Efficacy and safety of tacrolimus compared with ciclosporin-A in renal  transplantation: 7-year observational results.

Immunosuppressive Agents; 83HN0GTJ6D (Cyclosporine); WM0HAQ4WNM (Tacrolimus); Cyclosporine/therapeutic use; Graft Rejection/prevention & control; Graft Survival; Humans; Immunosuppression Therapy; Immunosuppressive Agents/therapeutic use; Kidney Transplantation; Tacrolimus/therapeutic use; acute rejection; adverse events; calcineurin inhibitor; investigator-initiated study; long-term follow-up

Abstract :

[en] 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.

Disciplines :

Surgery
Urology & nephrology

Author, co-author :

Krämer, Bernhard K; Universitätsmedizin Mannheim, Vth Department of Medicine, Medical Faculty of the

Montagnino, Giuseppe; Division of Nephrology and Dialysis, Ospedale Maggiore di Milano IRCCS, Milano,

Krüger, Bernd; Universitätsmedizin Mannheim, Vth Department of Medicine, Medical Faculty of the

Margreiter, Raimund; Landeskrankenhaus, University of Innsbruck, Innsbruck, Austria.

Olbricht, Christoph J; Katharinenhospital, Stuttgart, Germany.

Marcen, Roberto; Hospital Ramón y Cajal, Madrid, Spain.

Sester, Urban; Universitätsklinik des Saarlandes, Homburg, Germany.

Kunzendorf, Ulrich; Klinik für Nephrologie, University of Kiel, Kiel, Germany.

Dietl, Karl-Heinz; Universitätsklinik Münster, Münster, Germany.

Rigotti, Paolo; Universitá di Padova, Padua, Italy.

More authors (6 more)

Other collaborator :

Dietl, K H

Ortuño, J

Pascual, J

Marcen, R

Krämer, B K

Banas, B

Kammerl, M

Krüger, B

Sester, U

Kunzendorf, U

More authors (40 more)

Language :

English

Title :

Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results.

Publication date :

March 2016

Journal title :

Transplant International

ISSN :

0934-0874

eISSN :

1432-2277

Publisher :

Frontiers Publishing Partnerships, Lausanne, Ch

Volume :

Issue :

Pages :

307-14

Peer reviewed :

Peer Reviewed verified by ORBi

Commentary :

Available on ORBi :

since 30 July 2023

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