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29.08.2010 – 14:40

sanofi-aventis Group

Multaq(R) First-line Option in New 2010 ESC Guidelines for the Management of Atrial Fibrillation

Paris, August 29, 2010 (ots/PRNewswire)

Sanofi aventis  announced
today that the European Society of Cardiology (ESC) 2010 new
Guidelines for the Management of Atrial Fibrillation (AF) have been
released and recommend that Multaq(R) (dronedarone) should be used
for maintenance of sinus rhythm as a first-line treatment option in
all patients with paroxysmal and persistent AF (class of
recommendation I, level of evidence A) other than those with CHF NYHA
class III/IV or unstable CHF NYHA class II (class of recommendation
III, level of evidence B).
To view the Multimedia News Release, please click:
Multaq(R) was granted a Class I recommendation, a designation
assigned in the guidelines when "there is evidence and/or general
agreement that a given procedure/therapy is beneficial, useful, and
effective." The Task Force for the Management of Atrial Fibrillation
of the ESC recognised the extensive clinical development of
Multaq(R), giving it their highest ranking A for level of evidence.
Moreover, the guidelines recommend that Multaq(R) may also be used to
achieve rate control in non-permanent AF except for patients with
NYHA class III - IV or unstable heart failure (class of
recommendation IIa, level of evidence B).(1)
Importantly the new guidelines include, for the first time, a
statement on the importance of reducing hospitalisation as a key
therapeutic goal in the management of AF. They also state that
Multaq(R) should be considered in order to reduce cardiovascular
hospitalisation in patients with non-permanent AF and cardiovascular
risk factors (Class of recommendation IIa, level of evidence B) as
well as in patients with AF and stable heart failure (NYHA Class I,
II) (Class of recommendation IIa, level of evidence C).(1)
The guidelines do not recommend use of Multaq(R) in patients with
NYHA class III and IV or with recently unstable (decompensation
within the prior month) NYHA class II heart failure.(1)
"Sanofi-aventis is pleased with this first-line recommendation
for Multaq(R) in the AF guidelines which recognises the extensive
clinical development for the product as well as the innovative
outcome of reducing cardiovascular hospitalisation as demonstrated in
the ATHENA trial," said Marc Cluzel, M.D., PhD, Executive Vice
President, Research and Development, sanofi-aventis. "Multaq(R)
provides symptom control and for the first time for an
anti-arrhythmic drug, a long term benefit by reducing the risk of
distressing and repeat cardiovascular hospitalisations. AF
Hospitalisations represent a significant human and economic burden
for patients, healthcare practitioners and payers as recently
More about the Guidelines
ESC Clinical Practice Guidelines are scientifically recognised
worldwide as providing practicing physicians with the best possible
recommendations on diagnosis, treatment and management of specific
topics in cardiology medicine. Guidelines are created and edited
under the umbrella of the ESC Board and the Committee for Practice
Guidelines (CPG), who form a Task Force of appropriate experts from
the ESC Associations, Working Groups, Councils, and National
Societies, and from other bodies when required. They are the result
of consensus amongst the Task Force appointed to prepare them, and
they are peer-reviewed in a thorough and rigorous process that
ensures accuracy, best-practice and relevance. Guidelines are
available in a variety of printed and electronic media and in
multiple formats including full documents, pocket guides and
About Atrial Fibrillation
The incidence of atrial fibrillation is growing worldwide in
relation to aging populations. It is emerging as a public health
concern, affects about 4.5 million people in Europe and represents
one-third of hospitalizations for arrhythmia in the European
Union.(3) Atrial fibrillation leads to potential life-threatening
complications. AF increases the risk of stroke up to five-fold (4),
worsens the prognosis of patients with cardiovascular risk factors
(5), and doubles the risk of mortality (6) with significant burden on
patients, health care providers and payers. Seventy percent of AF
management costs are driven by hospital care and interventional
procedures in the European Union.(7)
About AF Hospitalisation
AF is associated with high rates of hospitalisation.(3) There are
a variety of reasons for AF hospitalisation, including palpitations,
initiation of antiarrhythmic therapy, procedures, complications of
co-morbid conditions, as well as readmissions related to these
causes. There is evidence that the rate of AF-related
hospitalisations and associated cost is increasing over time, mainly
because of the aging population.(3) In the U.S., hospitalisations for
AF were almost three times higher in 2000 compared to two decades
earlier.(8) In France, one study found that 31.3 percent of AF
patients were hospitalised over a one-year period.(9)
AF is a chronic, progressive disease and cost increases with each
recurrence, mainly driven by hospitalisation. The proportion of
