Long-term study of steroid avoidance in renal transplant patients: a single-center experience.
Nagib AM, Abbas MH, et al.Transplantation Proceedings 2015; 47(4): 1099-1104.
Aims
To assess the costs and benefits of a steroid-free immunosuppression regimen in living-donor renal transplantation
Interventions
The study group received tacrolimus (Tac), mycophenolic acid (MPA), basiliximab induction and steroids for 3 days, compared to the control group on Tac, MPA maintenance, simulect induction, and steroid maintenance.
Participants
428 living donor transplant recipients with end-stage kidney disease
Outcomes
Measured outcomes were graft and patient survival, rejection episodes, graft function, hypertension, malignancy, infection and incidence of new-onset diabetes after transplantation (NODAT).
Follow-up
66±41 months
CET Conclusions
This large study randomised 428 low-risk living-donor transplant recipients to either early steroid withdrawal (day 3 post-op) or steroid maintenance. Baseline immunosuppression was tacrolimus, MMF and basiliximab. At a median follow-up of 66 months graft function and patient and graft survival did not differ between groups. There was significant benefit from early steroid withdrawal in cardiovascular risk factors including incidence of post-transplant diabetes and hypertension. This study echoes the results of previous systematic reviews, although in this low-risk cohort there did not seem to be an excess risk of acute rejection following steroid withdrawal. The length of follow-up should be commended. It should, however, be noted that the maintenance steroid dose was relatively high (around 10mg/day), and our own work has suggested that the metabolic benefits of steroid withdrawal are only apparent when withdrawing form doses higher than 5mg/day.
Data analysis
Per protocol analysis
Trial registration
None