Development and validation of limited sampling strategies for tacrolimus and mycophenolate in steroid-free renal transplant regimens

Therapeutic Drug Monitoring

Volumn 33, Issue 1, 2011, Pages 50-55

  Poulin, Eric ^a   Greanya, Erica D ^b   Partovi, Nilufar ^b   Shapiro, R Jean ^b   Al Khatib, Mai ^b   Ensom, Mary H H ^b  

^a VANCOUVER COASTAL HEALTH   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

immunosuppressive agents; limited sampling strategies; mycophenolic acid; pharmacokinetics; renal transplantation; steroid free; tacrolimus; therapeutic drug monitoring

Indexed keywords

CORTICOSTEROID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS;

ACCURACY; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; DRUG DOSE REGIMEN; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LIMITED DRUG SAMPLING STRATEGY; MALE; MULTIPLE REGRESSION; PREDICTION; PRIORITY JOURNAL; SAMPLING; STEADY STATE; VALIDATION STUDY;

ADULT; AGED; AREA UNDER CURVE; BLOOD SPECIMEN COLLECTION; CROSS-SECTIONAL STUDIES; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS; TACROLIMUS;

EID: 78751646010     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3182028b23     Document Type: Article

References (50)

1. Sinclair NR. Low-dose steroid therapy in cyclosporine-treated renal transplant recipients with well-functioning grafts. The Canadian Multi-centre Transplant Study Group. CMAJ. 1992;147:645-657.
2. Srinivas TR, Meier-Kriesche HU. Minimizing immunosuppression, an alternative approach to reducing side effects: objectives and interim result. Clin J Am Soc Nephrol. 2008;3(Suppl 2):S101-S116.
3. Ting LS, Villeneuve E, Ensom MH. Beyond cyclosporine: a systematic review of limited sampling strategies for other immunosuppressants. Ther Drug Monit. 2006;28:419-430.
4. Wong KM, Shek CC, Chau KF, et al. Abbreviated tacrolimus area-under-the-curve monitoring for renal transplant recipients. Am J Kidney Dis. 2000;35:660-666.
5. Armendariz Y, Pou L, Cantarell C, et al. Evaluation of a limited sampling strategy to estimate area under the curve of tacrolimus in adult renal transplant patients. Ther Drug Monit. 2005;27:431-434.
6. Chen YH, Zheng KL, Chen LZ, et al. Clinical pharmacokinetics of tacrolimus after the first oral administration in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients. Transplant Proc. 2005;37:4246-4250.
7. Op den Buijsch RA, van de Plas A, Stolk LM, et al. Evaluation of limited sampling strategies for tacrolimus. Eur J Clin Pharmacol. 2007;63: 1039-1044.
8. Cheung CY, van der Heijden J, Hoogtanders K, et al. Dried blood spot measurement: application in tacrolimus monitoring using limited sampling strategy and abbreviated AUC estimation. Transpl Int. 2008;21: 140-145.
9. Mendonza AE, Zahir H, Gohh RY, et al. Tacrolimus in diabetic kidney transplant recipients: pharmacokinetics and application of a limited sampling strategy. Ther Drug Monit. 2007;29:391-398.
10. Miura M, Satoh S, Niioka T, et al. Limited sampling strategy for simultaneous estimation of the area under the concentration-time curve of tacrolimus and mycophenolic acid in adult renal transplant recipients. Ther Drug Monit. 2008;30:52-59.
11. Pawinski T, Hale M, Korecka M, et al. Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem. 2002; 48:1497-1504.
12. Zicheng Y, Peijun Z, Da X, et al. Investigation on pharmacokinetics of mycophenolic acid in Chinese adult renal transplant patients. Br J Clin Pharmacol. 2006;62:446-452.
13. Fleming DH, Mathew BS, John GT, et al. A six-hour extrapolated sampling strategy for monitoring mycophenolic acid in renal transplant patients in the Indian subcontinent. J Postgrad Med. 2006;52: 248-252.
