March 5, 2009
New heart arrhythmia drug shows promise
Dronedarone, a new antiarrhythmic drug being developed to treat patients with atrial fibrillation, reduced the incidence of hospitalization due to cardiovascular events or deaths in patients with atrial fibrillation, according to a study published in the Feb. 12 issue of the New England Journal of Medicine.
Richard Page, UW professor of medicine and head of the Division of Cardiology, was the lone U.S. co-author and member of the steering committee for this latest study of dronedarone, with patient enrollment in 37 countries worldwide. Page said the study is the largest randomized study of atrial fibrillation ever performed.
Atrial fibrillation is a common type of cardiac arrhythmia, and it affects almost four percent of the U.S. population over age 60. It is age-related; almost one in ten Americans over age 80 will have atrial fibrillation. “It is an epidemic,” said Page.
In the study, known as ATHENA, researchers found a marked benefit in the time to the combined endpoint—those who died from any cause and/or required cardiovascular hospitalization. Specifically, the study showed a 24 percent reduction in the likelihood of those events occurring.
“Dying from cardiovascular causes was statistically reduced,” said Page. “Typically, when we’re talking about anti-arrhythmic agents, we’re worried about the drug causing death. So this is unique among the anti-arrhythmic drugs.”
To look at it differently, Page said patients in the study receiving the drug had more than one hospital day’s stay eliminated per year.
In the past, drugs have been disappointing in terms of efficacy and safety, said the cardiologist. Complications arising from previously studied drugs, for example, include arrhythmias, life-threatening lung conditions, and thyroid, liver, skin and neurologic complications.
Some 30 percent of patients in the study discontinued use of dronedarone, but the same number stopped taking the placebo. Page said that this likely reflects that over time, patients were encountering atrial fibrillation in both groups, although less frequently with the dronedarone.
The U.S. Food and Drug Administration will convene an expert panel in March to review dronedarone, and will provide recommendation as to whether the drug should be approved.
