The evaluation of enteric-coated mycophenolate sodium in cardiac deceased donor liver transplant patients in China

Abstract

Objective: The management of liver receivers requires intense immunosuppression to prevent graft rejection. Mycophenolate mofetil (MMF) is a common immunosuppressant but frequently suffer dose reduction for gastrointestinal adverse reactions (GI). Hence, the enteric-coated mycophenolate sodium (EC-MPS) is introduced as a substitute for MMF to reduce GI. The study was designed to investigate the efficacy, safety and exposure equation of EC-MPS in liver transplant patients in China.

Methods: Ninety-two liver receivers who administered EC-MPS or MMF as a primary immunosuppressant were enrolled in this single-center study and divided into MMF group and EC-MPC group, respectively. Efficacy and safety of EC-MPS were compared with MMF. The MPA exposure was measured at time 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12?h after mean 4.5 days of EC-MPS treatment. An equation of limited time points for estimating serum MPA exposure of EC-MPS was established using multiple stepwise regression model.

Results: Data show an interpatient variation in MPA AUC, C_max and T_max. After a first dose of EC-MPS, the mean value of serum AUC_0-12?h was 20.68 mg/L (SD 8.94, range 8.1–46.3). C_max was 9.7 mg/L (SD 6.48, range 2.7–16.3); T_max was 1.90?h (SD 0.97, range 0.5–4). The best equation for estimating the AUC was 6.0 1 4?+?0.946C₂?+?0.606C₃?+?1.154C₄?+?2.479C₆?+?5.07C₁₂. Comparing with MMF, EC-MPS not only effectively maintained immunosuppression, but also had similar incidences of infection, renal dysfunction and hematological disorders. However, EC-MPS markedly improved GI, the incidence of GI was half of the MMF group.

Conclusion: This analysis presented that EC-MPS is an effective and safe immunosuppressant as similar as MMF. The conversion of MMF to EC-MPS could be administered.