Evidence map›Paper›PMID 34374766›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2022

Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter.

Anne B Curtis, Emily P Zeitler, Aysha Malik, Andrew Bogard, Nidhi Bhattacharyya, John Stewart, Stefan H Hohnloser

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00174785 (A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00174785 phase3completednot on this map

A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)

TypeinterventionalSponsorSanofiRan2005 to 2008Enrolled4,628ConditionsAtrial Fibrillation, Atrial FlutterArmsdronedarone (SR33589), placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Trial
  2. Effect of dronedarone vs. placebo on atrial fibrillation progression: a post hoc analysis from ATHENA trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Trial
  3. Trial
  4. Article
  5. Practical compendium of antiarrhythmic drugs: a clinical consensus statement of the European Heart Rhythm Association of the European Society of Cardiology.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Review
  6. Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4.Clinical research in cardiology : official journal of the German Cardiac Society · 2025
    Article
  7. Article
  8. Real-world utilization of the pill-in-the-pocket method for terminating episodes of atrial fibrillation: data from the multinational Antiarrhythmic Interventions for Managing Atrial Fibrillation (AIM-AF) survey.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Anne B CurtisDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo General Medical Center, 100 High Street, D2-76, Buffalo, NY 14203, USA.ORCID 0000-0002-9115-8051
Emily P ZeitlerDepartment of Cardiology, Dartmouth-Hitchcock Medical Center, The Dartmouth Institute, Lebanon, NH, USA.
Aysha MalikDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo General Medical Center, 100 High Street, D2-76, Buffalo, NY 14203, USA.
Andrew BogardUS General Medicines Medical, Sanofi, Bridgewater, NJ, USA.
Nidhi BhattacharyyaUS General Medicines Medical, Sanofi, Bridgewater, NJ, USA.
John StewartBiostatistics, Sanofi, Laval, QC, Canada.
Stefan H HohnloserDepartment of Cardiology, J.W. Goethe University, Frankfurt, Germany.
Buffalo General Medical Center · USSanofi (United States) · USDartmouth–Hitchcock Medical Center · USGoethe University Frankfurt · DESanofi (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAge and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF treated with dronedarone vs. placebo. METHODS AND

resultsEfficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65-74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60-0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65-0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64-0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67-0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged <65 years (n = 873), cardiovascular hospitalization or death due to any cause with dronedarone vs. placebo was associated with an HR of 0.89 (95% CI 0.71-1.11; P = 0.3). The incidence of all treatment-emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation was comparable among males and females, and increased with increasing age.

conclusionsThese results support the use of dronedarone for the improvement of clinical outcomes among patients aged ≥65 years and regardless of sex.

Indexed as

AmiodaroneAtrial FibrillationAtrial FlutterAnti-Arrhythmia AgentsDronedaroneFemaleHumansInfant, NewbornMaleAmiodaroneAnti-Arrhythmia AgentsDronedaroneAntiarrhythmic drugAtrial fibrillationCardiovascular outcomesDronedarone

Identifiers

PMID34374766
PMCPMC9681127
OpenAlexW3187665451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.