Kraemer, Bernhard K. and Del Castillo, Domingo and Margreiter, Raimund and Sperschneider, Heide and Olbricht, Christoph J. and Ortuno, Joaquin and Sester, Urban and Kunzendorf, Ulrich and Dietl, Karl-Heinz and Bonomini, Vittorio and Rigotti, Paolo and Ronco, Claudio and Tabernero, Jose M. and Rivero, Manuel and Banas, Bernhard and Muehlbacher, Ferdinand and Arias, Manuel and Montagnino, Giuseppe (2008) Efficacy and safety of tacrolimus compared with ciclosporin A in renal transplantation: three-year observational results. NEPHROLOGY DIALYSIS TRANSPLANTATION, 23 (7). pp. 2386-2392. ISSN 0931-0509, 1460-2385
Full text not available from this repository. (Request a copy)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 <= 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 mu mol/L with tacrolimus and 149.0 +/- 92.1 mu mol/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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | RANDOMIZED-TRIAL; FOLLOW-UP; KIDNEY-TRANSPLANTATION; CHRONIC REJECTION; MICROEMULSION; IMMUNOSUPPRESSION; MULTICENTER; acute rejection; calcineurin inhibitors; follow-up; graft survival; patient survival |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Oct 2020 05:54 |
| Last Modified: | 29 Oct 2020 05:54 |
| URI: | https://pred.uni-regensburg.de/id/eprint/30701 |
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