Population pharmacokinetics and Bayesian estimator of mycophenolic acid in children with idiopathic nephrotic syndrome

British Journal of Clinical Pharmacology

Volumn 69, Issue 4, 2010, Pages 358-366

  Zhao, Wei ^a   Elie, Valéry ^a   Baudouin, Véronique ^a   Bensman, Albert ^b   André, Jean Luc ^c   Brochard, Karine ^d   Broux, Françoise ^e   Cailliez, Mathilde ^f   Loirat, Chantal ^a   Jacqz Aigrain, Evelyne ^a  

^a HÔPITAL ROBERT DEBRÉ   (France)

^b ARMAND TROUSSEAU HOSPITAL   (France)

^c Hôpital Nancy   (France)

^d HÔPITAL DES ENFANTS   (France)

^e HÔPITAL CHARLES NICOLLE   (France)

^f TIMONE HOSPITAL   (France)

Author keywords

Bayesian estimation; MMF; MPA; Nephrotic syndrome; Paediatrics; Pharmacokinetics

Indexed keywords

MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE; SERUM ALBUMIN;

AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; BODY SURFACE; BODY WEIGHT; CHILD; CLINICAL ARTICLE; COMPARTMENT MODEL; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG SAFETY; FEMALE; HUMAN; INDIVIDUALIZATION; MALE; NEPHROTIC SYNDROME; PHARMACODYNAMICS; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

ADMINISTRATION, ORAL; ADOLESCENT; AREA UNDER CURVE; BAYES THEOREM; CHILD; CHILD, PRESCHOOL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ENZYME INHIBITORS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MODELS, BIOLOGICAL; MYCOPHENOLIC ACID; NEPHROTIC SYNDROME; PROSPECTIVE STUDIES;

EID: 77949422466     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03615.x     Document Type: Article

References (46)

