What is the safety of Multaq (dronedarone) 400mg twice daily (BID) for atrial fibrillation?

From the Guidelines

Multaq (dronedarone) 400mg twice daily is not recommended as a first-line treatment for atrial fibrillation due to its significant safety concerns, as highlighted in the European Heart Journal study 1. The study emphasizes the importance of careful consideration when prescribing antiarrhythmic drugs, especially in older adults, due to the risk of adverse effects such as bradycardia, atrioventricular block, and hepatotoxicity. Given the potential risks, alternative rhythm control options with better safety profiles, such as flecainide, propafenone, sotalol, or amiodarone, should be considered depending on the patient's cardiac structure and comorbidities 1. Additionally, rate control strategies using beta-blockers, calcium channel blockers, or digoxin may be more appropriate for many patients, as recommended by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 1. Some key points to consider when managing atrial fibrillation include:

• Monitoring liver function and ECG for patients taking antiarrhythmic medications
• Avoiding the use of certain medications, such as quinidine, due to the risk of QT prolongation and torsades de pointes
• Considering the patient's age, cardiac structure, and comorbidities when selecting a treatment option
• Weighing the effectiveness of a treatment against its potential risks and side effects, as seen with Multaq (dronedarone) 1.

From the FDA Drug Label

WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure; MULTAQ doubles the risk of death. In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm.

The safety of Multaq 400mg BID for atrial fibrillation is a concern due to the increased risk of:

• Death
• Stroke
• Heart failure in patients with decompensated heart failure or permanent atrial fibrillation. Multaq is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure, and in patients in atrial fibrillation who will not or cannot be cardioverted into normal sinus rhythm 2.

From the Research

Safety of Multaq 400mg BID for Atrial Fibrillation

• The safety of Multaq (dronedarone) 400mg BID for atrial fibrillation has been evaluated in several studies 3, 4, 5, 6, 7.
• Dronedarone has been approved by the FDA for oral treatment of atrial fibrillation and flutter, and is considered to have a better safety profile compared to amiodarone, although it is less effective 3, 5.
• Common adverse effects of dronedarone include gastrointestinal disorders, diarrhea, nausea, vomiting, and cutaneous disorders 4.
• Dronedarone has also been associated with an increased risk of mortality in some studies, although this risk is still being evaluated 4.
• The safety of dronedarone in patients with renal impairment has been evaluated in several post hoc analyses, which suggest that the drug is effective and safe in patients with atrial fibrillation and chronic kidney disease 6, 7.
• However, treatment-emergent adverse events leading to treatment discontinuation were more frequent with dronedarone versus placebo in patients with severe renal impairment 6.
• Overall, the available evidence suggests that dronedarone 400mg BID is a safe and effective treatment option for atrial fibrillation, although patients should be closely monitored for potential adverse effects 3, 4, 5, 6, 7.

Efficacy and Safety in Renal Impairment

• The efficacy and safety of dronedarone in patients with renal impairment have been evaluated in several post hoc analyses 6, 7.
• These analyses suggest that dronedarone is effective and safe in patients with atrial fibrillation and chronic kidney disease, although the risk of adverse events may be higher in patients with severe renal impairment 6, 7.
• The available evidence suggests that dronedarone can be used in patients with renal impairment, although close monitoring is recommended to minimize the risk of adverse effects 6, 7.

Comparison to Other Antiarrhythmic Drugs

• Dronedarone has been compared to other antiarrhythmic drugs, including amiodarone, in several studies 3, 4, 5.
• These studies suggest that dronedarone has a better safety profile compared to amiodarone, although it is less effective 3, 5.
• The available evidence suggests that dronedarone is a safe and effective treatment option for atrial fibrillation, although the choice of antiarrhythmic drug should be individualized based on patient characteristics and medical history 3, 4, 5.