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Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children

Authors


Mara Medeiros, MD, PhD, Laboratorio de Investigación en Nefrologia y Metabolismo Mineral, Hospital Infantil de México Federico Gómez, Dr. Marquez 162 Col. Doctores CP 06720, D.F., México
Tel.: 52289917 Ext 1135
Fax: 52555 57618974
E-mail: medeiro.mara@gmail.com

Abstract

Reyes H, Hernández AM, Valverde S, Cataneo A, Mendoza A, Barrera I, Ortíz L, García-Roca P, Lopéz-Martínez B, Castañeda-Hernández G, Medeiros M. Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children.
Pediatr Transplantation 2010: 14:746–752. © 2010 John Wiley & Sons A/S.

Abstract:  The aim of the study was to evaluate the efficacy and safety of the conversion of MMF to EC-MPS in pediatric renal transplant recipients. We included 12 patients with stable graft function who were receiving MMF treatment. In the first visit, a complete medical examination was performed, which included a GSRS, a nine-point pharmacokinetic profile, samples for renal, liver and hematological tests and evaluation of IMPDH2 gene expression. The patients were transferred to an equimolar dose of EC-MPS. Two wk later, a clinical evaluation and blood collection, as in the first visit were performed. There was no change in serum creatinine, leukocyte count, serum albumin, or transaminase levels, but we found a statistically significant reduction of hemoglobin after conversion (13.2 ± 1.6 g/dL with MMF vs. 12.5 ± 1.3 g/dL when receiving EC-MPS). The GSRS total mean score was 16 ± 12 with MMF vs. 8 ± 5 with EC-MPA (p < 0.05). There was no statistically significant difference between formulations in the gene expression of IMPDH 2, in the AUC0-12h or in Cmax. However, peak concentration occurred later with EC-MPS.

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