Kraemer, Bernhard K. and Montagnino, Giuseppe and Krueger, Bernd and Margreiter, Raimund and Olbricht, Christoph J. and Marcen, Roberto and Sester, Urban and Kunzendorf, Ulrich and Dietl, Karl-Heinz and Rigotti, Paolo and Ronco, Claudio and Hoersch, Silke and Banas, Bernhard and Muehlbacher, Ferdinand and Arias, Manuel (2016) Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results. TRANSPLANT INTERNATIONAL, 29 (3). pp. 307-314. ISSN 0934-0874, 1432-2277
Full text not available from this repository. (Request a copy)Abstract
The European Tacrolimus versus Ciclosporin-A Microemulsion (CsA-ME) Renal Transplantation Study demonstrated that tacrolimus decreased acute rejection rates at 6 months. Primary endpoints of this investigator-initiated, observational 7-year follow-up study were acute rejection rates, patient and graft survival rates, and a composite endpoint (BPAR, graft loss, and patient death). We analyzed data from the original intent-to-treat population (n = 557; 286 tacrolimus, 271 CsA-ME). A total of 237 tacrolimus and 208 CsA-ME patients provided data. At 7 years, Kaplan-Meier estimated rates of patients free from BPAR were 77.1% in the tacrolimus arm and 59.9% in the CsA-ME arm, graft survival rates amounted to 82.6% and 80.6%, and patient survival rates to 89.9% and 88.1%. Estimated combined endpoint-free survival rates were 60.2% in the tacrolimus arm and 47.0% in the CsA-ME arm (P = <0.0001). A higher number of patients from the CsA-ME arm crossed over to tacrolimus during 7 year follow-up: 19.7% vs. 7.9% (P = <0.002). More patients in the tacrolimus group stopped steroids and received immunosuppressive monotherapy. Significantly, more CsA-ME patients received lipid-lowering medication and experienced cosmetic and cardiovascular adverse events. Tacrolimus-treated renal transplant recipients had significantly higher combined endpoint-free survival rates mainly driven by lower acute rejection rates despite less immunosuppressive medication at 7 years.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | STEROID WITHDRAWAL; FOLLOW-UP; KIDNEY-TRANSPLANTATION; CALCINEURIN INHIBITOR; RANDOMIZED-TRIAL; MYCOPHENOLATE-MOFETIL; GRAFT-SURVIVAL; MICROEMULSION; METAANALYSIS; RECIPIENTS; acute rejection; adverse events; calcineurin inhibitor; investigator-initiated study; long-term follow-up |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Nephrologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 12 Mar 2019 08:28 |
| Last Modified: | 12 Mar 2019 08:28 |
| URI: | https://pred.uni-regensburg.de/id/eprint/2369 |
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