Document Type

Article

Publication Date

11-1-2025

Comments

This article is the author’s final published version in Clinical and Translational Science, Volume 18, Issue 11, 2025, Article number e70392.

The published version is available at https://doi.org/10.1111/cts.70392. Copyright © 2025 The Author(s).

Abstract

Despite common coadministration in nonvalvular atrial fibrillation (NVAF), there is minimal evidence regarding the impact of concomitant amiodarone use on apixaban pharmacokinetics (PK). We described the population PK of apixaban (2.5 and 5mg twice daily) in 106 hospitalized patients with and without concomitant amiodarone administration at steady state. Apixaban PK was reasonably described by a one-compartment model with first-order absorption and linear elimination. Aside from the receipt of amiodarone, age was retained as a statistically significant covariate on apparent clearance. Model-based simulations depicted concomitant amiodarone use increasing AUCT for both 2.5mg (1.58, 90% CI [1.28, 1.87]) and 5mg (1.12, 90% CI [0.91, 1.34]) dosing groups based on geometric mean ratios relative to the apixaban only groups. Similarly, Cmax was also increased for both 2.5mg (1.48, 90% CI [1.21, 1.75]) and 5mg (1.09, 90% CI [0.92, 1.27]) dose groups. Lastly, concomitant amiodarone increased Cmin for both 2.5mg (1.68, 90% CI [1.35, 2]) and 5mg (1.11, 90% CI [0.85, 1.37]) dose groups. Overall differences in apixaban exposures do not appear to be clinically significant across both dosing regimens, but amiodarone coadministration was found to decrease apixaban clearance by 33% (ranging from 12% to 48%). The results support the current practice of no empiric dose adjustment for apixaban when concurrently administered with amiodarone.

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Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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Supplementary Materials.docx (454 kB)

Language

English

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