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Efficacy and safety of tacrolimus compared with ciclosporin A in renal transplantation: three-year observational results.
Authors:Bernhard K Kr?mer  Domingo Del Castillo  Raimund Margreiter  Heide Sperschneider  Christoph J Olbricht  Joaquín Ortu?o  Urban Sester  Ulrich Kunzendorf  Karl-Heinz Dietl  Vittorio Bonomini  Paolo Rigotti  Claudio Ronco  Jose M Tabernero  Manuel Rivero  Bernhard Banas  Ferdinand Mühlbacher  Manuel Arias  Giuseppe Montagnino
Affiliation:Klinik und Poliklinik für Innere Medizin II--Nephrologie, Klinikum der Universit?t Regensburg, Germany. bernhard.kraemer@klinik.uni-regensburg.de
Abstract:BACKGROUND: The European tacrolimus versus ciclosporin A microemulsion (CsA-ME) renal transplantation study showed that tacrolimus was significantly more effective in preventing acute rejection and had a superior cardiovascular risk profile at 6 months. METHODS: The endpoints of this investigator-initiated, observational, 36-month follow-up were acute rejection incidence rates, rates of patient and graft survival and renal function. An additional analysis was performed using the combined endpoints BPAR, graft loss and patient death. Data available from the original ITT population (557 patients; 286 tacrolimus and 271 CsA-ME) were analysed. RESULTS: A total of 231 tacrolimus and 217 CsA-ME patients participated. At 36 months, Kaplan-Meier-estimated BPAR-free survival rates were 78.8% in the tacrolimus group and 60.6% in the CsA-ME group, graft survival rates were 88.0% and 86.9% and patient survival rates were 96.6% and 96.7%, respectively. The estimated combined endpoint-free survival rate was 71.4% with tacrolimus and 55.4% with CsA-ME (P 6 mmol/L (26.3% versus 12.6%, P
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