Dronedarone for atrial fibrillation: a new therapeutic agent

Figures & data

Table 1 Summary of clinical trials

Trial	Subjects enrolled	Follow-up period	Main outcome	Common side effects
DAFNE^Citation15	270	6 months	First AF recurrence was 5.8% with 800 mg, 8.2% with 1200 mg and 14.8% with 1600 mg dronedarone vs 3.1% in placebo (P = 0.0261)	Gastrointestinal
EURIDIS and ADONIS^Citation16	612 in EURIDIS and 625 in ADONIS	12 months	First recurrence of AF/AFL was 64.1% with dronedarone vs 75.2% with placebo (P < 0.001)	Gastrointestinal (diarrhea)
ERATO^Citation17	174	6 months	Reduction of 11.7 beats per minute in ventricular rate at day 14 (P < 0.0001) – this effect was sustained for the duration of trial (−8.8 beat/minute at 4 months) (P < 0.001)	Infections Mild increase in serum creatinine levels
ANDROMEDA^Citation18	627	13 months (including additional 6 months after premature discontinuation of study)	Premature termination of trial due to excess mortality related to the worsening of heart failure in dronedarone group (hazard ratio of 2.13; 95% CI 1.07 to 4.25; P = 0.03)	Worsening heart failure Increase in serum creatinine levels
ATHENA^Citation21	4628	21 months	First hospitalization due to cardiovascular events or death was 31.9% in dronedarone group vs 39.4% in placebo group (hazard ratio of 0.76; 95% CI 0.69 to 0.84; P < 0.001)	Gastrointestinal (diarrhea, nausea) Increase in serum creatinine levels Rash Bradycardia

Abbreviations: AF, atrial fibrillation; AFL, atrial flutter; CI, confidence interval.

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