Tacrolimus-based, steroid-free regimens in renal transplantation

• Verfasst von: Krämer, Bernhard [VerfasserIn]
• Verfasst von: Krüger, Bernd [VerfasserIn]
• Titel: Tacrolimus-based, steroid-free regimens in renal transplantation
• Titelzusatz: 3-year follow-up of the ATLAS trial
• Verf.angabe: Bernhard K. Krämer, Marian Klinger, Štefan Vítko, Maciej Glyda, Karsten Midtvedt, Sergio Stefoni, Franco Citterio, Frank Pietruck, Jean-Paul Squifflet, Giuseppe Segoloni, Bernd Krüger, Heide Sperschneider, Bernhard Banas, Lars Bäckman, Markus Weber, Mario Carmellini, Ferenc Perner, Kerstin Claesson, Wojciech Marcinkowski, Marek Ostrowski, Grzegorz Senatorski, Johan Nordström, and Kaija Salmela
• E-Jahr: 2012
• Jahr: September 15, 2012
• Umfang: 7 S.
• Fussnoten: Gesehen am 06.11.2018
• Titel Quelle: Enthalten in: Transplantation
• Ort Quelle: Hagerstown, Md. : Lippincott Williams & Wilkins, 1963
• Jahr Quelle: 2012
• Band/Heft Quelle: 94(2012), 5, Seite 492-498
• ISSN Quelle: 1534-6080
• DOI: doi:10.1097/TP.0b013e31825c1d6c
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1582613621

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.