1. Churg J, Habib R, White RHR. Pathology of nephrotic syndrome in children: a report for the International Study of Kidney Disease in Children. Lancet 1970; 760: 1299-302.
2. Cattran DC, Alexopoulos E, Heering P, Hoyer PF, Johnston A, Meyrier A, Ponticelli C, Saito T, Choukroun G, Nachman P, Praga M, Yoshikawa N. Cyclosporin in idiopathic glomerular disease associated with the nephrotic syndrome: workshop recommendations. Kidney Int 2007; 72: 1429-47.
3. Hino S, Takemura T, Okada M, Murakami K, Yagi K, Fukushima K, Yoshioka K. Follow-up of children with nephrotic syndrome treated with a long-term moderate dose of cyclosporine. Am J Kidney Dis 1998; 31: 932-9.
4. Okada M, Hino S, Takemura T, Fukushima K, Yoshioka K. Cyclosporine therapy in children with steroid-resistant nephrotic syndrome. Clin Exp Nephrol 1999; 3: S34-9.
5. Moudgil A, Bagga A, Jordan SC. Mycophenolate mofetil therapy in frequently relapsing steroid-dependent and steroid-resistant nephrotic syndrome of childhood: current status and future directions. Pediatr Nephrol 2005; 20: 1376-81.
6. Sollinger HW. Mycophenolates in transplantation. Clin Transplant 2004; 18: 485-92.
7. Afzal K, Bagga A, Menon S, Hari P, Jordan SC. Treatment with mycophenolate mofetil and prednisolone for steroid-dependent nephrotic syndrome. Pediatr Nephrol 2007; 22: 2059-65.
8. Mendizabal S, Zamora I, Berbel O, Sanahuja MJ, Fuentes J, Simon J. Mycophenolate mofetil in steroid/cyclosporine-dependent/resistant nephrotic syndrome. Pediatr Nephrol 2005; 20: 914-9.
9. Ulinski T, Dubourg L, Said MH, Parchoux B, Ranchin B, Cochat P. Switch from cyclosporine A to mycophenolate mofetil in nephrotic children. Pediatr Nephrol 2005; 20: 482-5.
10. Gellermann J, Querfeld U. Frequently relapsing nephrotic syndrome: treatment with mycophenolate mofetil. Pediatr Nephrol 2004; 19: 101-4.
11. Barletta GM, Smoyer WE, Bunchman TE, Flynn JT, Kershaw DB. Use of mycophenolate mofetil in steroid-dependent and -resistant nephrotic syndrome. Pediatr Nephrol 2003; 18: 833-7.
12. Novak I, Frank R, Vento S, Gauthier B, Trachtman H. Efficacy of mycophenolate mofetil in pediatric patients with steroid-dependent nephrotic syndrome. Pediatr Nephrol 2005; 20: 1265-8.
13. Fujinaga S, Ohtomo Y, Umino D, Takemoto M, Shimizu T, Yamashiro Y, Kaneko K. A prospective study on the use of mycophenolate mofetil in children with cyclosporine-dependent nephrotic syndrome. Pediatr Nephrol 2007; 22: 71-6.
14. Bagga A, Hari P, Moudgil A, Jordan SC. Mycophenolate mofetil and prednisolone therapy in children with steroid dependent nephrotic syndrome. Am J Kidney Dis 2003; 42: 1114-20.
15. Kaysen GA. Plasma composition in the nephrotic syndrome. Am J Nephrol 1993; 13: 347-59.
16. Bergrem H. Pharmacokinetics and protein binding of prednisolone in patients with nephrotic syndrome and patients undergoing hemodialysis. Kidney Int 1983; 23: 876-81.
17. Miller PF, Bowmer CJ, Wheeldon J, Brocklebank JT. Pharmacokinetics of prednisolone in children with nephrosis. Arch Dis Child 1990; 65: 196-200.
18. Jacqz-Aigrain E, Montes C, Brun P, Loirat C. Cyclosporine pharmacokinetics in nephrotic and kidney-transplanted children. Eur J Clin Pharmacol 1994; 47: 61-5.
19. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet 1998; 34: 429-55.
20. Dorresteijn EM, Kist-van Holthe JE, Levtchenko EN, Nauta J, Hop WC, van der Heijden AJ. Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome. Pediatr Nephrol 2008; 23: 2013-20.
21. Maitre PO, Bührer M, Thomson D, Stanski DR. A three-step approach combining Bayesian regression and NONMEM population analysis: application to midazolam. J Pharmacokinet Biopharm 1991; 19: 377-84.
22. Yano Y, Beal SL, Sheiner LB. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodyn 2001; 28: 171-92.
23. Zhao W, Baudouin V, Zhang D, Deschênes G, Guellec CL, Jacqz-Aigrain E. Population pharmacokinetics of ganciclovir following administration of valganciclovir in paediatric renal transplant patients. Clin Pharmacokinet 2009; 48: 321-8.
24. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503-12.
25. Djebli N, Rousseau A, Hoizey G, Rerolle JP, Toupance O, Le Meur Y, Marquet P. Sirolimus population pharmacokinetic/pharmacogenetic analysis and Bayesian modelling in kidney transplant recipients. Clin Pharmacokinet 2006; 45: 1135-48.
26. Le Guellec C, Bourgoin H, Büchler M, Le Meur Y, Lebranchu Y, Marquet P, Paintaud G. Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet 2004; 43: 253-66.
27. Staatz CE, Duffull SB, Kiberd B, Fraser AD, Tett SE. Population pharmacokinetics of mycophenolic acid during the first week after renal transplantation. Eur J Clin Pharmacol 2005; 61: 507-16.
28. Shum B, Duffull SB, Taylor PJ, Tett SE. Population pharmacokinetic analysis of mycophenolic acid in renal transplant recipients following oral administration of mycophenolate mofetil. Br J Clin Pharmacol 2003; 56: 188-97.
29. Schutz E, Shipkova M, Armstrong VW, Wieland E, Oellerich M. Identification of a pharmacologically active metabolite of mycophenolic acid in plasma of transplant recipients treated with mycophenolate mofetil. Clin Chem 1999; 45: 419-22.
30. Payen S, Zhang D, Maisin A, Popon M, Bensman A, Bouissou F, Loirat C, Gomeni R, Bressolle F, Jacqz-Aigrain E. Population pharmacokinetics of mycophenolic acid in kidney transplant pediatric and adolescent patients. Ther Drug Monit 2005; 27: 378-88.
31. van Hest RM, van Gelder T, Vulto AG, Mathot RA. Population pharmacokinetics of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet 2005; 44: 1083-96.
32. Van Hest RM, Van Gelder T, Bouw R, Goggin T, Gordon R, Mamelok RD, Mathot RA. Time-dependent clearance of mycophenolic acid in renal transplant recipients. Br J Clin Pharmacol 2007; 63: 741-52.
33. Filler G, Foster J, Berard R,Mai I, Lepage N. Age-dependency of mycophenolate mofetil dosing in combination with tacrolimus after pediatric renal transplantation. Transplant Proc 2004; 36: 1327-31.
34. David-Neto E, Pereira Araujo LM, Sumita NM, Mendes ME, Ribeiro Castro MC, Alves CF, Kakehashi E, Romano P, Yagyu EM, Queiroga M, Nahas WC, Ianhez LE. Mycophenolic acid pharmacokinetics in stable pediatric renal transplantation. Pediatr Nephrol 2003; 18: 266-72.
35. Orth SR, Ritz E. The nephrotic syndrome. N Engl J Med 1998; 338: 1202-11.
36. Gugler R, Shoeman DW, Huffman DH, Cohlmia JB, Azarnoff DL. Pharmacokinetics of drugs in patients with the nephrotic syndrome. J Clin Invest 1975; 55: 1182-9.
37. Zhao W, Fakhoury M, Deschênes G, Roussey G, Brochard K, Niaudet P, Tsimaratos M, André JL, Cloarec S, Cochat P, Bensman A, Azougagh S, Jacqz-Aigrain E. Population pharmacokinetics and pharmacogenetics of mycophenolic acid following administration of mycophenolate mofetil in de novo pediatric renal transplant patients. J Clin Pharmacol 2010; DOI:10.1177/0091270009357429.
38. Hale MD, Nicholls AJ, Bullingham RE, Hené R, Hoitsma A, Squifflet JP, Weimar W, Vanrenterghem Y, Van de Woude FJ, Verpooten GA. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64: 672-83.
39. Shaw LM, Korecka M, Aradhye S, Grossman R, Bayer L, Innes C, Cucciara A, Barker C, Naji A, Nicholls A, Brayman K. Mycophenolic acid area under the curve values in African American and Caucasian renal transplant patients are comparable. J Clin Pharmacol 2000; 40: 624-33.
40. Nowak I, Shaw LM. Mycophenolic acid binding to human serum albumin: characterization and relation to pharmacodynamics. Clin Chem 1995; 41: 1011-7.
41. van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit 2001; 23: 119-28.
42. El-Sheikh AA, van den Heuvel JJ, Koenderink JB, Russel FG. Interaction of nonsteroidal anti-inflammatory drugs with multidrug resistance protein (MRP) 2/ABCC2- and MRP4/ABCC4-mediated methotrexate transport. J Pharmacol Exp Ther 2007; 320: 229-35.
43. Cattaneo D, Perico N, Gaspari F, Gotti E, Remuzzi G. Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation. Kidney Int 2002; 62: 1060-7.
44. van Gelder T, Le Meur Y, Shaw LM, Oellerich M, DeNofrio D, Holt C, Holt DW, Kaplan B, Kuypers D, Meiser B, Toenshoff B, Mamelok RD. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit 2006; 28: 145-54.
45. Le Meur Y, Büchler M, Thierry A, Caillard S, Villemain F, Lavaud S, Etienne I, Westeel PF, Hurault de Ligny B, Rostaing L, Thervet E, Szelag JC, Rérolle JP, Rousseau A, Touchard G, Marquet P. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant 2007; 7: 2496-503.
46. Schütz E, Armstrong VW, Shipkova M, Weber L, Niedmann PD, Lammersdorf T, Wiesel M, Mandelbaum A, Zimmerhackl LB, Mehls O, Tönshoff B, Oellerich M. Limited sampling strategy for the determination of mycophenolic acid area under the curve in pediatric kidney recipients. German Study Group on MMF Therapy in Pediatric Renal Transplant Recipients. Transplant Proc 1998; 30: 1182-4.