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Friday, August 8, 2014

Efficacy and safety of conversion from cyclosporine to everolimus in living-donor kidney transplant recipients: an analysis from the ZEUS study

Transplant International Efficacy and safety of conversion from cyclosporine to everolimus in living-donor kidney transplant recipients: an analysis from the ZEUS study

Abstract

Conversion of living-donor kidney transplant patients from calcineurin inhibitor therapy to an mTOR inhibitor is poorly documented. In the prospective, multicenter ZEUS study, 300 kidney transplant recipients without prior rejection (Banff grade >1) and serum creatinine ≤265μmol/L were randomized to continue cyclosporine or convert to everolimus at 4.5 months post-transplant. In a post hoc analysis of 80 living-donor recipients, adjusted estimated GFR (Nankivell) at month 12 (the primary endpoint) was 74.3 (95%CI [70.7, 77.9]) mL/min/1.73m2 with everolimus versus 63.8 (95%CI [60.0, 67.7]) mL/min/1.73m2) with cyclosporine, a difference of 10.5 mL/min/1.73m2 in favor of everolimus (p<0.001). From randomization to month 12, adjusted estimated GFR increased by a mean of 9.8 (95%CI [6.2, 13.4]) mL/min/1.73m2 with everolimus, versus

-0.7 (95%CI [-4.6, 3.1]) mL/min/1.73m2) (p<0.001) with cyclosporine. There were six biopsy-proven acute rejection episodes in everolimus-treated patients (five Banff grade I) and one episode in cyclosporine-treated patients (Banff grade 1). Overall safety profile was similar between groups. Discontinuation due to adverse events occurred in three everolimus patients (7.1%) and five cyclosporine patients (13.2%) between randomization and month 12. Initiation of everolimus with early elimination of calcineurin therapy is associated with a significant renal benefit at 12 months post-transplant that is observed in both living and deceased-donor recipients.

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http://onlinelibrary.wiley.com/resolve/doi?DOI=10.1111%2Ftri.12411

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