title: Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children.
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 AUC(0-12h) or in C(max). However, peak concentration occurred later with EC-MPS.
authors.affiliation: Laboratorio de Farmacología, Hospital Infantil de México Federico Gómez, México D.F., México.
authors.forename: H
authors.initials: H
authors.lastname: Reyes
authors.forename: A M
authors.initials: AM
authors.lastname: Hernández
authors.forename: S
authors.initials: S
authors.lastname: Valverde
authors.forename: A
authors.initials: A
authors.lastname: Cataneo
authors.forename: A
authors.initials: A
authors.lastname: Mendoza
authors.forename: I
authors.initials: I
authors.lastname: Barrera
authors.forename: L
authors.initials: L
authors.lastname: Ortíz
authors.forename: P
authors.initials: P
authors.lastname: García-Roca
authors.forename: B
authors.initials: B
authors.lastname: Lopéz-Martínez
authors.forename: G
authors.initials: G
authors.lastname: Castañeda-Hernández
authors.forename: M
authors.initials: M
authors.lastname: Medeiros
mesh_terms: D000293:Adolescent; D019540:Area Under Curve; D002648:Child; D057915:Drug Substitution; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D011446:Prospective Studies; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid