Neoral induction in pediatric renal transplantation
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Transplantation Original article
Neoral induction in pediatric renal transplantation Timothy E. Bunchman, Rulan S. Parekh, Joseph T. Flynn, William E. Smoyer, David B. Kershaw, Rudolph P. Valentini, Brenda J. Pontillo, Jill Sandvordenker, Catherine Brown, and Aileen B. Sedman Division of Pediatric Nephrology, University of Michigan, Michigan, USA Received August 21, 1996; received in revised form June 27, 1997; accepted June 30, 1997
Abstract. Neoral was instituted in pediatric renal transplant patients with the hypothesis it would have more predictable kinetics than Sandimmun. However, significant questions have arisen concerning potential toxicity and dosing interval related to its rapid absorption with subsequent high initial peak. This is compounded by the fact that children appear to metabolize cyclosporine at a greater rate than adults. This combination of a rapid peak and rapid absorption may then result in lower trough levels at 12 h. We compared the trough cyclosporine levels of nine children who received Neoral with nine who received Sandimmun at the time of initial transplantation. More frequent dosing (every 8 h) was required in the Neoral population compared with the Sandimmun population for the 1st month in order to obtain comparable trough levels. Beyond the initial 4±6 weeks, trough levels were similar for Neoral and Sandimmun. Whereas 1-month creatinine levels and blood pressures were similar, the number of blood pressure medications was significantly higher in the Neoral group. At 5.5 + 1.1 months' followup, a single patient in the current Neoral group and in the retrospective Sandimmun group each experienced a single OKT3 allograft-treated rejection. We suggest that the area under the curve is different in Neoral than Sandimmun, and the initial dosing frequency may need to be adjusted accordingly. Key words: Pediatric kidney transplantation ± Neoral ± Sandimmun
Introduction Transplantation has become common practice in the pediatric patient with end-stage renal disease (ESRD). Evaluation of immunosuppression protocol demonstrates that
cyclosporine (CSA) has been an important medication for both induction and stability of treatment for renal transplantation. Prior to 1996, the available form of CSA was Sandimmun. Since the introduction of Sandimmun, allograft survival has improved compared with historical controls pre CSA [1, 2]. It has been evident over the last decade that, depending upon the age of the patients, the kinetics of the metabolism of Sandimmun varies [3, 4]: the younger the patient the more rapidly Sandimmun is metabolized [2±4]. In order to obtain target trough levels of CSA, one may increase the dose or change the dosing frequency. Increasing the dose of Sandimmun results in a higher peak concentration level. By shortening the dosing interval one may obtain lower peak levels, although a higher total daily dose of CSA may be prescribed. Data from the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS) have demonstrated that higher Sandimmun dosing has a positive
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