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8. German Society for Clinical Chemistry and Laboratory Medicine – areas of expertise: Division reports from the German Congress of Laboratory Medicine 2022 in Mannheim, 13–14 October 2022

Author

Nauck Matthias, Holdenrieder Stefan, Klein Hanns-Georg, Findeisen Peter, Winter Christof, Ceglarek Uta, Petersmann Astrid, Klouche Mariam, Lichtinghagen Ralf, Biemann Ronald, Adler Jakob, Streichert Thomas, von Meyer Alexander, Wieland Eberhard, Hofmann Walter, Aufenanger Johannes, Orth Matthias, Shipkova Maria, Bidlingmaier Martin, Birschmann Ingvild, Blüthner Martin, Conrad Karsten, Luppa Peter B., Kiehntopf Michael, Bietenbeck Andreas, Baum Hannsjörg, and Renz Harald

Subjects
german congress for laboratory medicine 2022, german society for clinical chemistry and laboratory medicine (dgkl), areas of expertise, division reports, Medical technology, R855-855.5
Abstract

The programme of the German Congress for Laboratory Medicine 2022 was essentially designed by the divisions of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Almost all chairpersons of the divisions organised a 90-min symposium on current topics, i.e. conceptualised the symposia and invited speakers. For this article all chairpersons summarised the lectures that were given within the symposia. The DGKL’s work is structured into 5 areas of expertise: Molecular Diagnostics, Learning & Teaching, Quality & Management, Laboratory & Diagnostics and Biobanks & Informatics. The areas of expertise are in turn subdivided into divisions. About the history of the establishment of this new structure within the DGKL you can find information in the editorial of this issue.

Published
2024
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17. Optimizing everolimus exposure when combined with calcineurin inhibitors in solid organ transplantation

Author

Gelder, T. (Teun) van, Fischer, L. (Lutz), Shihab, F. (Fuad), Shipkova, M. (Maria), Gelder, T. (Teun) van, Fischer, L. (Lutz), Shihab, F. (Fuad), and Shipkova, M. (Maria)

Abstract

The mammalian target of rapamycin (mTOR) inhibitor everolimus is a narrow therapeutic index drug for which optimal exposure levels are essential. The consistent pharmacokinetic profile of everolimus allows trough concentration (C0) measurement to be an appropriate and reliable index for therapeutic drug monitoring (TDM). Exposure-response analyses of data from early fixed-dose trials demonstrated that rates of biopsy-proven acute rejection (BPAR) are significantly higher if everolimus C0 declines below 3 ng/mL, an observation confirmed in subsequent concentration-controlled trials. Evidence for the most favorable upper limit is less clear but with reduced-exposure calcineurin inhibitor (CNI) therapy, an upper limit of 8 ng/mL appears to balance efficacy and safety outcomes. The recommended C0 range is 3-8 ng/mL in kidney, liver and heart transplantation patients, based on LC-MS/MS monitoring in whole blood. Randomized clinical trials based on this target range have demonstrated rates of BPAR comparable to a regimen of mycophenolic acid with standard-exposure CNI. Everolimus exhibits moderate intrapatient pharmacokinetic variability, and it can be challenging to maintain stable concentrations within target range in some individuals. Many factors can influence everolimus exposure for a given dose, including hepatic function, activity of the drug efflux pump P-glycoprotein, the rate of everolimus metabolism, drug-drug interactions (predominantly with CYP3A4 and P-glycoprotein inhibitors, including cyclosporine), intake of fatty food, and patient adherence to the prescribed regimen. Trough concentration levels should be monitored 4-5days after the first dose and after any change in everolimus dose, with additional monitoring in response to any change in concomitant medication or other clinical circumstances which could alter everolimus exposure. Although LC-MS/MS is the gold standard for everolimus monitoring, various immunoassays are widely used due to their relative s

Published
2017
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21. Intensivierte vs. standardmäßige Dosierung von magensaftresistentem Mycophenolat- Natrium bei De-novo-Nierentransplantatempfängern: 1-Jahres-Ergebnisse einer randomisierten Studie

Author

Arns, W., primary, Sommerer, C., additional, Glander, P., additional, Ariatabar, T., additional, Porstner, M., additional, May, C., additional, Paulus, E.-M., additional, Shipkova, M., additional, Fischer, W., additional, Liefeldt, L., additional, Hackenberg, R., additional, Schemmer, P., additional, Domhan, S., additional, Zeier, M., additional, and Budde, K., additional

Published
2014
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22. Glucuronide and glucoside conjugation of mycophenolic acid by human liver, kidney and intestinal microsomes

Author

Shipkova, M, Strassburg, C P, Braun, F, Streit, F, Gröne, H-J, Armstrong, V W, Tukey, R H, Oellerich, M, and Wieland, E

Subjects
Intestines, Glucuronides, Microsomes, Papers, Microsomes, Liver, Humans, Glucuronates, Glucuronosyltransferase, Mycophenolic Acid, Kidney
Abstract

Mycophenolic acid (MPA) is primarily metabolized to a phenolic glucuronide (MPAG) as well as to two further minor metabolites: an acyl glucuronide (AcMPAG) and a phenolic glucoside (MPAG1s). This study presents investigations of the formation of these metabolites by human liver (HLM), kidney (HKM), and intestinal (HIM) microsomes, as well as by recombinant UDP-glucuronosyltransferases. HLM (n=5), HKM (n=6), HIM (n=5) and recombinant UGTs were incubated in the presence of either UDP-glucuronic acid or UDP-glucose and various concentrations of MPA. Metabolite formation was followed by h.p.l.c. All microsomes investigated formed both MPAG and AcMPAG. Whereas the efficiency of MPAG formation was greater with HKM compared to HLM, AcMPAG formation was greater with HLM than HKM. HIM showed the lowest glucuronidation efficiency and the greatest interindividual variation. The capacity for MPAGls formation was highest in HKM, while no glucoside was detected with HIM. HKM produced a second metabolite when incubated with MPA and UDP-glucose, which was labile to alkaline treatment. Mass spectrometry of this metabolite in the negative ion mode revealed a molecular ion of m/z 481 compatible with an acyl glucoside conjugate of MPA. All recombinant UGTs investigated were able to glucuronidate MPA with K:(M:) values ranging from 115.3 to 275.7 microM l(-1) and V(max) values between 29 and 106 pM min(-1) mg protein(-1). Even though the liver is the most important site of MPA glucuronidation, extrahepatic tissues particularly the kidney may play a significant role in the overall biotransformation of MPA in man. Only kidney microsomes formed a putative acyl glucoside of MPA.

Published
2001

26. Twelve-month evaluation of the clinical pharmacokinetics of total and free mycophenolic acid and its glucuronide metabolites in renal allograft recipients on low dose tacrolimus in combination with mycophenolate mofetil

Author

UCL - MD/CHIR - Département de chirurgie, UCL - (SLuc) Service de chirurgie et transplantation abdominale, Kuypers, D. R. J., Mourad, Michel, Vanrenterghem, Y., Squifflet, Jean-Paul, Abramowicz, D., Oellerich, M., Armstrong, V, Shipkova, M., Daems, J., UCL - MD/CHIR - Département de chirurgie, UCL - (SLuc) Service de chirurgie et transplantation abdominale, Kuypers, D. R. J., Mourad, Michel, Vanrenterghem, Y., Squifflet, Jean-Paul, Abramowicz, D., Oellerich, M., Armstrong, V, Shipkova, M., and Daems, J.

Abstract

Background: The establishment of a rationale for therapeutic drug monitoring for mycophenolic acid (MPA) and outlining a therapeutic window remains a challenging task in renal transplantation. Furthermore, the pharmacokinetic characteristics of free and total MPA and its glucuronides depend directly or indirectly on graft function and the type of co-administered calcineurin-inhibitor. Methods: The authors conducted a prospective 12-month multicenter pharmacokinetic study on MPA (MPA, free MPA, free fraction MPA) and its metabolites (MPAG, Acyl-MPAG). The aim of this study was to examine the long-term pharmacokinetic characteristics of MMF when combined with tacrolimus in renal allograft recipients and to identify a possible relationship between these pharmacokinetic parameters and clinical outcome parameters. Results: They have demonstrated that in renal transplant recipients MPA, free MPA, Acyl-MPAG and MPAG have a particular pharmacokinetic profile when combined with tacrolimus which differs from the combination with CsA. They could not establish a relationship between pre-dose trough concentration of MPA and its metabolites and clinical efficacy endpoints and drug-related adverse events, except for anemia. Conclusions: These findings suggest that trough plasma concentration monitoring of MPA and its metabolites might not provide a useful clinical tool for guiding MMF dose adjustments to avoid drug-related toxicity. More extensive pharmacokinetic measurements like area under the concentration curves might be necessary for routine therapeutic drug monitoring of MMF.

