Sandimmun and Neoral treatment: pharmacokinetics and kidney function in paediatric and adolescent renal transplant
| Autor: | V.E De Nicolo, Mario Giordano, Fabrizio Palumbo, V Colella, M.T De Palma, D. A. Caringella |
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| Rok vydání: | 1998 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Urinary system Urology Cmax Renal function Administration Oral Kidney Function Tests chemistry.chemical_compound Pharmacokinetics Internal medicine medicine Humans Child Transplantation Creatinine business.industry Area under the curve Kidney Transplantation Endocrinology chemistry Intestinal Absorption Cyclosporine Trough level Surgery Emulsions Female business Immunosuppressive Agents |
| Zdroj: | Transplantation proceedings. 30(5) |
| ISSN: | 0041-1345 |
| Popis: | THE NEW microemulsion formulation of cyclosporine (CyA, Neoral) gives higher peak concentration and area under the curve (AUC) compared to the first marketed formulation (Sandimmune). Our aim was to study the pharmacokinetics and renal function of 10 (four girls, six boys) stable pediatric and adolescent renal transplant recipients during the conversion to the new formulation. CyA assays were performed by Abbot TDx analyser using a specific monoclonal antibody on whole blood. CyA concentrations were analysed by PKS software. Mann Whitney tests were performed. Absorption studies showed Sandimmune malabsorption: in fact, AUC was also significantly higher with Neoral than Sandimmune with significantly lower mean residence time (MRT) and higher t1/2 and Cmax (Table 1). There is a correlation between AUC and trough level (y 5 29.48x 1 713 r 5 0.68 P 5 .03) of CyA Neoral. Six months after the switch, creatinine clearance was improved in five patients, and decreased in only one patient who required a lower dose. Furthermore, we noticed an increased urinary creatinine excretion in 9 of 10 patients. In five of these nine patients the improvement was statistically significant (P 5 .002). In conclusion, the conversion of the original CyA (Sandimmune) to the microemulsion formulation (Neoral) was safe. Creatinine clearance increased in most of the patients, and this is probably related to a better absorption and an increase of the urinary excretion of creatinine in the patients. |
| Databáze: | OpenAIRE |
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