expenditure for AF treatment attributable to hospitalisation ranges
from 44 - 73 percent. (7,10,11,12,13) The total cost burden across
five EU countries was approximated at more than 6 billion
Euros.(9,12) In the UK, National Health Service spending for AF
hospital admissions increased 2.2-fold between 1995 and 2000.(11)
About Multaq(R)
Multaq(R), discovered and developed by sanofi-aventis, has been
studied in a clinical development program, including seven
international, multicenter, randomized clinical trials involving more
than 7000 patients with almost 4000 patients receiving Multaq(R). The
landmark ATHENA trial was the largest anti-arrhythmic drug trial
conducted in patients with AF/AFL, involving 4,628 patients with a
follow-up of 30 months. In this trial, Multaq(R), on top of standard
cardiovascular therapy, significantly reduced cardiovascular
hospitalization or death by 24 percent (p<0.001) when compared to
placebo, meeting the study's primary endpoint. This result was
entirely attributable to a reduction in cardiovascular
Multaq(R) has a fixed dose regimen of twice daily 400 mg tablets
to be taken with morning and evening meals. Treatment with Multaq(R)
does not require a loading dose and can be initiated in an outpatient
setting. Most common adverse reactions are diarrhea, nausea,
vomiting, abdominal pain, asthenia (weakness) and skin rash.
The European Commission granted marketing authorization for
Multaq(R) in November 2009. Multaq(R) is indicated in the EU in adult
clinically stable patients with a history of, or current
non-permanent atrial fibrillation (AF) to prevent recurrence of AF or
to lower ventricular rate. The use of Multaq(R) in unstable patients
with NYHA class III and IV heart failure is contraindicated. Because
of limited experience in stable patients with recent (1 to 3 months)
NYHA class III heart failure or with Left Ventricular Ejection
Fraction (LVEF) <35%, the use of Multaq(R) is not recommended in
these patients.(14)
In the U.S., Multaq(R) is indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a
recent episode of AF/AFL and associated cardiovascular risk factors
(i.e., age >70, hypertension, diabetes, prior cerebrovascular
accident, left atrial diameter is greater than or equal to 50 mm or
left ventricular ejection fraction  [LVEF] <40%), who are in sinus
rhythm or who will be cardioverted.(15)  Multaq(R) is contraindicated
in patients with NYHA Class IV heart failure,  or NYHA Class II-III
heart failure with a recent decompensation requiring  hospitalization
or referral to a specialized heart failure clinic.
Multaq(R) is currently available in 20 countries including the
U.S., Canada, Switzerland, Mexico, Taiwan, South Korea, Germany,
Denmark, Ireland, Norway, Finland, Austria, Cyprus, Malta, Estonia,
Sweden, Israel, Peru, Mexico, Hong Kong the UK and is being launched
in most European countries in 2010.
For more information about AF and Multaq(R):
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  and in New
York . For more information, please visit:
Forward-Looking Statements
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in the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
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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 EMA, 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, the Group's ability to benefit from external growth
opportunities 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, 2009. 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. The Task Force for the Management of Atrial Fibrillation of
the European Society of Cardiology. European Heart Journal 2010. doi:
10.1093/eurheartj/ehq278. Guidelines for the management of atrial
2. National Services Framework for Coronary Heart Disease.
Chapter Eight: Arrhythmia and Sudden Cardiac Death. March 2005
3. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed
atrial fibrillation in adults: national implications for rhythm
management and stroke prevention: the Anticoagulation and Risk
Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285:2370-5.
4. Lloyd-Jones et al. Lifetime Risk for Development of Atrial
Fibrillation: The Framingham Heart Study. Circulation. 2004;
5. Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management
of patients with atrial fibrillation. European Heart Journal (2006)
27, 1979-2030.
6. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB,
Levy D. Impact of atrial fibrillation on the risk of death: the
Framingham Heart Study. Circulation 1998 Sep 8; 98(10):946-52.
7. Ringborg et all, Europace 2008 10; 400-411
8. Wattigney WA et al. Circulation 2003;108:711-6
9. Le Heuzey JY et al. Am Heart J 2004;147:121-6
10. Coyne KS et al. Value Health 2006;9:348-56
11. Stewart S et al. Heart 2004;90:286-92
12. Reynolds MR et al. J Cardiovasc Electrophysiol 2007;18:628-33
13. McBride D et al. Value Health 2008;12:293-301
14. European Medicines Agency. European Public Assessment Report.
Doc. Ref.: EMA/625172/2009; EMEA/H/C/1043
nabled=true.  Last accessed 28 July.
15. MULTAQ U.S. Prescribing information Last accessed 28
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