* Review of studies shows no safety benefit for Multaq
* Study recommends Multaq as second choice
WASHINGTON, April 5 (Reuters) - Sanofi-Aventis’s (SASY.PA) heart rhythm drug Multaq, which has suffered from slow sales in the United States and Europe, is only modestly effective and has no clear safety benefits, researchers reported on Monday.
Multaq, known generically as dronedarone, is 50 percent less effective against atrial fibrillation than its rival amiodarone, sold under several brand names including Cordarone, the team at the Cedars-Sinai Heart Institute in Los Angeles reported.
“We believe that dronedarone should only be used as a second-line or third-line agent in individuals that are not able to tolerate amiodarone or other first-line agents recommended by the guidelines,” Dr. Sanjay Kaul, who led the study published in the Journal of the American College of Cardiology, said in a statement.
Atrial fibrillation, a common heart rhythm disorder that can lead to stroke, occurs when the heart’s upper chambers, or atria, quiver instead of beating properly.
Nearly 2.3 million Americans have atrial fibrillation or a similar heart rhythm disturbance called atrial flutter. Some 71,000 people die each year from the conditions in the United States.
Amiodarone works well against the conditions, but it can damage the lungs and thyroid. Multaq was designed to prevent these side-effects.
Kaul’s team reviewed studies involving about 30,000 heart patients, including the trial of more than 4,000 patients that was the main basis for U.S. Food and Drug Administration’s approval of Multaq last year.
“Dronedarone has, at best, modest effectiveness as an antiarrhythmic agent, and it has not been proven to be any safer than amiodarone,” Kaul said.
But cardiologist Dr. Christian Torp-Pedersen of Gentofte Hospital and the University of Copenhagen disagreed.
“Although dronedarone should clearly not be used for patients with severe heart failure, the safety of most antiarrhythmic drugs for intermediate-risk patients is uncertain,” Torp-Pederson wrote in a commentary in the same journal.
“For patients with low risk, dronedarone provides the only antiarrhythmic drug with a large safety database to prove reasonable safety,” he added.
Britain’s state health service approved Multaq just last month after some debate because the National Institute for Health and Clinical Excellence decided it was safer than its rival.
Multaq costs $3.36 a day in Britain, compared to just pennies for the generically available amiodarone.
Multaq generated revenue last year of $34 million, but current forecasts suggest this should rise to $1.9 billion by 2014, according to Thomson Reuters data.