Efficacy and safety of dronedarone: a review of randomized trials.
BACKGROUND
Dronedarone is developed for treatment of atrial fibrillation (AF) or flutter (AFL). It is a noniodinized amiodarone analogue and believed to be without the adverse effects of amiodarone. However, long-term adverse effects are not yet well investigated.


METHODS
This is a review of seven studies on dronedarone.


RESULTS
DAFNE established an effective dose to be 400 mg b.i.d. ADONIS and EURIDIS showed significant prevention of AF/AFL recurrence hazard ratio (HR 0.78 and 0.73) compared to placebo. In ATHENA, cardiovascular death/hospitalization was significantly reduced (HR 0.76) in patients with AF and additional risk factors. ANDROMEDA was stopped because dronedarone increased early mortality (HR 2.13) in advanced heart failure (HF). ERATO found that dronedarone significantly reduced heart rate compared to placebo in patients with AF. DIONYSOS showed that amiodarone was superior to dronedarone to maintain sinus rhythm in patients with AF/AFL.


CONCLUSIONS
Dronedarone is superior to placebo but less efficient than amiodarone in maintaining sinus rhythm in patients with a history of AF. In patients with AF and risk factors dronedarone reduces cardiovascular mortality and morbidity, but in patients with severe HF dronedarone significantly increases mortality.
Christiansen
Christine Benn
CB
University of Copenhagen, Gentofte Hospital, Department of Cardiology, Niels Andersensvej 65, 2900, Hellerup, Denmark.
Torp-Pedersen
Christian
C
Køber
Lars
L
D000368:Aged; D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000401:mortality; D001282:Atrial Flutter / Q000188:drug therapy*; D000077764:Dronedarone; D006333:Heart Failure / Q000188:drug therapy / Q000401:mortality; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone