Is Multaq (dronedarone) contraindicated in Congestive Heart Failure (CHF)?

From the Guidelines

Multaq (dronedarone) is contraindicated in patients with congestive heart failure (CHF), particularly in those with current or recent decompensated heart failure requiring hospitalization or NYHA Class IV heart failure. This contraindication is based on clinical evidence showing increased mortality in heart failure patients taking dronedarone, as seen in the ANDROMEDA trial, which was terminated early due to increased deaths in the dronedarone group 1. The medication can worsen heart failure by its negative inotropic effects, which decrease cardiac contractility. Key points to consider include:

• The ANDROMEDA trial's early termination due to increased mortality in the dronedarone group 1
• The potential for dronedarone to worsen heart failure through its negative inotropic effects
• The importance of careful clinical judgment and close monitoring when considering dronedarone for patients with stable, compensated heart failure (NYHA Class I-II)
• The need for immediate discontinuation of dronedarone if a patient develops heart failure or experiences worsening of existing heart failure
• The recommendation against using dronedarone in patients with an EF ≤40% due to safety concerns, including increased risk of hospital admission for cardiovascular causes and premature death 1. Healthcare providers should evaluate cardiac function before initiating dronedarone and monitor patients regularly during treatment for signs of heart failure development or progression.

From the FDA Drug Label

MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. MULTAQ doubles the risk of death in these patients (4,5.1,14. 3). In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure; MULTAQ doubles the risk of death.

Multaq is contraindicated in CHF with recent decompensation requiring hospitalization or NYHA Class IV symptoms 2, 2.

From the Research

Multaq Contraindication in CHF

• Multaq (dronedarone) is contraindicated in patients with New York Heart Association (NYHA) class IV heart failure or NYHA class II-III heart failure with a recent decompensation 3, 4.
• The ANDROMEDA trial and a case report suggest that dronedarone should be used cautiously in patients with heart failure and avoided in patients with a history of heart failure 5, 4.
• A post-hoc analysis of the ATHENA trial found that dronedarone did not increase mortality and showed a reduction of cardiovascular hospitalization or death in patients with atrial fibrillation and stable congestive heart failure (CHF) 4.
• However, the study also noted that dronedarone should be contraindicated in patients with NYHA class IV or unstable NYHA classes II and III CHF 4.
• Another study found that short-term treatment with dronedarone did not affect exercise capacity and did not decrease left ventricular ejection fraction (LVEF) in patients with severe left ventricular dysfunction and compensated stable heart failure 6.
• A real-world investigation 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 CHF 7.