Date: 2011-07-07
Type of information:
phase: 3
Announcement: discontinuation of the study
Company: Sanofi (France)
Product: Multaq® (dronedarone)
Action mechanism:
Disease: permanent atrial fibrillation
Therapeutic area: Cardiovascular diseases
Country:
Trial details: PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) was a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter Phase IIIb trial comparing the efficacy of dronedarone 400mg twice-daily to placebo in permanent AF patients. Patients were required to have an age above 65 years with co-morbid conditions, such as systemic arterial embolism, myocardial infarction, documented coronary artery disease, prior stroke, symptomatic heart failure, or the combination of age above 75 years, hypertension and diabetes mellitus. Exclusion criteria included New York Heart Association (NYHA) Class IV heart failure or unstable NYHA Class III heart failure. The trial had two composite co-primary endpoints: 1. Major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). 2. Cardiovascular hospitalization or death from any cause.
Latest
news: Sanofi has discontinued the PALLAS Phase IIIb trial in patients with permanent Atrial Fibrillation (AF), a population different from the population with non-permanent AF for which Multaq® (dronedarone) is currently approved. The decision follows recommendations from the study’s Operations Committee and the Data Monitoring Committee (DMC) which observed a significant increase in cardiovascular events in the dronedarone arm. The decision to terminate the study was not related to any hepatic adverse event. Sanofi has informed regulatory authorities of this decision. The company also has asked all PALLAS clinical investigators to inform their patients included in the trial to stop taking the study medication and consult their clinical trial center. This direction applies to the PALLAS study patients only.
- On July 11, 2011, The EMA announced that the agency is reviewing the cardiovascular risk of the anti-arrhythmic medicine Multaq® (dronedarone), from Sanofi. This follows the company's announcement on 7 July 2011 of its discontinuation of the PALLAS study, because of the occurrence of severe cardiovascular events in some patients taking Multaq®.
