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Association of clinical events with everolimus exposure in kidney transplant patients receiving reduced cyclosporine

 Fuad S. Shihab  ;  Diane Cibrik  ;  Laurence Chan  ;  Yu Seun Kim  ;  Mario Carmellini  ;  Rowan Walker  ;  Gazi Zibari  ;  James Pattison  ;  Catherine Cornu-Artis  ;  Zailong Wang  ;  Helio Tedesco-Silva Jr 
 CLINICAL TRANSPLANTATION, Vol.27(2) : 217-226, 2013 
Journal Title
Issue Date
Adult ; Cyclosporine/administration & dosage* ; Cyclosporine/adverse effects ; Cyclosporine/pharmacokinetics ; Cyclosporine/therapeutic use ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Monitoring ; Drug Therapy, Combination ; Everolimus ; Female ; Follow-Up Studies ; Graft Rejection/epidemiology ; Graft Rejection/prevention & control* ; Graft Survival ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/pharmacokinetics ; Immunosuppressive Agents/therapeutic use* ; Kidney Transplantation* ; Linear Models ; Logistic Models ; Male ; Middle Aged ; Postoperative Complications/chemically induced ; Postoperative Complications/epidemiology ; Postoperative Complications/prevention & control* ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives* ; Sirolimus/pharmacokinetics ; Sirolimus/therapeutic use ; Survival Analysis ; Treatment Outcome
Calcineurin inhibitor toxicity ; Cyclosporine ; Everolimus ; Renal function ; Renal transplantation
BACKGROUND: The association between clinical events and everolimus exposure in patients receiving reduced-exposure calcineurin inhibitor therapy is poorly explored. METHODS: In a pre-planned, descriptive analysis of data from a randomized controlled trial, events were correlated with everolimus trough concentrations in 556 newly transplanted kidney transplant patients receiving everolimus with reduced-exposure cyclosporine (CsA) and steroids. Influence of everolimus exposure on clinical events was stratified according to predefined time-normalized concentrations. RESULTS: The incidence of treated biopsy-proven acute rejection and graft loss at month 12 was highest in patients with everolimus <3 ng/mL (36.4% and 28.6%, respectively, vs. 9.1-15.3% and 0.9-5.0% with higher concentration ranges). A higher mortality rate was observed in patients with an everolimus trough concentration ≥ 12 ng/mL (10.0% vs. 1.7-5.6% with lower concentration ranges). The lowest rates of renal dysfunction (defined as poor renal function [estimated GFR, serum creatinine] or proteinuria), wound healing events, peripheral edema, new-onset diabetes mellitus, hypercholesterolemia and hypertriglyceridemia were generally observed with everolimus trough concentration in the range 3-8 ng/mL and CsA <100 ng/mL. Proteinuria occurred most frequently in patients with very low or very high everolimus trough concentrations. CONCLUSIONS: These results support an exposure-response relationship between clinical events and everolimus trough concentrations in kidney transplant patients receiving reduced-exposure CsA.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yu Seun(김유선) ORCID logo https://orcid.org/0000-0002-5105-1567
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