Efficacy of dronedarone versus propafenone in the maintenance of sinus rhythm in patients with atrial fibrillation after electrical cardioversion

Clin Ther. 2014 Sep 1;36(9):1169-75. doi: 10.1016/j.clinthera.2014.07.013. Epub 2014 Aug 16.

Abstract

Purpose: Our objective was to compare the efficacy of dronedarone and propafenone in maintaining sinus rhythm in patients with atrial fibrillation (AF) after electrical cardioversion.

Methods: In this single-center, open-label, randomized trial, we randomly assigned patients with AF after electrical cardioversion to receive dronedarone 400 mg BID or propafenone 150 mg TID. Follow-up clinical evaluations were conducted at 1, 2, 3, and 6 months of treatment. The primary end point was the time to the first recurrence of AF.

Findings: A total of 98 patients were enrolled (79 men; mean age, 59.2 years; n = 49 per group). The median times to first recurrence of AF were 31 days in the dronedarone group and 32 days in the propafenone group (P = 0.715). The median (interquartile range) ventricular rates at first recurrence of AF were 76.5 (67.3-86.5) beats/min in the dronedarone group and 83.0 (71.0-96.0) beats/min in the propafenone group (P = 0.059).

Implications: Dronedarone and propafenone had similar efficacies in maintaining sinus rhythm in patients with AF after electrical cardioversion. The ventricular rate at the first recurrence of AF was numerically but not statistically significantly lower in the dronedarone group than in the propafenone group. ClinicalTrials.gov identifier: NCT01991119.

Keywords: atrial fibrillation; dronedarone; electrical cardioversion; propafenone.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Amiodarone / analogs & derivatives*
  • Amiodarone / therapeutic use
  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / drug therapy*
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / therapy
  • Combined Modality Therapy
  • Dronedarone
  • Electric Countershock
  • Female
  • Follow-Up Studies
  • Heart Rate / drug effects
  • Humans
  • Male
  • Middle Aged
  • Propafenone / therapeutic use*
  • Recurrence
  • Time Factors

Substances

  • Anti-Arrhythmia Agents
  • Propafenone
  • Dronedarone
  • Amiodarone

Associated data

  • ClinicalTrials.gov/NCT01991119