Key result
Amiodarone plus DOACs linked to ~22% higher risk of major bleeding vs. DOACs alone.
Why the study?
Literature is conflicting regarding the clinical implications of drug-drug interactions between amiodarone and DOACs on bleeding risk in patients with atrial fibrillation.
Does concurrent use of amiodarone and DOACs increase the risk of major bleeding in patients receiving DOAC therapy?
Meta-Analysis (n=438,887)
Does concurrent use of amiodarone and DOACs increase the risk of major bleeding in patients receiving DOAC therapy?
Odds Ratio: 1.22 (95% CI 1.03–1.44)
Absolute Event Rate: 2.4% vs 2.1%
p-value: p=0.02
Concurrent administration of amiodarone and DOACs significantly increases the odds of major bleeding by 22%, emphasizing the need to closely monitor patients on this combination.
Warrants bleeding monitoring with amiodarone plus DOACs; extends observational interaction data but leaves causal confirmation open.
BACKGROUND AND AIMS: Amiodarone is frequently prescribed alongside direct oral anticoagulants (DOACs) in atrial fibrillation. There are concerns regarding drug-drug interactions (DDIs) between amiodarone and DOACs. The literature is conflicting on the clinical implications of this DDI, hence we conducted a meta-analysis to compare bleeding risk among patients receiving DOACs, with and without concurrent amiodarone. METHODS AND RESULTS: A systematic search was conducted for studies published between 1 January 2009 and 26 June 2024 in MEDLINE via PubMed, Embase, and CENTRAL. Included studies compared major bleeding in patients on concurrent amiodarone and DOACs to those on DOACs without amiodarone. Event rates were used to calculate odds ratios (ORs), which were pooled with a random-effects model. Nine studies were identified, which included 124 813 patients on amiodarone/DOACs, and 314 074 on DOACs. The average age was 77.2 years in the amiodarone/DOAC group, compared to 74.4 years in the DOAC group (P = 0.21). Among DOAC patients, there was a statistically significant increase in major bleeding with concurrent amiodarone (OR 1.22, 95% confidence interval (CI) 1.03-1.44, P = 0.02, I2 = 88%). Intracranial bleeding rate was numerically higher in the amiodarone/DOAC group (1.0 vs. 0.4%), but the difference did not reach statistical significance (OR 2.20, 95% CI 0.53-9.06, P = 0.27, I2 = 100%). There were no significant differences in gastrointestinal bleeding (OR 1.10, 95% CI 0.98-1.23, P = 0.12, I2 = 62%) and all-cause mortality (OR 1.38, 95% CI 0.70-2.73, P = 0.35, I2 = 99%). CONCLUSION: Concurrent use of amiodarone and DOACs was associated with an increase in major bleeding. This should be considered when co-prescribing these medications.
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Michael et al. (2024) conducted a meta-analysis in Atrial fibrillation (n=438,887). Concurrent amiodarone and DOACs vs. DOACs without amiodarone was evaluated on Major bleeding (OR 1.22, 95% CI 1.03-1.44, p=0.02). Concurrent use of amiodarone and DOACs was associated with a significant increase in major bleeding compared to DOACs alone (OR 1.22, 95% CI 1.03-1.44, P=0.02).
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