CME on Transplantation is dedicated to online CME conferences, courses and presentations (slides with voice over) on transplantation, given by local and international experts. Its mission is to keep you up-to-date with the most recent developments on transplantation.
Presentation
"Optimal Monitoring of Neoral - What Do the Data Show?" Dr. Edward H. Cole (biography) English - 2004-02-17 - 43 minutes
(63 slides)
Summary : In this presentation Dr Cole presents the rationale for using C2 or 2-hour post-dose concentration monitoring with Neoral, the microemulsion formulation of cyclosporin A (CsA), and reviews the latest data available on the use of this protocol in de novo and stable kidney transplant recipients, with some data from liver transplantation studies. C2 levels of Neoral were found to correlate well with Cmax (1), which in turn determines drug exposure as measured by the area under the curve (AUC) of cyclosporin levels with time post-dose; and C2 levels of Neoral were shown to reach peak levels in humans at 1-2h post-dose, producing 70-96% calcineurin inhibition (2).
Prospective experience with de novo kidney transplant recipients using cyclosporin microemulsion: Dr Cole describes his experience at the Toronto General Hospital, where all new renal transplant recipients receiving Neoral from August 2000 onwards were monitored with C2 in order to optimize CsA exposure. Results from this and other studies such as MO2ART and CONCERTO are described in terms of rejection rate, renal function, C2 targets and approach to poor absorbers. The distinction is made between poor absorbers (C4 level is still low) and slow absorbers (C4 level is higher than C2).
In a study of 175 stable renal transplant recipients at the Toronto General Hospital, C2 monitoring in these (maintenance) patients was found to be useful in allowing accurate targeting of CsA exposure, and dose reductions in many overexposed patients led to improvements in renal function and blood pressure (3). Also, no acute rejections were observed in this study, with a mean follow-up of 2.5 years.
Outstanding issues in C2 monitoring include the need for more data to determine optimal target levels, the possible influence of co-medications on target levels, and the need for further studies looking at once daily dosing of Neoral with C2 monitoring and its effect on nephrotoxicity.
