New England Journal of Medicine publishes results from the landmark ATHENA trial with Multaq(R) (dronedarone) in Atrial Fibrillation



    
    -Multaq(R) (dronedarone) significantly reduced the risk of cardiovascular
    hospitalization or death by 24 percent in patients with atrial
    fibrillation-
    

    PARIS, Feb. 11 /CNW/ - 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 less than 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 US1. 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 equals 0.18). First cardiovascular hospitalization was reduced by
26 per cent (p less than 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.
    




For further information:

For further information: MEDIA CONTACT: Philippe BARQUET, Tel: +33
(0)6.70.48.61.28, philippe.barquet@sanofi-aventis.com

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