Abstract
Introduction: Dronedarone reduced the risk of cardiovascular (CV) hospitalization or death compared with placebo among patients with nonpermanent atrial fibrillation/flutter (AF/AFL) in the ATHENA study (primary endpoint). Prior work suggests a differential response to AF/AFL management based on age and sex. This post hoc analysis assessed response to dronedarone in these important subgroups. Methods: Efficacy and safety of dronedarone vs placebo were analyzed by age (<65y, 65-74y, ≥75y) and sex. Results: Median duration of follow-up was 22 months overall in the ATHENA study. Of 4628 patients, 873 (19%), 1830 (40%), and 1925 (42%) were <65y, 65-74y, ≥75y old, respectively; 2459 (53%) were men. Older patients had a higher prevalence of structural heart disease and higher CHA 2 DS 2 -VASc scores. Dronedarone significantly reduced the risk of first CV hospitalization or death in the 65-74y and ≥75y subgroups, with a similar trend among patients <65y (Table). The same pattern was observed for first CV hospitalization and first AF/AFL recurrence. Dronedarone significantly reduced the risk of first CV hospitalization or death in both men (hazard ratio [HR]: 0.74 [95% confidence interval: 0.64, 0.84]; P < 0.0001) and women (HR: 0.77 [0.67, 0.89]; P = 0.0002). Dronedarone also significantly reduced the risk of first AF/AFL recurrence in men (HR: 0.85 [0.77, 0.94]; P = 0.0017) and women (HR: 0.71 [0.64, 0.80]; P < 0.0001). Treatment-emergent adverse events (TEAEs) led to treatment discontinuation in 8% [6%], 13% [6%], and 15% [11%] of patients with dronedarone [placebo] in the <65y, 65-74y, and ≥75y subgroups, respectively, without sex-based differences. Conclusions: In the ATHENA study, dronedarone decreased the risk of CV hospitalization or death and decreased AF/AFL recurrence regardless of patient sex as well as in patients 65y and older. A similar trend was observed in patients <65y. No new drug-related safety signals were identified across age and sex subgroups.
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