Can a patient initiate Multaq (dronedarone) without prior cardioversion?

From the Guidelines

Multaq (dronedarone) should not be prescribed without cardioversion for patients with permanent atrial fibrillation, but it can be considered for patients with paroxysmal or persistent atrial fibrillation after cardioversion. The use of Multaq without cardioversion is generally not recommended, especially in patients with significant cardiovascular disease burden, as evidenced by the PALLAS trial 1. In this trial, dronedarone was associated with an increased risk of cardiovascular events, including cardiovascular mortality, in patients with permanent atrial fibrillation. However, for patients with paroxysmal or persistent atrial fibrillation, Multaq can be used to maintain sinus rhythm after cardioversion, as supported by the ATHENA trial 1. The medication is typically prescribed at a dose of 400 mg twice daily with morning and evening meals. It is essential to note that Multaq should only be initiated and supervised by a specialist, such as a cardiologist, and regular monitoring of heart rhythm, liver function, and kidney function is necessary while taking this medication.

Some key points to consider when prescribing Multaq include:

• The patient's specific heart condition, symptoms, and overall health status
• The presence of any contraindications, such as unstable haemodynamic conditions, heart failure, or left ventricular dysfunction
• The need for regular monitoring and follow-up appointments to assess the effectiveness and safety of the medication
• The potential side effects, including gastrointestinal issues, weakness, and skin reactions, and the need to report any adverse effects to the prescribing physician.

Overall, the decision to use Multaq without cardioversion should be made on a case-by-case basis, taking into account the individual patient's needs and medical history, and under the guidance of a specialist 1.

From the FDA Drug Label

MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm. The answer is no, you cannot go on Multaq without cardioversion, as it is contraindicated in patients with permanent atrial fibrillation who will not or cannot be cardioverted into normal sinus rhythm 2.

From the Research

Atrial Fibrillation Treatment with Dronedarone

• Dronedarone, also known as Multaq, is a medication used to treat atrial fibrillation (AF) and prevent the risk of stroke and other cardiovascular events 3, 4, 5, 6.
• The medication works by blocking multiple channels in the heart, which helps to regulate heart rhythm and prevent irregular heartbeats.

Cardioversion and Dronedarone Treatment

• Cardioversion is a medical procedure used to convert an abnormal heart rhythm back to a normal rhythm, and it is often used in conjunction with dronedarone treatment 5.
• Studies have shown that dronedarone can be effective in preventing AF recurrence, regardless of whether cardioversion is performed or not 5.
• In fact, a post-hoc analysis of the EURIDIS and ADONIS trials found that dronedarone was associated with longer median time to first AF/AFL recurrence compared to placebo, regardless of cardioversion status 5.

Initiating Dronedarone Without Cardioversion

• While cardioversion is often used to convert AF to a normal rhythm, it is not always necessary to perform cardioversion before initiating dronedarone treatment 7, 4.
• In some cases, dronedarone may be initiated without cardioversion, especially in patients who are hemodynamically stable and do not have severe symptoms 7.
• However, the decision to initiate dronedarone without cardioversion should be made on a case-by-case basis, taking into account the individual patient's medical history, symptoms, and risk factors 7, 4.

Efficacy and Safety of Dronedarone

• Studies have consistently shown that dronedarone is effective in reducing the risk of cardiovascular events, including stroke and hospitalization due to worsening heart failure or acute coronary syndrome 3, 4, 6.
• Dronedarone has also been shown to be safe and well-tolerated, with a similar safety profile to placebo in clinical trials 3, 5, 6.