Prospective Randomized Trial Investigating the Influence of Pharmaceutical Care on the Intra-Individual Variability of Tacrolimus Concentrations Early After Kidney Transplant.
Bessa AB, Felipe CR, et al.Therapeutic Drug Monitoring 2016; 38(4): 447-455.
Aims
To evaluate the influence of pharmaceutical care (PhC) in the intra-individual variability of dose-corrected whole blood tacrolimus (TAC) trough concentrations in the early phase after kidney transplantation.
Interventions
Participants were randomized no later than 3 days after transplant surgery to receive either predefined instructions provided by a pharmacist (PhC group), or standard nurse staff instructions (control group).
Participants
128 recipients of their first kidney transplant aged ≥ 18 years who received immunosuppressive regimens consisting of TAC, prednisone, and mycophenolate sodium or azathioprine.
Outcomes
The primary outcome measured was the influence of PhC on the intra-individual variability of dose-corrected whole blood TAC concentration. Secondary measured outcomes included the percentage of patients who achieved TAC target concentrations in each study visit, comparison of mean dose-corrected whole blood concentration from day 7 to day 90, patient adherence, and clinical outcomes including incidence of infections, acute rejection, estimated glomerular filtration rate, death, graft loss, discontinuation of immunosuppression treatment and hospital readmissions.
Follow-up
3 months
CET Conclusions
High intrapatient variability (IPV) in tacrolimus concentrations has been repeatedly shown to predict poor graft outcomes following kidney transplantation. IPV may be in part due to poor adherence, although is also affected by other factors. This small single-centre study from Brazil investigated the effect of pharmacist-led medication education on tacrolimus IPV, with the hypothesis that specialist patient education during the first 3 months post-transplant would reduce IPV and potentially improve outcomes. The authors found no difference in tacrolimus IPV, and no difference in self-reported medication adherence or clinical outcomes. The methodology is fairly robust, and the intervention well described, but there are some limitations. The study is small, and involved a relatively large number of pharmacists (5) which may have led to some variability in the intervention. There was a numeric difference in education levels between the two groups which may have affected the findings. However, the results suggest that universal application of the intervention may not have a beneficial effect, with a need to target patients most at risk.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT02420140