Evidence map›Paper›PMID 22082198›Full record

Trial reportThe New England journal of medicine2011

Dronedarone in high-risk permanent atrial fibrillation.

Stuart J Connolly, A John Camm, Jonathan L Halperin, Campbell Joyner, Marco Alings, John Amerena, Dan Atar, Álvaro Avezum, Per Blomström, Martin Borggrefe and 46 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. 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 3 registered trials, which are not on this map. Cited by 178 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
178citing papers in PubMed, 9 pooled it
45.9field-weighted citation impact, top 1% 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.

NCT01151137 phase3terminatednot on this map

A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors

TypeinterventionalSponsorSanofiRan2010 to 2011Enrolled3,236ConditionsAtrial FibrillationArmsDronedarone, Placebo (for Dronedarone)
NCT02575534 nawithdrawnnot on this mapstarted 2015, after this paper: background citation

Acute Mechanical Response to Anti-arrhythmic Drug Therapy

TypeinterventionalSponsorEvan Adelstein, MDRan2015 to 2018Enrolled0ConditionsArrhythmiasArmsProcainamide
NCT05130268 phase4completednot on this mapstarted 2021, after this paper: background citation

Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation

TypeinterventionalSponsorAmerican Heart AssociationRan2021 to 2024Enrolled339ConditionsAtrial FibrillationArmsDronedarone
3 · Its place in the literature

Who cites it

178 citing papers in PubMed, 9 syntheses or guidelines pooled it, 535 citations in OpenAlex.

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118 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

56 authors at 1 institution in 1 country.

Stuart J ConnollyPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, ON L8L 2X2, Canada. connostu@phri.ca
A John Camm
Jonathan L Halperin
Campbell Joyner
Marco Alings
John Amerena
Dan Atar
Álvaro Avezum
Per Blomström
Martin Borggrefe
Andrzej Budaj
Shih-Ann Chen
Chi Keong Ching
Patrick Commerford
Antonio Dans
Jean-Marc Davy
Etienne Delacrétaz
Giuseppe Di Pasquale
Rafael Diaz
Paul Dorian
Greg Flaker
Sergey Golitsyn
Antonio Gonzalez-Hermosillo
Christopher B Granger
Hein Heidbüchel
Josef Kautzner
June Soo Kim
Fernando Lanas
Basil S Lewis
Jose L Merino
Carlos Morillo
Jan Murin
Calambur Narasimhan
Ernesto Paolasso
Alexander Parkhomenko
Nicholas S Peters
Kui-Hian Sim
Martin K Stiles
Supachai Tanomsup
Lauri Toivonen
János Tomcsányi
Christian Torp-Pedersen
Hung-Fat Tse
Panos Vardas
Dragos Vinereanu
Denis Xavier
Jun Zhu
Jun-Ren Zhu
Lydie Baret-Cormel
Estelle Weinling
Christoph Staiger
Salim Yusuf
Susan Chrolavicius
Rizwan Afzal
Stefan H Hohnloser
PALLAS Investigators
Population Health Research Institute · CA

Funding

British Heart Foundation RG/10/11/28457
6 · The paper itself

Abstract

backgroundDronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation.

methodsWe assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death.

resultsAfter the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02).

conclusionsDronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).

Indexed as

AgedAged, 80 and overAmiodaroneAnti-Arrhythmia AgentsAtrial FibrillationAtrial FlutterCardiovascular DiseasesChronic DiseaseDigoxinDouble-Blind MethodDronedaroneDrug Therapy, CombinationFemaleFollow-Up StudiesHeart FailureHeart RateAmiodaroneAnti-Arrhythmia AgentsDigoxinDronedarone

Identifiers

PMID22082198
OpenAlexW2121512872

What OpenQuestion holds

Textmetadata
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.