14. Jiao Z, Zhong JY, Zhang M, et al. Total and free mycophenolic acid and its 7-O-glucuronide metabolite in Chinese adult renal transplant patients: pharmacokinetics and application of limited sampling strategies. Eur J Clin Pharmacol. 2007;63:27-37.
15. Muller H, Solari S, Zuniga C, et al. Therapeutic drug monitoring of mycophenolic acid in kidney transplant patients: an abbreviated sampling strategy. Transplant Proc. 2007;39:596-599.
16. Zhou PJ, Xu D, Yu ZC, et al. Pharmacokinetics of mycophenolic acid and estimation of exposure using multiple linear regression equations in Chinese renal allograft recipients. Clin Pharmacokinet. 2007;46: 389-401.
17. Zicheng Y, Xianghui W, Peijun Z, et al. Evaluation of the practicability of limited sampling strategies for the estimation of mycophenolic acid exposure in Chinese adult renal recipients. Ther Drug Monit. 2007;29: 600-606.
18. Johnson AG, Rigby RJ, Taylor PJ, et al. The kinetics of mycophenolic acid and its glucuronide metabolite in adult kidney transplant recipients. Clin Pharmacol Ther. 1999;66:492-500.
19. Yeung S, Tong KL, Tsang WK, et al. Determination of mycophenolate area under the curve by limited sampling strategy. Transplant Proc. 2001; 33:1052-1053.
20. Le Guellec C, Buchler M, Giraudeau B, et al. Simultaneous estimation of cyclosporin and mycophenolic acid areas under the curve in stable renal transplant patients using a limited sampling strategy. Eur J Clin Pharmacol. 2002;57:805-811.
21. Cho EK, Han DJ, Kim SC, et al. Pharmacokinetic study of mycophenolic acid in Korean kidney transplant patients. J Clin Pharmacol. 2004;44: 743-750.
22. van Hest RM. Population-specific limited sampling strategies for therapeutic drug monitoring of mycophenolic acid. J Postgrad Med. 2006;52:244.
23. Premaud A, Le Meur Y, Debord J, et al. Maximum a posteriori Bayesian estimation of mycophenolic acid pharmacokinetics in renal transplant recipients at different postgrafting periods. Ther Drug Monit. 2005;27: 354-361.
24. Toda T, Watanabe H, Kurosawa N, et al. Limited sampling strategy for estimating area under the concentration curve for mycophenolic acid in renal transplant recipients with co-administration of tacrolimus. Jpn J Pharm Health Care Sci. 2004;30:1-7.
25. Teshima D, Maiguma T, Kaji H, et al. Estimation of the area under the curve for mycophenolic acid in adult renal transplant patients with concomitant tacrolimus using a limited sampling strategy. J Clin Pharm Ther. 2008;33:159-163.
26. Stoves J, Lindley EJ, Barnfield MC, et al. MDRD equation estimates of glomerular filtration rate in potential living kidney donors and renal transplant recipients with impaired graft function. Nephrol Dial Transplant. 2002;17:2036-2037.
27. Vancouver General Hospital Department of Pathology and Laboratory Medicine. Standard operating procedure: immunosuppressants by LC MSMS. Revised March 16, 2007;SOP 14768C 1-13.
28. Ting LS, Partovi N, Levy RD, et al. Pharmacokinetics of mycophenolic acid and its phenolic-glucuronide and ACYl glucuronide metabolites in stable thoracic transplant recipients. Ther Drug Monit. 2008;30:282-291.
29. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
30. Pawinski T, Durlik M, Szlaska I, et al. Comparison of mycophenolic acid pharmacokinetic parameters in kidney transplant patients within the first 3 months post-transplant. J Clin Pharm Ther. 2006;31:27-34.
31. Kuypers DRJ, Claes K, Evenepoel P, et al. Long-term changes in mycophenolic acid exposure in combination with tacrolimus and corticosteroids are dose dependent and not reflected by trough plasma concentration: a prospective study in 100 de novo renal allograft recipients. J Clin Pharmacol. 2003;43:866-880.
