Vitko, S and Klinger, M and Salmela, K and Wlodarczyk, Z and Tyden, G and Senatorski, G and Ostrowski, M and Fauchald, P and Kokot, F and Stefoni, S and Perner, F and Claesson, K and Castagneto, M and Heemann, U and Carmellini, M and Squifflet, JP and Weber, M and Segoloni, G and Backman, L and Sperschneider, H and Kramer, BK (2005) Corticosteroid-free regimens - Tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil - in comparison with a standard triple regimen in renal transplantation: Results of the Atlas study. TRANSPLANTATION, 80 (12). pp. 1734-1741. ISSN 0041-1337, 1534-6080
Full text not available from this repository. (Request a copy)Abstract
Background. The side effects associated with corticosteroids have led to efforts to minimize their use in renal transplant patients. In this study we compared two corticosteroid-free tacrolimus-based regimens with a standard triple therapy. Methods. This was a 6-month, phase III, open-label, parallel-group, multicenter study. The total analysis set comprised 451 patients, randomized (1: 1: 1) to receive tacrolimus (Tac) monotherapy following basiliximab (Bas) administration (n = 153), Tac/mycophenolate mofetil (MMF) (n = 151), or, Tac/MMF/corticosteroids triple therapy as a control (n = 147). Results. The study was completed by 91.2% (triple therapy), 94.7% (Tac/MMF), and 82.4% (Bas/Tac) of patients. Patient baseline characteristics were similar in all groups. The incidences of biopsy-proven acute rejection were 8.2% (triple therapy), 30.5% (Tac/MMF), and 26.1% (Bas/Tac), p < 0.001 (multiple test for comparison with triple therapy); Bas/Tac vs. Tac/MMF, p=ns. The incidences of corticosteroid-resistant acute rejection were 2.0%, 4.0%, and 5.2%, p=ns. Graft survival (95.9%, 96.7%, and 94.7%, p=ns) and patient survival (100%, 99.3%, and 99.3%, p=ns) were similar in all groups. Median serum creatinine at month 6 was 123.0 mu mol/l, (triple therapy), 134.7 mu mol/L (Tac/MMF) and 135.8 mu mol/L (Bas/Tac). The overall safety profiles were similar; differences (p < 0.05) were reported for anaemia (24.5% vs. 12.6% vs. 14.5%), diarrhoea (12.9% vs. 17.9% vs. 5.9%), and leukopenia (7.5% vs. 18.5% vs. 5.9%) for the triple therapy, Tac/MMF, and Bas/Tac group, respectively. The incidences of new-onset diabetes mellitus were 4.6%, 7.1%, and 1.4%, respectively. Conclusion. Corticosteroid-free immunosuppression was feasible with the Bas/Tac and the Tac/MMF regimens. Both corticosteroid-free regimens were equally effective in preventing acute rejection, with the Bas/Tac therapy offering some safety benefits.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SOLID-ORGAN TRANSPLANTATION; ACUTE CELLULAR REJECTION; MYCOPHENOLATE-MOFETIL; STEROID WITHDRAWAL; FOLLOW-UP; CYCLOSPORINE MICROEMULSION; ALLOGRAFT RECIPIENTS; MONOCLONAL-ANTIBODY; RANDOMIZED-TRIAL; GRAFT LOSS; tacrolimus; basiliximab; corticosteroid withdrawal; mycophenolate mofetil; renal transplantation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Mar 2021 09:46 |
| Last Modified: | 04 Mar 2021 09:46 |
| URI: | https://pred.uni-regensburg.de/id/eprint/35305 |
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