Kraemer, Bernhard K. and Klinger, Marian and Vitko, Stefan and Glyda, Maciej and Midtvedt, Karsten and Stefoni, Sergio and Citterio, Franco and Pietruck, Frank and Squifflet, Jean-Paul and Segoloni, Giuseppe and Krueger, Bernd and Sperschneider, Heide and Banas, Bernhard and Backman, Lars and Weber, Markus and Carmellini, Mario and Perner, Ferenc and Claesson, Kerstin and Marcinkowski, Wojciech and Ostrowski, Marek and Senatorski, Grzegorz and Nordstrom, Johan and Salmela, Kaija (2012) Tacrolimus-Based, Steroid-Free Regimens in Renal Transplantation: 3-Year Follow-Up of the ATLAS Trial. TRANSPLANTATION, 94 (5). pp. 492-498. ISSN 0041-1337, 1534-6080
Full text not available from this repository. (Request a copy)Abstract
Background. Long-term use of corticosteroids is associated with considerable morbidity, including cardiovascular and metabolic adverse effects. Methods. This study evaluated the long-term efficacy and safety of two steroid-free regimens compared with a triple immunosuppressive therapy in renal transplant recipients. This was a 3-year follow-up to a 6-month, open-label, randomized, multicenter study. Results. Data from 3 years were available for 421 (93.3%) of 451 patients in the original intent-to-treat population (143 tacrolimus/basiliximab [Tac/Bas], 139 tacrolimus/mycophenolate mofetil [Tac/MMF], and 139 tacrolimus/MMF/steroids [triple therapy]). In the time interval from 6 months to 3 years after transplantation, the incidence of biopsy-proven acute rejection was low and similar (Tac/Bas, 2.1%; Tac/MMF, 2.2%; triple therapy, 2.2%); Most rejection episodes occurred during the first 6 months of the study. Graft survival was high (Kaplan-Meier estimates: 92.7%, 92.5%, and 92.5%), as was patient survival (93.1%, 96.4%, and 97.0%). There were 10 graft losses (n=2, 4, and 4) and 12 patient deaths (n=5, 2, and 5). Renal function was well preserved throughout the study and similar between groups. There was a trend toward improved cardiovascular risk factors in the Tac/Bas group, including reduced total and low-density lipoprotein cholesterol and lower new-onset insulin use. There were no between-group differences in the incidence or type of adverse events. Conclusion. Higher rates of acute rejection early in treatment were seen with the steroid-free regimens, but this did not translate into poorer long-term outcomes, such as graft and patient survival and renal function. A trend for a more favorable cardiovascular risk profile was observed for steroid-free immunosuppression with Tac/Bas.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CORTICOSTEROID-FREE REGIMENS; STANDARD TRIPLE REGIMEN; LONG-TERM; MYCOPHENOLATE-MOFETIL; RHEUMATOID-ARTHRITIS; CYCLOSPORINE MICROEMULSION; KIDNEY-TRANSPLANTATION; FREE IMMUNOSUPPRESSION; RANDOMIZED-TRIAL; ADVERSE EVENTS; Tacrolimus; Renal transplant; Immunosuppression; Steroid; Long term |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Nephrologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 May 2020 05:30 |
| Last Modified: | 06 May 2020 05:30 |
| URI: | https://pred.uni-regensburg.de/id/eprint/18106 |
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