Key result
Off-label edoxaban overdosing linked to ~368% greater odds of higher-than-expected peak concentrations in AF.
Why the study?
Edoxaban exposure varies across ethnicities, prompting examination of risk factors associated with high or low edoxaban concentrations in Asian populations.
What factors are associated with high or low edoxaban concentrations in Asian patients with atrial fibrillation?
Observational (n=80)
No
What factors are associated with high or low edoxaban concentrations in Asian patients with atrial fibrillation?
Effect estimate: OR 4.68 (95% CI 1.24-17.70)
p-value: p=0.02
In Asian patients with atrial fibrillation, higher creatinine clearance and the 30 mg regimen are associated with low edoxaban trough concentrations, while off-label overdosing is associated with high peak concentrations.
Off-label edoxaban overdosing was associated with high peaks in AF; hypothesis-generating and should not yet change practice.
Background and Purpose: Edoxaban exposure varies across different ethnicities. The purpose of our study was to examine the risk factors associated with high or low edoxaban concentrations in Asian populations. Methods: Participants with atrial fibrillation who were undergoing edoxaban therapy were enrolled. Peak (1–4 h after edoxaban administration) and trough (24 ± 4 h from the last edoxaban dose) blood samples were collected to measure edoxaban concentrations using ultrahigh-performance liquid chromatography with tandem mass spectrometry. The edoxaban concentrations were compared to those observed in clinical trials to define a higher- or lower-than-expected range. Multivariate logistic regression was used to analyze the risk factors associated with high or low edoxaban concentrations. Results: Eighty participants (49 men, 61.3%) were enrolled and provided 78 trough and 76 peak samples. Twenty participants (25.6%) were determined to have low trough concentrations, which was associated with higher creatinine clearance and the use of the 30 mg regimen (odds ratio [OR] and 95% confidence interval [CI], 1.06 [1.01, 1.11], p = 0.01 and 5.77 [1.34, 24.75], p = 0.02, respectively). In contrast, 21 participants (27.6%) had high peak concentrations, which was associated with an off-label overdosing regimen (OR = 4.68 [1.23, 17.70], p = 0.02). Conclusion: Our study identified factors associated with increased or decreased edoxaban exposure. The measurement of edoxaban concentration may be recommended for patients with selected characteristics.
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Lin et al. (2021) conducted an observational in Atrial Fibrillation (n=80). Edoxaban vs. On-label dosing regimen was evaluated on Higher-than-expected-range peak edoxaban concentration (OR 4.68, 95% CI 1.24-17.70, p=0.02). An off-label overdosing regimen of edoxaban was significantly associated with higher-than-expected peak concentrations (OR 4.68) in patients with atrial fibrillation.
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