A comparison between two tacrolimus-based immunosuppression regimens in renal transplant recipients: 7-year follow-up.
Foroncewicz B, Mucha K, et al.Annals of Transplantation 2013; 18: 384-392.
Aims
To investigate patient and graft survival rates and adverse event incidence in patients treated with combinations of tacrolimus (TAC) and steroids, with either azathioprine (AZA) or mycophenolate mofetil (MMF).
Interventions
Patients were randomized to receive either TAC, AZA and steroids or TAC, MMF and steroids.
Participants
77 renal transplant recipients.
Outcomes
Primary outcomes included graft function, graft loss, and death, renal function was assessed by use of glomerular filtration rate. Secondary endpoints included incidence of post transplant diabetes mellitus and other adverse events as estimated by the length of the hospitalisation per patient per year.
Follow-up
Yearly for seven years.
CET Conclusions
In this RCT of modest quality recipients of a renal transplant were randomised to receive tacrolimus, azathioprine and steroids or tacrolimus, MMF and steroids. Follow-up was performed annually for 7 years and either on an intention to treat or on an available case analysis. There wasn’t any difference in graft function, graft loss, death nor in secondary endpoints of post transplant diabetes mellitus (PTDM) or other adverse events. The authors quite rightly wonder whether the increasing use of MMF is justified on the basis of these long term results, especially bearing in mind the cost differences.
Data analysis
Available case analysis
Quality notes
The data for this study was taken as part of the COSTAMP study, methods have been assessed from Wlodarcyzk Z et al. Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus treated kidney transplant recipients. Annals of transplantation. 2002; 7: 3: 28-31.
Trial registration
Not reported.