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

Int J Clin Pract Suppl. 2015 May:(183):1-7. doi: 10.1111/ijcp.12660.

Abstract

Aims: 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'.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • China / epidemiology
  • Dose-Response Relationship, Drug
  • Enzyme Inhibitors / administration & dosage
  • Female
  • Follow-Up Studies
  • Graft Rejection / drug therapy*
  • Graft Rejection / epidemiology
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Incidence
  • Kidney Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage*
  • Prospective Studies
  • Surgical Wound Infection / drug therapy*
  • Surgical Wound Infection / epidemiology
  • Tablets, Enteric-Coated
  • Tacrolimus / administration & dosage*
  • Transplant Recipients*

Substances

  • Enzyme Inhibitors
  • Immunosuppressive Agents
  • Tablets, Enteric-Coated
  • Mycophenolic Acid
  • Tacrolimus

Associated data

  • ChiCTR/CHICTR-IPR-14005509