title: Safety and tolerability of cyclosporine microemulsion versus cyclosporine: two-year data in primary renal allograft recipients: a report of the Neoral Study Group.
abstract: BACKGROUND
  The new microemulsion formulation of cyclosporine (CsA-ME) is more bioavailable than cyclosporine (CsA) in de novo renal transplant patients. Therefore, it was of interest to compare the safety profile of each formulation in such patients.
  
  
  METHODS
  In a multicenter, double-blind, parallel-group study, 101 renal transplant recipients were randomized after transplantation to receive either CsA (n=50) or CsA-ME (n=51) capsules twice daily for 2 years. Of these patients, 54 (CsA, n=26; CsA-ME, n=28) completed 1 year of the study and entered the second-year, double-blind extension. Initial dose at the time of transplantation was 5 mg/kg b.i.d.; doses were titrated to target trough levels.
  
  
  METHODS
  The mean (+/- SD) doses at the end of 2 years were 4.6 +/- 1.8 and 3.8 +/- 1.1 mg/kg per day for CsA- and CsA-ME-treated patients, respectively. The mean (+/- SD) CsA trough levels at end point were 187 +/- 63 and 210 +/- 95 ng/ml for CsA- and CsA-ME-treated patients, respectively. At least one adverse event was reported by 25/26 (96%) of CsA- and 27/28 (96%) of CsA-ME-treated patients. No patient discontinued the study because of adverse events. No deaths occurred during the study. Renal function, as measured by serum creatinine levels, and blood pressure were comparable over time in both treatment groups.
  
  
  CONCLUSIONS
  There was no significant difference in safety and tolerability between CsA- and CsA-ME-treated kidney recipients for 2 years after transplantation.
authors.affiliation: Department of Surgery, Indiana University, Indianapolis 46202, USA.
authors.forename: M D
authors.initials: MD
authors.lastname: Pescovitz
authors.forename: G
authors.initials: G
authors.lastname: Barone
authors.forename: M G
authors.initials: MG
authors.lastname: Choc
authors.forename: D E
authors.initials: DE
authors.lastname: Hricik
authors.forename: D S
authors.initials: DS
authors.lastname: Hwang
authors.forename: J H
authors.initials: JH
authors.lastname: Jin
authors.forename: J B
authors.initials: JB
authors.lastname: Klein
authors.forename: C L
authors.initials: CL
authors.lastname: Marsh
authors.forename: D I
authors.initials: DI
authors.lastname: Min
authors.forename: R
authors.initials: R
authors.lastname: Pollak
authors.forename: T L
authors.initials: TL
authors.lastname: Pruett
authors.forename: J B
authors.initials: JB
authors.lastname: Stinson
authors.forename: J S
authors.initials: JS
authors.lastname: Thompson
authors.forename: E
authors.initials: E
authors.lastname: Vasquez
authors.forename: T
authors.initials: T
authors.lastname: Waid
authors.forename: D G
authors.initials: DG
authors.lastname: Wombolt
authors.forename: R L
authors.initials: RL
authors.lastname: Wong
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D004655:Emulsions; D006801:Humans; D016030:Kidney Transplantation; D008875:Middle Aged
chemical_list: D004655:Emulsions; D016572:Cyclosporine