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 technolo gy, designed to provide increased and more reliable absorption of the medic ation. The aim of this study was to assess whether conversion from Sandimmu ne to Neoral provides safe and effective oral immunosuppression in stable l iver transplant recipients. We studied 59 stable liver transplant recipient s (being treated with prednisone, azathioprine, and Sandimmune). All patien ts were enrolled in an open-label study in which they were converted from S andimmune to Neoral therapy at a dose ratio of 1:1. Thirty-nine patients un derwent 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 levels measured at weeks 1, 2, 3, 4, 6, 8, and 12. To asses s safety and tolerability, we prospectively obtained serial information, in cluding laboratory data and information on side effects. Standard statistic al methodology was used. A total of 59 patients (23 men, 36 women; mean age , 55 years; mean follow-up after liver transplantation, 5.7 years) complete d 3 months of follow-up after conversion from Sandimmune to Neoral. There w ere 32 dosage changes; 22 (69%) required reduction of the Neoral dose. Mean cyclosporine trough levels remained above 100 ng/mL during the follow-up p eriod. There were no significant differences between cyclosporine levels in patients with duct-to-duct or Roux-en-Y bile duct anastomoses. There were no episodes of rejection during the 3-month follow-up period. The side effe ct profile was similar in both groups, except for a significant reduction i n the number of patients with headaches after Neoral conversion. Liver tran splant recipients can safely 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.