TY  - JOUR
A1  - Sommerer, Claudia
A1  - Witzke, Oliver
A1  - Lehner, Frank
A1  - Arns, Wolfgang
A1  - Reinke, Petra
A1  - Eisenberger, Ute
A1  - Vogt, Bruno
A1  - Heller, Katharina
A1  - Jacobi, Johannes
A1  - Guba, Markus
A1  - Stahl, Rolf
A1  - Hauser, Ingeborg A.
A1  - Kliem, Volker
A1  - Wüthrich, Rudolf
A1  - Mühlfeld, Anja
A1  - Suwelack, Barbara
A1  - Dürr, Michael
A1  - Paulus, Eva-Maria
A1  - Zeier, Martin
A1  - Porstner, Martina
A1  - Budde, Klemens
T1  - Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy : an analysis of two randomized, multicenter trials
T2  - BMC nephrology
N2  - 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.
Trial registration: clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40).
KW  - Diabetes
KW  - Everolimus
KW  - Kidney transplantation
KW  - TOR inhibitor
KW  - PTDM
KW  - Post-transplant
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/47020
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-470208
SN  - 1471-2369
N1  - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
VL  - 19
IS  - 1, Art. 237
SP  - 1
EP  - 13
PB  - BioMed Central
CY  - London
ER  -