Evidence mapPaperPMID 41865291Full record

Trial reportJournal of cardiovascular electrophysiology2026

Efficacy and Safety of Dronedarone in Overweight and Obesity: Post Hoc Analysis of the ATHENA Trial.

Mate Vamos, Anna Vagvolgyi, David S McKindley, Stefan H Hohnloser

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of cardiovascular electrophysiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
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

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mate VamosDepartment of Internal Medicine, Cardiology Center, University of Szeged, Szeged, Hungary.ORCID 0000-0003-1611-4443
Anna VagvolgyiDepartment of Internal Medicine, Endocrinology and Diabetology Center, University of Szeged, Szeged, Hungary.ORCID 0000-0002-8810-700X
David S McKindleySanofi, Morristown, New Jersey, USA.
Stefan H HohnloserDepartment of Cardiology, J. W. Goethe University, Frankfurt am Main, Germany.

Funding

Sanofi
6 · The paper itself

Abstract

introductionObesity represents a prevalent condition with multiple comorbidities, including atrial fibrillation (AF). Dronedarone, an antiarrhythmic drug (AAD), has demonstrated efficacy in patients with paroxysmal/persistent AF and cardiovascular (CV) risk factors. We aimed to evaluate the efficacy and safety of dronedarone in patients with AF across body mass index (BMI) categories. METHODS AND

resultsA post hoc analysis of data from the randomized, double-blind ATHENA trial (NCT00174785), which compared dronedarone with placebo, was conducted across the following BMI categories: normal/underweight ( < 25 kg/m²), overweight (25-30 kg/m²), and obese ( > 30 kg/m²). The primary outcome was time to first CV hospitalization or death from any cause. Treatment-emergent adverse events (TEAEs) were also assessed. Of 4628 patients, 25% (n = 1143) had BMI < 25 kg/m², 43% (n = 1996) had BMI 25-30 kg/m², and 32% (n = 1489) had BMI > 30 kg/m². Compared with placebo, dronedarone significantly reduced the risk of first CV hospitalization or death across all BMI groups with hazard ratios (HRs) ranging from 0.639 (95% confidence interval [CI] 0.524-0.780) to 0.818 (95% CI 0.691-0.968); no interaction by BMI was noted (p = 0.142). Risk of first hospitalization due to AF recurrence was lower in all BMI groups with dronedarone. All-cause mortality was significantly reduced in normal/underweight patients (HR 0.551 [95% CI 0.353-0.861]), but not in those who had overweight (HR 0.976 [95% CI 0.655-1.453]) or obesity (HR 1.184 [95% CI 0.742-1.889])(p for interaction=0.048). Incidences of serious TEAEs showed no apparent association with increasing BMI. TEAEs leading to discontinuation (primarily gastrointestinal) were more frequent with dronedarone.

conclusionDronedarone is an effective AAD for patients with AF across a range of BMI categories with a manageable safety profile.

trial registrationNCT00174785.

Indexed as

AmiodaroneAnti-Arrhythmia AgentsAtrial FibrillationObesityOverweightAgedBody Mass IndexDouble-Blind MethodDronedaroneFemaleHospitalizationHumansMaleMiddle AgedRisk FactorsTime FactorsAmiodaroneAnti-Arrhythmia AgentsDronedaroneantiarrhythmic drugATHENAatrial fibrillationbody mass indexdronedaroneobesity

Identifiers

PMID41865291
PMCPMC13182219

What Socratic holds

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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 Socratic graph.