What is the use of Multaq (dronedarone)?

From the Guidelines

Multaq (dronedarone) is used for the maintenance of sinus rhythm in patients with atrial fibrillation (AF), specifically those with paroxysmal or persistent AF, and to prevent recurrence and progression of AF.

Key Indications

• Paroxysmal or persistent AF: Dronedarone is recommended for patients with paroxysmal or persistent AF, including those with heart failure with mid-range ejection fraction (HFmrEF), heart failure with preserved ejection fraction (HFpEF), ischemic heart disease, or valvular disease 1.
• Cardiovascular risk factors: Dronedarone is also indicated for patients with AF and cardiovascular risk factors, such as those with a history of heart failure, coronary artery disease, or stroke 1.

Important Considerations

• Contraindications: Dronedarone is contraindicated in patients with permanent AF, recently decompensated heart failure, or unstable hemodynamic conditions 1.
• Monitoring: Patients treated with dronedarone should be monitored by a specialist, and the drug should not be initiated in general or family practice 1.
• Dose: The recommended dose of dronedarone is 400 mg twice daily 1.

Clinical Evidence

• ATHENA trial: The ATHENA trial demonstrated that dronedarone significantly reduced the risk of cardiovascular hospitalization or death in patients with paroxysmal or persistent AF and cardiovascular risk factors 1.
• PALLAS trial: The PALLAS trial showed that dronedarone increased the risk of cardiovascular events, including cardiovascular mortality, in patients with permanent AF, leading to a contraindication for its use in this population 1.

From the FDA Drug Label

INDICATIONS AND USAGE MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF

The use of Multaq (dronedarone) is to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF 2.

Key points:

• Indication: Reduce the risk of hospitalization for AF
• Patient population: Patients in sinus rhythm with a history of paroxysmal or persistent AF
• Mechanism: Antiarrhythmic drug

From the Research

Use of Multaq (Dronedarone)

• Dronedarone is an antiarrhythmic agent used for the reduction of cardiovascular-related hospitalizations in patients with paroxysmal or persistent atrial fibrillation or atrial flutter 3.
• It is a derivative of amiodarone, modified to reduce organ toxicities, and exerts its antiarrhythmic effects through multichannel blockade of sodium, potassium, and calcium channels, as well as antiadrenergic activity 3, 4.
• The efficacy of dronedarone for maintaining sinus rhythm, ventricular rate control, and reducing cardiovascular-related hospitalizations has been demonstrated in several randomized, placebo-controlled trials 3, 5.
• Dronedarone has been shown to reduce the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation, with a hazard ratio of 0.76 (95% confidence interval [CI], 0.69 to 0.84; P<0.001) 5.
• The drug is generally well-tolerated, with common adverse events including gastrointestinal events, bradycardia, QT-interval prolongation, and increased serum creatinine level 3, 5.
• However, dronedarone should be avoided in patients with New York Heart Association class IV or II-III heart failure with a recent decompensation, due to a possible increase in mortality 3, 6.

Clinical Use

• Dronedarone is approved for the maintenance of sinus rhythm in patients with nonpermanent atrial fibrillation (AF) 6.
• It is used to decrease the incidence of AF recurrence and the ventricular rate during recurrence, as well as to decrease rates of cardiovascular hospitalizations in patients with paroxysmal and persistent AF 6.
• Dronedarone is less effective than amiodarone but also has less toxicity, and direct comparison with other antiarrhythmic drugs is not available 6.
• The European Society of Cardiology lists dronedarone as an antiarrhythmically effective substance, which can be administered before catheter ablation 7.