BUENOS AIRES, Argentina, May 22 /PRNewswire-FirstCall/ -- On May 21,
2008 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, on the potential management of atrial fibrillation, a common
form of cardiac arrhythmia.
"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 hospitalization or death, as well
as a 45% reduction in arrhythmic death or 30% cardiovascular death,
dronedarone may become an appropriate treatment option for 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 hospitalizations 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 subgroups.
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) was well defined, in a
separate study of healthy volunteers. Multaq(R) showed a rate of
pro-arrhythmia similar to placebo and no excess of hospitalizations for
congestive heart failure. There was a similar rate of study drug
discontinuation between the 2 study groups.
ATHENA, was the largest double blind randomized 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 trial.
Atrial fibrillation is a major cause of hospitalization 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.
About Atrial Fibrillation / Flutter
Atrial fibrillation is a major cause of hospitalization 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.
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 fibrillation.
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 randomized, 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 hospitalizations 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 fibrillation.
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 hospitalization as compared to placebo. The
pre-specified secondary endpoints were death from any cause, cardiovascular
death and hospitalization 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 hospitalization 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, the US.
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 this new 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.
About sanofi-aventis
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include product development, product potential projections
and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis' management believes that
the expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMEA, regarding
whether and when to approve any drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of guarantee
that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic alternatives as
well as those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2007. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking
information or statements.
CONTACT Marisol Peron: 908-981-6565
marisol.peron@sanofi-aventis.com
SOURCE sanofi-aventis
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Related links:
http://www.sanofi-aventis.us/
http://www.prnewswire.com/comp/232375.html/
CONTACT:
Marisol Peron of sanofi-aventis,
+1-908-981-6565, marisol.peron@sanofi-aventis.com
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