PARIS, July 7 (UPI) -- A drug company in Paris said it's stopped its trial on a drug used to treat patients with permanent atrial fibrillation.
The PALLAS Phase IIIb trial, in patients with permanent atrial fibrillation -- a population different from those with non-permanent atrial fibrillation for which Multaq, or dronedarone, is currently approved -- was discontinued after a significant increase in cardiovascular events was observed, Sanofi officials said.
"Patient safety is of highest priority for Sanofi. We are notifying regulatory authorities in all countries where the product is approved or under review on this matter," Dr. Jean-Pierre Lehner, chief medical officer of Sanofi, said in a statement.
"We remain committed to Multaq as an essential treatment option for non-permanent atrial fibrillation patients."
The benefit-risk of Multaq remains unchanged in its approved indication in non-permanent atrial fibrillation and patients currently taking Multaq should not stop their therapy and should consult their treating physician should they have any questions, Sanofi officials said.
There are two types of atrial fibrillation patients, non-permanent and permanent -- those with atrial fibrillation for at least six months. Permanent atrial fibrillation patients are at an even higher increased risk of major adverse cardiovascular events as compared to non-permanent atrial fibrillation patients, patients for whom Multaq is currently approved, Sanofi officials said.
