Sirolimus Conversion Regimen Versus Continued Calcineurin Inhibitors in Liver Allograft Recipients: A Randomized Trial.
Abdelmalek MF, Humar A, et al.American Journal of Transplantation 12(3):694-705, 2012.
Aims
To evaluate conversion from calcineurin inhibitor (CNI)-based to sirolimus (SRL)-based immunosuppression for preservation of renal function in liver transplantation patients.
Interventions
Abrupt conversion (less than 24 hours) from CNI to SRL versus continuation of CNI.
Participants
607 liver transplant patients.
Outcomes
The primary efficacy endpoint was glomerular filtration rate 12 months after randomization. The primary safety endpoint was a composite of cumulative rates of graft loss or death at 12 months after randomization. Secondary endpoints included incidence and severity of biopsy-confirmed acute rejection, hypertension and incidence of malignancy, infection and adverse events.
Follow-up
12 months after conversion
CET Conclusions
This large prospective randomised trial was of good quality and showed that conversion of patients with a stable liver allograft and stable CNI immunosuppression between 6 months and 144 months after transplantation to sirolimus did not result in any better renal function at 12 months after conversion. In addition the sirolimus conversion was associated with higher rates of biopsy confirmed acute rejection and discontinuations primarily for adverse events. Thus there did not appear to be any demonstrable benefit in liver transplantation by conversion from a CNI to a sirolimus based immunosuppression. (It should be noted that the trial was funded by Wyeth and the paper written in part by a commercial company paid for by Wyeth).
Data analysis
Strict intention-to-treat analysis
Trial registration
Not reported