Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: one year observational results

Kraemer, Bernhard K. and Klinger, Marian and Wlodarczyk, Zbigniew and Ostrowski, Marek and Midvedt, 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 Baeckman, Lars and Weber, Markus and Carmellini, Mario and Perner, Ferenc and Claesson, Kerstin and Marcinkowski, Wojciech and Vitko, Stefan and Senatorski, Grzegorz and Salmela, Kaija and Nordstrom, Johan (2010) Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: one year observational results. CLINICAL TRANSPLANTATION, 24 (1). E1-E9. ISSN 0902-0063, 1399-0012

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Abstract

Side effects of steroid use have led to efforts to minimize their use in transplantation. Two corticosteroid-free regimens were compared with a triple immunosuppressive therapy. Data from the original intent-to-treat (ITT) population (153 tacrolimus/basiliximab [Tac/Bas], 151 tacrolimus/MMF [Tac/MMF], and 147 tacrolimus/ MMF/steroids [control]) were analyzed in a 12-month follow-up. Percentage of graft survival were 92.8%, 95.4%, and 95.9% ( KM estimates 89.9%, 95.3%, 95.9%), percentage of surviving patients were 98.7%, 98.0%, and 100% ( KM estimates 95.9%, 92.8%, and 100%). During months 7-12, graft loss occurred in 3 Tac/Bas, 2 Tac/MMF, and zero control patients, patient deaths in 1 Tac/Bas, 2 Tac/MMF, and zero control, and biopsy-proven acute rejection episodes in 4 Tac/Bas, 3 Tac/MMF, and zero control. Mean serum creatinine at month 12 was 141.9 +/- 69.6 mu M, 144.0 +/- 82.1 mu M, and 134.5 +/- 71.2 mu M (ns). New-onset insulin use in previously non-diabetic patients at month 12 was 1/138, 6/127, and 4/126. Patient and graft survival as well as renal function at 12 months were not different between patient groups, despite considerably higher rates of acute rejection occurring within the first six months after transplantation in both steroid-free patient groups. Tac/Bas therapy might offer benefits in terms of a trend for a more favorable cardiovascular risk profile.

Item Type: Article
Uncontrolled Keywords: SOLID-ORGAN TRANSPLANTATION; MYCOPHENOLATE-MOFETIL; STEROID WITHDRAWAL; RANDOMIZED-TRIAL; ALLOGRAFT REJECTION; LONG-TERM; FOLLOW-UP; TACROLIMUS/MYCOPHENOLATE MOFETIL; KIDNEY-TRANSPLANTATION; FREE IMMUNOSUPPRESSION; basiliximab; corticosteroid withdrawal; mycophenolate mofetil; renal transplantation; tacrolimus
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Zentren des Universitätsklinikums Regensburg > Transplantationszentrum
Depositing User: Dr. Gernot Deinzer
Date Deposited: 17 Aug 2020 05:46
Last Modified: 17 Aug 2020 05:46
URI: https://pred.uni-regensburg.de/id/eprint/25417

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