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Early initiation of dronedarone feasible

Data from a post-hoc analysis presented today at the 59th Annual Scientific Session of the American College of Cardiology in Atlanta, Georgia, evaluated transition to Multaq® (dronedarone) in patients with atrial fibrillation (AF) or atrial flutter (AFL) following prior treatment with amiodarone.

The data comes from a post-hoc analysis of pooled data from the EURIDIS and ADONIS sinus rhythm maintenance trials and assessed the impact of initiation of dronedarone therapy on safety and efficacy within two days after stopping amiodarone.

The analysis included 223 patients previously treated with amiodarone, in which Multaq (dronedarone) or placebo was initiated in a subgroup of 154 patients (Multaq = 98, placebo = 56) within two days of discontinuing amiodarone. The subgroup represents 18 percent of the patients enrolled in the EURIDIS and ADONIS studies (7.9% treated with Multaq) and was compared with a group of patients who had no prior treatment with amiodarone (n=1014). Groups were compared on the primary study endpoint, time to first recurrence of AF/AFL as well as incidence of adverse events.

In this subgroup, dronedarone decreased AF/AFL recurrence compared to placebo (HR=0.64 [95% CI 0.44-0.95], P=0.022) which is consistent with the overall study results in which dronedarone decreased the rate of AF recurrence by HR=0.75 [95% CI 0.65-0.87], P=0.001. The rate of serious adverse events was low and similar across groups with no episodes of torsades de pointes reported. There were more bradyarrhythmic events in patients treated with dronedarone (3.1%) compared to placebo (0%) and drug discontinuation due to QTc-prolongations (dronedarone = 7.9% versus placebo = 3.6% with QTc >500 msec) in the patients previously treated with amiodarone, as expected from the pharmacodynamic profile of the drugs.1

“The data presented today suggest it may be possible to initiate Multaq following discontinuation of amiodarone in paroxysmal and persistent patients within two days, while maintaining efficacy at preventing AF recurrence. Caution should be given to heart rate and QTc intervals prior to consideration of early initiation of dronedarone. ,” said Peter Kowey, M.D., FACC, Chief of the Division of Cardiovascular Diseases at the Main Line Health System, Wynnewood, Pennsylvania. “These results are hypothesis generating and indicate that a prospective trial is warranted which is currently being put in place sponsored by the manufacturers.”

Reference

  1. Kowey, P. “Impact of Dronedarone Started Rapidly After Amiodarone Discontinuation” abstract. ACC 2010.

Published on: March 22, 2010

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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