation is still evident after three years.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CHRONIC KIDNEY-DISEASE; GLOMERULAR-FILTRATION-RATE; RENAL-FUNCTION; ALLOGRAFT RECIPIENTS; SERUM CREATININE; RISK-FACTORS; FOLLOW-UP; CONVERSION; THERAPY; MULTICENTER; Calcineurin inhibitor; everolimus; liver transplantation; long-term; withdrawal |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 Nov 2019 08:20 |
| Last Modified: | 21 Nov 2019 08:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/10595 |
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