Does Bioequivalence Between Modified Cyclosporine Formulations Translate into Equal Outcomes?

Autor: Taber, David J., Baillie, G Mark, Ashcraft, Elizabeth E., Rogers, Jeffrey, Lin, Angello, Afzal, Fuad, Baliga, Prabhakar, Rajagopalan, P R., Chavin, Kenneth D.
Zdroj: Transplantation; December 2005, Vol. 80 Issue: 11 p1633-1635, 3p
Abstrakt: 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 (n88) or Neoral (n100) 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%, P0.04), more likely to have a second rejection episode (13% vs. 4%; P0.03), or to have received an antibody preparation to treat acute rejection (19% vs. 8%; P0.02). 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.
Databáze: Supplemental Index