Published in:
Open Access
01-12-2018 | Research article
Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials
Authors:
Claudia Sommerer, Oliver Witzke, Frank Lehner, Wolfgang Arns, Petra Reinke, Ute Eisenberger, Bruno Vogt, Katharina Heller, Johannes Jacobi, Markus Guba, Rolf Stahl, Ingeborg A. Hauser, Volker Kliem, Rudolf P. Wüthrich, Anja Mühlfeld, Barbara Suwelack, Michael Duerr, Eva-Maria Paulus, Martin Zeier, Martina Porstner, Klemens Budde, on behalf of the ZEUS and HERAKLES study investigators
Published in:
BMC Nephrology
|
Issue 1/2018
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Abstract
Background
Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes.
Methods
PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497).
Results
There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes).
Conclusions
Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes.