Key result
Dronedarone reduces hospitalizations and death in paroxysmal or persistent atrial fibrillation, though it may cause adverse events in patients with permanent atrial fibrillation or heart failure.
Why the study?
Does dronedarone improve patient-relevant outcomes such as hospitalization and death in patients with atrial fibrillation?
Does dronedarone improve patient-relevant outcomes such as hospitalization and death in patients with atrial fibrillation?
Dronedarone shows promise in reducing hospitalizations and death in paroxysmal or recent-onset persistent AF, but safety concerns in permanent AF and heart failure highlight the need for head-to-head trials against active comparators.
Atrial fibrillation (AF) is a substantial cause of mortality and morbidity in the Western world. It is a massive burden on health care systems, and its prevalence is expected to double over the next 20 years. Trials evaluating antiarrhythmic drugs or catheter ablation have focused on recurrence of arrhythmia, perhaps neglecting outcomes relevant to patients, such as symptoms, need for antiarrhythmic drugs, need for hospitalization, and rates of stroke and death. An association has been demonstrated between sinus rhythm and survival in several studies, and there is evidence emerging that successful catheter ablation may reduce rates of stroke and death. Similarly, dronedarone has been shown to reduce hospitalizations and death in patients with paroxysmal AF or persistent AF of recent onset, although it may cause adverse events in permanent AF. New antiarrhythmic drugs are a welcome addition to the armamentarium, since there are limitations to current antiarrhythmic drugs. In particular, sotalol, flecainide, and propafenone cannot be used safely in those with structural heart disease, and amiodarone has important adverse reactions that limit long-term use. Indeed, the use of conventional antiarrhythmic drugs may negate any survival benefit derived from maintaining sinus rhythm. Although dronedarone appears promising with respect to hard endpoints such as stroke and death in certain patients, it may not be safe for those with heart failure or those with permanent AF. Furthermore, the trials suggesting that dronedarone may impact on these endpoints were compared with placebo rather than with an active comparator group. Further "head-to-head" comparisons between dronedarone and other antiarrhythmic drugs are needed to determine whether this property is unique to dronedarone alone.
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Hunter et al. (2012) conducted a review in Atrial fibrillation. Dronedarone vs. Placebo was evaluated. Dronedarone reduces hospitalizations and death in paroxysmal or persistent atrial fibrillation, though it may cause adverse events in patients with permanent atrial fibrillation or heart failure.
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