| Autor: |
van Gelder, T., Hilbrands, L.B., Vanrenterghem, Y., Weimar, W., de Fijter, J.W. Hans, Squifflet, J.P., Hené, R.J., Verpooten, Gert A., Navarro, M.T., Hale, M.D., Nicholls, A.J., Hilbrands, LB, de Fijter, JW, Squifflet, JP, Hene, RJ, Verpooten, GA, Navarro, MT, Hale, MD, Nicholls, AJ |
| Jazyk: |
angličtina |
| Rok vydání: |
1999 |
| Předmět: |
|
| Zdroj: |
Transplantation |
| ISSN: |
0041-1337 |
| Popis: |
Background. Adding a fixed dose of 1 g b.i.d. of mycophenolate mofetil (MMF) to an immunosuppressive regimen consisting of cyclosporine and prednisone results in a 50% reduction in the incidence of acute rejection after kidney transplantation. This study was designed to investigate the relationship between pharmacokinetic data (mycophenolic acid area under the curve; MPA AUG) and the prevention of rejection after kidney transplantation. Methods. A total of 154 adult recipients of a primary or secondary cadaveric kidney graft were randomly allocated, in this double-blind trial, to receive MMF treatment aimed at three predefined target MPA AUC values (16.1, 32.2, and 60.6 mu g . hr/ml). During the first 6 months after transplantation, plasma samples for nine AUCs were collected. After analysis of the samples, a coded dose adjustment advice was generated using a Bayesian algorithm, maintaining the double blinding. Immunosuppressive therapy further consisted of cyclosporine and prednisone, The primary end point of this study was the occurrence of biopsy-proven acute rejection within the 6-month study period. Results. A total of 150 patients were eligible for analysis. Although after day 21, the mean MMF dose was reduced, the mean MPA AUC gradually increased and target MPA AUC values were exceeded in all three groups. The incidences of biopsy-proven acute rejection in the low, intermediate, and high target MPA AUC groups were 14 of 51 (27.5%), 7 of 47 (14.9%), and 6 of 52 (11.5%), respectively. The incidences of premature withdrawal from the study due to adverse events in the three groups were 4 of 51 (7.8%), 11 of 47 (23.4%), and 23 of 52 (44.2%), respectively. Logistic regression analysis showed a highly statistically significant relationship between median In(MPA AUG) and the occurrence of a biopsy-proven rejection (P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
