title: 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, Cmax and Tmax. After a first dose of EC-MPS, the mean value of serum AUC0-12 h was 20.68 mg/L (SD 8.94, range 8.1-46.3). Cmax was 9.7 mg/L (SD 6.48, range 2.7-16.3); Tmax 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: Zuoyi
authors.initials: Z
authors.lastname: Wang
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: J J
authors.initials: JJ
authors.lastname: He
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: X Y
authors.initials: XY
authors.lastname: Liu
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: Bingyi
authors.initials: B
authors.lastname: Lin
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhang
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: Lei
authors.initials: L
authors.lastname: Geng
authors.affiliation: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.
authors.forename: Shusen
authors.initials: S
authors.lastname: Zheng
mesh_terms: D000328:Adult; D002681:China / Q000453:epidemiology; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D006331:Heart Diseases / Q000401:mortality*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016031:Liver Transplantation / Q000009:adverse effects* / Q000639:trends; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D013608:Tablets, Enteric-Coated; D014019:Tissue Donors
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid
keywords: Donation after cardiac death; enteric-coated mycophenolate sodium; liver transplantation; mycophenolate mofetil