title: Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials
creator: Sommerer, Claudia
creator: Witzke, Oliver
creator: Lehner, Frank
creator: Arns, Wolfgang
creator: Reinke, Petra
creator: Eisenberger, Ute
creator: Vogt, Bruno
creator: Heller, Katharina
creator: Jacobi, Johannes
creator: Guba, Markus
creator: Stahl, Rolf
creator: Hauser, Ingeborg A.
creator: Kliem, Volker
creator: Wüthrich, Rudolf P.
creator: Mühlfeld, Anja
creator: Suwelack, Barbara
creator: Duerr, Michael
creator: Paulus, Eva-Maria
creator: Zeier, Martin
creator: Porstner, Martina
creator: Budde, Klemens
subject: ddc-610
subject: 610 Medical sciences Medicine
description: 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  ).
publisher: BioMed Central
date: 2018
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserver/25467/1/12882_2018_Article_1031.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-254678
identifier:   Sommerer, Claudia ; Witzke, Oliver ; Lehner, Frank ; Arns, Wolfgang ; Reinke, Petra ; Eisenberger, Ute ; Vogt, Bruno ; Heller, Katharina ; Jacobi, Johannes ; Guba, Markus ; Stahl, Rolf ; Hauser, Ingeborg A. ; Kliem, Volker ; Wüthrich, Rudolf P. ; Mühlfeld, Anja ; Suwelack, Barbara ; Duerr, Michael ; Paulus, Eva-Maria ; Zeier, Martin ; Porstner, Martina ; Budde, Klemens  (2018) Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials.  BMC Nephrology, 19 (237).  pp. 1-13.  ISSN 1471-2369     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/25467/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng