COMPLICATIONS - METABOLIC

S. Dhadda, W. Fitzsimmons, R. Croy, J. Holman, M.R. First
Development, Astellas Pharma, Deerfield/IL/UNITED STATES OF AMERICA

Body: Introduction: New-onset diabetes mellitus after transplantation (NODAT) is a common occurrence. Prior definitions of NODAT have been inconsistent. Based on past definitions and the recently proposed ADA criteria, we propose a new definition of NODAT.

METHODS: Analysis of 1433 at-risk transplant recipients was performed. These data were from 3 de novo Astellas sponsored, registration transplant studies (2 kidney;1 liver) evaluating NODAT in 637 at-risk patients receiving tacrolimus extended release (Advagraf), 642 at-risk patients receiving tacrolimus (Prograf), and 154 at-risk patients receiving cyclosporine (Neoral). NODAT was defined as a composite endpoint consisting of first occurrence of one of 4 parameters: (1) Two fasting plasma glucose (FPG) levels > 126 mg/dL 30> days apart. (2) Oral hypoglycemic agent use for 30> consecutive days. (3) Insulin therapy for > 30 consecutive days and (4) HgbA1c >6.5%.

RESULTS: Results are illustrated below. Use of composite definition for NODAT is recommended. NODAT incidence was higher with tacrolimus formulations than cyclosporine; however, there were no differences in the incidence of NODAT between the 2 tacrolimus formulations in any of the parameters.
CONCLUSIONS: Based on our analyses, the ADA criterion of a single FPG≥126 mg/dL is too sensitive in transplant recipients. Likewise, two FPG≥126 mg/dL was a frequent occurrence in the early post transplant period. The older definition of insulin use of ≥30 days underestimates the true incidence of NODAT. We propose the definition of NODAT should incorporate broader criteria. Use of appropriate definitions for NODAT provides for a better understanding of the incidence of this complication and may lead to earlier initiation of therapy.

Disclosure: All authors have declared no conflicts of interest.