PMID: 8588239Dec 1, 1995Paper

Potential applications of therapeutic drug monitoring of sirolimus immunosuppression in clinical renal transplantation

Therapeutic Drug Monitoring
B D KahanK Napoli

Abstract

Sirolimus is a potent immunosuppressive agent with a novel mechanism of action. It inhibits the transduction of cytokine signals necessary for the proliferation and maturation of T cells. Because sirolimus blocks a broad spectrum of cytokine signals, it seems logical to use it as an adjunct to CsA-based immunosuppression. The high degree of synergy between these two agents, as suggested by the rigorous median-effect analysis, has been confirmed by a reduced rate of rejection episodes among human renal allograft recipients. However, Phase I studies document wide interindividual variation in the pharmacokinetic parameters of 26 stable renal transplant patients, thereby suggesting that optimal therapy may require monitoring of drug concentrations, which is a task that has been somewhat simplified by the good correlation of trough level to AUC. Development of a monoclonal antibody assay system may simplify the monitoring of drug concentrations further. Additional studies of sirolimus will be required to determine the therapeutic concentrations and ratios of sirolimus to CsA that provide optimal immunosuppression, and to assess the possibility of a steroid-free regimen.

Citations

Dec 1, 1996·Journal of Clinical Pharmacology·S E Hughes, S A Gruber
Feb 29, 2000·Clinical Biochemistry·D L DavisS J Soldin
Jun 24, 1998·Transplantation Proceedings·D A GerberA W Thomson
Sep 2, 1998·Transplantation Proceedings·M Bernabeu
Oct 10, 2001·Therapeutic Drug Monitoring·K L Napoli, P J Taylor
Mar 9, 2000·Transplantation·O ViklickýU Heemann
Jan 1, 1997·Drug Metabolism and Drug Interactions·D W Holt, A Johnston
Nov 24, 2007·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·S M Tsunoda, F T Aweeka
May 24, 2000·Clinical Therapeutics·D L Davis, S J Soldin
Jan 17, 2002·The Urologic Clinics of North America·P P Luke, M L Jordan
Oct 7, 2004·Journal of the American College of Cardiology·Ron WaksmanUNKNOWN Oral Rapamune to Inhibit Restenosis study
Jun 15, 1999·Journal of Cardiovascular Pharmacology·S E BurkeC D Wegner
Dec 14, 1999·Biopharmaceutics & Drug Disposition·P A KellyB D Kahan
Jun 11, 1999·Journal of the American Society of Nephrology : JASN·J F GummertR E Morris

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