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Further Analysis From ATHENA Study Showed That Multaq(R)(Dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
Date:9/2/2008

tment of Cardiology, Hamilton Canada, co-principal investigator of the ATHENA study.

The most frequently reported adverse events of Multaq(R) vs. placebo in the ATHENA trial as seen in the pre-specified safety analysis, were gastrointestinal effects (26% vs. 22%), skin disorders (10% vs. 8%, mainly rash) and a mild increase in blood creatinine (4.7% vs. 1%) due to inhibition of tubular secretion of creatinine in the kidneys. The mechanism of blood creatinine increase was well defined in a separate study of healthy volunteers. In the ATHENA trial, compared to placebo, Multaq(R) showed a low risk of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuation between the 2 study groups.

About Atrial Fibrillation / Flutter and Stroke

Atrial Fibrillation (AF) is the most common cardiac arrhythmia in clinical practice and is one of the most important independent risk factors for stroke. Stroke is a major public health problem because this acute event often causes permanent neurological disabilities and death. Atrial fibrillation increases the risk of stroke by up to 5 times. It also is responsible for 15-20% of all strokes, which if caused by AF, are 2.2 times more likely to leave patients bedridden.

Atrial fibrillation is a major cause of hospitalisation and mortality and affects about 2.5 million people in the USA and 4.5 million people in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the next 20 years. Without appropriate management, atrial fibrillation can lead to serious complications, such as stroke and congestive heart failure.

About the ATHENA Study

The landmark ATHENA study is the only double-blind, anti-arrhythmic, morbidity-mortality study in patients with atrial fibrillation. It was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients.

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SOURCE Sanofi-aventis
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