A MICROEMULSION OF CYCLOSPORINE WITHOUT INTRAVENOUS CYCLOSPORINE IN LIVER-TRANSPLANTATION

A microemulsion formulation of cyclosporine (CsA) has improved absorpt ion compared with the original form, The purpose of this case control study was to assess the safety and efficacy of the microemulsion witho ut intravenous CsA for induction immunosuppression in adult liver tran splantation, Twenty-one consecutive patients receiving induction immun osuppression with the microemulsion 15 mg/kg/day were compared with 20 patients receiving intravenous CsA and the original oral form, Both g roups received the same dose of methylprednisilone, Twenty of 21 patie nts receiving the microemulsion required no intravenous CsA to achieve target CsA levels, All patients receiving the original form received initial intravenous CsA. There was no difference in trough CsA levels between the two groups at 24 and 48 hours, The microemulsion group had 24 hr and 48 hr trough CsA levels of 227+/-15 and 520+/-300 ng/ml by monoclonal RIA while the intravenous CsA group had 24 and 48 hr trough levels of 293+/-18 and 405+/-91 ng/ml. CsA levels analyzed by HPLC we re 20% lower than by RIA. The frequency of adverse events resulting in reduction of drug dosage was similar for the microemulsion and the or iginal form: neurotoxicity (23 vs, 40%, P=.30); nephrotoxicity (25 vs, 45%, P=.32), and no patients required dialysis. There was no differen ce in septic complications, One patient required discontinuation of th e microemulsion in an attempt to reverse severe neurotoxicity, A total of 75% of microemulsion patients were rejection free at 3 months whil e only 35% of CsA patients remained rejection free (P=0.02). These dat a suggest that the use of the microemulsion without intravenous CsA in liver transplantation is safe and efficacious, and may result in decr eased episodes of acute rejection.