32. van Duijnhoven EM, Boots JM, Christiaans MH, et al. Increase in tacrolimus trough levels after steroid withdrawal. Transpl Int. 2003;16:721-725.
33. Anglicheau D, Flamant M, Schlageter MH, et al. Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation. Nephrol Dial Transplant. 2003;18:2409-2414.
34. Shimada T, Terada A, Yokogawa K, et al. Lowered blood concentration of tacrolimus and its recovery with changes in expression of CYP3A and P-glycoprotein after high-dose steroid therapy. Transplantation. 2002;74: 1419-1424.
35. Cattaneo D, Perico N, Gaspari F, et al. Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation. Kidney Int. 2002;62:1060-1067.
36. Soars MG, Petullo DM, Eckstein JA, et al. An assessment of UDP-glucuronosyltransferase induction using primary human hepatocytes. Drug Metab Dispos. 2004;32:140-148.
37. Kanou M, Usui T, Ueyama H, et al. Stimulation of transcriptional expression of human UDP-glucuronosyltransferase 1A1 by dexametha-sone. Mol Biol Rep. 2004;31:151-158.
38. Djebli N, Picard N, Rerolle JP, et al. Influence of the UGT2B7 promoter region and exon 2 polymorphisms and comedications on Acyl-MPAG production in vitro and in adult renal transplant patients. Pharmacogenet Genomics. 2007;17:321-330.
39. Nawrocki A, Korecka M, Solari S, et al. Mycophenolic acid. In: Burton ME, Shaw LM, Schentag JJ, et al, eds. Applied Pharmacokinetics & Pharmacodynamics. Principles of Therapeutic Drug Monitoring, 4th ed. Baltimore: Lippincott Williams & Wilkins; 2006:563-594.
40. Kuypers DRJ, Claes K, Evenepoel P, et al. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination therapy with mycophenolic acid and corticosteroids. Clin Pharmacokinet. 2004;43:741-762.
41. Balbontin FG, Kiberd B, Squires J, et al. Tacrolimus monitoring by simplified sparse sampling under the concentration time curve. Transplant Proc. 2003;35:2445-2448.
42. Scholten EM, Cremers SCLM, Schoemaker RC, et al. AUC-guided dosing of tacrolimus prevents progressive systemic overexposure in renal transplant recipients. Kidney Int. 2005;67:2440-2447.
43. Mardigyan V, Giannetti N, Cecere R, et al. Best single time points to predict the area-under-the-curve in long-term heart transplant patients taking mycophenolate mofetil in combination with cyclosporine or tacrolimus. J Heart Lung Transplant. 2005;24:1614-1618.
44. Keown P, Landsberg D, Halloran P, et al. A randomized, prospective multicenter pharmacoepidemiologic study of cyclosporine microemulsion in stable renal graft recipients. Transplantation. 1996;62:1744-1752.
45. Cantarovich M, Barkun JS, Tchervenkov JI, et al. Comparison of neoral dose monitoring with cyclosporine through levels versus 2-hr postdose levels in stable liver transplant patients. Transplantation. 1998;66: 1621-1627.
46. Cantarovich M, Besner JG, Barkun JS, et al. Two-hour cyclosporine level determination is the appropriate tool to monitor neoral therapy. Clin Transplant. 1998;12:243-249.
47. Mahalati K, Kahan BD. Pharmacological surrogates of allograft outcome. Ann Transplant. 2000;5:14-23.
48. Gaston RS, Kaplan B, Shah T, et al. Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: the Opticept trial. Am J Transplant. 2009;9:1607-1619.
49. Le Meur Y, Buchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant. 2007;11: 2496-2503.
50. Barraclough KA, Isbel NM, Staatz CE. Evaluation of the mycophenolic acid exposure estimation methods used in the APOMYGERE, FDCC, and Opticept trials. Transplantation. 2010;90:44-51.