The pharmacokinetic features and therapeutic effects of two formulations of mycophenolate mofetil in renal transplant recipients at the early postoperative stage

Objective To compare the basic pharmacokinetic features of mycophenolic acid(MPA) in renal transplant recipients at the early postoperative stage when mycophenolate mofetil dispersible tablets(MMF-DT) or mycophenloate mofetil tablets(MMF-T) were administered,and to observe both therapeutic effects.Methods Thirty de novo renal transplant recipients were randomly divided into the MMF-DT group and MMF-T group.Both drugs were administered twice daily,1.5 g per day,initiating within 24 h posttransplantation.Peripheral vein blood samples were harvested right before drug administration and at 0.5,1,1.5,2,3,4,6,8,10,12 h after administration on day 7 and 14 posttransplant.The MPA concentration was monitored by high performance liquid chromatography.Maximum concentration(MPA-Cmax),time to Cmax(MPA-Tmax),and area under curve(MPA-AUC0-12 h) were compared,as well as renal graft function,acute rejection,and side effect rates.Results In the MMF-DT and MMF-T groups,MPA-Tmax were(1.27±0.88) and(1.27±0.68) h on day 7(P0.05),and(0.73±0.32) and(0.80±0.46) h on day 14(P0.05).MPA-Tmax was shorter on day 14 than that on day 7 in both groups(P0.05).MPA-Cmax were(12.10±5.00) and(12.20±5.60) ng/mL on day 7,and(15.40±6.36) and(12.80±6.36) ng/mL on day 14,with no in-group statistical difference in both groups(P0.05).MPA-AUC0-12 h were(31.90±15.62) and(31.50±12.88) mg· h·L-1 on day 7,(33.30±8.68) and(34.30±7.31) mg· h·L-1 on day 14.MPA-AUC0-12 h increased on day 14,but no statistical difference was found(P0.05).No significant difference was noted as compared serum creatinine levels in both groups.No acute rejection happened in both groups.Four patients in the MMF-DT group and 3 in the MMF-T group had side effects.Conclusions The basic pharmacokinetic features of MMF-DT and MMF-T and their therapeutic effects are not significantly different at early stage of renal transplantation.Therefore,it is safe and effective to use MMF-DT in renal transplant recipients at the early stage,and its long term efficacy and safety need further to study.