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Dronedarone vs Sotalol Among Patients With Atrial Fibrillation : A Meta-Analysis of Retrospective Observational Databases

Singh, Jagmeet P. ; Wieloch, Mattias LU ; Reynolds, Shannon L. ; Blomström-Lundqvist, Carina ; Sandhu, Alex T. ; Camm, A. John ; Kabadi, Shaum ; Pundi, Krishna ; Turakhia, Mintu P. and Boiron, Rania , et al. (2025) In JACC: Clinical Electrophysiology 11(7). p.1531-1542
Abstract

Background: Dronedarone and sotalol are antiarrhythmic drugs (AADs) recommended in similar populations per atrial fibrillation (AF) guidelines; however, comparative safety data are limited. Objectives: The goal of this study was to assess the safety of dronedarone vs sotalol for treatment of AF in AAD-naive patients. Methods: This was a prespecified noninterventional meta-analysis of 4 retrospective observational cohort studies from 4 databases (Optum Clinformatics Data Mart, Merative MarketScan, Veterans Health Administration Electronic Health Record, and the Swedish National Patient Register) conducted by using one master protocol. Each analysis emulated the target trial using an active comparator (dronedarone vs sotalol), new user... (More)

Background: Dronedarone and sotalol are antiarrhythmic drugs (AADs) recommended in similar populations per atrial fibrillation (AF) guidelines; however, comparative safety data are limited. Objectives: The goal of this study was to assess the safety of dronedarone vs sotalol for treatment of AF in AAD-naive patients. Methods: This was a prespecified noninterventional meta-analysis of 4 retrospective observational cohort studies from 4 databases (Optum Clinformatics Data Mart, Merative MarketScan, Veterans Health Administration Electronic Health Record, and the Swedish National Patient Register) conducted by using one master protocol. Each analysis emulated the target trial using an active comparator (dronedarone vs sotalol), new user design with an as-treated approach. Primary outcomes were tested hierarchically for dronedarone vs sotalol: first for statistical significance of cardiovascular (CV) hospitalization, and then for statistical significance of ventricular arrhythmias. Propensity score matching (PSM) was used for confounding control, and negative control outcomes were used to assess residual confounding. Outcomes were evaluated by using Cox proportional hazards regression; meta-analysis was performed by using fixed effects models. Results: The dronedarone and sotalol cohorts were well balanced within databases before and after PSM (after PSM mean age range: 62.5-70.9 years; mean CHA2DS2-VASc score range: 1.81-3.15). Negative control outcomes exhibited little-to-no evidence of residual confounding. Meta-analysis found significantly lower rates of CV hospitalization (pooled HR: 0.91; 95% CI: 0.85-0.97) and ventricular arrhythmias (pooled HR: 0.77; 95% CI: 0.69-0.85) with dronedarone vs sotalol. Conclusions: In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF.

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organization
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type
Contribution to journal
publication status
published
subject
keywords
antiarrhythmic drugs, atrial fibrillation, dronedarone, meta-analysis, safety, sotalol
in
JACC: Clinical Electrophysiology
volume
11
issue
7
pages
12 pages
publisher
Elsevier
external identifiers
  • scopus:105003451858
  • pmid:40272320
ISSN
2405-500X
DOI
10.1016/j.jacep.2025.02.029
language
English
LU publication?
yes
id
cb4d473c-9a7a-4ea2-95fd-1a0a1f4a355b
date added to LUP
2025-09-29 13:23:04
date last changed
2025-09-29 14:32:08
@article{cb4d473c-9a7a-4ea2-95fd-1a0a1f4a355b,
  abstract     = {{<p>Background: Dronedarone and sotalol are antiarrhythmic drugs (AADs) recommended in similar populations per atrial fibrillation (AF) guidelines; however, comparative safety data are limited. Objectives: The goal of this study was to assess the safety of dronedarone vs sotalol for treatment of AF in AAD-naive patients. Methods: This was a prespecified noninterventional meta-analysis of 4 retrospective observational cohort studies from 4 databases (Optum Clinformatics Data Mart, Merative MarketScan, Veterans Health Administration Electronic Health Record, and the Swedish National Patient Register) conducted by using one master protocol. Each analysis emulated the target trial using an active comparator (dronedarone vs sotalol), new user design with an as-treated approach. Primary outcomes were tested hierarchically for dronedarone vs sotalol: first for statistical significance of cardiovascular (CV) hospitalization, and then for statistical significance of ventricular arrhythmias. Propensity score matching (PSM) was used for confounding control, and negative control outcomes were used to assess residual confounding. Outcomes were evaluated by using Cox proportional hazards regression; meta-analysis was performed by using fixed effects models. Results: The dronedarone and sotalol cohorts were well balanced within databases before and after PSM (after PSM mean age range: 62.5-70.9 years; mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score range: 1.81-3.15). Negative control outcomes exhibited little-to-no evidence of residual confounding. Meta-analysis found significantly lower rates of CV hospitalization (pooled HR: 0.91; 95% CI: 0.85-0.97) and ventricular arrhythmias (pooled HR: 0.77; 95% CI: 0.69-0.85) with dronedarone vs sotalol. Conclusions: In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF.</p>}},
  author       = {{Singh, Jagmeet P. and Wieloch, Mattias and Reynolds, Shannon L. and Blomström-Lundqvist, Carina and Sandhu, Alex T. and Camm, A. John and Kabadi, Shaum and Pundi, Krishna and Turakhia, Mintu P. and Boiron, Rania and Din, Natasha and Fan, Jun and Heller, Caroline G. and Leeming, Reno C. and McKindley, David S. and Sajedian, Renee M. and Kowey, Peter R.}},
  issn         = {{2405-500X}},
  keywords     = {{antiarrhythmic drugs; atrial fibrillation; dronedarone; meta-analysis; safety; sotalol}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{1531--1542}},
  publisher    = {{Elsevier}},
  series       = {{JACC: Clinical Electrophysiology}},
  title        = {{Dronedarone vs Sotalol Among Patients With Atrial Fibrillation : A Meta-Analysis of Retrospective Observational Databases}},
  url          = {{http://dx.doi.org/10.1016/j.jacep.2025.02.029}},
  doi          = {{10.1016/j.jacep.2025.02.029}},
  volume       = {{11}},
  year         = {{2025}},
}