Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results

Kramer, B. K., Montagnino, G., Kruger, B., Margreiter, R., Olbricht, C. J., Marcen, R., Sester, U., Kunzendorf, Ulrich, Dietl, K. H., Rigotti, P., Ronco, C., Horsch, S., Banas, B., Muhlbacher, F., Arias, M. and European Tacrolimus Versus, Ciclosp (2016) Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results Transplant International, 29 (3). pp. 307-314. DOI 10.1111/tri.12716.

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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.

Document Type: Article
Additional Information: Times Cited: 0 Kraemer, Bernhard K. Montagnino, Giuseppe Krueger, Bernd Margreiter, Raimund Olbricht, Christoph J. Marcen, Roberto Sester, Urban Kunzendorf, Ulrich Dietl, Karl-Heinz Rigotti, Paolo Ronco, Claudio Hoersch, Silke Banas, Bernhard Muehlbacher, Ferdinand Arias, Manuel
Research affiliation: OceanRep > The Future Ocean - Cluster of Excellence
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Refereed: Yes
DOI etc.: 10.1111/tri.12716
ISSN: 0934-0874
Projects: Future Ocean
Date Deposited: 27 Feb 2017 08:54
Last Modified: 27 Feb 2017 08:54
URI: http://eprints.uni-kiel.de/id/eprint/36174

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