Key result
Dronedarone prevents atrial fibrillation/flutter recurrences and reduces cardiovascular hospitalizations in high-risk patients, but increases mortality in those with decompensated heart failure.
Why the study?
Does dronedarone safely and effectively prevent recurrences and control rate in patients with atrial fibrillation/flutter?
Does dronedarone safely and effectively prevent recurrences and control rate in patients with atrial fibrillation/flutter?
Dronedarone is an effective front-line antiarrhythmic for rhythm and rate control in AF/AFl, but is strictly contraindicated in patients with advanced heart failure or permanent AF due to increased mortality risk.
Highlights mortality risk with dronedarone in decompensated HF; leaves open its net benefit in evolving AF populations.
Dronedarone is an amiodarone analog but differs structurally from amiodarone in that the iodine moiety was removed and a methane-sulfonyl group was added. These modifications reduced thyroid and other end-organ adverse effects and makes dronedarone less lipophilic, shortening its 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 and slows the ventricular response during AF. Dronedarone is approved in Europe for rhythm and rate control indications. In patients with decompensated heart failure, dronedarone treatment increased mortality and cardiovascular hospitalizations. However, when dronedarone was used in elderly high risk AF/AFl patients excluding such high risk heart failure, cardiovascular hospitalizations were significantly reduced and the drug was approved in the USA for this indication in 2009 by the Food and Drug Administration. Updated guidelines suggest dronedarone as a front-line antiarrhythmic in many patients with AF/Fl but caution that the drug should not be used in patients with advanced heart failure. In addition, the recent results of the PALLAS trial suggest that dronedarone should not be used in the long-term treatment of patients with permanent AF.
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Naccarelli et al. (2011) conducted a review in Atrial Fibrillation/Flutter. Dronedarone was evaluated. Dronedarone prevents atrial fibrillation/flutter recurrences and reduces cardiovascular hospitalizations in high-risk patients, but increases mortality in those with decompensated heart failure.
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