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- Title
Cyclosporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation.
- Authors
Keown, Paul; Niese, Detlef; Group, on behalf of the International Sandimmun Neoral Study
- Abstract
Cyclosporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation. Background . The new oral microemulsion formulation of cyclosporine (Neoral® ) possesses superior pharmacokinetics to the conventional formulation, Sandimmun® (SIM), providing more complete and predictable absorption, and less pharmacokinetic variability. Methods. The safety and tolerability of Neoral® , together with the incidence of acute rejection episodes and graft survival, were compared to the conventional cyclosporine formulation, SIM, in a prospective, randomized, double-blind multicenter trial. A total of 167 patients who received a first or second cadaveric renal transplant in 21 participating centers in six countries were randomized equally to two treatment groups and followed for three months after transplantation. Outcomes were analyzed across treatment, center and regional groups. In addition, a nested pharmacokinetic study was performed in four of these centers throughout the period of follow-up. Results. No difference was detected between the safety or tolerability of the two formulations. Kidney function and other laboratory parameters remained comparable in Neoral® - and SIM-treated patients throughout the study. However, the number of patients experiencing acute rejection was significantly reduced for the Neoral group (44.2% vs. 60.5%; P = 0.044), and significantly fewer patients experienced multiple episodes of rejection (12.8% vs. 22.2%, P = 0.028). The proportion of patients free of rejection at three months was significantly higher in patients treated with Neoral® than in those receiving SIM (Kaplan-Meier estimated probability of remaining rejection-free at 3 months = 55% for the Neoral® group, compared with 39% for the SIM group, P = 0.046, log rank test). Similar results were obtained when acute...
- Subjects
UNITED States; CYCLOSPORINE; KIDNEY transplantation
- Publication
Kidney International, 1998, Vol 54, Issue 3, p938
- ISSN
0085-2538
- Publication type
Article
- DOI
10.1046/j.1523-1755.1998.00042.x