Population Pharmacokinetics of Prednisolone in Relation to Clinical Outcome in Children with Nephrotic Syndrome

Therapeutic Drug Monitoring

Volumn 38, Issue 4, 2016, Pages 534-545

  Teeninga, Nynke ^a   Guan, Zheng ^b   Stevens, Jasper ^b   Kist Van Holthe, Joana E ^c   Ackermans, Mariëtte T ^d   Van Der Heijden, Albert J ^a   Van Schaik, Ron H N ^e   Van Gelder, Teun ^e   Nauta, Jeroen ^a  

^a SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d ACADEMIC MEDICAL CENTER   (Netherlands)

^e ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

children; nephrotic syndrome; population pharmacokinetics; prednisolone; saliva

Indexed keywords

CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; MULTIDRUG RESISTANCE PROTEIN 1; PREDNISOLONE; IMMUNOSUPPRESSIVE AGENT;

ALLELE; ALLOMETRY; AREA UNDER THE CURVE; ARTICLE; CHILD; CHILDHOOD DISEASE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EXPOSURE; FEMALE; GENE FREQUENCY; GENETIC POLYMORPHISM; GENETIC VARIABILITY; HUMAN; HYPOALBUMINEMIA; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEPHROTIC SYNDROME; OUTCOME ASSESSMENT; PHARMACOKINETIC PARAMETERS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; REMISSION; SENSITIVITY ANALYSIS; TANDEM MASS SPECTROMETRY; VOLUME OF DISTRIBUTION; ADOLESCENT; ADULT; CLINICAL TRIAL; DRUG MONITORING; GENETICS; KIDNEY TRANSPLANTATION; METABOLIC CLEARANCE RATE; PHYSIOLOGY; PROCEDURES; YOUNG ADULT;

ADOLESCENT; ADULT; AREA UNDER CURVE; DRUG MONITORING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; METABOLIC CLEARANCE RATE; NEPHROTIC SYNDROME; POLYMORPHISM, GENETIC; PREDNISOLONE; PROSPECTIVE STUDIES; YOUNG ADULT;

EID: 84966553276     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0000000000000308     Document Type: Article

References (50)

1. Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003; 362:629-639
2. Hodson EM, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2007:CD001533
3. Teeninga N, Kist-Holthe JE, van Rijswijk N, et al. Extending prednisolone treatment does not reduce relapses in childhood nephrotic syndrome. J Am Soc Nephrol. 2013;24:149-159
4. Kabuki N, Okugawa T, Hayakawa H, et al. Influence of age at onset on the outcome of steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 1998;12:467-470
5. Schachter AD. The pediatric nephrotic syndrome spectrum: clinical homogeneity and molecular heterogeneity. Pediatr Transpl. 2004;8: 344-348
6. Sasse B, Hailemariam S, Wuthrich RP, et al. Angiotensin converting enzyme gene polymorphisms do not predict the course of idiopathic nephrotic syndrome in Swiss children. Nephrology (Carlton). 2006;11: 538-541
7. Constantinescu AR, Shah HB, Foote EF, et al. Predicting first-year relapses in children with nephrotic syndrome. Pediatrics. 2000;105: 492-495
8. Andersen RF, Thrane N, Noergaard K, et al. Early age at debut is a predictor of steroid-dependent and frequent relapsing nephrotic syndrome. Pediatr Nephrol. 2010;25:1299-1304
9. Vivarelli M, Moscaritolo E, Tsalkidis A, et al. Time for initial response to steroids is a major prognostic factor in idiopathic nephrotic syndrome. J Pediatr. 2010;156:965-971
10. Takeda A, Takimoto H, Mizusawa Y, et al. Prediction of subsequent relapse in children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 2001;16:888-893
11. Baron S, Raux Demay MC, Vasmant D, et al. Pharmacokinetics of prednisolone in children. Study of a correlation with tolerability and therapeutic effect in nephrosis [in French]. Presse Med. 1988;17: 632-635
12. Rostin M, Barthe P, Houin G, et al. Pharmacokinetics of prednisolone in children with the nephrotic syndrome. Pediatr Nephrol. 1990;4:470-473
13. Frey BM, Frey FJ. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokinet. 1990;19:126-146
14. Bergmann TK, Barraclough KA, Lee KJ, et al. Clinical pharmacokinetics and pharmacodynamics of prednisolone and prednisone in solid organ transplantation. Clin Pharmacokinet. 2012;51:711-741
15. Bergrem HA, Bergrem H, Hartmann A, et al. Role of prednisolone pharmacokinetics in postchallenge glycemia after renal transplantation. Ther Drug Monit. 2008;30:583-590
16. Gatti G, Perucca E, Frigo GM, et al. Pharmacokinetics of prednisone and its metabolite prednisolone in children with nephrotic syndrome during the active phase and in remission. Br J Clin Pharmacol. 1984; 17:423-431
17. Teeninga N, Guan Z, Freijer J, et al. Monitoring prednisolone and prednisone in saliva: a population pharmacokinetic approach in healthy volunteers. Ther Drug Monit. 2013;35:485-492
18. Germann UA, Pastan I, Gottesman MM. P-glycoproteins: mediators of multidrug resistance. Semin Cell Biol. 1993;4:63-76
19. Renner E, Horber FF, Jost G, et al. Effect of liver function on the metabolism of prednisone and prednisolone in humans. Gastroenterology. 1986;90:819-828
20. Miura M, Satoh S, Inoue K, et al. Influence of CYP3A5, ABCB1 and NR1I2 polymorphisms on prednisolone pharmacokinetics in renal transplant recipients. Steroids. 2008;73:1052-1059
21. Rosenfeld JM, Vargas R Jr, Xie W, et al. Genetic profiling defines the xenobiotic gene network controlled by the nuclear receptor pregnane X receptor. Mol Endocrinol. 2003;17:1268-1282
22. Metalidis C, Naesens M, et al. The P450 oxidoreductase 28 SNP is associated with low initial tacrolimus exposure and increased dose requirements in CYP3A5-expressing renal recipients. Pharmacogenomics. 2011;12:1281-1291
23. Talma HSY, Bakker B, Hirasing R, et al. Growth Diagrams 2010: Manual for Measuring and Weighing Children and the Use of Growth Diagrams. Leiden, the Netherlands: TNO kwaliteit van leven; 2010
24. Poll EM, Kreitschmann-Andermahr I, Langejuergen Y, et al. Saliva collection method affects predictability of serum cortisol. Clin Chim Acta. 2007;382:15-19
25. Hansen AM, Garde AH, Persson R. Sources of biological and methodological variation in salivary cortisol and their impact on measurement among healthy adults: a review. Scand J Clin Lab Invest. 2008; 68:448-458
26. Ruiter AF, Teeninga N, Nauta J, et al. Determination of unbound prednisolone, prednisone and cortisol in human serum and saliva by on-line solid-phase extraction liquid chromatography tandem mass spectrometry and potential implications for drug monitoring of prednisolone and prednisone in saliva. Biomed Chromatogr. 2011;26:789-796
27. Elens L, Bouamar R, Hesselink DA, et al. The new CYP3A4 intron 6 C.T polymorphism (CYP3A4 22) is associated with an increased risk of delayed graft function and worse renal function in cyclosporinetreated kidney transplant patients. Pharmacogenet Genomics. 2012; 22:373-380
28. Bouamar R, Hesselink DA, van Schaik RH, et al. Polymorphisms in CYP3A5, CYP3A4, and ABCB1 are not associated with cyclosporine pharmacokinetics nor with cyclosporine clinical end points after renal transplantation. Ther Drug Monit. 2011;33:178-184
29. NONMEM Users Guides. San Francisco, CA: NONMEM Project Group, University of California; 1998
30. Post TM, Freijer JI, Ploeger BA, et al. Extensions to the visual predictive check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn. 2008;35:185-202
31. Wang C, Peeters MY, Allegaert K, et al. A bodyweight-dependent allometric exponent for scaling clearance across the human life-span. Pharm Res. 2012;29:1570-1581
32. Wu G. Sensitivity analysis of pharmacokinetic parameters in onecompartment models. Pharmacol Res. 2000;41:445-453
33. Vogt M, Derendorf H, Kramer J, et al. Biowaiver monographs for immediate release solid oral dosage forms: prednisone. J Pharm Sci. 2007;96: 1480-1489
34. Bergrem H, Grottum P, Rugstad HE. Pharmacokinetics and protein binding of prednisolone after oral and intravenous administration. Eur J Clin Pharmacol. 1983;24:415-419
35. Pickup ME, Lowe JR, Leatham PA, et al. Dose dependent pharmacokinetics of prednisolone. Eur J Clin Pharmacol. 1977;12:213-219
36. Rose JQ, Yurchak AM, Jusko WJ. Dose dependent pharmacokinetics of prednisone and prednisolone in man. J Pharmacokinet Biopharm. 1981; 9:389-417
37. Jusko WJ, Rose JQ. Monitoring prednisone and prednisolone. Ther Drug Monit. 1980;2:169-176
38. Vogeser M, Mohnle P, Briegel J. Free serum cortisol: quantification applying equilibrium dialysis or ultrafiltration and an automated immunoassay system. Clin Chem Lab Med. 2007;45:521-525
39. Pretorius CJ, Galligan JP, McWhinney BC, et al. Free cortisol method comparison: ultrafiltation, equilibrium dialysis, tracer dilution, tandem mass spectrometry and calculated free cortisol. Clin Chim Acta. 2011; 412:1043-1047
40. Ho JT, Al-Musalhi H, Chapman MJ, et al. Septic shock and sepsis: a comparison of total and free plasma cortisol levels. J Clin Endocrinol Metab. 2006;91:105-114
41. Petersen KB, Jusko WJ, Rasmussen M, et al. Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2003;51:465-473
42. Agutter PS, Wheatley DN. Metabolic scaling: consensus or controversy? Theor Biol Med Model. 2004;1:13
43. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303-332
44. Glazier DS. Beyond the "3/4-power law": variation in the intra-and interspecific scaling of metabolic rate in animals. Biol Rev Camb Philos Soc. 2005;80:611-662
45. West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science. 1997;276:122-126
46. Czock D, Keller F, Rasche FM, et al. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44:61-98
47. Lamberts SW, Huizenga AT, de Lange P, et al. Clinical aspects of glucocorticoid sensitivity. Steroids. 1996;61:157-160
48. Manenschijn L, van den Akker EL, Lamberts SW, et al. Clinical features associated with glucocorticoid receptor polymorphisms. An overview. Ann N Y Acad Sci. 2009;1179:179-198
49. Wasilewska A, Zalewski G, Chyczewski L, et al. MDR-1 gene polymorphisms and clinical course of steroid-responsive nephrotic syndrome in children. Pediatr Nephrol. 2007;22:44-51
50. Raju KS, Taneja I, Singh SP, et al. Utility of noninvasive biomatrices in pharmacokinetic studies. Biomed Chromatogr. 2013;27:1354-1366