Buenos Aires, Argentina (ots/PRNewswire) - Today at the
World Congress of Cardiology (WCC), the press conference entitled
"New Perspectives in Atrial Fibrillation Management" chaired by John
Camm, Professor of Clinical Cardiology, St George's University of
London, highlighted the importance of the newly announced ATHENA
clinical trial results, as the way forward in the future management
of Atrial fibrillation, the most common form of cardiac arrhythmia.
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"ATHENA is truly a landmark trial, that marks a paradigm change
for the management of atrial fibrillation," said Prof Christopher
Cannon, a Senior Investigator in the TIMI Study Group at Brigham and
Women's Hospital, Harvard Medical School, who was not involved in the
study. "Atrial fibrillation is a very common disease, and our prior
treatment options have been focused only on symptom relief and a hope
to not do harm, which has been the problem with prior antiarrhythmic
drugs. Now, with a highly significant reduction in cardiovascular
hospitalisation or death, as well as a 45% reduction in arrhythmic
death or 30% cardiovascular death, dronedarone may become a first
line treatment of atrial fibrillation."
The ATHENA study results were presented by Prof Stefan Hohnloser
last week (15th May 08) at the Heart Rhythm Society's 29th Annual
Scientific Sessions in San Francisco, USA. The study results show
that dronedarone significantly decreased the risk of cardiovascular
hospitalisations or death from any cause by 24% (p=0.00000002),
meeting the study's primary endpoint. Results of the primary endpoint
were consistent across all the pre-specified clinically relevant
The most frequently reported adverse events of Multaq(R) vs.
placebo in the ATHENA trial were gastro-intestinal effects (26% vs.
22%), skin disorders (10% vs. 8%, mainly rash) and increased blood
creatinine (4.7% vs. 1%). The mechanism of blood creatinine increase
(inhibition of creatinine secretion at the renal tubular level) is
well defined. 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.
Atrial fibrillation is a major cause of hospitalisation and
mortality and affects about 2.5 million people in the United States,
as well as 4.5 million people in the European Union and is emerging
as a growing public health concern due to an aging population.
Patients suffering from atrial fibrillation have twice the risk of
death, an increased risk of stroke and cardiovascular complications,
including congestive heart failure.
ATHENA, was the largest double blind randomised study in patients
with atrial fibrillation, and conducted in more than 550 sites in 37
countries and enrolled a total of 4,628 patients. The landmark ATHENA
trial is the first morbidity-mortality study as part of the Multaq(R)
phase III clinical development program, which also included five
other multinational clinical studies: an initial study, ANDROMEDA,
conducted in patients with severe congestive heart failure and a
recent decompensation, and a total of 4 international studies in
atrial fibrillation: EURIDIS/ADONIS, ERATO, and the ongoing DIONYSOS
About Atrial Fibrillation / Flutter
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
AF is a condition in which the upper chambers of the heart beat
in an uncoordinated and disorganised fashion, resulting in an
irregular and fast heart rhythm (i.e. an irregular heartbeat). Atrial
flutter is an abnormal fast heart rhythm that occurs in the atria of
the heart. This rhythm occurs often in individuals with other heart
conditions (e.g. pericarditis, coronary artery disease, and
cardiomyopathy). Atrial flutter frequently degenerates to atrial
fibrillation. However, it may persist for months to years.
When blood is not completely pumped out of the heart's chambers,
it can pool and clot. If a blood clot forms in the atria, it can exit
the heart and block an artery in the brain, resulting in a stroke.
Consequently, about 15 percent of all strokes result from atrial
The most common symptoms of atrial fibrillation include
palpitations (a rapid, irregular, "flopping" movement or pounding
sensation in the chest or neck), shortness of breath, dizziness and
feeling of heaviness, or constriction in the chest. The disorder may
even be more common than diagnosed, as patients may experience atrial
fibrillation episodes that either do not cause symptoms or are not
documented during their visits to the doctor.
About the ATHENA Study
The landmark ATHENA study is a randomised, placebo controlled,
international multi-center study that evaluated for the first time a
treatment on top of standard background therapy for the management of
patients with atrial fibrillation in reducing morbidity and mortality
by preventing cardiovascular hospitalisations or death from any
cause. The study included 4,628 patients, which make it the largest
ever outcome study of an anti-arrhythmic treatment for atrial
The ATHENA study objectives were to show a potential benefit of
Multaq(R) on the primary composite endpoint of all-cause mortality
combined with cardiovascular hospitalisation as compared to placebo.
The pre-specified secondary endpoints were death from any cause,
cardiovascular death and hospitalisation for cardiovascular reasons.
Furthermore from the study secondary endpoints, Multaq(R), showed a
significant decrease in the risk of cardiovascular death by 30%
(p=0.03) on top of standard therapy, including rate control and
antithrombotic drugs, in patients with atrial fibrillation or atrial
flutter. Multaq(R) also significantly decreased the risk of
arrhythmic death by 45% (p=0.01) and there were numerically fewer
deaths (16%) from any cause in the dronedarone group compared to
placebo (p=0.17). First cardiovascular hospitalisation was reduced by
25% (p=0.000000009) in the dronedarone group. The pre-specified
safety endpoint was the incidence of treatment emergent adverse
events (time of observation for treatment emergent adverse events)
including: all adverse events, serious adverse events, adverse events
leading to study drug discontinuation.
The atrial fibrillation or atrial flutter patients studied were
either 75 years of age or over (with or without cardiovascular risk
factor) or were below 75 years of age with at least one additional
cardiovascular risk factor (hypertension, diabetes, previous
cerebrovascular event, left atrium size greater than 50 mm or left
ventricular ejection fraction lower than 40 percent). Patients
suffering from decompensated heart failure were excluded from the
study. Patients were randomised to receive Multaq(R) 400 mg BID or
placebo, with a maximum follow-up of 30 months.
The countries which enrolled patients included: Argentina,
Australia, Austria, Belgium, Canada, Chile, China, Czech Republic,
Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy,
Malaysia, Mexico, Morocco, New Zealand, Norway, Philippines, Poland,
Portugal, Russia, South Africa, Singapore, South Korea, Spain,
Sweden, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, the UK,
About Multaq(R) (dronedarone)
Dronedarone (brand name Multaq(R)) is an investigational new
treatment for patients with atrial fibrillation, which has been
discovered and developed by sanofi-aventis for the prevention and
treatment of patients with atrial fibrillation or atrial flutter.
Dronedarone is a multi-channel blocker that affects calcium,
potassium and sodium channels and has anti-adrenergic properties.
Dronedarone does not contain the iodine radical and did not show any
evidence of thyroid or pulmonary toxicity in clinical trials.
Based upon the new ATHENA clinical data, sanofi-aventis plans to
submit a registration dossier to the European Medicines Agency
(EMEA), and a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) during the 3rd quarter of 2008.
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).
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ots Originaltext: sanofi-aventis Group
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