Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients—A Prospective, Randomized Study
Storset E, Ã…sberg A, et alTransplantation 2015 [Record in progress]
Aims
To evaluate the target concentration of Tacrolimus (Tac) using computerized dosing compared with conventional dosing performed by experienced transplant physicians.
Interventions
Patients were randomized to receive either computerized dosing (computer group) or conventional dosing (control group) of Tac during the first 8 weeks after transplantation.
Participants
Eighty adult kidney transplant recipients (aged >18 years) who used Tac-based immunosuppression without concomitant drugs known to interact with Tac pharmacokinetics
Outcomes
Primary outcomes were Tac trough concentrations within the target range, the median proportion, median time to reach the target and intrasubject variability. Secondary outcomes were the incidence of biopsy-confirmed acute rejections and infections, renal function and glucose tolerance.
Follow-up
8 weeks
CET Conclusions
This interesting study investigated the use of a computerised model to predict optimum tacrolimus dosing in the early post-transplant period following renal transplantation. The model incorporates tacrolimus levels, lab results and patient demographics to predict the optimal dose. This strategy is compared to standard physician-led dosing based upon trough levels alone in a randomised fashion. A significant benefit in terms of concentrations in target range is seen with computerised dosing, with a suggestion towards improved clinical outcomes. A couple of caveats should be noted. Firstly, no power calculation is performed, so it is difficult to draw conclusions regarding the clinical benefits of improved dosing. Secondly, the decision as to whether to adhere to the computer recommendation for dose was left to the discretion of the treating clinician. Whether these recommendations were adhered to is not recorded. Previous experience from computerised MMF dosing trials suggest that clinicians over-ride the dosing prediction in a high proportion of cases, potentially reducing the impact of the intervention. Nevertheless, this is a very promising strategy for optimising early tacrolimus exposure.
Data analysis
Per protocol analysis
Trial registration
Clinicaltrials.gov - NCT02010320