title: Enteric-coated mycophenolate sodium given in combination with tacrolimus has a lower incidence of serious infections in Asian renal-transplant recipients compared with mycophenolate mofetil.
abstract: OBJECTIVE
  To compare the characteristics of the enteric-coated formulation of mycophenolate sodium (EC-MPS, myfortic) and mycophenolate mofetil (MMF, CellCept) given in combination with tacrolimus in Asian renal-transplant recipients.
  
  
  METHODS
  In a 24-month, single-centre, randomized, open-label, prospective study, 101 live-donor kidney transplant recipients were randomized to the EC-MPS (n = 50) or MMF (n = 51) group. The incidence of infection, therapeutic effect and adverse events were monitored.
  
  
  RESULTS
  The incidences of infection were 40% and 49% for the EC-MPS and MMF groups, respectively (p = 0.362). However, serious infection was only observed in the MMF group (11.8%; p = 0.027). The incidences of gastro-intestinal adverse events (GI AEs) were 24% and 41.2% for EC-MPS and MMF, respectively (p = 0.066). However, serious diarrhoea only occurred in the MMF group (9.8%; p = 0.056). The trough level of FK 506 at the time of diarrhoea (13.22 ± 3.66 ng/ml) was significantly higher than the level within 1 month before (9.18 ± 1.12 ng/ml; p < 0.05) and 1 month after diarrhoea (9.13 ± 0.85 ng/ml; p < 0.05). The infection rate of patients with diarrhoea was significantly higher than those without diarrhoea (68%, 39%, p = 0.024). The serum creatinine level was 698 ± 60 μmol/l for EC-MPS and 673 ± 68 μmol/l for MMF from baseline (p > 0.05), and it decreased to 66 ± 6 μmol/l for EC-MPS and 69 ± 8 μmol/l for MMF at 24 months (p > 0.05). The incidences of biopsy proven acute rejection (BPAR) were 20% and 25.5% for EC-MPS and MMF, respectively (p = 0.511).
  
  
  CONCLUSIONS
  Enteric-coated formulation of mycophenolate sodium, given in combination with tacrolimus, has a lower incidence of serious infection in Asian renal-transplant recipients compared with MMF, and the therapeutic effect of EC-MPS is similar to MMF. The clinical trial registration number is ChiCTR-IPR-14005509. The registry name is 'Effect of Enteric-coated mycophenolate sodium on posttransplant infection rate after renal transplantation compared with Mycophenolate mofetil'.
authors.affiliation: Department of Organ Transplantation, Qilu Hospital of Shandong University, Jinan, Shandong, China.
authors.forename: J J
authors.initials: JJ
authors.lastname: Feng
authors.affiliation: Department of Organ Transplantation, Qilu Hospital of Shandong University, Jinan, Shandong, China.
authors.forename: L W
authors.initials: LW
authors.lastname: Zhang
authors.affiliation: Department of Organ Transplantation, Qilu Hospital of Shandong University, Jinan, Shandong, China.
authors.forename: P
authors.initials: P
authors.lastname: Zhao
authors.affiliation: Department of Surgery Transplantation, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: L M
authors.initials: LM
authors.lastname: Bow
authors.affiliation: Department of Organ Transplantation, Qilu Hospital of Shandong University, Jinan, Shandong, China.
authors.forename: J
authors.initials: J
authors.lastname: Tian
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002681:China / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004791:Enzyme Inhibitors / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage*; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000188:drug therapy* / Q000453:epidemiology; D013608:Tablets, Enteric-Coated; D016559:Tacrolimus / Q000008:administration & dosage*; D066027:Transplant Recipients
chemical_list: D004791:Enzyme Inhibitors; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid; D016559:Tacrolimus