High Intrapatient Variability of Tacrolimus Levels and Outpatient Clinic Nonattendance Are Associated With Inferior Outcomes in Renal Transplant Patients

Abstract

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Assessment of tacrolimus intrapatient variability in stable adherent transplant recipients: Establishing baseline values

“…16,17,19,23,24,63 Our data showing that more than 75% of the weekly CVs were less than 25% strengthen the evidence that values above this range should begin to elicit concern as they vary from the The current study is unique in its ability to minimize many suspected cofounders. 16,17,19,23,24,63 Our data showing that more than 75% of the weekly CVs were less than 25% strengthen the evidence that values above this range should begin to elicit concern as they vary from the The current study is unique in its ability to minimize many suspected cofounders.…”

“…12,13,16,19,20,24 TA B L E 5 Demographic factors associated with CV > 30% from venipuncture in kidney subjects found a significant relationship (R 2 = 0.93) with a Passing and Bablok fit of y = 1.00x -0.23 (95% CI slope, 0.91-1.08; intercept, −0.69-0.3). However, none of the methods confirm medication ingestion with certainty.…”

“…[16][17][18][19]23,24 Second, additional information is needed regarding the contribution of the individual factors altering tacrolimus IPV. Coefficient of variation (CV) is the most commonly reported measure of IPV with cutoffs, often simply selected as the median value for the population, ranging from 14.9% to 40% in previous retrospective studies.…”

Off‐label use of tacrolimus in children with glomerular disease: Effectiveness, safety and pharmacokinetics

“…Although the efficacy and safety data of tacrolimus in paediatric patients with glomerular disease are available, its narrow therapeutic index and high intra‐ and inter‐individual pharmacokinetic variability still hinder its clinical application . Both underexposure and overexposure to tacrolimus may have serious consequences in terms of an increased risk of treatment failure or toxic side effects …”

Routine adherence monitoring after renal transplantation

“…Measurement of tacrolimus IPV is also straightforward, requiring three or more trough tacrolimus measurements over a time‐period that can be used to calculate a co‐efficient of variation. High IPV has shown association with poor clinical outcomes , and is associated with other non‐adherence attitudes and behaviours . However, it only captures adherence to tacrolimus, and adherence to other immunosuppressants may differ depending on dose frequency and side effect profile.…”