NDT Advance Access originally published online on February 7, 2008
Nephrology Dialysis Transplantation 2008 23(7):2386-2392; doi:10.1093/ndt/gfn004
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Efficacy and safety of tacrolimus compared with ciclosporin A in renal transplantation: three-year observational results
1 Klinik und Poliklinik für Innere Medizin II—Nephrologie, University of Regensburg, Germany 2 Hospital Reina Sofía, Córdoba, Spain 3 Landeskrankenhaus, University of Innsbruck, Austria 4 KfH Nierenzentrum, Jena 5 Katharinenhospital, Stuttgart, Germany 6 Hospital Ramón y Cajal, Madrid, Spain 7 Universitätsklinik des Saarlandes, Homburg 8 Med. Klinik IV, University of Erlangen 9 Universitätsklinik Münster, Germany 10 Universitá di Bologna 11 Universitá di Padova 12 Universitá di Vicenza, Italy 13 Hospital Clínico Universitario, Salamanca 14 Hospital Puerta del Mar, Cádiz, Spain 15 Allgemeines Krankenhaus Wien, University of Wien, Austria 16 Hospital Marqués de Valdecilla, Santander, Spain 17 Division of Nephrology and Dialysis, Ospedale Maggiore di Milano IRCCS, Milano, Italy
Correspondence and offprint requests to: Bernhard Krämer, Klinik und Poliklinik für Innere Medizin II—Nephrologie, Klinikum der Universität Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany. Tel: +49-941-9447301; Fax: +49-941-9447302; E-mail: bernhard.kraemer{at}klinik.uni-regensburg.de
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Abstract |
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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 
0.001, chi-square test). Significantly more CsA-ME patients crossed over to tacrolimus during the 3-year follow-up: 21.2% versus 2.6%, P 0.0001, chi-square test. Most patients in the tacrolimus arm discontinued steroids and received monotherapy and fewer tacrolimus patients remained on a triple regimen. Mean serum creatinine concentration was 145.4 ± 90.9 µmol/L with tacrolimus and 149.0 ± 92.1 µmol/L with CsA-ME. Significantly more CsA-ME patients had a classified cholesterol value >6 mmol/L (26.3% versus 12.6%, P 0.0003, chi-square test).
Conclusions. Patients treated with tacrolimus had significantly higher combined endpoint-free survival rates and lower acute rejection rates with less immunosuppressive medication at 36 months.
Keywords: acute rejection; calcineurin inhibitors; follow-up; graft survival; patient survival
* Other investigators are listed in the Acknowledgements section.
Received for publication: 7.10.07
Accepted in revised form: 2. 1.08