Dronedarone trial suspended due to CV events

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Dronedarone trial suspended due to CV events

Post by freckles1880 » July 7th, 2011, 12:14 pm

http://www.theheart.org/article/1251405 ... 7_breaking

Dronedarone trial suspended due to CV events in permanent atrial fibrillation
JULY 7, 2011 | Shelley Wood
Paris, France - Sanofi, maker of dronedarone (Multaq), has suspended its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients randomized to dronedarone [1]. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.
The trial's operations and data monitoring committees made the decision to halt the study after seeing a significant increase in cardiovascular events among patients taking the study drug, as compared with patients on placebo. In both arms of the trial, patients were also receiving antithrombotic and rate-control medications.
According to a press release issued by Sanofi today, the company has informed regulators about the decision to stop the trial and asked trial investigators to get in touch with patients to tell them to stop taking the drug. Patients taking Multaq outside of the trial, however, "should not stop their therapy and should consult their treating physician if they have any questions," the Sanofi release states.
Of note, the press release notes that the "decision to terminate the study was not related to any hepatic adverse event." Liver injuries are a known side effect of the drug and have previously prompted warnings by both US and European regulators.
PALLAS was launched in July 2010 and was designed to enroll 10 000 patients, with an estimated completion date of August 2013.

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