Enteric-coated mycophenolate sodium in de novo and maintenance kidney-pancreas transplant recipients.

ABSTRACT

BACKGROUND: Our objective was to describe efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in de novo and maintenance recipients of kidney-pancreas transplant in the clinical practice. METHODS: Observational, multicentre, prospective, 12-month study. RESULTS: We included 24 de novo and 24 maintenance patients. EC-MPS mean (± SD) doses at initiation in de novo patients were 1440 ± 0 vs. 1268 ± 263 mg/d at month 12 (M12). Patient and renal graft survival at one yr were 100%, and pancreatic graft survival was 83.3% (two losses owing to technical failure and two owing to rejection). In the maintenance cohort, EC-MPS was introduced at a median (P25-P75) of 30 (6-71) months after transplant. Baseline doses were 585 ± 310 vs. 704 ± 243 mg/d at M12. In this group, a significant increase in creatinine clearance was observed (65 ± 22 at baseline vs. 74 ± 20 mL/min at M12, p = 0.011). Patient, renal, and pancreatic graft survival were 100%, 95.8%, and 100%, respectively (one kidney graft loss owing to rejection). During follow-up, one patient from each group discontinued EC-MPS. CONCLUSIONS: The efficacy of EC-MPS in the clinical practice of kidney-pancreas transplantation is good, with high patient and grafts survival at 12 months, and good safety profile. The maintenance group displayed an improvement in renal function.