eprintid: 25467 rev_number: 11 eprint_status: archive userid: 1589 dir: disk0/00/02/54/67 datestamp: 2018-10-23 11:03:53 lastmod: 2024-05-03 19:44:17 status_changed: 2018-10-23 11:03:53 type: article metadata_visibility: show creators_name: Sommerer, Claudia creators_name: Witzke, Oliver creators_name: Lehner, Frank creators_name: Arns, Wolfgang creators_name: Reinke, Petra creators_name: Eisenberger, Ute creators_name: Vogt, Bruno creators_name: Heller, Katharina creators_name: Jacobi, Johannes creators_name: Guba, Markus creators_name: Stahl, Rolf creators_name: Hauser, Ingeborg A. creators_name: Kliem, Volker creators_name: Wüthrich, Rudolf P. creators_name: Mühlfeld, Anja creators_name: Suwelack, Barbara creators_name: Duerr, Michael creators_name: Paulus, Eva-Maria creators_name: Zeier, Martin creators_name: Porstner, Martina creators_name: Budde, Klemens title: Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials subjects: ddc-610 divisions: i-910200 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. Trial registration: clinicaltrials.gov , NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT ( 2006-007021-32 and 2004-004346-40 ). date: 2018 publisher: BioMed Central id_scheme: DOI ppn_swb: 1657218082 own_urn: urn:nbn:de:bsz:16-heidok-254678 language: eng bibsort: SOMMERERCLONSETANDPR2018 full_text_status: public publication: BMC Nephrology volume: 19 number: 237 place_of_pub: London pagerange: 1-13 issn: 1471-2369 citation: 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 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/25467/1/12882_2018_Article_1031.pdf