AN OPEN-LABEL STUDY OF THE SAFETY AND TOLERABILITY OF CONVERTING STABLE LIVER-TRANSPLANT RECIPIENTS TO NEORAL

Neoral is a new formulation of cyclosporine based on microemulsion tec hnology, designed to provide increased and more reliable absorption of the medication. The aim of this study was to assess whether conversio n from Sandimmune to Neoral provides safe and effective oral immunosup pression in stable liver transplant recipients. We studied 59 stable l iver transplant recipients (being treated with prednisone, azathioprin e, and Sandimmune). All patients were enrolled in an open-label study in which they were converted from Sandimmune to Neoral therapy at a do se ratio of 1:1. Thirty-nine patients underwent duct-to-duct bile duct anastomoses, and 20 underwent Roux-en-Y bile duct anastomoses. After conversion, the Neoral dosage was adjusted on the basis of trough leve ls measured at weeks 1, 2, 3, 4, 6, 8, and 12. To assess safety and to lerability, we prospectively obtained serial information, including la boratory data and information on side effects. Standard statistical me thodology was used. A total of 59 patients (23 men, 36 women; mean age , 55 years; mean follow-up after liver transplantation, 5.7 years) com pleted 3 months of follow-up after conversion from Sandimmune to Neora l. There were 32 dosage changes; 22 (69%) required reduction of the Ne oral dose. Mean cyclosporine trough levels remained above 100 ng/mL du ring the follow-up period. There were no significant differences betwe en cyclosporine levels in patients with duct-to-duct or Roux-en-Y bile duct anastomoses. There were no episodes of rejection during the 3-mo nth follow-up period. The side effect profile was similar in both grou ps, except for a significant reduction in the number of patients with headaches after Neoral conversion. Liver transplant recipients can saf ely be converted from Sandimmune to Neoral. Neoral was well tolerated in this population. Copyright (C) 1998 by the American Association for the Study of Liver Diseases.