An open multicenter trial of conversion from sandimmun to neoral in stable kidney-transplant patients

Results obtained in organ transplantation have considerably improved with the introduction of Cyclosporine (CsA). However, the management of the drug in the sandimmun formulation is hampered by its low, highly variable bioavailability as well as the inter- and intrasubject variability of its pharmacokinetic parameters. The new galenic formulation of CsA, Neoral, based on the microemulsion principle, makes CsA absorption less dependent on gastric repletion, the presence of biliary salts and pancreatic enzymes, and concomitant administration of food. Digestive absorption and, subsequently, drug bioavailability are improved. Pharmacological studies in healthy volunteers and transplanted patients 1,2 have shown that pharmacokinetic profile of CsA becomes more reproducible from patient to patient as well as in the same patient over time. The aim of our study was to analyze the clinical outcome and the variations in the parameters of CsA monitoring after conversion from CsA-Sandimmun (SIM) to CsA-Neoral (NEO) in stable kidney recipients transplanted for more than 6 months.