Dronedarone: A Cautionary Tale from PALLAS

Dronedarone increased the risk for cardiovascular events in high-risk patients with permanent atrial fibrillation of at least 6 months' duration.

In the placebo-controlled ATHENA trial, the antiarrhythmic drug dronedarone reduced the number of first hospitalizations for cardiac causes, without increasing mortality, in patients with intermittent atrial fibrillation (AF; JW Cardiol Feb 11 2009). Emboldened by those results, the drug manufacturer launched the PALLAS trial involving patients for whom dronedarone's antiarrhythmic properties would presumably be less important than its clinical effects: those with permanent AF. In PALLAS, 3236 patients with permanent AF of ≥6 months' duration and risk factors for major vascular events were randomized to receive dronedarone (400 mg twice daily) or placebo.

At a median follow-up of 3.5 months, safety concerns prompted the data monitoring commi…

Reviewing Author

Mark S. Link, MD

Disclosures

Editorial BoardsCirculation; UpToDate

Mark S. Link, MD

Disclosures

Editorial BoardsCirculation; UpToDate