| Abstract: | Ricart MJ, Oppenheimer F, Andrés A, Morales JM, Alonso Á, Fernández C, on behalf of the Epi‐trasplante Study, MIDATA Kidney–Pancreas Sub‐study Group. Enteric‐coated mycophenolate sodium in de novo and maintenance kidney–pancreas transplant recipients. Clin Transplant 2011 DOI: 10.1111/j.1399‐0012.2011.01526.x. © 2011 John Wiley & Sons A/S. 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. |
