*Purpose: Calcineurin inhibitor (CNI) and/or corticosteroid therapy are associated with significant risk of new onset diabetes after transplantation (NODAT). It is not clearly established whether CNI avoidance provides further reduction in NODAT beyond early corticosteroid withdrawal (ESW). This study analyzed five predefined NODAT definitions from a randomized trial with long term follow-up.
*Methods: A multicenter randomized trial was conducted with 3 groups, with ESW: A: Alemtuzumab/belatacept, B: rATG/belatacept, C: rATG/tacrolimus. NODAT was defined as any of the following: use of insulin or oral medication, fasting glucose) > 126 on two consecutive samples, or hemoglobin A1C > 6.5%.
*Results: 168 patients (pts) from two highest enrolling centers (comprising >50% of pts) were analyzed with median follow-up approximating 8 yr. 109 pts without pre-transplant DM and were assessed for NODAT by ITT. Belatacept NODAT rates were half that observed with tacrolimus (18.9% versus 37.1%, p=0.04). CV risk factors were similar, except for higher triglycerides in bela-treated pts (p=0.01). CV events and death were similar between groups.

*Conclusions: 1) At 8 yrs, CNI avoidance provided a striking reduction in NODAT from 37% under tacrolimus to 18.9% with belatacept, 2) reductions in other CV risk factors, CV events, and patient death were not observed, and 3) aging of patients over 8 years, or prolonged cumulative exposure to tacrolimus may underlie the increase in NODAT.

Estefany Yanqui

University of Cincinnati

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