Limited sampling strategies for the estimation of sirolimus daily exposure in kidney transplant recipients on a calcineurin inhibitor-Free Regimen

Journal of Clinical Pharmacology

Volumn 49, Issue 7, 2009, Pages 773-781

  Cattaneo, Dario ^a,b   Cortinovis, Monica ^b   Baldelli, Sara ^a,b   Gotti, Eliana ^b   Remuzzi, Giuseppe ^b   Perico, Norberto ^b  

^a UNIVERSITY OF MILAN   (Italy)

^b MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

Area under the concentration time curve; Kidney transplantation; Limited sampling strategies; Pharmacokinetics; Sirolimus; Therapeutic drug monitoring

Indexed keywords

ALEMTUZUMAB; BASILIXIMAB; CALCINEURIN INHIBITOR; CYCLOSPORIN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; THYMOCYTE ANTIBODY;

ADULT; AGED; ALGORITHM; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL PRACTICE; CONTROLLED STUDY; DRUG DISTRIBUTION; DRUG EXPOSURE; DRUG MONITORING; FEMALE; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MALE;

ADULT; AGED; CALCINEURIN; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MIDDLE AGED; MODELS, STATISTICAL; SIROLIMUS; TRANSPLANTATION;

EID: 67650478330     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009332811     Document Type: Article

References (30)

1. Saunders RN, Metcalfe MS, Nicholson ML Rapamycin in transplantation: a review of the evidence. Kidney Int. 2001 ; 59: 3-16. (Pubitemid 32055209)
2. Sehagal SN Sirolimus: its discovery, biological properties, and mechanisms of action. Transplant Proc. 2003 ; 35: 7S - 14S.
3. Sehgal SN, Molnar-Kimber K., Ocain TD, et al. Rapamycin: a novel immunosuppressive macrolide. Med Res Rev. 1994 ; 14: 1-22. (Pubitemid 24035973)
4. Lee VWS, Chapman JR Sirolimus: its role in nephrology. Nephrology. 2005 ; 10: 606.
5. Cattaneo D., Merlini S., Pellegrino M., et al. Therapeutic drug monitoring of sirolimus: effect of concomitant immunosuppressive therapy and optimization of drug dosing. Am J Transplant. 2004 ; 4: 1345-1351. (Pubitemid 39013583)
6. Napoli KL, Taylor PJ From beach to bedside: history of the development of sirolimus. Ther Drug Monit. 2001 ; 23: 559-586. (Pubitemid 32912281)
7. Meier-Kriesche HU, Kaplan B. Toxicity and efficacy of sirolimus: relationship to whole-blood concentrations. Clin Ther. 2000 ; 22: B93 - B100.
8. Kahan BD, Napoli KL, Kelly PA, et al. Therapeutic drug monitoring of sirolimus: correlations with efficacy and toxicity. Clin Transplant. 2000 ; 14: 97-109. (Pubitemid 30171208)
9. Dansirikul C., Duffull SB, Morris RG, et al. Relationships between sirolimus dosing, concentration and outcomes in renal transplant recipients. Br J Clin Pharmacol. 2005 ; 60: 560-565. (Pubitemid 41532457)
10. Kovarik JM, Kahan BD, Kaplan B., et al. Longitudinal assessment of everolimus in de novo renal transplant recipients over the first post-transplant year: pharmacokinetics, exposure-response relationships, and influence on cyclosporine. Clin Pharmacol Ther. 2001 ; 69: 48-56. (Pubitemid 32108671)
11. Kovarik JM, Kaplan B., Tedesco Silva H., et al. Exposure-response relationships for everolimus in de novo kidney transplantation: defining a therapeutic range. Transplantation. 2002 ; 73: 920-925. (Pubitemid 34252356)
12. Stenton SB, Partovi N., Ensom MH Sirolimus: the evidence for clinical pharmacokinetic monitoring. Clin Pharmacokinet. 2005 ; 44: 769-786. (Pubitemid 41126927)
13. Yatscoff RW, Boeckx R., Holt DW, et al. Consensus guidelines for therapeutic drug monitoring of rapamycin: report of the consensus panel. Ther Drug Monit. 1995 ; 17: 676-671.
14. Johnston A., Holt DW Immunosuppressant drug-the role of therapeutic drug monitoring. Br J Clin Pharmacol. 2001 ; 52: 61S - 73S. (Pubitemid 32823033)
15. Kelly P., Kahan BD Review: metabolism of immunosuppressant drugs. Curr Drug Metab. 2002 ; 3: 275-287. (Pubitemid 34625040)
16. Ting LSL, Villeneuve E., Ensom MHH. Beyond cyclosporine: a systematic review of limited sampling strategies for other immunosuppressants. Ther Drug Monit. 2006 ; 28: 419-430. (Pubitemid 44314932)
17. David OJ, Johnston A. Limited sampling strategies for estimating cyclosporin area under the concentration-time curve: review of current algorithms. Ther Drug Monit. 2001 ; 2: 100-108.
18. Kaplan B., Meier-Kriesche HU, Napoli K., Kahan BD A limited sampling strategy for estimating sirolimus area-under-the-concentration curve. Clin Chem. 1997 ; 43: 539-541.
19. Djebli N., Rousseau A., Hoizey G., et al. Sirolimus population pharmacokinetic/pharmacogenetic analysis and Bayesian modelling in kidney transplant recipients. Clin Pharmacokinet. 2006 ; 45: 1135-1148. (Pubitemid 44631392)
20. Noris M., Casiraghi F., Todeschini M., et al. Regulatory T cells and T cell depletion: role of immunosuppressive drugs. J Am Soc Nephrol. 2007 ; 18: 1007-1018. (Pubitemid 46434518)
21. Ruggenenti P., Codreanu I., Cravedi P., et al. Basiliximab combined with low-dose rabbit anti-human thymocyte globulin: a possible further step toward effective and minimally toxic T cell- targeted therapy in kidney transplantation. Clin J Am Soc Nephrol. 2006 ; 1: 546-551.
22. Ritschel WA Handbook of Basic Pharmacokinetics. 4 th ed. Hamilton, Ill: Drug Intelligence Publications ; 1992.
23. Cattaneo D., Perico N., Gaspari F. Assessment of sirolimus concentrations in whole blood by high-performance liquid chromatography with ultraviolet detection. J Chromatog B. 2002 ; 774: 187-194. (Pubitemid 34655490)
24. Holt DW Sirolimus International proficiency testing scheme. http://www.bioanalytics.uk. Accessed June 2008.
25. Wong KM, Shek CC, Chau KF, Li CS Abbreviated tacrolimus area-under-the-curve monitoring for renal transplant recipients. Am J Kidney Dis. 2000 ; 35: 660-666.
26. Bland JM, Altman DG Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 ; 1i: 307-310. (Pubitemid 16134762)
27. MacDonald A. A randomized trial of sirolimus, cyclosporine and prednisone vs cyclosporine and prednisone alone in recipients of mismatched first kidney grafts: results at one year. Transplantation. 1999 ; 67: S546 - S549.
28. Zimmerman JJ, Kahan BD Pharmacokinetics of sirolimus in stable renal transplant patients after multiple oral dose administration. J Clin Pharmacol. 1997 ; 37: 405-415. (Pubitemid 27215068)
29. Kuypers DR Immunosuppressive drug monitoring-what to use in clinical practice today to improve renal graft outcome. Transpl Int. 2005 ; 18: 140-146.
30. Geissler EK, Schlitt HJ, Thomas G. mTOR, cancer and transplantation. Am J Transplant. 2008 ; 8: 2212-2218.