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New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial With Multaq(R) (dronedarone) in Atrial Fibrillation

Paris (ots/PRNewswire)

- Multaq(R) (dronedarone) Significantly Reduced the Risk of
Cardiovascular Hospitalization or Death by 24 Percent in Patients
With  Atrial Fibrillation
Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE:
SNY) announced today that the ATHENA trial was published in the New
England Journal of Medicine. The trial showed that Multaq(R)
(dronedarone), in addition to standard therapy, significantly reduced
the risk of first cardiovascular hospitalization or death by 24
percent (31.9% vs. 39.4%, p<0.001) in patients with atrial
fibrillation (AF)/atrial flutter (AFL) or a recent history of these
conditions.
Atrial fibrillation is the leading cause of hospitalization for
arrhythmia in the US(1) and represents one-third of hospitalizations
for arrhythmia in Europe.(2) Hospitalization due to AF has increased
dramatically (two-to-three fold) in recent years in the US(1). Atrial
fibrillation is a complex disease that increases the risk of stroke
up to five-fold(3), worsens the prognosis of patients with
cardiovascular risk factors(4) and that doubles the risk of
mortality.(5)
The authors' findings, as reported in the New England Journal of
Medicine, showed a significant decrease in the risk of cardiovascular
death by 29 per cent (p=0.03) in patients with AF. Multaq
significantly decreased the risk of arrhythmic death by 45 per cent
(p=0.01) and there were numerically fewer deaths (16 per cent) from
any cause in the dronedarone group compared to placebo (p=0.18).
First cardiovascular hospitalization was reduced by 26 per cent
(p<0.001) in the dronedarone group.
"The ATHENA trial is the first trial to show a reduction in the
incidence of cardiovascular hospitalization or death in patients
taking an anti-arrhythmic drug for atrial fibrillation" commented Dr.
Stefan H. Hohnloser J.W., Goethe University's Division of Clinical
Electrophysiology, Frankfurt, Germany, principal investigator of the
ATHENA study.
Reported significant adverse events in the Multaq(R) arm vs.
placebo arm included diarrhea (9.7% vs. 6.2%), nausea (5.3% vs.
3.1%), bradycardia (3.5% vs. 1.2%), QT-interval prolongation (1.7%
vs. 0.6%); skin disorders (10.3% vs. 7.6%) consisting mainly of rash,
and an increase in blood creatinine (4.7% vs. 1.3%)*. There was no
difference in permanent study drug discontinuation between Multaq(R)
and placebo (30.2% vs. 30.8%).
Dr. Stuart J. Connolly, Director of the division of cardiology at
McMaster University, Ontario, Canada and co-principal investigator of
the ATHENA trial said "The clinical benefits observed with
dronedarone in ATHENA occurred without a significantly higher rate of
thyroid or pulmonary disorders compared with placebo reported within
the study period."
* The mechanism of blood creatinine increase was well
       defined in a separate study of healthy volunteers and is
       not indicative of renal toxicity
About the ATHENA Study
The landmark ATHENA study is the only double-blind,
antiarrhythmic study in patients with AF that assesses
morbidity-mortality. The study was conducted at more than 550 sites
in 37 countries and enrolled a total of 4,628 patients.
The patients studied in ATHENA were either 75 years of age or
older (with or without cardiovascular risk factors) or below 75 years
of age with at least one additional cardiovascular risk factor
(hypertension, diabetes, previous ischemic cerebrovascular event,
left atrium size greater than 50 mm or left ventricular ejection
fraction lower than 40 percent). Patients with recently decompensated
heart failure or in New York Heart Association (NYHA) class IV were
excluded. Patients were randomized to receive dronedarone 400 mg BID
or placebo, with a mean follow-up of 21 months.
The ATHENA study objectives were designed to show a potential
benefit of dronedarone on the primary composite endpoint of all-cause
mortality combined with cardiovascular hospitalization compared with
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 (between first study drug intake
and last study drug intake plus 10 days) including all adverse
events, serious adverse events and adverse events leading to study
drug discontinuation.
About Atrial Fibrillation
AF is a common heart arrhythmia in which the upper chambers of
the heart beat in an uncoordinated and disorganized fashion, which
can cause palpitations, shortness of breath and fatigue. AF currently
represents a major economic burden for society. Seventy percent of
the annual cost of AF management in Europe is driven by in-patient
care and interventional procedures. Hospitalizations for AF have
increased dramatically (two-to-three-fold) in recent years. AF
hospitalizations now represent a third of all hospitalizations for
arrhythmia and mortality in the US and Europe. AF affects nearly 7
million people in the European Union and the United States.
The condition is increasingly frequent with advancing age and is
often caused by age-related changes in the heart or as a result of
cardiovascular disease. AF increases the risk of stroke up to
five-fold and heart failure two-to-three-fold. AF also doubles the
risk of mortality.
Without appropriate management, AF can lead to serious
complications such as stroke and congestive heart failure. In
addition to preventing stroke and reducing the burden of the disease,
successful management of AF should also aim at further reducing
cardiovascular morbidity and mortality.
The goals of treatment for patients with AF are related to
managing the arrhythmia itself and to the prevention of
thromboembolism. AF may be treated with medications that either slow
the heart rate or revert the heart rhythm back to normal sinus
rhythm.
About dronedarone (Multaq(R))
Multaq(R) (dronedarone) is an investigational treatment and the
only antiarrhythmic drug to have shown a significant reduction in
cardiovascular hospitalization or death in patients with AF/AFL.
Multaq(R), discovered and developed by sanofi-aventis, has been
studied in a clinical development program including more than 6,200
patients. Multaq(R) is one of the major therapeutic innovations in
atrial fibrillation for the last twenty years. Multaq(R) has been
granted a priority review by the U.S. Food and Drug Administration
(FDA) and a registration dossier is also under regulatory review by
the European Medicines Agency (EMEA).
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.
    (1) Singh SN et al. J Am Coll Cardiol. 2006;48:721-730
    (2) Fuster V et al. ACC/AHA/ESC Guidelines. European Heart Journal
        2006;27:1979-2030
    (3) Wolf et al. Stroke. 1991;22:983-988.
    (4) Wachtell K et al. J Am Coll Cardiol. 2005;45:712-719.
    (5) Benjamin EJ et al. Circulation. 1998;98:946-952.

Contact:

MEDIA CONTACT : Philippe Barquet, Tel: +33(0)6-70-48-61-28, Email:
philippe.barquet@sanofi-aventis.com

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