title: Does bioequivalence between modified cyclosporine formulations translate into equal outcomes?
abstract: Neoral was replaced with a generic cyclosporine formulation on our hospital formulary. We compared outcomes for de novo kidney transplant recipients who either received Gengraf (n=88) or Neoral (n=100) in a single-center, retrospective review. As compared to patients who received Neoral, patients who received Gengraf were significantly more likely to have an acute rejection episode (39% vs. 25%, P=0.04), more likely to have a second rejection episode (13% vs. 4%; P=0.03), or to have received an antibody preparation to treat acute rejection (19% vs. 8%; P=0.02). Patients treated with Gengraf had a higher degree of intrapatient variability for cyclosporine trough concentrations as determined by %CV (P<0.05). The incidence of acute rejection at 6 months posttransplant was significantly higher in patients who received Gengraf compared to Neoral. A larger, prospective analysis is warranted to compare these formulations of cyclosporine in de novo kidney transplant recipients.
authors.affiliation: School of Pharmacy, Wingate University, Wingate, NC, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Taber
authors.forename: G Mark
authors.initials: GM
authors.lastname: Baillie
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Ashcraft
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Rogers
authors.forename: Angello
authors.initials: A
authors.lastname: Lin
authors.forename: Fuad
authors.initials: F
authors.lastname: Afzal
authors.forename: Prabhakar
authors.initials: P
authors.lastname: Baliga
authors.forename: P R
authors.initials: PR
authors.lastname: Rajagopalan
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Chavin
mesh_terms: D001706:Biopsy; D002626:Chemistry, Pharmaceutical; D016572:Cyclosporine / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology* / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012189:Retrospective Studies; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine