Limited sampling strategy for the estimation of mycophenolic acid area under the curve in Tunisian renal transplant patients

Gaïes, Emna; Sassi, Mouna; Jebari, Hanene El; Jebabli, Nadia; Charfi, Rim; Chokri, Ichraf; Salouage, Issam; Klouz, Anis; Trabelsi, Sameh

doi:10.1016/j.nephro.2017.02.010

Cited by 4 publications

(8 citation statements)

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“…For tacrolimus (Tac) co-administration (30 LSSs), the time points most often included were C4 (19% of all time points, 57% of the equations), and C2 (15% of all time points, 47% of the equations). LSS established by Gaies et al [ 25 ] was not included as the authors did not separately analyze patients receiving CsA and Tac.…”

Section: Resultsmentioning

confidence: 99%

“…The latter equation had the advantage of being validated in an external group of patients. The LSSs which was characterized by very good bias and precision was MPA AUC pred = 0.414 + 1.210 × C0.5 + 2.256 × C1.5 + 4.134 × C4 [ 25 ], which had the advantages of being validated in a validation group and applied to patients receiving either CsA or Tac; however, the r 2 was < 0.950. High r 2 was observed for the following equations: AUC pred = 8.32 + 0.904 × C1.5 + 1.955 × C4 + 10.206 × C10 [ 35 ], AUC pred = 15.3 + 7.06 × C4 + 6.77 × C8 − 3.76 × C12, and AUC pred = – 0.247 + 11.73 × C6 + 2.92 × C2 [ 44 ]; however, the bias and precision were given in AUC units [ 35 ] or not given at all [ 44 ], so it is therefore difficult to compare these results with those expressed as percentages.…”

Section: Resultsmentioning

confidence: 99%

“…These studies are not included in Table 4 . In the majority of studies [ 18 – 20 , 22 , 25 , 32 – 44 , 46 – 49 , 51 , 52 , 55 – 59 , 61 , 62 , 65 , 68 , 69 ], the high-performance liquid chromatography (HPLC) method was used for MPA determination. In 15 studies, MPA concentrations were determined based on enzyme multiplied immunoassay technique (EMIT) [ 16 , 17 , 24 , 27 – 29 , 45 , 53 , 54 , 60 , 63 , 65 – 67 , 71 ] (in one study both methods were applied [ 65 ]).…”

Section: Resultsmentioning

confidence: 99%

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confidence: 99%

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A Systematic Review of Multiple Linear Regression-Based Limited Sampling Strategies for Mycophenolic Acid Area Under the Concentration–Time Curve Estimation

Sobiak

Resztak

2021

Eur J Drug Metab Pharmacokinet

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Background and Objective One approach of therapeutic drug monitoring in the case of mycophenolic acid (MPA) is a limited sampling strategy (LSS), which allows the evaluation of the area under the concentration-time curve (AUC) based on few concentrations. The aim of this systematic review was to review the MPA LSSs and define the most frequent time points for MPA determination in patients with different indications for mycophenolate mofetil (MMF) administration. Methods The literature was comprehensively searched in July 2021 using PubMed, Scopus, and Medline databases. Original articles determining multiple linear regression (MLR)-based LSSs for MPA and its free form (fMPA) were included. Studies on enteric-coated mycophenolic sodium, previously established LSS, Bayesian estimator, and different than twice a day dosing were excluded. Data were analyzed separately for (1) adult renal transplant recipients, (2) adults with other than renal transplantation indication, and (3) for pediatric patients. Results A total of 27, 17, and 11 studies were found for groups 1, 2, and 3, respectively, and 126 MLR-based LSS formulae (n = 120 for MPA, n = 6 for fMPA) were included in the review. Three time-point equations were the most frequent. Four

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

A Systematic Review of Multiple Linear Regression-Based Limited Sampling Strategies for Mycophenolic Acid Area Under the Concentration–Time Curve Estimation

