From the Guidelines
Multaq (dronedarone) 400mg twice daily should not be used in patients with permanent atrial fibrillation or significant cardiovascular disease burden due to increased risk of cardiovascular events and mortality, as evidenced by the PALLAS trial 1. When considering the use of Multaq for atrial fibrillation management, it is crucial to assess the patient's specific condition and medical history. For patients with paroxysmal or persistent atrial fibrillation, Multaq may be considered after cardioversion, under the supervision of a specialist familiar with antiarrhythmic drugs 1. The medication has been shown to reduce cardiovascular outcome events, including unplanned cardiovascular hospitalizations and all-cause mortality, in patients at moderate risk for cardiovascular events, as demonstrated in the ATHENA trial 1. However, the benefits and risks must be carefully weighed, particularly in patients with a history of heart failure or left ventricular dysfunction, as these conditions are contraindications for Multaq use 1.
Key considerations for Multaq use include:
- Contraindications: unstable haemodynamic conditions, history of or current heart failure, left ventricular dysfunction, permanent atrial fibrillation, and significant liver or lung disease 1
- Common side effects: gastrointestinal issues, weakness, and skin reactions
- Serious concerns: potential liver injury, lung toxicity, and QT interval prolongation
- Regular monitoring requirements: liver function tests, ECGs, and kidney function assessment
- Drug interactions: avoidance of grapefruit products and certain medications that interact with Multaq
- Administration: take with morning and evening meals to improve absorption
In summary, while Multaq can be effective in managing atrial fibrillation in certain patients, its use must be approached with caution, and careful consideration of the patient's individual risk factors and medical history is essential to minimize the risk of adverse events 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 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 due to the increased risk of:
- Death
- Stroke
- Heart failure in patients with permanent atrial fibrillation. Multaq is contraindicated in patients with permanent atrial fibrillation who will not or cannot be cardioverted into normal sinus rhythm 2. It is essential to carefully evaluate the patient's condition and consider the potential risks before initiating Multaq therapy. Key considerations include:
- Cardioversion: Patients should be cardioverted into normal sinus rhythm before starting Multaq.
- Monitoring: Patients treated with Multaq should undergo monitoring of cardiac rhythm no less often than every 3 months.
- Contraindications: Multaq is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms, and in patients with permanent 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 compared to other antiarrhythmic drugs in several studies 3, 4, 5, 6.
- Dronedarone was designed to cause fewer adverse effects than amiodarone, and studies have shown it to be safer but less effective 3.
- A real-world investigation found no significant differences in the hazard ratios of cardiovascular events, stroke, congestive heart failure, interstitial lung disease, and acute liver injury between dronedarone and other antiarrhythmics, except that amiodarone was associated with a higher risk of cardiovascular events and stroke 4.
- Another study found that dronedarone could be an alternative therapy option with a lower risk of cardiovascular events than amiodarone for patients without a history of congestive heart failure 4.
- A comparative effectiveness study found that amiodarone, class 1C agents, and sotalol were more effective for rhythm control than dronedarone, but the risk of stroke was similar among all groups 5.
- A study comparing the safety of sotalol versus amiodarone in patients with atrial fibrillation and coronary artery disease found that sotalol was associated with an increased risk of all-cause death compared to no drug, but a decreased risk of death compared to amiodarone 6.
Comparison to Other Antiarrhythmic Drugs
- Dronedarone has been compared to amiodarone, sotalol, flecainide, and propafenone in terms of safety and effectiveness 4, 5, 6.
- Amiodarone was associated with a higher risk of cardiovascular events, stroke, and congestive heart failure than dronedarone in patients without a history of congestive heart failure 4.
- Sotalol was associated with an increased risk of all-cause death compared to no drug, but a decreased risk of death compared to amiodarone 6.
- Class 1C agents were associated with lower rates of admissions for atrial fibrillation and all-cause mortality compared to dronedarone 5.