What is the safety of Multaq (dronedarone) for atrial fibrillation?

From the Guidelines

Multaq (dronedarone) 400mg BID is generally considered safe for the treatment of atrial fibrillation, but its use is contraindicated in patients with permanent atrial fibrillation, unstable haemodynamic conditions, or a history of heart failure.

Safety Profile

• The safety of Multaq has been established through several clinical trials, including the ATHENA trial, which demonstrated a significant reduction in cardiovascular hospitalizations and all-cause mortality 1.
• Dronedarone has a more favorable safety profile compared to other antiarrhythmic medications, such as amiodarone, with lower rates of thyroid and liver toxicity 1.
• However, the PALLAS trial showed that dronedarone increased mortality in patients with permanent atrial fibrillation, and its use is therefore contraindicated in this population 1.

Efficacy

• Dronedarone has been shown to be effective in maintaining sinus rhythm and reducing the risk of stroke and other cardiovascular events in patients with paroxysmal or persistent atrial fibrillation 1.
• The recommended dosage of 400mg twice daily has been shown to be effective in reducing the risk of cardiovascular events and improving symptoms in patients with atrial fibrillation 1.

Key Considerations

• Patients with permanent atrial fibrillation should not be treated with dronedarone, particularly those with a significant cardiovascular disease burden 1.
• Dronedarone should only be initiated and monitored by a specialist, such as a cardiologist or hospital-based staff familiar with the use of antiarrhythmic drugs 1.
• The European Summary of Product Characteristics for dronedarone advises that it should not be initiated in general or family practice, and subsequent monitoring should include input from an appropriate specialist 1.

From the FDA Drug Label

Safety of Multaq (dronedarone) for Atrial Fibrillation

Overview of Multaq

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

Key Points

• Multaq is indicated for patients with a history of paroxysmal or persistent atrial fibrillation (AF)
• The drug is used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm
• Clinical studies have been conducted to evaluate the efficacy of Multaq in reducing the risk of hospitalization for atrial fibrillation 2

Indications and Usage

The indications and usage of Multaq are as follows:

Indication	Patient Population
Reduce the risk of hospitalization for atrial fibrillation	Patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF)

Note: The safety and efficacy of Multaq have been evaluated in clinical studies, as mentioned in the drug label 2.

From the Research

Safety of Multaq (Dronedarone) for Atrial Fibrillation

The safety of Multaq (dronedarone) for atrial fibrillation has been evaluated in several studies.

• Dronedarone is considered a moderately efficacious anti-arrhythmic agent that is safe for use in a carefully selected patient population, maintained in normal sinus rhythm, without advanced congestive heart failure, structural heart disease, permanent atrial fibrillation, or digoxin use 3.
• A comparison of dronedarone and amiodarone in patients with atrial fibrillation after catheter ablation found that the incidence of adverse drug events (ADE) was higher in the dronedarone group than in the amiodarone group, with gastrointestinal events being the most common ADE in the dronedarone group 4.
• However, dronedarone has been shown to increase rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who are at risk for major vascular events, and should not be used in such patients 5.

Patient Selection

The safety of dronedarone for atrial fibrillation depends on careful patient selection.

• Dronedarone is suitable for patients who are maintained in normal sinus rhythm, without advanced congestive heart failure, structural heart disease, permanent atrial fibrillation, or digoxin use 3.
• Patients with permanent atrial fibrillation who are at risk for major vascular events should not be treated with dronedarone due to the increased risk of heart failure, stroke, and death from cardiovascular causes 5.

Adverse Events

The adverse events associated with dronedarone for atrial fibrillation include:

• Gastrointestinal events, which were the most common adverse drug event in the dronedarone group in one study 4.
• Heart failure, stroke, and death from cardiovascular causes, which were increased in patients with permanent atrial fibrillation who were at risk for major vascular events 5.