title: Clinical success of Neoral absorption profile.
abstract: We investigated the clinical benefits of cyclosporine microemulsion preconcentrate (CyA-MEPC; Neoral) in 16 de novo renal transplant recipients. The dose of CyA-MEPC was managed from AUC(0-4h), with serial target values of AUC(0-4h) at 5000-->4000-->3000-->2000 ng. hr/mL. The frequency of acute rejection episodes was 25%. The decreased renal function reached a low value of 12.5%, and creatinine was stable. Therefore, setting the target AUC(0-4h) value in the early phase at 5000 ng.hr/mL is an effective strategy to prevent acute rejection episodes. The single dose of Neoral given immediately after the renal transplant was 6 mg/kg (making a daily dose of 12 mg/kg). Thereafter, the dose-normalized AUC(0-4h) was set at a constant value to 4 weeks posttransplant. At week 4, the single dose was decreased to 4 mg/kg twice daily (a daily dose of 8 mg/kg). From these studies a daily dose of 12 mg/kg is suggested to be the appropriate amount for the first dose immediately after transplant. The renal biopsy performed at 6 months posttransplant showed neither cyclosporine-induced renal impairments, nor findings of chronic rejection, suggesting that 2000 ng.hr/mL is an appropriate target AUC(0-4h) value in the maintenance phase. These results suggest that it is possible to set the target value of C2 monitoring in the maintenance phase to a value slightly lower than that proposed from other studies.
authors.affiliation: Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya-city, Japan. uchida@minos.ocn.ne.jp
authors.forename: K
authors.initials: K
authors.lastname: Uchida
authors.forename: Y
authors.initials: Y
authors.lastname: Tominaga
authors.forename: T
authors.initials: T
authors.lastname: Haba
authors.forename: A
authors.initials: A
authors.lastname: Katayama
authors.forename: S
authors.initials: S
authors.lastname: Matsuoka
authors.forename: N
authors.initials: N
authors.lastname: Goto
authors.forename: T
authors.initials: T
authors.lastname: Ueki
authors.forename: T
authors.initials: T
authors.lastname: Kimata
authors.forename: A
authors.initials: A
authors.lastname: Takeda
authors.forename: K
authors.initials: K
authors.lastname: Morozumi
authors.forename: H
authors.initials: H
authors.lastname: Takagi
authors.forename: A
authors.initials: A
authors.lastname: Nakao
mesh_terms: D000328:Adult; D019540:Area Under Curve; D016572:Cyclosporine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D007408:Intestinal Absorption / Q000502:physiology*; D016030:Kidney Transplantation / Q000276:immunology* / Q000502:physiology; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011184:Postoperative Period; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid