Comparison of the exposure of mycophenolate mofetil and enteric-coated mycophenolate sodium in recipients of kidney-pancreas transplantation

Ann Transplant. 2014 Feb 10:19:76-81. doi: 10.12659/AOT.889691.

Abstract

Background: Patients with a simultaneous pancreas-kidney transplant (SPKT), especially those with gastroparesis, often have gastro-intestinal (GI) disorders that can modify immunosuppressant pharmacokinetics. We compared the MPA 12-hours area under the curve (AUC(0-12)) in SKPT patients with severe gastroparesis receiving mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS).

Material/methods: Fifteen SKPT patients having a severe gastroparesis were switched, at 182 (69-1523) days post-transplantation, from MMF to EC-MPS because of GI disorders. MPA AUC(0-12) values were obtained before and after the switch, ie, under MMF (500 mg b.i.d.) at 169 (51-1522) days post-transplantation and EC-MPS (360 mg b.i.d.) at 102 (26-355) days after the switch.

Results: Mean MPA AUC(0-12) h did not differ significantly under MMF and EC-MPS, ie, 40.13±14 and 38.24±15.5 mg*h/L, respectively. Trough and maximal MPA concentrations were similar with both MPA formulations. Although all patients had GI disorders under MMF (100%), only 3 had persistent GI disorders under EC-MPS (20%) (p<0.001).

Conclusions: In SKPT patients with severe gastroparesis, exposure to MPA is similar under MMF and EC-MPS. However, the incidence of GI disorders is significantly lower when patients are given EC-MPS.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Diabetes Mellitus, Type 1 / surgery
  • Diabetes Mellitus, Type 2 / surgery
  • Diabetic Nephropathies / surgery
  • Female
  • Follow-Up Studies
  • Gastroparesis / drug therapy
  • Graft Rejection / drug therapy
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacokinetics*
  • Kidney Transplantation*
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / pharmacokinetics
  • Pancreas Transplantation*
  • Retrospective Studies
  • Tablets, Enteric-Coated / administration & dosage
  • Tablets, Enteric-Coated / pharmacokinetics*
  • Young Adult

Substances

  • Immunosuppressive Agents
  • Tablets, Enteric-Coated
  • Mycophenolic Acid