Sobiak

Resztak

2021

Eur J Drug Metab Pharmacokinet

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“…To assess the predictive performance of LSSs available in the literature, we calculated r 2 as well as the bias and precision for AUC pred as the mean relative prediction error (%MPE) and the percentage of the mean absolute relative prediction error (%MAE), respectively, both with 95% confidence intervals. According to the literature, precision and bias ±15% were considered acceptable [ 22 , 59 , 60 ], although some authors defined the clinical acceptance as ±20% [ 18 ] or even as ±33% [ 61 ]. Although it does not translate into clinical practice, lower percentages of precision and bias result in more accurate calculations.…”

Section: Methodsmentioning

confidence: 99%

The Evaluation of Multiple Linear Regression–Based Limited Sampling Strategies for Mycophenolic Acid in Children with Nephrotic Syndrome

et al. 2021

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We evaluated mycophenolic acid (MPA) limited sampling strategies (LSSs) established using multiple linear regression (MLR) in children with nephrotic syndrome treated with mycophenolate mofetil (MMF). MLR-LSS is an easy-to-determine approach of therapeutic drug monitoring (TDM). We assessed the practicability of different LSSs for the estimation of MPA exposure as well as the optimal time points for MPA TDM. The literature search returned 29 studies dated 1998–2020. We applied 53 LSSs (n = 48 for MPA, n = 5 for free MPA [fMPA]) to predict the area under the time-concentration curve (AUCpred) in 24 children with nephrotic syndrome, for whom we previously determined MPA and fMPA concentrations, and compare the results with the determined AUC (AUCtotal). Nine equations met the requirements for bias and precision ±15%. The MPA AUC in children with nephrotic syndrome was predicted the best by four time-point LSSs developed for renal transplant recipients. Out of five LSSs evaluated for fMPA, none fulfilled the ±15% criteria for bias and precision probably due to very high percentage of bound MPA (99.64%). MPA LSS for children with nephrotic syndrome should include blood samples collected 1 h, 2 h and near the second MPA maximum concentration. MPA concentrations determined with the high performance liquid chromatography after multiplying by 1.175 may be used in LSSs based on MPA concentrations determined with the immunoassay technique. MPA LSS may facilitate TDM in the case of MMF, however, more studies on fMPA LSS are required for children with nephrotic syndrome.

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A short overview on mycophenolic acid pharmacology and pharmacokinetics

Ferreira

Thiesen

Pereira

et al. 2020

Clinical Transplantation

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Immunosuppressive therapy is used in solid organ transplant treatment, and mycophenolic acid (MPA) is one of the immunosuppressive drugs most used worldwide. It is a potent, selective, non‐competitive, and reversible inosine monophosphate dehydrogenase (IMPDH) inhibitor that acts to inhibit guanine synthesis. To improve solubility, MPA is used as the prodrug mycophenolate mofetil (MMF) or as an enteric‐coated mycophenolate sodium salt (EC‐MPS). It is metabolized into mycophenolic acid phenyl glucuronide (MPAG), the inactive and major metabolite, and into acyl glucuronide (AcMPAG), pharmacologically active. In kidney transplantation, combined immunosuppressive therapy with cyclosporine (CsA) and tacrolimus (Tac) is widely used, showing beneficial effects. This paper aimed to review papers published in the last two decades and discuss factors that can interfere with the pharmacokinetics of MPA. Data collected confirm that MPA plasma levels should be monitored to evaluate immunosuppressive therapy since pharmacokinetics can be influenced by factors such as interpatient variability, coadministration of other immunosuppressive agents, post‐transplant period, renal function, and dose. However, to perform drug monitoring, costs and facility may be limitations. Monitoring MPAG together with MPA would be a great improvement in therapy as it represents a big part of MPA levels and can be related to the increase of adverse effects.

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Limited sampling strategy for the estimation of mycophenolic acid area under the curve in Tunisian renal transplant patients

Cited by 4 publications

References 21 publications

A Systematic Review of Multiple Linear Regression-Based Limited Sampling Strategies for Mycophenolic Acid Area Under the Concentration–Time Curve Estimation

A Systematic Review of Multiple Linear Regression-Based Limited Sampling Strategies for Mycophenolic Acid Area Under the Concentration–Time Curve Estimation

The Evaluation of Multiple Linear Regression–Based Limited Sampling Strategies for Mycophenolic Acid in Children with Nephrotic Syndrome

A short overview on mycophenolic acid pharmacology and pharmacokinetics

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