Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation

• Verfasst von: Krämer, Bernhard [VerfasserIn]
• Verfasst von: Krüger, Bernd [VerfasserIn]
• Titel: Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation
• Titelzusatz: 7-year observational results
• Verf.angabe: 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
• Jahr: 2016
• Jahr des Originals: 2015
• Umfang: 8 S.
• Fussnoten: Gesehen am 04.03.2019 ; Published online: 11 December 2015
• Titel Quelle: Enthalten in: Transplant international
• Ort Quelle: Lausanne : Frontiers Media, 1988
• Jahr Quelle: 2016
• Band/Heft Quelle: 29(2016), 3, Seite 307-314
• ISSN Quelle: 1432-2277
• DOI: doi:10.1111/tri.12716
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: adverse events
• Sach-SW: acute rejection
• Sach-SW: calcineurin inhibitor
• Sach-SW: investigator-initiated study
• Sach-SW: long-term follow-up
• K10plus-PPN: 1588311961

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.