Conversion from Sandimmun (R) to Neoral (R) in pediatric kidney transplants.

Background. - The ciclosporin microemulsion formulation Neoral(R), which al lows a better absorption and a more regular pharmacokinetic profile, is pro posed for replacing the original formulation, Sandimmun(R). The present stu dy reports the results of conversion from Sandimmun(R) to Neoral(R) in chil dren with a kidney graft, a population for which information remains limite d. Methods and patients. - Twenty children, 2.5 to 10.5 years of age, who land a kidney graft with a stable renal function for between sir months to five years (m = 2.6) were the subjects of this study. The patients were switche d from Sandimmun(R) to Neoral(R) at the same dose, adjusted afterwards on a ciclosporin trough level. Results. - After sir months, the mean nose decreased from 9.1 mg/kg/d to 8. 4 mg/kg/d, ie., 12.5%. After one year, the mean dose was 7 mg mg/kg/d, ie., 28%. Of the 65% of patients who had a decreased dose, most of them had the highest dose of Sandimmun(R) at the start Mean serum creatinine levels sli ghtly increased from 85.6 to 89.5 mu mol/L after sir months (P = 0.03) None of the patients had a rejection crisis during the first sir months under N eoral(R) Blood pressure did not change significantly, hirsutism improved in two cases but increased or appeared in two cases as well. Gingival hypertr ophy increased or appeared in four cases. Discussion. - A decrease in the dose was decided on either to maintain the trough CsA blood level in the desired range or because of the appearance of a symptom suggesting a side effect of ciclosporine, especially the increas e of creatininemia. The trough level did not appear to be the best index fo r adapting the dose. Conclusion. - in stable pediatric kidney transplant recipients, the slr itc h from Sandimmun(R) to Neoral(R) provided a reduction in drug dosage in 65% of cases without an increase in adverse events. (C) 1999 Editions scientif iques et medicales Elsevier SAS.