Dronedarone not safe in high-risk permanent atrial fibrillation

January 01, 0001

Dronedarone not safe in high-risk permanent atrial fibrillation

Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular anti-arrhythmic effects. These investigators from multiple countries hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. They assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death.

They found: "After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81)."

The authors concluded: "Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients."

Dronedarone was clearly harmful compared with placebo.

For the full abstract, click here.

N Engl J Med published online 14 November 2011 © 2011 to the Massachusetts Medical Society
Dronedarone in High-Risk Permanent Atrial Fibrillation. Stuart J. Connolly, A. John Camm, Jonathan L. Halperin, et al. Correspondence to Dr. Connolly: connostu@phri.ca

Category: K. Circulatory. Keywords: Dronedarone was clearly harmful compared with placebo. atrial fibrillation, dronedarone, cardiovascular events, death, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 6 December 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.