Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2025 Jul;11(7):1531-1542.
doi: 10.1016/j.jacep.2025.02.029. Epub 2025 Apr 23.

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

Jagmeet P Singh  1 , Mattias Wieloch  2 , Shannon L Reynolds  3 , Carina Blomström-Lundqvist  4 , Alex T Sandhu  5 , A John Camm  6 , Shaum Kabadi  7 , Krishna Pundi  8 , Mintu P Turakhia  5 , Rania Boiron  9 , Natasha Din  10 , Jun Fan  10 , Caroline G Heller  7 , Reno C Leeming  3 , David S McKindley  7 , Renee M Sajedian  3 , Peter R Kowey  11
Affiliations
Free article
Meta-Analysis

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

Jagmeet P Singh et al. JACC Clin Electrophysiol. 2025 Jul.
Free article

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 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.

Keywords: antiarrhythmic drugs; atrial fibrillation; dronedarone; meta-analysis; safety; sotalol.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures Funding for the conduct of this study and medical writing of the manuscript was provided by Sanofi. Sanofi had a role in the study design, interpretation of data, writing of the manuscript, and decision to publish. Dr Singh has received consultation fees from Abbott, Biosense Webster, Biotronik Inc, Boston Scientific, Cardiac Rhythm Group, Cardiologs Inc, CVRx Inc, EBR Inc, Impulse Dynamics, Implicity Inc, Medtronic Inc, Medscape Inc, Microport Inc, Orchestra Biomed, and Sanofi. Drs Wieloch, Kabadi, Boiron, and McKindley and Ms Heller are employees of Sanofi and may hold shares and/or stock options in the company. Ms Reynolds, Ms Heller, Dr Leeming, and Ms Sajedian are current or former employees at Aetion, which received funding for the conduct of this study and medical writing of the manuscript from Sanofi. Ms Reynolds, Ms Heller, and Ms Sajedian hold stock options in Aetion. Dr Blomström-Lundqvist has received personal fees from Abbott, Bayer, Boston Scientific, CathPrint, Johnson & Johnson, Medtronic Inc, Milestone, Organon, Sanofi, and Philips. Dr Camm has received personal fees from Abbott, Anthos, Bayer, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Medtronic Inc, Menarini, Milestone, and Sanofi. Dr Sandhu has received consultation fees from Lexicon Pharmaceuticals and Reprieve Cardiovascular. Dr Pundi has received grants or personal fees from 100Plus, the American College of Cardiology, the American Heart Association, Evidently, and iRhythm Technologies Inc. Dr Turakhia has received grants or personal fees from the American Heart Association, Apple, Bayer, Bristol Myers Squibb, FDA, Gilead Sciences, Johnson & Johnson, Medtronic Inc, Myokardia, Pfizer, and Sanofi; is a shareholder of AliveCor, Connect America, Evidently, Forward, iRhythm, and PocketRN; and is an employee of iRhythm Technologies, Inc. Dr Kowey has received consultation fees from Sanofi. Ms Din and Mr Fan have reported that they have no relationships relevant to the contents of this paper to disclose.

MeSH terms

LinkOut - more resources