Abstract 13392: Efficacy and Safety of Dronedarone vs Placebo Across Age and Sex Subgroups: A Post Hoc Analysis of the Athena Study Among Patients With Nonpermanent Atrial Fibrillation/flutter
Bibliographic record
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".