BRIDGEWATER, N.J., May 15 /PRNewswire-FirstCall/ -- Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) announced today that findings from the
landmark ATHENA study showed Multaq(R) (dronedarone), a potential therapy
for the treatment of patients with atrial fibrillation or atrial flutter,
decreased the risk of cardiovascular hospitalizations or death from any
cause by a statistically significant 24% (p=0.00000002), meeting the study
primary endpoint. The ATHENA results will be presented at the late breaking
clinical trial session of Heart Rhythm 2008, the Heart Rhythm Society's
29th Annual Scientific Sessions in San Francisco, USA.
For the first time in twenty years of clinical drug trials in atrial
fibrillation, an investigational medicine, 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 for arrhythmic death by 45% (p=0.01), and
there were numerically less 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 ATHENA results have the potential to change the face of atrial
fibrillation management. For atrial fibrillation patients, who together
with their physicians struggle on a daily basis to manage the dramatic
consequences of this complex disease, Multaq(R) carries hope for patients,"
said Marc Cluzel, sanofi-aventis Senior Vice President, R&D. "This
milestone is indicative of sanofi-aventis' commitment to bringing
innovative therapies to market, and of our ongoing commitment to provide
patients, physicians and public health stakeholders with breakthrough
medicines in those therapeutic areas where there are major healthcare needs
and limited solutions."
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 because of the aging of the population. Patients suffering
from atrial fibrillation have twice the risk of death, an increased risk of
stroke and cardiovascular complications, including congestive heart
failure. Furthermore atrial fibrillation considerably impairs patients'
lives, mainly because of their inability to perform normal daily activities
due to complaints of palpitations, chest pain, dyspnoea, fatigue or
light-headedness, without consideration of the cumbersome and sometime
serious constraints imposed by current therapies of atrial fibrillation.
"In atrial fibrillation where treatment morbidity-mortality benefit
still needed to be demonstrated, ATHENA is a unique trial using clinically
relevant outcomes such as cardiovascular hospitalization or death as the
primary endpoint. In this regard, the trial has clearly achieved these
safety and efficacy endpoints," said Dr Stefan H. Hohnloser, J.W. from the
Goethe University, Division of Clinical Electrophysiology, Frankfurt,
Germany, who served as co-principal investigator of the ATHENA study. "As a
consequence, dronedarone is the first potential treatment for atrial
fibrillation, which was demonstrated in the ATHENA trial to reduce
cardiovascular hospitalization or mortality in patients with AF," he added.
The most frequently reported adverse events of Multaq(R) vs. placebo
induced gastro-intestinal effect (26% vs. 22%), skin disorder (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 is truly a landmark trial, that marks a potential paradigm
change for the management of atrial fibrillation," said Dr. Christopher
Cannon, a Senior Investigator in the TIMI Study Group at Brigham and
Women's Hospital, 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 the ATHENA study
demonstrating a highly significant reduction in death or hospitalization,
as well as a 45% reduction in arrhythmic death or 30% cardiovascular death,
dronedarone may become an appropriate treatment option for atrial
fibrillation."
ATHENA, the largest double blind randomized study in patients with
atrial fibrillation, was conducted in more than 550 sites in 37 countries
and enrolled a total of 4,628 patients. The ATHENA landmark 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.
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 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 disorganized 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 metacentre 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 made 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 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. 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 patient population studied
were either greater than or equal to 75 years (with or without
cardiovascular risk factor) or were <75 years with at least one additional
cardiovascular risk factor (hypertension, diabetes, previous
cerebrovascular event, left atrium size >50 mm or left ventricular ejection
fraction <40 percent). Patients suffering from decompensated heart failure
were excluded from the study. Patients were randomized 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.
About sanofi-aventis in Cardiology and Thrombosis
Sanofi-aventis' unmatched experience in the treatment of millions of
patients suffering from cardiovascular disease (CVD) and thrombosis has
uniquely prepared us to take on the growing challenges in these domains.
Today, together with academic institutions and healthcare professionals, we
are a major contributor in the effort to reduce the public health burden
across the broad CVD spectrum and in thrombosis.
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, sanofi-aventis
P: 908-981-6565
E-mail: marisol.peron@sanofi-aventis.com
Amy Ba, sanofi-aventis
P: 908-981-6563
E-mail: amy.ba@sanofi-aventis.com
SOURCE sanofi-aventis
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Related links:
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http://www.prnewswire.com/comp/232375.html /
CONTACT:
Marisol Peron, +1-908-981-6565,
marisol.peron@sanofi-aventis.com, or Amy Ba, +1-908-981-6563,
amy.ba@sanofi-aventis.com, both of sanofi-aventis
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