Evidence map›Paper›PMID 37140726›Full record

ArticleClinical pharmacokinetics2023

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

Panagiotis Nikolaos Lalagkas, Jorge Iliou, Raul Rigo, Marta Miarons, Beatriz Fernández-Alarcon, Oriol Bestard, Josep M Cruzado, Edoardo Melilli, Joan Torras, Josep M Grinyó and 2 more

Open access · hybridAbstract read
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Article in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Panagiotis Nikolaos Lalagkas *Biopharmaceutics and Pharmacokinetics Unit, Department of Pharmacy and Pharmaceutical Technology and Physical-Chemistry, School of Pharmacy and Food Sciences, University of Barcelona, Avda. Joan XXIII, s/n, 08028, Barcelona, Spain.ORCID 0000-0002-8245-1758
Jorge Iliou *Biopharmaceutics and Pharmacokinetics Unit, Department of Pharmacy and Pharmaceutical Technology and Physical-Chemistry, School of Pharmacy and Food Sciences, University of Barcelona, Avda. Joan XXIII, s/n, 08028, Barcelona, Spain.
Raul RigoBiochemistry Department, IDIBELL, Hospital Universitari de Bellvitge, Barcelona, Spain.
Marta MiaronsPharmacy Service, Hospital de la Vall d'Hebron, Barcelona, Spain.
Beatriz Fernández-AlarconBiopharmaceutics and Pharmacokinetics Unit, Department of Pharmacy and Pharmaceutical Technology and Physical-Chemistry, School of Pharmacy and Food Sciences, University of Barcelona, Avda. Joan XXIII, s/n, 08028, Barcelona, Spain.
Oriol BestardNephrology Service, Hospital Universitari de Bellvitge, IDIBELL, Lab Exp Nephrology 4122, Pav. Govern, 4a planta, UB, Feixa Llarga s/n, L'Hospitalet de Llobregat, Llobregat, 08907, Barcelona, Spain.
Josep M CruzadoNephrology Service, Hospital Universitari de Bellvitge, IDIBELL, Lab Exp Nephrology 4122, Pav. Govern, 4a planta, UB, Feixa Llarga s/n, L'Hospitalet de Llobregat, Llobregat, 08907, Barcelona, Spain.
Edoardo MelilliNephrology Service, Hospital Universitari de Bellvitge, IDIBELL, Lab Exp Nephrology 4122, Pav. Govern, 4a planta, UB, Feixa Llarga s/n, L'Hospitalet de Llobregat, Llobregat, 08907, Barcelona, Spain.
Joan TorrasNephrology Service, Hospital Universitari de Bellvitge, IDIBELL, Lab Exp Nephrology 4122, Pav. Govern, 4a planta, UB, Feixa Llarga s/n, L'Hospitalet de Llobregat, Llobregat, 08907, Barcelona, Spain.
Josep M GrinyóDepartment of Clinical Sciences, University of Barcelona, Barcelona, Spain.
Nuria LloberasNephrology Service, Hospital Universitari de Bellvitge, IDIBELL, Lab Exp Nephrology 4122, Pav. Govern, 4a planta, UB, Feixa Llarga s/n, L'Hospitalet de Llobregat, Llobregat, 08907, Barcelona, Spain. nlloberas@ub.edu.
Helena ColomBiopharmaceutics and Pharmacokinetics Unit, Department of Pharmacy and Pharmaceutical Technology and Physical-Chemistry, School of Pharmacy and Food Sciences, University of Barcelona, Avda. Joan XXIII, s/n, 08028, Barcelona, Spain. helena.colom@ub.edu.
Bellvitge University Hospital · ESUniversitat de Barcelona · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe 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.

methodsA 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

Cytomegalovirus InfectionsOrgan TransplantationRenal Insufficiency, ChronicAntiviral AgentsGanciclovirHumansKidneyValganciclovirAntiviral AgentsGanciclovirValganciclovir

Identifiers

PMID37140726
PMCPMC10256675
OpenAlexW4368358165

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.