Miniatura

Fitxers

818507.pdf (2.75 MB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2023-06-01

Llicència de publicació

cc by-nc (c) Panagiotis Nikolaos Lalagkas, et al., 2023
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/220201

Comparison of Three Renal Function Formulas for Ganciclovir/Valganciclovir Dose Individualization in CMV-Infected Solid Organ Transplantation Patients Using a Population Approach

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1007/s40262-023-01237-3

Resum

Background and objective: The gold standard treatment of established cytomegalovirus infection or prevention in solid organ transplantation is the intravenous administration of ganciclovir (GCV) or oral administration of valganciclovir (VGCV), both adjusted to the renal function. In both instances, there is a high interindividual pharmacokinetic variability, mainly owing to the wide range of variation of both the renal function and body weight. Therefore, accurate estimation of the renal function is crucial for GCV/VGCV dose optimization. This study aimed to compare three different formulas for estimating the renal function in solid organ transplantation patients with cytomegalovirus infection, for individualizing antiviral therapy with GCV/VGCV, using a population approach. Methods: A population pharmacokinetic analysis was performed using NONMEM 7.4. A total of 650 plasma concentrations obtained after intravenous GCV and oral VGCV administrations were analyzed, from intensive and sparse sampling designs. Three different population pharmacokinetic models were built with the renal function given by Cockcroft-Gault, Modification of Diet in Renal Disease, or Chronic Kidney Disease EPIdemiology Collaboration (CKD-EPI) formulas. Pharmacokinetic parameters were allometrically scaled to body weight. Results: The CKD-EPI formula was identified as the best predictor of between-patient variability in GCV clearance. Internal and external validation techniques showed that the CKD-EPI model had better stability and performed better compared with the others. Conclusions: The model based on the more accurate estimation of the renal function with the CKD-EPI formula and body weight as a size metric most used in the clinical practice can refine initial dose recommendations and contribute to GCV and VGCV dose individualization when required in the prevention or treatment of cytomegalovirus infection in solid organ transplantation patients.

Matèries

Malalties del ronyó, Trasplantament renal

Matèries (anglès)

Kidney diseases, Kidney transplantation

Citació

Col·leccions

Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

Citació

LALAGKAS, Panagiotis nikolaos, ILIOU, Jorge, RIGO BONNIN, Raúl, MIARONS BLANCO, Meritxell, FERNÁNDEZ-ALARCÓN, Beatriz, BESTARD MATAMOROS, Oriol, CRUZADO, Josep ma., MELILLI, Edoardo, TORRAS AMBRÒS, Joan, GRINYÓ BOIRA, Josep m., LLOBERAS BLANCH, Núria, COLOM CODINA, Helena. Comparison of Three Renal Function Formulas for Ganciclovir/Valganciclovir Dose Individualization in CMV-Infected Solid Organ Transplantation Patients Using a Population Approach. _Clinical Pharmacokinetics_. 2023. [consulta: 21 de gener de 2026]. ISSN: 0312-5963. [Disponible a: https://hdl.handle.net/2445/220201]

Exportar metadades

JSON - METS

Compartir registre