What is the efficacy and safety of dronedarone for sinus rhythm control in patients with atrial fibrillation (Afib) (AF)?

Updated: Nov 18, 2019
  • Author: Lawrence Rosenthal, MD, PhD, FACC, FHRS; Chief Editor: Jeffrey N Rottman, MD  more...
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Dronedarone is structurally similar to amiodarone, but it lacks amiodarone's iodine moieties. Although the lack of iodine moieties reduces the incidence of adverse events, dronedarone is less effective for rhythm control than amiodarone. [111] Dronedarone has been found to be associated with increased mortality in patients with permanent AF. The randomized, double-blind, phase III Permanent Atrial fibriLLation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) trial was halted following a preliminary review that revealed that dronedarone was associated with a 2-fold rise in risk of death. [112] Two-fold increases in two other endpoints, stroke and hospitalization for heart failure, were also noted when compared with placebo.

The FDA advises healthcare professionals not to prescribe dronedarone to patients with permanent AF. A separate study by Connolly et al also found that dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent AF who were at risk for major vascular events; the authors of that study suggested that dronedarone should not be used in this group of patients. [113]  The 2014 ACC/AHA/HRS guidelines for the management of AF advise against using dronedarone for patients with New York Heart Association (NYHA) class III and IV heart failure or for patients who have had an episode of decompensated heart failure in the past 4 weeks. [1]

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