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Early Exposure of Everolimus with and without Calcineurin Inhibitors.

C. Felipe, A. Ferreira, T. Abait, A. Bessa, P. Ruppel, L. Hiramoto, M. Ivani, H. Tedesco, J. Medina- Pestana.

Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, SP, Brazil

Meeting: 2017 American Transplant Congress

Abstract number: D113

Keywords: Calcineurin, Immunosuppression, Kidney transplantation, Pharmacokinetics

Session Information

Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Tuesday, May 2, 2017

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Hall D1

This study aimed to evaluate the effect of cyclosporine (CSA) or tacrolimus (TAC) on early exposure of everolimus (EVR).

A cohort of 306 kidney transplant recipients were selected according to the initial immunosuppressant regimens: reduced dose CSA combined with EVR 0.75 mg BID (CSA/EVR0.75, N= 32) or 1.5 mg BID (CSA/EVR1.5, N= 31), reduced dose TAC combined with EVR 1.5 mg BID (TAC/EVR1.5, N= 176) and EVR 1.5 mg BID (EVR1.5, N= 67) alonewith TAC introduction at day 7. EVR blood concentrationswere compared at day 3 after transplantation.

Results: Recipient age (42±14. vs. 40±12 vs. 44±14 vs. 52±12, p= 0.000 years),proportion of diabetes mellitus (17%. vs. 3% vs. 9% vs. 25%, p= 0.000) and proportion of grafts from living donors (91% vs. 97% vs. 30% vs. 0%, p= 0.000) were different among the groups, respectively.

Dose adjusted EVR concentrations were higher when combined with CSA than with TAC or alone. No differences were observed comparing dose adjusted EVR concentrations combined with TAC or alone. The proportion of patients with EVR concentration below the target range (<3 ng/ml) was higher when combined with TAC or when administered alone.

Table 1 CSA + EVR

N= 32

CSA + EVR

N= 31

TAC + EVR

N= 176

EVR

N= 67

p
EVR dose, mg BID 0.75 1.5 1.5 1.5 0.000
EVR concentration, ng/mL 5.0 ± 4.4 8.1 ± 3.3 3.6 ± 1.3 3.3 ± 1.0 0.000
Dose adjusted EVR concentration, ng/mL/mg 6.7 ± 5.9 5.4 ± 2.2 2.4 ± 0.9 2.2 ± 0.7 0.000
Patients with EVR bellow 3ng/mL (%) 8 (25) 1 (3) 67 (38) 33 (49)
Patients with EVR between 3- 8 ng/mL (%) 21 (66) 16 (52) 107 (61) 34 (51)
Patients with EVR above 3ng/mL (%) 2 (6) 14 (45) 2 (1) 0

Conclusion: In de novo kidney transplant recipients, the initial dose of EVR should consider the choice of calcineurin inhibitor (CSA or TAC) to achieve EVR target concentration range in a higher proportion of patients.

CITATION INFORMATION: Felipe C, Ferreira A, Abait T, Bessa A, Ruppel P, Hiramoto L, Ivani M, Tedesco H, Medina- Pestana J. Early Exposure of Everolimus with and without Calcineurin Inhibitors. Am J Transplant. 2017;17 (suppl 3).

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To cite this abstract in AMA style:

Felipe C, Ferreira A, Abait T, Bessa A, Ruppel P, Hiramoto L, Ivani M, Tedesco H, Pestana JMedina-. Early Exposure of Everolimus with and without Calcineurin Inhibitors. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/early-exposure-of-everolimus-with-and-without-calcineurin-inhibitors/. Accessed May 9, 2025.

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