RISKS ASSOCIATED WITH CONVERSION OF STABLE PATIENTS AFTER LIVER-TRANSPLANTATION TO THE MICROEMULSION FORMULATION OF CYCLOSPORINE

Background. Neoral is a microemulsion formulation of cyclosporine that has a better pharmacokinetic profile than the standard formulation (S andimmune). To prove the safety of converting stable liver transplant patients from Sandimmune to Neoral, we conducted a prospective trial i nvolving 54 patients. Method. The average time from transplantation to conversion was 48.5 +/- 21.6 months. Thirty of 54 patients (55%) requ ired a dose reduction during the study for various reasons. Five of 30 patients had the first dose reduction because of increased levels of cyclosporine. Seven patients required more than one dose reduction. Re sults. Sixteen patients suffered serious adverse events. Six patients had a biopsy-proven rejection. Four of 6 patients had trough cyclospor ine levels within 20% of baseline value immediately before developing rejection. Conclusion. Converting patients from the standard formulati on to the microemulsion formulation of cyclosporine seems to expose st able patients to unnecessary risks.