Managing atrial fibrillation in the elderly: critical appraisal of dronedarone

Figures & data

Figure 1 Chemical structure of dronedarone.

Notes: Chemical structure of the noniodinated benzofuran derivative of amiodarone, dronedarone. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide.

Table 1 Adverse drug reactions more frequent than placebo

	Placebo (n = 2875)	Dronedarone 400 mg twice daily (n = 3282)
Gastrointestinal
Diarrhea	6%	9%
Nausea	3%	5%
Abdominal pain	3%	4%
Vomiting	1%	2%
Dyspeptic signs and symptoms	1%	2%
General
Asthenic conditions	5%	7%
Cardiac
Bradycardia	1%	3%
Skin and subcutaneous tissue
Including rashes (generalized, macular, maculopapular, erythematous), pruritus, eczema, dermatitis, dermatitis allergic	3%	5%

Data from Touboul P, Brugada J, Capucci A, Crijns HJ, Edvardsson N, Hohnloser SH. Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J. 2003;24(16):1481–1487.

Table 2 Laboratory data and electrocardiographic parameters not necessarily reported as adverse events

	Placebo	Dronedarone 400 mg twice daily
Serum creatinine increased ≥10%	(n = 2875)	(n = 3282)
5 days after treatment initiation	21%	51%
QTc Bazett prolonged	(n = 2237)	(n = 2701)
(>450 milliseconds in males and >470 milliseconds in females)	19%	28%

Data from Touboul P, Brugada J, Capucci A, Crijns HJ, Edvardsson N, Hohnloser SH. Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J. 2003;24(16):1481–1487.