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
Keywords:	acute rejection adverse events calcineurin inhibitor investigator‐initiated study long‐term follow‐up
Research affiliation:	Kiel University OceanRep > The Future Ocean - Cluster of Excellence
Refereed:	Yes
Open Access Journal?:	No
Publisher:	John Wiley & Sons: Blackwell Publishing
Projects:	Future Ocean
Date Deposited:	27 Feb 2017 08:54
Last Modified:	23 Sep 2019 19:55
URI:	https://oceanrep.geomar.de/id/eprint/36174

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