title: Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results.
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.
authors.affiliation: Universitätsmedizin Mannheim, Vth Department of Medicine, Medical Faculty of the University of Heidelberg, Mannheim, Germany.
authors.forename: Bernhard K
authors.initials: BK
authors.lastname: Krämer
authors.affiliation: Division of Nephrology and Dialysis, Ospedale Maggiore di Milano IRCCS, Milano, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Montagnino
authors.affiliation: Universitätsmedizin Mannheim, Vth Department of Medicine, Medical Faculty of the University of Heidelberg, Mannheim, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Krüger
authors.affiliation: Landeskrankenhaus, University of Innsbruck, Innsbruck, Austria.
authors.forename: Raimund
authors.initials: R
authors.lastname: Margreiter
authors.affiliation: Katharinenhospital, Stuttgart, Germany.
authors.forename: Christoph J
authors.initials: CJ
authors.lastname: Olbricht
authors.affiliation: Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Roberto
authors.initials: R
authors.lastname: Marcen
authors.affiliation: Universitätsklinik des Saarlandes, Homburg, Germany.
authors.forename: Urban
authors.initials: U
authors.lastname: Sester
authors.affiliation: Klinik für Nephrologie, University of Kiel, Kiel, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kunzendorf
authors.affiliation: Universitätsklinik Münster, Münster, Germany.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Dietl
authors.affiliation: Universitá di Padova, Padua, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Rigotti
authors.affiliation: Universitá di Vicenza, Vicenza, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Ronco
authors.affiliation: Koehler eClinical GmbH, Freiburg, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Hörsch
authors.affiliation: Abteilung für Nephrologie, University of Regensburg, Regensburg, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Banas
authors.affiliation: Allgemeines Krankenhaus Wien, Medical University of Vienna, Austria.
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Mühlbacher
authors.affiliation: Hospital Marqués de Valdecilla, Santander, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Arias
mesh_terms: D006801:Humans; D016572:Cyclosporine / Q000627:therapeutic use; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation; D016559:Tacrolimus / Q000627:therapeutic use
chemical_list: D016572:Cyclosporine; D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: acute rejection; adverse events; calcineurin inhibitor; investigator-initiated study; long-term follow-up