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, particularly the risk of fatal hepatotoxicity and increased mortality in certain patient populations, as highlighted in the 2022 European Heart Journal review by the European Society of Cardiology working group on cardiovascular pharmacotherapy 1. The safety profile of Multaq is a major concern, with potential adverse effects including bradycardia, AV block, heart failure, hypotension, and anticholinergic effects, as well as cognitive impairment and fatal hepatotoxicity 1.
- Key considerations for Multaq use include:
- Contraindications: permanent atrial fibrillation, severe heart failure (NYHA class IV or recent decompensation), liver or lung toxicity, and QT prolongation
- Monitoring requirements: regular liver function tests, especially during the first six months of treatment, and ECG monitoring to check for QT prolongation
- Potential interactions with other medications, including digoxin, calcium channel blockers, beta-blockers, and statins, which may require dose adjustments In light of these concerns, alternative treatments for atrial fibrillation, such as beta-blockers or non-dihydropyridine calcium channel blockers, may be preferred, as they have a more favorable safety profile and are recommended as first-line rate control agents in the 2016 ESC guidelines for the management of atrial fibrillation 1.
- The 2016 ESC guidelines suggest that beta-blockers, such as bisoprolol or metoprolol, or non-dihydropyridine calcium channel blockers, such as diltiazem or verapamil, may be used for rate control in atrial fibrillation, with careful consideration of potential side effects and contraindications 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 and efficacy of dronedarone, the active ingredient in Multaq, have been evaluated in several studies 3, 4, 5, 6, 7.
- Dronedarone has been shown to be associated with a lower risk of mortality and liver disease compared to other antiarrhythmic drugs 5.
- However, it has also been found to be less effective than amiodarone in maintaining normal sinus rhythm 3, 6, 7.
- The most common adverse effects of dronedarone include gastrointestinal disorders, diarrhea, nausea, vomiting, and cutaneous disorders 3.
- Dronedarone is contraindicated in severe or deteriorating heart failure 6.
- The ATHENA trial showed that dronedarone significantly reduced the incidence of hospitalization due to cardiovascular events or death in high-risk patients with atrial fibrillation 6.
- A study comparing the effectiveness of antiarrhythmic drugs for rhythm control of atrial fibrillation found that amiodarone, class 1C agents, and sotalol were more effective than dronedarone 4.
Efficacy of Multaq 400mg BID for Atrial Fibrillation
- Dronedarone has been shown to be effective in reducing the risk of hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter and other cardiovascular risk factors 6, 7.
- However, its efficacy is lower than that of amiodarone, and it is not recommended for patients with severe or unstable congestive heart failure 3, 6, 7.
- The DIONYSOS trial found that dronedarone was less efficient than amiodarone in maintaining normal sinus rhythm 6.
Comparison with Amiodarone
- Dronedarone is a safer alternative to amiodarone, with fewer adverse effects 3, 7.
- However, it is less effective than amiodarone in maintaining normal sinus rhythm 3, 6, 7.
- A study comparing the two drugs found that amiodarone had a higher success rate in preventing atrial fibrillation recurrence, but was associated with more adverse effects 3.