Date: Tuesday, May 5, 2015
Session Name: Concurrent Session: Kidney: Cardiovascular and Metabolic
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). http://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 19, 2017.
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