Why the study?
Does dronedarone improve outcomes in patients with atrial fibrillation/flutter?
Does dronedarone improve outcomes in patients with atrial fibrillation/flutter?
Dronedarone is an effective front-line antiarrhythmic for AF/AFl but is contraindicated in patients with advanced heart failure or permanent AF due to increased mortality and cardiovascular hospitalizations.
May warrant avoiding dronedarone in decompensated HF or permanent AF; leaves open its comparative role in other AF populations.
Dronedarone is an amiodarone analog that differs structurally from amiodarone in that the iodine moiety was removed and a methane-sulfonyl group was added. These modifications reduce thyroid and other end-organ adverse effects and makes dronedarone less lipophilic, with a shorter half-life. Dronedarone has been shown to prevent atrial fibrillation/ flutter (AF/AFl) recurrences in several multi-center trials. In addition to its rhythm control properties, dronedarone has rate control properties. In patients with decompensated heart failure, dronedarone treatment increased mortality and cardiovascular hospitalizations. When dronedarone was used in elderly high risk AF/AFl patients, excluding those with advanced heart failure, cardiovascular hospitalizations were significantly reduced. The results of the PALLAS trial suggest that dronedarone should not be used in the long-term treatment of patients with permanent AF. Post-marketing data have demonstrated rare hepatic toxicity to be associated with dronedarone use. Updated practice and regulatory guidelines have positioned dronedarone as a front-line antiarrhythmic in many patients with AF/Fl. However, the drug should not be used in patients with advanced heart failure and in patients who develop permanent AF.
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Naccarelli et al. (2014) studied this question.
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