Transplantation_i1000精选.pptVIP

* Goal of the Efficacy Limiting Toxicity Elimination (ELITE)- Symphony study was to assess whether a mycophenolate mofetil (MMF)-based regimen would permit lower doses of adjunct immunosuppressive agents (e.g., cyclosporine, tacrolimus, and sirolimus) yet still maintain an acceptable rate of acute rejection and a more favorable tolerability profile. Unlike other studies, this trial used low dose maintenance levels of these adjunct agents from the day of transplantation. * This is the study conclusion. Low dose tacrolimus therapy is a step forward in reducing the nephrotoxicity of these drugs. * Key point here is that unlike the SYMPHONY study where target tacrolimus trough levels were 6 ng/mL, in this study after 90 days tacrolimus was tapered to a trough level of 3 ng/mL. * As we have just seen in these previous studies and as concluded by Prof. Wallemacq, Univ. of St.-Luc, Brussels, Belgium at an Abbott sponsored Transplant Webcast in Nov. 2007, lower dosage therapies are now in use and will require clinical laboratories to reassess the methods they are using in the laboratory to ensure they can measure precisely these low blood levels of therapeutic drugs required for maintenance immunosuppression * We would like to review the highlights of the last IATDMCT 2007 meeting held in Nice, France in September. The recent developments in low dosage drug therapy have been recognized by experts in the field as an area of concern for TDM in the diagnostic laboratory. * Within their recommendations, the panel recognized the trend towards lower dosing and cited the SYMPHONY study as one example of the utilization of lower dose drug therapies for transplant recipients This recognized trend led to the panel’s recommendation for analytical methods with a LLOQ, or functional sensitivity, of 1 ng/mL. We are even seeing the need for this lower functional sensitivity here in the US today. We have polled laboratories across the country and found that anywhere from 20 – 50%