From the Guidelines
Multaq (dronedarone) 400mg twice daily should be used with caution in patients with atrial fibrillation due to its potential to increase the risk of bradycardia, heart failure, and liver toxicity, as highlighted in the 2022 European Heart Journal review 1.
Safety Concerns
The use of Multaq in patients with atrial fibrillation is associated with several safety concerns, including:
- Increased risk of bradycardia and heart failure, particularly in patients with pre-existing heart disease
- Potential for liver toxicity, which requires regular monitoring of liver function
- Interactions with other medications, such as warfarin, digoxin, and statins, which may require dose adjustments
Patient Selection
Multaq should only be used in patients with paroxysmal or persistent atrial fibrillation who have returned to normal sinus rhythm, and not in patients with permanent atrial fibrillation. It is contraindicated in patients with severe heart failure, recent decompensated heart failure, or left ventricular systolic dysfunction, as it can increase mortality in these populations.
Monitoring and Dose Adjustments
Regular monitoring of liver function, especially during the first six months of treatment, is necessary to minimize the risk of liver toxicity. Patients should also be monitored for signs of bradycardia and heart failure, and the dose of Multaq should be adjusted accordingly. The doses of concomitant medications, such as digoxin and warfarin, should also be reduced upon initiation of Multaq to minimize the risk of interactions.
Alternative Treatments
Multaq is typically a second-line option for the treatment of atrial fibrillation, and other antiarrhythmic medications, such as amiodarone, flecainide, and propafenone, may be preferred due to their more favorable safety profiles, as outlined in the 2011 Circulation guidelines 1.
From the FDA Drug Label
In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure. MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm. The recommended dosage of MULTAQ is 400 mg twice daily in adults
The safety of Multaq 400mg BID for atrial fibrillation is a concern, as it doubles the risk of death, stroke, and hospitalization for heart failure in patients with permanent atrial fibrillation. Additionally, Multaq is contraindicated in patients with permanent atrial fibrillation who will not or cannot be cardioverted into normal sinus rhythm. Therefore, Multaq 400mg BID should be used with caution in patients with atrial fibrillation, and only in those who can 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.
- A study published in the Journal of Atrial Fibrillation found that dronedarone was associated with a lower risk of cardiovascular events, stroke, and congestive heart failure compared to amiodarone in patients without a history of congestive heart failure 3.
- Another study published in Prescrire International noted that dronedarone was better tolerated but less effective than amiodarone in the short term, and that little is known about its potential long-term adverse effects 4.
- A study published in the Journal of the American College of Cardiology found that dronedarone was not associated with an increased risk of mortality or liver disease in patients with atrial fibrillation 5.
- A review of clinical trials and real-world evidence published in Europace found that dronedarone was effective in reducing the risk of hospitalization in patients with paroxysmal or persistent atrial fibrillation, and that its safety profile was similar to other antiarrhythmics 7.
- The same review noted that concerns about liver safety and mortality risk in patients with permanent atrial fibrillation should be balanced against the significant reduction in hospitalizations and low risk of proarrhythmias following dronedarone treatment 7.
Adverse Effects
- Common adverse effects of dronedarone include gastrointestinal disorders, diarrhea, nausea, vomiting, and cutaneous disorders 4.
- Dronedarone has also been associated with a risk of liver toxicity, although recent real-world evidence suggests that this risk is similar to other antiarrhythmics 7.
- The risk of proarrhythmia with dronedarone is low in patients with paroxysmal or persistent atrial fibrillation 7.
Interactions with Other Medications
- Dronedarone has been shown to interact with certain medications, including digoxin, which may increase the risk of mortality 7.
- The safety of combining dronedarone with direct oral anticoagulants such as apixaban, edoxaban, and dabigatran has been evaluated in real-world studies and clinical trials, and no significant safety risks have been found 7.