Key result
Amiodarone co-administration is linked to ~49% higher trough apixaban levels versus apixaban monotherapy.
Why the study?
Evidence about apixaban plasma levels and bleeding outcomes in patients receiving apixaban with amiodarone for non-valvular atrial fibrillation has been limited.
Does the co-administration of amiodarone increase apixaban plasma levels and bleeding risk in patients with non-valvular atrial fibrillation?
Observational (n=33)
No
Does the co-administration of amiodarone increase apixaban plasma levels and bleeding risk in patients with non-valvular atrial fibrillation?
Absolute Event Rate: 162.05% vs 108.49%
p-value: p=0.028
Co-administration of amiodarone with apixaban in patients with non-valvular atrial fibrillation significantly increases trough apixaban plasma levels but appears generally well tolerated without a clear increase in bleeding risk.
Amiodarone was associated with higher apixaban trough levels; observational data leaves open bleeding risk and dose-adjustment needs.
BACKGROUND: Apixaban and amiodarone are drugs used for non-valvular atrial fibrillation (NVAF) in routine practice. The evidence about apixaban plasma levels in patients who receive apixaban with amiodarone, including bleeding outcomes, has been limited. This study aimed to compare the apixaban plasma levels and bleeding outcomes between apixaban monotherapy and apixaban with amiodarone groups. METHODS: This study was a prospective, observational, and single-center research which was conducted from January 2021 to January 2022 in NVAF patients who received apixaban at a tertiary care hospital located in the center of Bangkok, Thailand. RESULTS: Thirty-three patients were measured for their median (5th-95th percentile) apixaban plasma levels. The trough of apixaban plasma level (Ctrough) were 108.49 [78.10-171.52] and 162.05 [87.94-292.88] μg/L in the apixaban monotherapy and apixaban with amiodarone groups, respectively (p = 0.028). Additionally, the peaks of apixaban plasma level (Cpeak) were 175.36 [122.94-332.34] and 191 [116.88-488.21] μg/L in the apixaban monotherapy and apixaban with amiodarone groups, respectively (p = 0.375). There was bleeding that occurred in 7 patients (21.21%); 5 patients in the apixaban monotherapy group and 2 patients in the apixaban with amiodarone group, respectively. CONCLUSIONS: Amiodarone may increase the peaks and troughs of apixaban plasma levels. The co-administration of apixaban with amiodarone is generally well tolerated. However, the careful observation of bleeding symptoms in individual cases is necessary to ensure safety.
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Limcharoen et al. (2024) conducted an observational in Non-valvular Atrial Fibrillation (NVAF) (n=33). Amiodarone vs. Apixaban monotherapy was evaluated on Trough apixaban plasma level (Ctrough) (p=0.028). Amiodarone co-administration with apixaban significantly increased median trough apixaban plasma levels to 162.05 μg/L compared to 108.49 μg/L with apixaban monotherapy.
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