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Sanofi Aventis Antiarrhythmia Drug Trial Halted Early Due to Cardiovascular Events


Sanofi-Aventis France announced this week that they are discontinuing the PALLAS Phase IIIb trial of dronedarone (Multaq) because of increased cardiovascular events among patients receiving the drug. Although the company would not release specific details, co-primary investigator Dr. Stuart Connolly called the events “major”.

Multaq Remains Approved for Non-Permanent Atrial Fibrillation

In the United States, more than 850,000 people are hospitalized for an arrhythmia (irregular heartbeat) each year. Atrial fibrillation (AF or a-fib) is the most common abnormal rhythm of the heart. A-fib can be chronic and sustained for more than six months (permanent), or brief and intermittent (paroxysmal) lasting for just minutes or hours.

Multaq was approved in 2009 by the European Commission and last year by the US Food and Drug Administration to treat paroxysmal AF patients as well as atrial flutter. The latest study known as PALLAS was testing Multaq for patients with permanent atrial fibrillation.

Read: FDA Approves Multaq for Heart Arrhythmias

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The phase IIIb trial launched in July 2010 and had enrolled over 3,000 patients with permanent AF with 70% showing symptoms for more than 2 years. The participants also had at least one other cardiac disease risk factor present and were taking antithrombotic and rate-control medications. These patients are already at high risk for major cardiovascular events which were defined by the researchers as stroke, MI (heart attack), systemic embolism, or cardiovascular death.

Unfortunately, this isn’t the first negative trial for Sanofi-Aventis’ Multaq. An earlier trial called ANDROMEDA tested dronedarone in patients with severe heart failure, but was also halted early when mortality in patients receiving the drug was found to be twice that seen in the control group. Also, in January the FDA warned patients of reports of acute liver injury associated with the drug. The company notes that the PALLAS trial had not shown any liver problems in patients taking dronedarone.

Read: American Heart Association Issues More Lenient Guidelines for Atrial Fibrillation

"Patient safety is of highest priority for Sanofi,” said Jean-Pierre Lehner MD, Chief Medical Officer, Sanofi. “We remain committed to Multaq as an essential treatment option for non-permanent AF patients.”

Sanofi stresses to patients taking Multaq outside of the trial that they "should not stop their therapy and should consult their treating physician if they have any questions.”