The Conversion of Once-daily Extended-release Tacrolimus is Safe in Stable Liver Transplant Recipients: A Randomized Prospective Study.
Kim JM, Kwon CH, et al.Liver Transpl 2015 [record in progress]
Aims
To compare the efficacy and safety of once-daily extended-release tacrolimus regimen and twice-daily tacrolimus regimen in stable liver transplant recipients.
Interventions
Patients were randomly assigned to either remain on a twice-daily tacrolimus regimen, or be converted to a once-daily regimen.
Participants
94 recipients of a primary liver transplant from a deceased or living donor who were at least 12 months posttransplant, aged >20 years with stable liver function and receiving a calcineurin inhibitor
Outcomes
The primary outcome measured was the proportion of patients with biopsy-proven acute rejection within 6 months. Secondary outcomes measured included graft failure, mortality, adverse events, blood pressure, and serum tacrolimus levels.
Follow-up
24 weeks
CET Conclusions
This non-inferiority, single-centre Korean trial evaluated late conversion (≥ 1 year) of 94 stable liver transplant patients from conventional twice-daily tacrolimus to once-daily, extended-release tacrolimus. Sample size calculations, method of randomisation and whether allocation was concealed were not described. After six months, graft and patient survival were 100% in both groups. There were no episodes of acute rejection and no safety concerns. These short-term data suggest that it is safe to convert stable liver transplant recipients to once-daily tacrolimus but long-term follow up of these patients is needed.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinical Research Information Service database - KCT0000478