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Review Questions Use of Dronedarone for A-Fib

Researchers say drug has only modest efficacy, express concerns about its safety profile

FRIDAY, April 9 (HealthDay News) -- Dronedarone appears to have only modest antiarrhythmic efficacy, with questions remaining about its safety, suggesting that its role in atrial fibrillation should be as a second- or third-line agent in select patients, according to a review published in the April 13 issue of the Journal of the American College of Cardiology.

David Singh, M.D., of the Cedars-Sinai Medical Center in Los Angeles, and colleagues write that pooled data from four studies (DAFNE, EURIDIS, ADONIS, and ATHENA) show that 43 percent of patients on dronedarone were estimated to have had a first recurrence of atrial fibrillation/atrial flutter versus 54 percent of placebo-treated patients.

According to the researchers, the DIONYSOS trial found that dronedarone had a 50 percent reduced efficacy in maintaining sinus rhythm compared to amiodarone, and wasn't significantly better tolerated. In terms of safety, the authors discuss the findings of the ATHENA study in urging caution for considering dronedarone in patients with heart failure.

"To further understand how dronedarone will fare against amiodarone in the wider population with heart disease, more studies with longer follow-up are needed. At the very least, these studies need to demonstrate superior tolerability of dronedarone without unacceptable loss of efficacy in the maintenance of sinus rhythm and quality of life, or without an increase in morbidity or mortality compared with amiodarone. Until then, dronedarone may be best viewed only as half a step forward in our efforts to expand the antiarrhythmic armamentarium," the authors conclude.

A coauthor is on the Speakers' Panel of Merck.

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