Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results
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 gra...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2016
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| In: |
Transplant international
Year: 2015, Volume: 29, Issue: 3, Pages: 307-314 |
| ISSN: | 1432-2277 |
| DOI: | 10.1111/tri.12716 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1111/tri.12716 Verlag, Volltext: https://onlinelibrary-wiley-com.ezproxy.medma.uni-heidelberg.de/doi/abs/10.1111/tri.12716 
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| Author Notes: | Bernhard K. Krämer, Giuseppe Montagnino, Bernd Krüger, Raimund Margreiter, Christoph J. Olbricht, Roberto Marcen, Urban Sester, Ulrich Kunzendorf, Karl-Heinz Dietl, Paolo Rigotti, Claudio Ronco, Silke Hörsch, Bernhard Banas, Ferdinand Mühlbacher and Manuel Arias for the European Tacrolimus versus Ciclosporin Microemulsion Renal Transplantation Study Group |
MARC
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| 245 | 1 | 0 | |a Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation |b 7-year observational results |c Bernhard K. Krämer, Giuseppe Montagnino, Bernd Krüger, Raimund Margreiter, Christoph J. Olbricht, Roberto Marcen, Urban Sester, Ulrich Kunzendorf, Karl-Heinz Dietl, Paolo Rigotti, Claudio Ronco, Silke Hörsch, Bernhard Banas, Ferdinand Mühlbacher and Manuel Arias for the European Tacrolimus versus Ciclosporin Microemulsion Renal Transplantation Study Group |
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| 520 | |a 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. | ||
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