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 (AUC0–12) in SKPT patients with severe gastroparesis receiving mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS).

MATERIAL AND 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 AUC0–12 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 AUC0–12 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.

Keywords: Gastro-intestinal disorders, Pharmacokinetics, enteric-coated mycophenolate sodium, Mycophenolic Acid, Kidney Transplantation, Pancreas Transplantation