From the Guidelines
Dronedarone is contraindicated in patients with heart failure exacerbation, particularly those with New York Heart Association (NYHA) Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a heart failure specialist. This recommendation is based on the evidence from the ANDROMEDA trial, which showed that dronedarone may derive harm in patients with moderate-to-severe congestive heart failure 1. The 2012 focused update of the ESC guidelines for the management of atrial fibrillation also states that dronedarone should not be given to patients with moderate or severe heart failure, and should be avoided in patients with less-severe heart failure if appropriate alternatives exist 1.
The contraindication exists because dronedarone has been shown to increase the risk of death and cardiovascular hospitalization in patients with severe heart failure, likely due to its negative inotropic effects, which can further depress cardiac function in already compromised hearts 1. Additionally, dronedarone can interact with other heart failure medications, potentially leading to adverse effects.
For patients with heart failure exacerbation who require antiarrhythmic therapy, alternative medications such as amiodarone or dofetilide may be considered under careful medical supervision. However, the specific choice depends on the individual patient's condition and should be determined by a cardiologist. Patients with stable NYHA Class I or II heart failure may be able to use dronedarone, but it should be used with caution and close monitoring.
Key points to consider when using dronedarone in patients with heart failure include:
- Avoiding its use in patients with moderate or severe heart failure
- Using alternative medications in patients with heart failure exacerbation
- Close monitoring of patients with stable NYHA Class I or II heart failure who are taking dronedarone
- Considering the potential interactions between dronedarone and other heart failure medications.
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 5.1 Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure MULTAQ is contraindicated in patients with NYHA Class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization because it doubles the risk of death. 5. 4 New Onset or Worsening Heart Failure New onset or worsening of heart failure has been reported during treatment with MULTAQ in the postmarketing setting
Dronedarone (Multaq) is contraindicated in exacerbation of heart failure, specifically in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure, as it doubles the risk of death 2.
From the Research
Dronedarone Contraindications
- 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 requiring hospitalization or referral to a specialized heart failure clinic 3, 4, 5, 6, 7
- The ANDROMEDA trial showed that dronedarone was associated with increased mortality in patients with NYHA III/IV heart failure and left ventricular ejection fractions of less than 35% who had a recent hospitalization for decompensated heart failure 5, 6
- The ATHENA trial, on the other hand, showed that dronedarone reduced cardiovascular hospitalizations in patients with paroxysmal or persistent atrial fibrillation/atrial flutter, but excluded high-risk patients with heart failure 5, 7
Heart Failure and Dronedarone
- Dronedarone should be avoided in patients with NYHA class IV or II-III heart failure with a recent decompensation 3
- A post-hoc analysis of the ATHENA trial showed that dronedarone did not increase mortality and reduced cardiovascular hospitalization or death in patients with stable congestive heart failure, but this does not apply to patients with unstable heart failure 7
- Dronedarone is contraindicated in patients with severe or deteriorating heart failure, as shown in the ANDROMEDA trial 6