Key result
Amiodarone exposure in patients with incident atrial fibrillation was not significantly associated with an increased risk of interstitial lung disease (HR 1.45; 95% CI 0.97-2.44; P=0.09).
Why the study?
Amiodarone-related interstitial lung disease is its most severe adverse effect, but most available data derive from periods when amiodarone was prescribed at higher doses than currently used.
Does amiodarone increase the risk of interstitial lung disease in patients with incident atrial fibrillation?
Cohort (n=12,078)
Yes
Does amiodarone increase the risk of interstitial lung disease in patients with incident atrial fibrillation?
Hazard Ratio: 1.45 (95% CI 0.97–2.44)
p-value: p=0.09
In a contemporary AF population, low-dose amiodarone was not significantly associated with an increased risk of interstitial lung disease or primary lung cancer, and was associated with lower all-cause mortality.
Low-dose amiodarone showed no clear ILD increase in contemporary AF; leaves open need for prospective confirmation before changing practice.
BACKGROUND AND AIMS: Amiodarone-related interstitial lung disease (ILD) is the most severe adverse effect of amiodarone treatment. Most data on amiodarone-related ILD are derived from periods when amiodarone was given at higher doses than currently used. METHODS: A nationwide population-based study was conducted among patients with incident atrial fibrillation (AF) between 1 December 1999 and 31 December 31 2021. Amiodarone-exposed patients were matched 1:1 with controls unexposed to amiodarone based on age, sex, ethnicity, and AF diagnosis duration. The final patient cohort included only matched pairs where amiodarone therapy was consistent throughout follow-up. Directed acyclic graphs and inverse probability treatment weighting (IPTW) modelling were used. Patients with either prior ILD or primary lung cancer (PLC) were excluded. The primary outcome was the incidence of any ILD. Secondary endpoints were death and PLC. RESULTS: The final cohort included 6039 amiodarone-exposed patients who were matched with unexposed controls. The median age was 73.3 years, and 51.6% were women. After a mean follow-up of 4.2 years, ILD occurred in 242 (2.0%) patients. After IPTW, amiodarone exposure was not significantly associated with ILD [hazard ratio (HR): 1.45, 95% confidence interval (CI): 0.97, 2.44, P = 0.09]. There was a trivial higher relative risk of ILD among amiodarone-exposed patients between Years 2 and 8 of follow-up [maximal risk ratio (RR): 1.019]. Primary lung cancer occurred in 97 (0.8%) patients. After IPTW, amiodarone was not associated with PLC (HR: 1.18, 95% CI: 0.76, 2.08, P = 0.53). All-cause death occurred in 2185 (18.1%) patients. After IPTW, amiodarone was associated with reduced mortality risk (HR: 0.65, 95% CI: 0.60, 0.72, P < 0.001). The results were consistent across a variety of sensitivity analyses. CONCLUSION: In a contemporary AF population, low-dose amiodarone was associated with a trend towards increased risk of ILD (15%-45%) but a clinically negligible change in absolute risk (maximum of 1.8%), no increased risk of PLC, and a lower risk of all-cause mortality.
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Tsaban et al. (2023) conducted a cohort in Incident atrial fibrillation (n=12,078). Amiodarone vs. Unexposed controls was evaluated on Incidence of any interstitial lung disease (ILD) (HR 1.45, 95% CI 0.97-2.44, p=0.09). Amiodarone exposure in patients with incident atrial fibrillation was not significantly associated with an increased risk of interstitial lung disease (HR 1.45; 95% CI 0.97-2.44; P=0.09).
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