The Dos and Don’ts of Dronedarone

Volume 12, Issue 1

Atrial fibrillation (AF) remains the most common dysrhythmia in the United States, with an incidence that continues to rise as the population ages. Many antiarrhythmic medications are available to restore sinus rhythm, although toxicity can limit the effective use of these agents. As a result, AF ablation is becoming a more common modality for restoring sinus rhythm in patients with symptomatic disease.

In this week’s issue of Talking Therapeutics, we discuss a recent trial looking at 2 different antiarrhythmic drug therapies after AF ablation.

Dronedarone Dos: Consider Use After AF Ablation

A recent paper in the Journal of the American Heart Association looked at dronedarone vs sotalol in patients undergoing AF catheter ablation.

The retrospective cohort study involved 1815 patients receiving dronedarone matched with a cohort receiving sotalol. Researchers conducted a comparative analysis using the IBM MarketScan Research Databases for propensity-score matching.

“Risk of cardiovascular hospitalization was lower with dronedarone versus sotalol at 3 months (adjusted hazard ratio [aHR], .77 [95% CI, .61-.97]), 6 months (aHR, .76 [95% CI, .63-.93]), and 12 months after ablation (aHR, .7 [95% CI, .66-.93]),” authors found.

Both groups had similar risk of repeat ablation and cardioversion, but authors noted a lower risk of proarrhythmia in the dronedarone cohort at 3 months (aHR, .76 [95% CI, .64-.9]), 6 months (aHR, .8 [95% CI, .70-.93]), and 12 months (aHR, .83 [95% CI, .73-.94]) after ablation.

This finding was particularly noteworthy in light of some of the prior analysis, which segues into my next talking point nicely….

Dronedarone Don’ts: Use in Heart Failure or Permanent AF

The prior studies with dronedarone in AF haven’t always been pretty.

The ANDROMEDA study in patients with heart failure found that overall mortality was more than double in the dronedarone group compared with placebo (8.1% vs. 3.8%, HR, 2.13 (95% CI 1.07-4.25, P = .03), mostly due to an increase in cardiovascular mortality.

Subsequently, the PALLAS trial was conducted in patients with permanent AF and found that there were excessive cardiovascular deaths in the dronedarone group vs placebo, including more deaths from arrhythmia (HR, 3.26; 95% CI, 1.06-10; P = .03).

Taken together, these 2 points paint a picture of a narrow window of use for dronedarone. While the new data suggesting efficacy after AF ablation are encouraging, we must take caution and avoid the use of this drug in patients with heart failure or those who progress to permanent AF.