Conversion from tacrolimus to cyclosporine in patients with new-onset diabetes after renal transplant: an open-label randomized prospective pilot study.
Rathi M, Rajkumar V, et al.Transplantation Proceedings 2015; 47(4): 1158-1161.
Aims
To determine the effect of switching from tacrolimus (Tac) to cyclosporine (CsA) in patients with new-onset diabetes after transplantation (NODAT).
Interventions
Patients in the study group converted from Tac to CsA ,while patients in the control group continued on Tac.
Participants
67 renal transplant patients aged > 18 years with NODAT and on Tac-based immunosuppression
Outcomes
Primary outcomes measured were fasting and 2-hour postprandial plasma glucose levels and fasting insulin. Secondary outcomes were resolution of diabetes, mean change in HbA1c, the percentage of patients treated with insulin or oral hypoglycaemic agents (OHA), acute rejection and safety profile.
Follow-up
3 months
CET Conclusions
This small but interesting trial from India randomised renal transplant recipients with new onset diabetes after transplantation to continue tacrolimus or switch to cyclosporin. Both groups demonstrated improvement in glycaemic control after randomisation with improved HbA1C and reduced insulin requirements. When comparing the two groups, the improvement in fasting blood glucose and reduction in insulin requirements were significantly greater in the cyclosporine group. The results of this trial are interesting, but the sample size is small (and it is unclear how the sample size was chosen) meaning that there is not enough power to detect differences in key outcomes such as HbA1C or acute rejection rates. Follow-up is short (3 months). It should also be noted that all patients in the study received maintenance steroids, and the relative benefits of switching from Tac to CsA versus withdrawal of steroids on glycaemic control are unclear. As the authors rightly point out, this study is a first step and requires validation in a larger, more heterogeneous patient population with longer follow-up.
Data analysis
Per protocol analysis
Trial registration
None