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You are here: Home In The News Cardiology Dronedarone Effective in Patients with Atrial Fibrillation
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Dronedarone Effective in Patients with Atrial Fibrillation PDF Print E-mail
Posted by Dr. Johanne Perez M.D   
Wednesday, 11 March 2009 12:01
In the long-awaited results of ATHENA, dronedarone reduced the number of first hospitalizations for cardiac causes without increasing mortality.

News ImageRandomized, controlled trial results have shown dronedarone, an amiodarone analogue, to be superior to placebo in reducing atrial fibrillation. However, findings of increased mortality with dronedarone in heart failure patients have raised concerns. Therefore, these results from ATHENA, an international study sponsored and administered by dronedarone’s manufacturer, have been eagerly anticipated. Eligible patients had AF and at least one of the following conditions: hypertension, diabetes, previous stroke or transient ischemic attack, left atrial enlargement, or LV ejection fraction of ≤40%. In all, 4628 patients were randomized to receive dronedarone (400 mg twice a day) or placebo. Only 3.9% of participants had LVEFs ≤35%.

During a mean follow-up of 21 months, the primary endpoint (first hospitalization for a cardiac event or death from any cause) occurred in 32% of patients in the dronedarone group and in 39% of those in the placebo group (P<0.001). The number of first cardiac hospitalizations was significantly lower in the dronedarone group than in the placebo group, primarily because of a reduction in hospitalizations for AF, although a significant reduction was also seen in acute coronary syndromes. Other than hospitalization, no data were provided on symptomatic AF incidence. No significant difference in overall mortality was found between the two groups (116 deaths with dronedarone and 139 with placebo; hazard ratio, 0.84; 95% confidence interval, 0.66–1.08).

Rates of bradycardia, QT prolongation, gastrointestinal complaints, and elevated creatinine levels were significantly higher in dronedarone recipients than in placebo recipients; however, no between-group difference was found in pulmonary, liver, or thyroid toxicity. The rate of study drug discontinuation exceeded 30% in both groups; reasons for discontinuation included adverse events (12.7% of dronedarone recipients and 8.1% of placebo recipients), patient’s request (7.5% in each group), and other reasons (9.4% of dronedarone recipients and 14.4% of placebo recipients).

Comment: To date, dronedarone is the only antiarrhythmic agent to be evaluated for the prevention of hospitalization and mortality in patients with AF. Perhaps as important as the reduction in hospitalization for cardiac events achieved in this trial is the fact that dronedarone did not appear to increase patients’ mortality risk, as has been observed with other antiarrhythmic agents and was also found with dronedarone in patients with advanced heart failure and recent decompensation. Dronedarone also seems to deliver on its promise to avoid the pulmonary, liver, and thyroid toxicity associated with amiodarone. I would expect that dronedarone will soon become a valuable part of our arsenal, largely replacing amiodarone for AF management.

— Mark S. Link, MD

Published in Journal Watch Cardiology February 11, 2009

Citation(s):

Hohnloser SH et al for the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009 Feb 12; 360:668.