A Prospective and Randomized Study of Conversion from Tacrolimus to Cyclosporine A to Improve Glucose Metabolism in Patients With New-Onset Diabetes Mellitus After Renal Transplantation
1Universitair Ziekenhuis Brussel, Brussels, Belgium
2Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium
3Centre Hospitalier Universitaire Liège, Liège, Belgium
4Charité
Universitätsmedizin Berlin, Berlin, Germany
5Westpfalz Klinikum Kaiserslautern, Kaiserslautern, Germany
6Universitätsklinikum Essen, Essen, Germany
7Universitair Ziekenhuis Leuven, Leuven, Belgium.
Meeting: 2015 American Transplant Congress
Abstract number: 382
Keywords: FK506, Kidney transplantation, Metabolic complications
Session Information
Session Name: Concurrent Session: Kidney: Cardiovascular and Metabolic
Session Type: Concurrent Session
Date: Tuesday, May 5, 2015
Session Time: 2:15pm-3:45pm
Presentation Time: 3:15pm-3:27pm
Location: Terrace I-III
Background: The present prospective and randomized study was designed to assess whether conversion from tacrolimus (Tac) to cyclosporine A (CsA) can reverse posttransplantation diabetes mellitus in at least 25% of patients.
Methods: Patients with NODAT according to the 2005 ADA criteria, persisting at least 6 month after renal transplantation, were randomized to either replacement of Tac with CsA or continuation of their Tac-based regimen. Randomization was stratified for type of glucose-lowering therapy (insulin, oral agents, none), steroid therapy and HCV status.
Results: 84 out of 87 randomized patients received the allocated intervention (CsA N=43; Tac N=41). Half of the patients in both arms were steroid-free at the moment of inclusion. At one year, 14 of 41 patients with complete data in the CsA arm (34%; 95%CI 19% to 49%) were free of diabetes vs. 4 of 39 patients (10%; 95%CI 3% to 20%) in the Tac arm (P=0.01). Among 61 patients receiving glucose-lowering therapy at inclusion reversibility of NODAT was observed in 5 of 31 patients (16%) in the CsA arm versus none of the 30 patients in the Tac arm (P=0.05). At 12 months 16/41 patients (39%) in the CsA arm were off glucose-lowering medication vs. 5/38 patients (13%) of in the tacrolimus arm (P=0.01). The CsA group reached a significantly lower HbA1c as compared to the TAC group (6.0±0.9% vs. 7.1±1.7%; P=0.002). During the follow-up one borderline and one acute cellular rejection occurred in each arm (P=NS). Serum creatinine increased from 1.41 mg/dl to 1.61 mg/dl in the CsA arm (P<0.0001) and from 1.47 mg/dl to 1.59 mg/dl in the Tac arm (P=0.05) during the one year follow up, without significant between-group differences.
Conclusions: The prospective and randomized REVERSE study shows that conversion from tacrolimus to cyclosporine improves glucose metabolism and reverses new onset diabetes after transplantation in a significant proportion of patients. Conversion did not increase the risk of acute rejection.
To cite this abstract in AMA style:
Wissing K, Abramowicz D, Weekers L, Budde K, Rath T, Witzke O, Kuypers D. A Prospective and Randomized Study of Conversion from Tacrolimus to Cyclosporine A to Improve Glucose Metabolism in Patients With New-Onset Diabetes Mellitus After Renal Transplantation [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/a-prospective-and-randomized-study-of-conversion-from-tacrolimus-to-cyclosporine-a-to-improve-glucose-metabolism-in-patients-with-new-onset-diabetes-mellitus-after-renal-transplantation/. Accessed November 21, 2024.« Back to 2015 American Transplant Congress