Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children.
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.
Reyes
H
H
Laboratorio de Farmacología, Hospital Infantil de México Federico Gómez, México D.F., México.
Hernández
A M
AM
Valverde
S
S
Cataneo
A
A
Mendoza
A
A
Barrera
I
I
Ortíz
L
L
García-Roca
P
P
Lopéz-Martínez
B
B
Castañeda-Hernández
G
G
Medeiros
M
M
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
D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid