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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
  • Elias David-NetoEmail author
Original Research Article
  • 90 Downloads

Abstract

Background and Objectives

Elderly 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.

Methods

In 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.

Results

The 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).

Conclusions

These 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.

Notes

Compliance with Ethical Standards

Conflict of interest

The authors declare no conflict of interest.

Financial support

The nEverOld study was supported by an unrestricted grant from Novartis Pharma Brazil as an Investigator Initiated Trial. Novartis had no role in the study design, data collection, and analysis, the decision to publish, or the preparation of the manuscript.

Ethics approval

All procedures used in this study were in accordance with the 1964 Declaration of Helsinki and its subsequent amendments. The study protocol was approved by the Institutional Review Board of the Hospital das Clínicas (CAPPESQ # 26423). Clinical Trials.gov identifier: NCT 01631058.

Informed consent

Written informed consent was obtained from all of the patients included in this study, or their caregivers.

Supplementary material

13318_2018_506_MOESM1_ESM.pdf (147 kb)
Supplementary material 1 (PDF 146 kb)

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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Paschoalina Romano
    • 2
    • 3
  • Fabiana Agena
    • 1
  • Pérsio de Almeida Rezende Ebner
    • 3
  • Nairo Massakazu Sumita
    • 3
  • Ana Heloísa Kamada Triboni
    • 1
  • Fernanda Ramos
    • 1
  • Márcio dos Santos Garcia
    • 3
  • Nilo José Coelho Duarte
    • 3
  • Francine Brambate Carvalhinho Lemos
    • 1
  • Nelson Zocoler Galante
    • 1
  • Elias David-Neto
    • 1
    • 2
    Email author
  1. 1.Renal Transplantation Service, Division of Urology, Hospital das ClínicasSão Paulo University School of MedicineSão PauloBrazil
  2. 2.Division of Nephrology, Hospital das ClínicasSão Paulo University School of MedicineSão PauloBrazil
  3. 3.Division of Central Laboratory (LIM-03), Hospital das ClínicasSão Paulo University School of MedicineSão PauloBrazil

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