Is Multaq (dronedarone) contraindicated in cardiomyopathy without congestive heart failure (CHF)?

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Last updated: April 3, 2025View editorial policy

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From the Guidelines

Multaq (dronedarone) is contraindicated in patients with cardiomyopathy without CHF if they have a history of or current heart failure or left ventricular dysfunction, as it may increase the risk of cardiovascular events and mortality. The European Medicines Agency has updated the contraindications for dronedarone to include patients with unstable haemodynamic conditions, a history of (or current) heart failure or left ventricular dysfunction 1. Although cardiomyopathy without CHF may not be explicitly listed as a contraindication, the presence of left ventricular dysfunction or a history of heart failure would warrant caution and potentially contraindicate the use of Multaq.

The ATHENA trial demonstrated the efficacy of dronedarone in reducing cardiovascular hospitalizations and death in patients with paroxysmal or persistent atrial fibrillation, but the PALLAS trial showed an increased risk of cardiovascular events in patients with permanent atrial fibrillation 1. The ANDROMEDA trial was stopped prematurely due to increased mortality with dronedarone in patients with advanced heart failure 1. These trials highlight the importance of careful patient selection and monitoring when using dronedarone.

Key considerations for the use of Multaq in patients with cardiomyopathy without CHF include:

  • Close monitoring for development of heart failure symptoms
  • Regular cardiac evaluations, including ECGs and assessment of cardiac function
  • Caution in patients with left ventricular dysfunction or a history of heart failure
  • Typical dosage of 400 mg twice daily with meals
  • Potential for increased risk of cardiovascular events and mortality in certain patient populations 1.

From the Research

Multaq Contraindications

  • The studies provided do not directly address the contraindication of Multaq in cardiomyopathy without CHF.
  • However, the studies suggest that dronedarone (Multaq) should be contraindicated in patients with NYHA class IV or unstable NYHA classes II and III CHF, as indicated in the study 2.
  • Additionally, the study 3 found that dronedarone reduced the risk of cardiovascular events in patients with atrial fibrillation and heart failure with preserved or mildly reduced ejection fraction, but did not specifically address cardiomyopathy without CHF.
  • The other studies 4, 5, and 6 discuss the efficacy and safety of dronedarone in treating atrial fibrillation, but do not provide information on its use in cardiomyopathy without CHF.

Key Findings

  • Dronedarone is associated with reduced cardiovascular events in patients with atrial fibrillation and heart failure with preserved or mildly reduced ejection fraction 3.
  • Dronedarone should be contraindicated in patients with NYHA class IV or unstable NYHA classes II and III CHF 2.
  • The studies do not provide direct evidence on the contraindication of Multaq in cardiomyopathy without CHF.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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