Conversion from cyclosporine to everolimus at 4.5 months posttransplant: 3-year results from the randomized ZEUS study.
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Conversion from cyclosporine to everolimus at 4.5 months posttransplant: 3-year results from the randomized ZEUS study. / Budde, K; Lehner, F; Sommerer, C; Arns, W; Reinke, P; Eisenberger, U; Wüthrich, R P; Scheidl, S; May, C; Paulus, E-M; Mühlfeld, A; Wolters, H H; Pressmar, K; Stahl, Rolf A.K.; Witzke, O; Investigators, ZEUS Study.
in: AM J TRANSPLANT, Jahrgang 12, Nr. 6, 6, 2012, S. 1528-1540.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Conversion from cyclosporine to everolimus at 4.5 months posttransplant: 3-year results from the randomized ZEUS study.
AU - Budde, K
AU - Lehner, F
AU - Sommerer, C
AU - Arns, W
AU - Reinke, P
AU - Eisenberger, U
AU - Wüthrich, R P
AU - Scheidl, S
AU - May, C
AU - Paulus, E-M
AU - Mühlfeld, A
AU - Wolters, H H
AU - Pressmar, K
AU - Stahl, Rolf A.K.
AU - Witzke, O
AU - Investigators, ZEUS Study
PY - 2012
Y1 - 2012
N2 - The long-term effect of conversion from calcineurin inhibitor (CNI) therapy to an mTOR inhibitor requires clarification. Following completion of the 12-month, open-label, multicenter ZEUS study, in which 300 kidney transplant recipients were randomized to continue cyclosporine (CsA) or convert to everolimus at 4.5 months posttransplant, outcomes were assessed at month 36 (n = 284; 94.7%). CNI therapy was reintroduced in 28.4% of everolimus patients by month 36. The primary efficacy endpoint, estimated glomerular filtration rate (Nankivell, ANCOVA) was significantly higher with everolimus versus the CsA group at month 24 (7.6 mL/min/1.73 m(2) , 95%CI 4.3, 11.0 mL/min/1.73 m(2) ; p <0.001) and month 36 (7.5 mL/min/1.73 m(2) , 95%CI 3.6, 11.4 mL/min/1.73 m(2) ; p <0.001). The incidence of biopsy-proven acute rejection from randomization to month 36 was 13.0% in the everolimus arm and 4.8% in the CsA arm (p = 0.015). Patient and graft survival, as well as incidences of malignancy, severe infections and hospitalization, were similar between groups. Kidney transplant patients who are converted from CsA to everolimus at month 4.5 and who remain on everolimus thereafter may achieve a significant improvement in renal function that is maintained to 3 years. There was a significantly higher rate of rejection in the everolimus arm but this did not exert a deleterious effect by 3 years posttransplant.
AB - The long-term effect of conversion from calcineurin inhibitor (CNI) therapy to an mTOR inhibitor requires clarification. Following completion of the 12-month, open-label, multicenter ZEUS study, in which 300 kidney transplant recipients were randomized to continue cyclosporine (CsA) or convert to everolimus at 4.5 months posttransplant, outcomes were assessed at month 36 (n = 284; 94.7%). CNI therapy was reintroduced in 28.4% of everolimus patients by month 36. The primary efficacy endpoint, estimated glomerular filtration rate (Nankivell, ANCOVA) was significantly higher with everolimus versus the CsA group at month 24 (7.6 mL/min/1.73 m(2) , 95%CI 4.3, 11.0 mL/min/1.73 m(2) ; p <0.001) and month 36 (7.5 mL/min/1.73 m(2) , 95%CI 3.6, 11.4 mL/min/1.73 m(2) ; p <0.001). The incidence of biopsy-proven acute rejection from randomization to month 36 was 13.0% in the everolimus arm and 4.8% in the CsA arm (p = 0.015). Patient and graft survival, as well as incidences of malignancy, severe infections and hospitalization, were similar between groups. Kidney transplant patients who are converted from CsA to everolimus at month 4.5 and who remain on everolimus thereafter may achieve a significant improvement in renal function that is maintained to 3 years. There was a significantly higher rate of rejection in the everolimus arm but this did not exert a deleterious effect by 3 years posttransplant.
KW - Adult
KW - Humans
KW - Aged
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - Kidney Transplantation
KW - Analysis of Variance
KW - Immunosuppressive Agents/administration & dosage
KW - Cyclosporine/administration & dosage
KW - Sirolimus/administration & dosage/analogs & derivatives
KW - Adult
KW - Humans
KW - Aged
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - Kidney Transplantation
KW - Analysis of Variance
KW - Immunosuppressive Agents/administration & dosage
KW - Cyclosporine/administration & dosage
KW - Sirolimus/administration & dosage/analogs & derivatives
M3 - SCORING: Journal article
VL - 12
SP - 1528
EP - 1540
JO - AM J TRANSPLANT
JF - AM J TRANSPLANT
SN - 1600-6135
IS - 6
M1 - 6
ER -
