Pharmacokinetic and pharmacodynamic analysis of enteric-coated mycophenolate sodium: limited sampling strategies and clinical outcome in renal transplant patients
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Therapeutic drug monitoring of mycophenolate mofetil is a promising tool for reducing acute rejection episodes after renal transplantation. • Limited sampling algorithms of mycophenolic acid in mycophenolate mofetil-treated renal transplant patients have be...
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| Main Authors: | , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
11 March 2010
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| In: |
British journal of clinical pharmacology
Year: 2010, Volume: 69, Issue: 4, Pages: 346-357 |
| ISSN: | 1365-2125 |
| DOI: | 10.1111/j.1365-2125.2009.03612.x |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/j.1365-2125.2009.03612.x Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2125.2009.03612.x 
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| Author Notes: | Claudia Sommerer, Sandra Müller-Krebs, Matthias Schaier, Petra Glander, Klemens Budde, Vedat Schwenger, Gerd Mikus & Martin Zeier |
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| 520 | |a WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Therapeutic drug monitoring of mycophenolate mofetil is a promising tool for reducing acute rejection episodes after renal transplantation. • Limited sampling algorithms of mycophenolic acid in mycophenolate mofetil-treated renal transplant patients have been established. • Recently published study results indicate that the intensity of early drug exposure might determine the risk of acute rejection episodes. WHAT THIS STUDY ADDS • This study provides pharmacokinetic and pharmacodynamic data of mycophenolic acid in enteric-coated mycophenolate sodium-treated renal transplant patients. • Limited sampling algorithms are evaluated and a practical sampling strategy with five sampling time points within the first 4 h after oral drug intake is provided in renal transplant patients with combined immunosuppression consisting of enteric-coated mycophenolate sodium and ciclosporin A. • The association between pharmacokinetic and pharmacodynamic parameters and the risk of adverse events are evaluated. • Both pharmacokinetic and pharmacodynamic parameters contribute to optimized individual immunosuppression. AIMS Pharmacokinetic (PK) and pharmacodynamic (PD) monitoring strategies and clinical outcome were evaluated in enteric-coated mycophenolate sodium (EC-MPS)-treated renal allograft recipients. METHODS PK [mycophenolic acid (MPA)] and PD [inosine monophosphate dehydrogenase (IMPDH) activity] data were analysed in 66 EC-MPS and ciclosporin A (CsA)-treated renal allograft recipients. Adverse events were considered in a follow-up period of 12 weeks. RESULTS Analyses confirmed a limited sampling strategy (LSS) consisting of PK and PD data at predose, 1, 2, 3 and 4 h after oral intake as an appropriate sampling method (MPA r2= 0.812; IMPDH r2= 0.833). MPA AUC0-12 of patients with early biopsy-proven acute rejection was significantly lower compared with patients without a rejection (median MPA AUC0-12 28 µg*h ml−1 (7-45) vs. 40 µg*h ml−1 (16-130), P < 0.01), MPA AUC0-12 of patients with recurrent infections was significantly higher compared with patients without infections (median MPA AUC0-12 65 µg*h ml−1 (range 37-130) vs. 37 µg*h ml−1 (range 7-120), P < 0.005). Low 12-h IMPDH enzyme activity curve (AEC0-12) was associated with an increased frequency of gastrointestinal side-effects (median IMPDH AEC0-12 43 nmol*h mg−1 protein h−1[range 12-67) vs. 75 nmol*h mg−1 protein h−1 (range 15-371), P < 0.01]. CONCLUSIONS Despite highly variable absorption data, an appropriate LSS might be estimated by MPA AUC0-4 and IMPDH AEC0-4 in renal transplant patients treated with EC-MPS and CsA. Regarding adverse events, the suggested MPA-target AUC0-12 from 30 to 60 µg*h ml−1 seems to be appropriate in renal allograft recipients. | ||
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