Using cyclosporine Neoral immediately after liver transplantation. United Kingdom Neoral Pilot Study Group

Cyclosporine Neoral was used as an alternative to intravenous Sandimmun in an open-label pilot study performed at five British liver transplant centres. Twenty primary orthotopic liver graft recipients received Neoral (5 mg/kg body weight bid via a nasogastric tube) together with azathioprine and glucocorticoids from the day of transplantation. None of the twenty patients required supplemental intravenous cyclosporine during follow-up (minimum 44 days). Cyclosporine blood levels (analyzed at a central laboratory using a specific fluorescence polarisation immunoassay) reached a mean trough value of 205 micrograms/L after the second Neoral dose. During the first postoperative week there was no significant difference between trough cyclosporine levels in patients with duct-to-duct (n = 14) or Roux-en-Y (n = 5) biliary drainage. Blood profiles showed a progressive increase in the rate and extent of cyclosporine absorption from days 1 to 3 to 5 (mean tmax 5.4, 2.7, and 2.3 h, respectively; mean area under the curve 1092, 1716, and 1758 micrograms/L.h per 100-mg dose, respectively). Acute rejection episodes occurred in 37% of cases within the first postoperative month and the early incidence of nephrotoxicity (16%) and neurotoxicity (37%) was unexceptional. Our preliminary data demonstrate that the 20 liver transplant recipients in this pilot study were safely and effectively managed without intravenous cyclosporine by administering Neoral from the day of transplantation.