Dose-dependent effects of oral dronedarone on the circadian variation of RR and QT intervals in healthy subjects: implications for antiarrhythmic actions

J Cardiovasc Pharmacol Ther. 2006 Sep;11(3):184-90. doi: 10.1177/1074248406290678.

Abstract

Dronedarone, a non-iodinated benzofuran derivative, was developed as a potentially less toxic alternative to amiodarone. This study describes Holter data of dronedarone in humans. Five groups of healthy subjects were given 1 of 5 oral doses of dronedarone in a twice-daily regimen or placebo. Holter recordings of circadian rhythmicity of RR and QT intervals were evaluated. Dronedarone prolonged RR and QT intervals as a function of dose, without effect on circadian patterns. The relative prolongation of QT, QTc, and RR by dronedarone was significant. The QTc interval did not exhibit a clearly recognizable circadian pattern, suggesting that the circadian pattern of the QT interval was mostly a reflection of circadian changes in the RR interval in the study population. Dronedarone resembled amiodarone in class III and sympatholytic effects, indicating its potential as a unique antiarrhythmic compound seemingly devoid of the side effects mediated by iodine in amiodarone.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Amiodarone / administration & dosage
  • Amiodarone / analogs & derivatives*
  • Analysis of Variance
  • Anti-Arrhythmia Agents / administration & dosage*
  • Circadian Rhythm / drug effects*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Dronedarone
  • Electrocardiography, Ambulatory
  • Heart Conduction System / drug effects*
  • Heart Rate / drug effects*
  • Heart Ventricles / drug effects
  • Humans
  • Linear Models
  • Male
  • Reference Values

Substances

  • Anti-Arrhythmia Agents
  • Dronedarone
  • Amiodarone