Abstract

This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial. Among 138 patients enrolled in the original trial, 92 patients with ≥ 5 months of medication event monitoring system (MEMS) use and ≥ 4 tacrolimus trough values were included in this post hoc analysis. The variability of tacrolimus trough levels was calculated using coefficient variation (CV) and mean absolute deviation. Adherence was assessed using MEMS and self-report via the Basal Assessment of Adherence to Immunosuppressive Medication Scale. There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6–25.5%] and 16.0% [11.5–23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33). There was also no significant correlation between the CV and adherence detected by MEMS (taking adherence, ρ = − 0.067, P = .527; dosing adherence, ρ = − 0.098, P = .352; timing adherence, ρ = − 0.113, P = .284). Similarly, adherence measured by self-report did not significantly affect the IPV (P = .452). In this post hoc analysis, nonadherent behavior, measured through electronic monitoring or self-report, did not affect the IPV.

Highlights

  • This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial

  • We performed post hoc analysis to investigate the relationship between adherence and tacrolimus IPV using the dataset from the original randomized controlled trial (RCT)

  • High IPV was associated with de novo donor-specific antibodies (dnDSA) development, which was concordant with previous ­reports[5,6]

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Summary

Introduction

This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial. Abbreviations BAASIS Basal Assessment of Adherence to Immunosuppressive Medication Scale CV Coefficient variation CYP Cytochrome P450 dnDSA De novo donor-specific antibodies eGFR Estimated glomerular filtration rate EM Electronic monitoring IS Immunosuppressive IPV Intrapatient variability IQR Interquartile range MAD Mean absolute deviation MEMS Medication event monitoring system MMF Mycophenolate mofetil PRIMA ImPRoving adherence to Immunosuppressive therapy by Mobile internet Application RCT Randomized controlled trial TTR Time in therapeutic range. EM is an objective method of detecting nonadherence in nature and has been proven useful in quantifying medication adherence and associated clinical outcomes in prospective studies involving adult kidney transplant ­recipients[12]. In this context, data from clinical trials using EM of tacrolimus may provide the best opportunity to investigate the association between tacrolimus IPV and nonadherence

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