Due to its behavior as a critical-dose drug, therapeutic monitoring to measure sirolimus concentrations by a LC/UV method may provide clinicians with a tool to optimize outcomes.

The present study evaluated whether the addition of sirolimus to a cyclosporine (CyA)/prednisone (Pred) regimen mitigated the greater proclivity to acute rejection episodes and graft loss characteristic of African-American renal transplant recipients. Using Kaplan-Meier and log-rank tests, African-American renal transplant recipients treated with either CyA/Pred (n = 90) or sirolimus/CyA/Pred (n = 47) were compared with 120 Caucasian patients treated with sirolimus/CyA/Pred for 2-year rates of patient and graft survival as well as acute rejection episodes. Mean laboratory values were compared using analysis of variance and F-tests. Addition of sirolimus to the CyA/Pred regimen reduced the incidence of acute rejection episodes in African-Americans from 43.3% to 19.2% (P = 0.004), a value similar to Caucasian patients. The 97.9% 2-year graft survival rate among 47 African-American patients treated with sirolimus/CyA/Pred was significantly higher than the 85.6% rate shown among the 90 CyA/Pred-treated African-American transplant recipients (P = 0.0479) and similar to that in Caucasians. The 95.7% patient survival rate among the African-American sirolimus/CyA/Pred group was similar to the 97.8% rate in the African-American CyA/Pred cohort. Interestingly, there was no evident toxicity from the addition of sirolimus. The addition of sirolimus to a CyA-based regimen reduced acute rejection episodes and graft loss experienced by African-American renal transplant recipients.

No abstract

The present study evaluated whether the addition of sirolimus to a cyclosporine (CyA)/prednisone (Pred) regimen mitigated the greater proclivity to acute rejection episodes and graft loss characteristic of African-American renal transplant recipients. Using Kaplan-Meier and log-rank tests, AfricanAmerican renal transplant recipients treated with either CyNPred ( n = 90) or sirolimus/CyA/Pred (n = 47) were compared with 120 Caucasian patients treated with sirolimus/CyA/Pred for 2-year rates of patient and graft survival as well as acute rejection episodes. Mean laboratory values were compared using analysis of variance and Ftests. Addition of sirolimus to the CyNPred regimen reduced the incidence of acute rejection episodes in African-Americans from 43.3 % to 19.2 % ( P = 0.004), a value similar to Caucasian patients. The 97.9 % 2-year graft survival rate among 47 African-American patients treated with sirolimuslCy A/Pred was significantly higher than the 85.6 % rate shown among the 90 CyA/Predtreated African-American transplant recipients ( P = 0.0479) and similar to that in Caucasians. The 95.7 % patient survival rate among the African-American sirolimus/ CyA/Pred group was similar to the 97.8 % rate in the African-American CyA/Pred cohort. Interestingly, there was no evident toxicity from the addition of sirolimus. The addition of sirolimus to a CyA-based regimen reduced acute rejection episodes and graft loss experienced by African-American renal transplant recipients.

No abstract