Transplant Trial Watch

Association between medication adherence and intrapatient variability in tacrolimus concentration among stable kidney transplant recipients.

Ko, H., et al.

Scientific Reports 2021; 11(1): 5397.


Aims
This study is a post-hoc analysis of a randomised controlled trial (RCT) evaluating the effectiveness of a mobile medication manager application in improving medication adherence in renal transplant patients. The aim of this study was to investigate the link between intrapatient variability (IPV) of tacrolimus concentrations and adherence to medication among the renal transplant patients included in the RCT.

Interventions
Participants were randomised to either the mobile group or the control group.

Participants
92 renal transplant recipients.

Outcomes
The main outcome of interest was the assessment of IPV and the time in therapeutic range (TTR) in the adherent versus the nonadherent group. Additionally, the study measured the incidence of de novo donor-specific antibodies (dnDSA) and estimated glomerular filtration rate (eGFR) between the groups.

Follow-up
6 months

CET Conclusions
Previous studies have shown an association between intrapatient variability in tacrolimus levels (IPV) and graft outcomes following kidney transplantation. Studies have worked on the assumption that IPV relates to poor adherence, with missed doses and suboptimal dose timing resulting in increased variability. This study investigates the relationship between IPV and adherence in a post-hoc analysis of an RCT using electronic medication monitoring and self-reported adherence. The authors found no relationship between any of the adherence measures used and tacrolimus IPV, suggesting that the use of IPV as a surrogate for compliance is not justified. It should be noted that the population included in this study had a low IPV overall, and previous studies have suggested that the relationship between IPV and adverse outcomes is seen at higher levels than typically seen in patients in the present study. Therefore, selection of a more poorly adherent population at baseline may have led to different findings.

Trial registration
Clinicaltrials.gov - NCT01905514

Funding source
Not reported