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<p>In our therapeutic drug monitoring (TDM) laboratory, over one-third of approximately 350 analyzed samples from patients on edoxaban were &lt; 12&#xa0;ng/mL, which is below concentrations reported in clinical trials. Our study aimed to explore the effect of factors potentially associated with low edoxaban concentrations in patients monitored with TDM. A retrospective cohort study of previously analyzed edoxaban plasma concentrations collected at Karolinska University Hospital between November 2017 and May 2023 was performed. Low concentration was defined as &lt; 12&#xa0;ng/mL (30&#xa0;mg) and &lt; 16&#xa0;ng/mL (60&#xa0;mg). Fifty samples from 34 individuals were included. No significant difference in trough concentration between 30 and 60&#xa0;mg dose group was found. Low concentrations were observed in 42% of samples. Higher estimated glomerular filtration rate (eGFR) was found among patients with low edoxaban concentrations (<i>p</i> = 0.004); however, the correlation between eGFR and concentration was weak (rho =  − 0.4; <i>p</i> &lt; 0.05). Off-label dose reduction (<i>n</i> = 4) and drug-drug interactions (DDIs) (<i>n</i> = 4) were found in cases with low concentrations. In a TDM-setting, low trough concentrations of edoxaban were frequently observed. Potential explanations include normal renal function, drug-drug interactions, and off-label dose reductions. These findings suggest that TDM may be beneficial in selected clinical scenarios. However, the study is limited by its small sample size and selected study population.</p>

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Low plasma edoxaban concentrations during therapeutic drug monitoring: a single-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月3日

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  • Paulina Flis,
  • Roza Chaireti,
  • Rickard E. Malmström,
  • Karolina Nowinski

摘要

In our therapeutic drug monitoring (TDM) laboratory, over one-third of approximately 350 analyzed samples from patients on edoxaban were < 12 ng/mL, which is below concentrations reported in clinical trials. Our study aimed to explore the effect of factors potentially associated with low edoxaban concentrations in patients monitored with TDM. A retrospective cohort study of previously analyzed edoxaban plasma concentrations collected at Karolinska University Hospital between November 2017 and May 2023 was performed. Low concentration was defined as < 12 ng/mL (30 mg) and < 16 ng/mL (60 mg). Fifty samples from 34 individuals were included. No significant difference in trough concentration between 30 and 60 mg dose group was found. Low concentrations were observed in 42% of samples. Higher estimated glomerular filtration rate (eGFR) was found among patients with low edoxaban concentrations (p = 0.004); however, the correlation between eGFR and concentration was weak (rho =  − 0.4; p < 0.05). Off-label dose reduction (n = 4) and drug-drug interactions (DDIs) (n = 4) were found in cases with low concentrations. In a TDM-setting, low trough concentrations of edoxaban were frequently observed. Potential explanations include normal renal function, drug-drug interactions, and off-label dose reductions. These findings suggest that TDM may be beneficial in selected clinical scenarios. However, the study is limited by its small sample size and selected study population.