MedPath

Dronedarone

Generic Name
Dronedarone
Brand Names
Multaq
Drug Type
Small Molecule
Chemical Formula
C31H44N2O5S
CAS Number
141626-36-0
Unique Ingredient Identifier
JQZ1L091Y2
Background

Dronedarone is a Class III antiarrhythmic drug that works to restore the normal sinus rhythm in patients with paroxysmal or persistent atrial fibrillation. Atrial fibrillation is a common sustained arrhythmia where the treatment primarily focuses on stroke prevention and symptom management. It is managed by rate control, rhythm control, prevention of thromboembolic events, and treatment of the underlying disease. Similar to amiodarone, dronedarone is a multichannel blocker that works to control rhythm and rate in atrial fibrillation. It meets criteria of all four Vaughan Williams antiarrhythmic drug classes by blocking sodium, potassium, and calcium ion channels and inhibiting β-adrenergic receptors.

Dronedarone is a related benzofuran compound to amiodarone but its chemical structure lacks iodine moieties which are associated with amiodarone-induced thyroid problems. Additionally, the methyl sulfonyl group in its structure renders dronedarone to be more lipophilic with a shorter half-life than amiodarone. This ultimately leads to reduced tissue accumulation of the drug and decreased risk for organ toxicities, such as thyroid and pulmonary toxicities. Commonly marketed as Multaq®, dronedarone was approved by the FDA in July 2009 and Health Canada in August 2009. A safety concern for the risk of drug-induced hepatocellular injury has been issued following marketing of dronedarone.

Indication

Dronedarone is indicated for the management of atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF to reduce the risk of hospitalization.

Associated Conditions
Atrial Fibrillation

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

Phase 3
Not yet recruiting
Conditions
Atrial Fibrillation, Persistent
Interventions
First Posted Date
2023-07-11
Last Posted Date
2023-07-11
Lead Sponsor
Region Örebro County
Target Recruit Count
220
Registration Number
NCT05939076
Locations
🇭🇺

Electrophysiology Department, Heart Institute, University of Pecs, Pecs, Hungary

🇸🇪

Institute of Medicine. Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

🇸🇰

Div. of Arrhythmia and Pacing, National Cardiovascular Institute, Faculty of Medicine, Slovak Medical University, Bratislava, Slovakia

and more 3 locations

Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

Phase 4
Recruiting
Conditions
Atrial Fibrillation
Interventions
Drug: Placebo
First Posted Date
2022-12-19
Last Posted Date
2023-04-13
Lead Sponsor
Shanghai East Hospital
Target Recruit Count
268
Registration Number
NCT05655468
Locations
🇨🇳

Shanghai East Hospital, Shanghai, China

Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
First Posted Date
2022-03-15
Last Posted Date
2024-01-09
Lead Sponsor
Sanofi
Target Recruit Count
87810
Registration Number
NCT05279833
Locations
🇫🇷

Sanofi-Aventis, France, Chilly-Mazarin, France

Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation

Phase 4
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2021-11-23
Last Posted Date
2025-01-28
Lead Sponsor
American Heart Association
Target Recruit Count
339
Registration Number
NCT05130268
Locations
🇺🇸

The MetroHealth System, Cleveland, Ohio, United States

🇺🇸

Golden Touch Clinical Research, Miami, Florida, United States

🇺🇸

The Miami Research Group, Miami, Florida, United States

and more 99 locations

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

Phase 4
Terminated
Conditions
Atrial Fibrillation Recurrent
Atrial Fibrillation
Interventions
First Posted Date
2021-01-11
Last Posted Date
2023-04-10
Lead Sponsor
Tulane University School of Medicine
Target Recruit Count
22
Registration Number
NCT04704050
Locations
🇺🇸

Tulane University School of Medicine, New Orleans, Louisiana, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

🇺🇸

University of Colorado Health Memorial, Colorado Springs, Colorado, United States

and more 1 locations

Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG

Phase 2
Conditions
Postoperative Atrial Fibrillation
Interventions
First Posted Date
2019-04-05
Last Posted Date
2019-04-05
Lead Sponsor
doaa rashwan
Target Recruit Count
48
Registration Number
NCT03905759
Locations
🇪🇬

Faculty Of Medicine, Beni-Suef University, Banī Suwayf, Egypt

Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)

Not Applicable
Conditions
Atrial Fibrillation
Quality of Life
Interventions
First Posted Date
2014-11-19
Last Posted Date
2017-05-09
Lead Sponsor
Uppsala University Hospital
Target Recruit Count
152
Registration Number
NCT02294955
Locations
🇸🇪

Carina Blomström Lundqvist, Uppsala, Sweden

Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Not Applicable
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2013-11-25
Last Posted Date
2013-11-25
Lead Sponsor
Samsung Medical Center
Target Recruit Count
98
Registration Number
NCT01991119
Locations
🇰🇷

Cardiac and Vascular Center, Seoul, Korea, Republic of

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

Phase 2
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2012-01-31
Last Posted Date
2020-11-06
Lead Sponsor
Gilead Sciences
Target Recruit Count
134
Registration Number
NCT01522651
Locations
🇬🇧

Investigational Site, London, England, United Kingdom

Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Not Applicable
Conditions
ICD
ICD SHOCKS
DRONEDARONE
Interventions
First Posted Date
2011-09-08
Last Posted Date
2011-09-08
Lead Sponsor
Rabin Medical Center
Target Recruit Count
20
Registration Number
NCT01430806
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