MONDAY, Nov. 14 (HealthDay News) -- Dronedarone, an antiarrhythmic agent that stabilizes patients with intermittent atrial fibrillation, appears to increase the risk of hospitalization and death in certain patients with permanent atrial fibrillation, according to a study published online Nov. 14 in the New England Journal of Medicine to coincide with presentation at the American Heart Association's Scientific Sessions 2011, held from Nov. 12 to 16 in Orlando, Fla.
Stuart J. Connolly, M.D., of the Population Health Research Institute in Hamilton, Canada, and colleagues assigned 3,236 patients aged 65 and older with a six-month or longer history of permanent atrial fibrillation and risk factors for major vascular events to either dronedarone or placebo. The authors sought to test their hypothesis that the drug would reduce major vascular events in this patient population.
The study was stopped early due to safety concerns. The researchers found that stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes occurred in 43 patients receiving dronedarone, compared with 19 patients receiving placebo. Death due to cardiovascular causes occurred in 21 patients from the treatment group and 10 patients from the placebo group.
"Dronedarone increased the rates of stroke, heart failure, and death from cardiovascular causes in patients with permanent atrial fibrillation and risk factors for vascular events. Our data show that dronedarone is hazardous in such patients," the authors write.
The study was funded in part by Sanofi-Aventis; several authors disclosed financial relationships with pharmaceutical companies, including Sanofi-Aventis.