Five‐Year Outcomes in Kidney Transplant Patients Converted From Cyclosporine to Everolimus: The Randomized ZEUS Study. Issue 1 (17th December 2014)

• Record Type: Journal Article
• Authors: Budde, K.; Lehner, F.; Sommerer, C.; Reinke, P.; Arns, W.; Eisenberger, U.; Wüthrich, R. P.; Mühlfeld, A.; Heller, K.; Porstner, M.; Veit, J.; Paulus, E.‐M.; Witzke, O.; on behalf of the ZEUS Study Investigators
• Is Part Of: American journal of transplantation. Volume 15:Issue 1(2015:Jan.)
• Page Start: 119
• Page End: 128
• Publication Date: 2014-12-17
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.12952
• Languages: English
• ISSNs: 1600-6135

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ajt12952-sec-0001" sec-type="section"> <p>ZEUS study was an open‐label, 12‐month, multicenter study in which 300 <italic>de novo</italic> kidney transplant recipients were randomized to continue receiving cyclosporine (CsA) or convert to everolimus at 4.5 months posttransplant. Five‐year follow‐up data were available for 245/269 patients (91.1%) who completed the core 12‐month study (123 everolimus, 109 CsA). At 5 years, adjusted estimated GFR was 66.2 mL/min/1.73 m<sup>2</sup> with everolimus versus 60.9 mL/min/1.73 m<sup>2</sup> with CsA; the mean difference was 5.3 mL/min/1.73 m<sup>2</sup> in favor of everolimus (95% CI 2.4, 8.3; p < 0.001 [intent‐to‐treat population]). In a <italic>post hoc</italic> analysis of patients remaining on study drug at 5 years (everolimus 77, CsA 86), mean difference was 8.2 mL/min/1.73 m<sup>2</sup> (95% CI 4.3, 12.1; p < 0.001) in favor of everolimus. The cumulative incidence of biopsy‐proven acute rejection postrandomization was 13.6% with everolimus versus 7.5% with CsA (p = 0.095), largely accounted for by grade I rejection (16/21 patients and 7/11 patients, respectively). Postrandomization, graft loss, mortality, serious adverse events and neoplasms were similar in both arms. In conclusion, conversion of kidney transplant patients to everolimus at 4.5 months posttransplant is associated with a significant improvement in renal function that is maintained to at least 5 years. The increase in early mild acute rejection did not affect long‐term graft function.</p> </sec> </abstract>