Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring.
Kuypers DR, Peeters PC, et al.Transplantation 2013; 95(2):333-340.
Aims
The primary objective of the Adherence Measurement in Stable Renal Transplant Patients Following Conversion From Prograf to Advagraf (ADMIRAD) study is to compare medication adherence in patients receiving once-daily versus twice-daily tacrolimus regimens.
Interventions
Participants
Stable adult renal transplant patients who were on tacrolimus twice daily for at least 3 months before inclusion and between 6 months and 6 years post surgery for their first or second transplant.
Outcomes
The primary outcome was medication adherence to the once-daily and twice-daily regimens, which was measured in terms of persistence and implementation. Secondary outcomes included comparison between prerandomization and postrandomization adherence to the regimen for each group, comparison of within-subject variability of tacrolimus concentration, acute rejection rate, and number of dose adaptations between the two groups.
Follow-up
6 months
CET Conclusions
In this well designed study patients receiving once daily tacrolimus did have better adherence to the dosage regimen, 88.2% of the once daily group and 78.8% of the twice daily group. The patients on the twice daily dose missed more doses in the evening than in the morning. However a persistent failure of adherence was identified in some patients and additional measures would have to be taken even with the once daily dose to ensure total compliance. The differences were not marked but nevertheless this is the first data we have on compliance comparing dosing with either twice daily or once daily dosing tacrolimus.
Data analysis
Strict intention-to-treat analysis
Trial registration
BE-02-RG-186