Evidence map›Paper›PMID 30229398›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2019

Longitudinal Pharmacokinetics of Mycophenolic Acid in Elderly Renal Transplant Recipients Compared to a Younger Control Group: Data from the nEverOld Trial.

Paschoalina Romano, Fabiana Agena, Pérsio de Almeida Rezende Ebner, Nairo Massakazu Sumita, Ana Heloísa Kamada Triboni, Fernanda Ramos, Márcio Dos Santos Garcia, Nilo José Coelho Duarte, Francine Brambate Carvalhinho Lemos, Nelson Zocoler Galante and 1 more

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Article
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

11 authors at 1 institution in 1 country.

Paschoalina RomanoDivision of Nephrology, Hospital das Clínicas, São Paulo University School of Medicine, São Paulo, Brazil.
Fabiana AgenaRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil.
Pérsio de Almeida Rezende EbnerDivision of Central Laboratory (LIM-03), Hospital das Clínicas, São Paulo University School of Medicine, São Paulo, Brazil.
Nairo Massakazu SumitaDivision of Central Laboratory (LIM-03), Hospital das Clínicas, São Paulo University School of Medicine, São Paulo, Brazil.
Ana Heloísa Kamada TriboniRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil.
Fernanda RamosRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil.
Márcio Dos Santos GarciaDivision of Central Laboratory (LIM-03), Hospital das Clínicas, São Paulo University School of Medicine, São Paulo, Brazil.
Nilo José Coelho DuarteDivision of Central Laboratory (LIM-03), Hospital das Clínicas, São Paulo University School of Medicine, São Paulo, Brazil.
Francine Brambate Carvalhinho LemosRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil.
Nelson Zocoler GalanteRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil.
Elias David-NetoRenal Transplantation Service, Division of Urology, Hospital das Clínicas, São Paulo University School of Medicine, Av. Dr.Enéas de Carvalho Aguiar, 255, São Paulo, 05403-900, Brazil. elias@cntt.com.br.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesElderly patients are increasingly likely to be recipients of transplants. However, the pharmacokinetics of mycophenolic acid (MPA) in this population are yet to be studied in detail. The objective of this study was to assess whether there were differences in MPA pharmacokinetic parameter values between elderly recipients and younger-adult recipients during the 6 months immediately following renal transplantation.

methodsIn this analysis, the longitudinal 12-h pharmacokinetics of MPA, administered as enteric-coated mycophenolate sodium (EC-MPS), were evaluated in 44 elderly renal transplant recipients and compared with the corresponding pharmacokinetics of MPA in 31 younger adult recipients. Measurements were performed at 7, 30, 60, 90, and 180 days post-transplantation. All patients received tacrolimus and prednisone.

resultsThe elderly patients were 30 years older than the younger controls, with a predominance of males and Caucasians. Elderly patients had lower serum albumin than the younger controls during the first 6 months after transplantation. The mean estimated total body MPA clearance of the elderly recipients was not significantly different from that of the controls at any analyzed time point (the mean clearance across all time points was 0.31 ± 0.17 vs 0.30 ± 0.25 L/h/kg). MPA exposure, as evaluated from the area under the 12-h time versus measured MPA concentration (adjusted for dose/body weight) curve, did not differ between the groups at any time point (mean exposure across all time points was 4.68 ± 3.61 vs 5.95 ± 4.29 µg·h/mL per mg/kg for the elderly recipients and the controls).

conclusionsThese data show that the pharmacokinetics of MPA in elderly renal transplant recipients were no different to those of younger-adult recipients in this study population. CLINICALTRIALS.GOV: NCT 01631058.

Indexed as

Data AnalysisAdultAgedAge FactorsAgingAntibiotics, AntineoplasticFemaleHumansKidney TransplantationLongitudinal StudiesMaleMycophenolic AcidProspective StudiesTablets, Enteric-CoatedAntibiotics, AntineoplasticMycophenolic AcidTablets, Enteric-Coated

Identifiers

PMID30229398
OpenAlexW2892186204

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.