Published
2003

31. Twelve-Month Evaluation of the Clinical Pharmacokinetics of Total and Free Mycophenolic Acid and Its Glucuronide Metabolites in Renal Allograft Recipients on Low Dose Tacrolimus in Combination with Mycophenolate Mofetil

Author

Kuypers, D. R. J., primary, Vanrenterghem, Y., additional, Squifflet, J. P., additional, Mourad, M., additional, Abramowicz, D., additional, Oellerich, M., additional, Armstrong, V., additional, Shipkova, M., additional, and Daems, J., additional

Published
2003
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42. Therapeutic drug monitoring of total and free mycophenolic acid (MPA) and limited sampling strategy for determination of MPA-AUC in paediatric renal transplant recipients

Author

Weber, L., primary, Schutz, E., additional, Lamersdorf, T., additional, Shipkova, M., additional, Niedmann, P., additional, Oellerich, M., additional, Zimmerhackl, L., additional, Staskewitz, A., additional, Mehls, O., additional, Armstrong, V., additional, and Tonshoff, B., additional

Published
1999
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45. Pharmacokinetics of mycophenolic acid (MPA) and determinants of MPA free fraction in pediatric and adult renal transplant recipients. German Study group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients.

Author

Weber, L T, primary, Shipkova, M, additional, Lamersdorf, T, additional, Niedmann, P D, additional, Wiesel, M, additional, Mandelbaum, A, additional, Zimmerhackl, L B, additional, Schütz, E, additional, Mehls, O, additional, Oellerich, M, additional, Armstrong, V W, additional, and Tönshoff, B, additional

Published
1998
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48. Clinical utility of therapeutic drug monitoring of mycophenolic acid in transplantation medicine: where are we?

Author

Shipkova M

Abstract

Mycophenolate mofetil (MMF, CellCept®, Roche Pharmaceuticals) received its first approval for the prevention of renal allograft rejection in 1995 and has now become the most frequently used antiproliferative agent in maintenance immunosuppressive therapy for kidney, pancreas, liver, and heart transplantation. In 2004, a second mycophenolate formulation DS the enteric-coated mycophenolate sodium (EC-MPS, Myfortic®, Novartis Pharma) DS was introduced. Whereas therapeutic drug monitoring (TDM) is well established for other immunosuppressants, the use of this tool for individualization and optimization of mycophenolate therapy remains a matter of debate during these years. This article focuses on the basic pharmacology of mycophenolic acid and current knowledge about the utility of monitoring mycophenolic acid concentrations. Different tools for performing TDM of mycophenolic acid, current recommendations for TDM of MMF in transplantation medicine, as well as analytical techniques available will be discussed. [ABSTRACT FROM AUTHOR]

Published
2009
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49. Identification of glucoside and carboxyl-linked glucuronide conjugates of mycophenolic acid in plasma of transplant recipients treated with mycophenolate mofetil.

Author

Shipkova, Maria, Armstrong, Victor William, Wieland, Eberhard, Niedmann, Paul Dieter, Schütz, Ekkehard, Brenner-Weiß, Gerald, Voihsel, Martin, Braun, Felix, Oellerich, Michael, Shipkova, M, Armstrong, V W, Wieland, E, Niedmann, P D, Schütz, E, Brenner-Weiss, G, Voihsel, M, Braun, F, and Oellerich, M

Published
1999
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50. TwelveMonth Evaluation of the Clinical Pharmacokinetics of Total and Free Mycophenolic Acid and Its Glucuronide Metabolites in Renal Allograft Recipients on Low Dose Tacrolimus in Combination with Mycophenolate Mofetil

Author

Kuypers, D. R. J., Vanrenterghem, Y., Squifflet, J. P., Mourad, M., Abramowicz, D., Oellerich, M., Armstrong, V., Shipkova, M., and Daems, J.

Abstract

The establishment of a rationale for therapeutic drug monitoring for mycophenolic acid MPA and outlining a therapeutic window remains a challenging task in renal transplantation. Furthermore, the pharmacokinetic characteristics of free and total MPA and its glucuronides depend directly or indirectly on graft function and the type of coadministered calcineurininhibitor.

Published
2003

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