Does bioequivalence between modified cyclosporine formulations translate into equal outcomes?

Transplantation. 2005 Dec 15;80(11):1633-5. doi: 10.1097/01.tp.0000188688.15639.03.

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.

Publication types

  • Comparative Study

MeSH terms

  • Biopsy
  • Chemistry, Pharmaceutical*
  • Cyclosporine / pharmacokinetics*
  • Cyclosporine / therapeutic use*
  • Female
  • Graft Rejection / epidemiology*
  • Graft Rejection / pathology
  • Humans
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Middle Aged
  • Reproducibility of Results
  • Retrospective Studies
  • Therapeutic Equivalency
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Cyclosporine