Tous Actualités
Suivre
Abonner sanofi-aventis Group

sanofi-aventis Group

Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients With Atrial Fibrillation

New Orleans, Louisiana, November 11 (ots/PRNewswire)

- New Post-Hoc Analysis From Athena Study Showed That Multaq(R)
on Top of Standard Therapy Significantly Decreased the Total Number
of Hospital Days by 28% in Patients With Atrial Fibrillation or
Flutter
NEW ORLEANS, Louisiana, November 11 /PRNewswire/ --
New data from the landmark ATHENA trial showed that dronedarone
significantly reduced the incidence and total duration of hospital
stays among patients with atrial fibrillation / atrial flutter
(AF/AFL). This post-hoc analysis was presented at the American Heart
Association Scientific Sessions 2008 in New Orleans, Louisiana.
In this new analysis, dronedarone significantly reduced the total
number of hospital days by 28 percent (p<0.001) versus placebo (9,995
days vs. 13,986 days), and decreased by 35 percent (p<0.001) the
total length of time spent in hospital for cardiovascular reasons
(5,875 days vs. 9,073 days).
In addition to the demonstrated reduction of AF-related
hospitalization by 37 percent (p<0.001), dronedarone reduced the
incidence of first non-AF related CV hospitalization (e.g. myocardial
infarction or unstable angina) by 14 percent (p=0.016). Dronedarone
did not increase the incidence of non-cardiovascular hospitalizations
in comparison to the placebo arm.
"The incidence of AF-related hospital admissions has dramatically
increased in recent years, and therapeutic solutions to reduce this
burden are needed," said Dr Christian Torp-Pedersen from the Gentofte
University Hospital, Copenhagen, Denmark and a member of the steering
committee of the ATHENA study. "These new ATHENA data showed that for
the first time, an anti-arrhythmic drug significantly and
consistently reduced hospitalization incidence and duration, which
led to a substantial reduction of total hospitalization burden in
this patient population."
A second post-hoc analysis from ATHENA also presented during the
AHA, confirming the rhythm and rate controlling properties of
dronedarone, previously demonstrated in lower risk populations
studied in the EURIDIS(1), ADONIS(1) and ERATO(2) trials. This
analysis showed that dronedarone reduced the incidence of first AF
recurrence by 25 percent in patients in sinus rhythm at study
initiation (p<0.001), and the incidence of first electrical
cardioversion by 31 percent (p<0.001), compared with placebo.
Dronedarone also decreased mean heart rate during atrial
fibrillation to 78 beats per minute, compared with 87 for placebo
(p<0.001). Fewer patients developed permanent atrial fibrillation
during the study in the dronedarone group - 178 patients (7.7%)
compared with 295 patients (12.7%) in the placebo arm (p<0.001). In
these patients, the non-significant  reduction of CV hospitalization
or death was 26% lower for those receiving  dronedarone (p=0.096).
These results are consistent with the overall study  results.
"This study demonstrates both significant rhythm and rate
controlling properties of dronedarone in the ATHENA population, which
consisted of higher-risk patients with atrial fibrillation" added Dr.
Richard Page, Professor and Head of the Division of Cardiology at the
University of Washington School of Medicine, Seattle, USA and a
member of the steering committee of the ATHENA study. "It is
intriguing that there was a trend toward reduction of the primary
endpoint of cardiovascular hospitalization or death even in patients
with permanent AF, suggesting that the benefit of dronedarone may not
only be linked to arrhythmia control" .
The most frequently reported adverse events of dronedarone vs.
placebo in the ATHENA trial were gastrointestinal effects (26% vs.
22%), skin disorders (10% vs. 8%, mainly rash) and mild increase in
blood creatinine (4.7% vs. 1%) due to inhibition of tubular secretion
of creatinine in the kidneys. The mechanism of blood creatinine
increase was well defined in a separate study of healthy volunteers
and is not indicative of renal toxicity. In the ATHENA trial,
compared to placebo, dronedarone showed a low risk of pro-arrhythmia
and no excess of hospitalizations for congestive heart failure. There
was a similar rate of study drug discontinuation between the 2 study
groups.
About Atrial Fibrillation
Atrial fibrillation (AF) is a common heart arrhythmia in which
the upper chambers of the heart beat in an uncoordinated and
disorganised fashion, which can cause palpitations, shortness of
breath and fatigue. Atrial fibrillation (AF) currently represents a
major economic burden for society.(3) 70 percent of the annual cost
of AF management is driven by inpatient care and interventional
procedures.(4) Hospitalizations for AF have increased dramatically
(2- to 3-fold) in recent years.(5) AF hospitalizations now represent
a third of all hospitalizations for arrhythmia and mortality. AF
affects nearly seven million people in the European Union and the
United States.(6)
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 five-fold and
heart failure two- to three-fold. AF also doubles the risk of
mortality and is an independent risk factor for sudden cardiac death.
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 CV
morbidity and mortality.(7)
The aims of treatment for patients with AF are related to
managing the arrhythmia itself and to the prevention of
thromboembolism (obstruction of a blood vessel caused by fragments of
a blood clot carried from the site of origin to obstruct another
vessel). Atrial fibrillation may be treated with medications which
either slow the heart rate or revert the heart rhythm back to normal.
About the ATHENA Study
The landmark ATHENA study is the only double-blind,
anti-arrhythmic, morbidity-mortality study in patients with AF. It
was conducted in more than 550 sites in 37 countries and enrolled a
total of 4,628 patients.
Previous results from the landmark ATHENA study have shown that
dronedarone on top of standard therapy decreased the combined primary
endpoint of cardiovascular hospitalization or death from any cause by
a statistically significant 24 percent (p<0.001) as compared to
placebo and reduced the risk of cardiovascular hospitalization by 25
percent (p<0.001).  These results were achieved with a favorable
safety profile.
The patients studied in ATHENA were either 75 years of age or
older (with or without cardiovascular risk factor) either 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 with decompensated heart failure (NYHA
class IV) were excluded. Patients were randomized to receive
dronedarone 400 mg BID or placebo, with a maximum follow-up of 30
months.
The ATHENA study objectives were to show a potential benefit of
dronedarone 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 hospitalisation 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, adverse events leading to study drug
discontinuation.
About dronedarone (Multaq(R))
Dronedarone (Multaq(R)) is an investigational treatment and the
only Anti-Arrhythmic Drug (AAD) to have shown a significant reduction
in morbidity and mortality in AF/AFL patients with a favourable
safety profile as evidenced by a low incidence of pro-arrhythmia
(including torsades de pointes) and extra-cardiac organ toxicity.
Dronedarone, discovered and developed by sanofi-aventis, has been
studied in a clinical development program including more than 6,200
patients. Dronedarone is one of the major therapeutic innovations in
atrial fibrillation for the last twenty years. Dronedarone
(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).
    References
    (1) Singh et al. Dronedarone for maintenance of sinus rhythm
        in atrial fibrillation or flutter. N Engl J Med. 2007 Sep
        6;357(10):987-99
    (2) Davy JM. Herold M et al. Dronedarone for the control of
        ventricular rate in permanent atrial fibrillation: the Efficacy and
        safety of dRonedArone for the cOntrol of ventricular rate during
        atrial fibrillation (ERATO) study. Am Heart J. 2008
        Sep;156(3):527.e1-9.
    (3) Le Heuzey, Jean-Yves MD a,*; Paziaud, Olivier MD a; Piot,
        Olivier MD b; Ait Said, Mina MD a; Copie, Xavier MD, PhD b; Lavergne,
        Thomas MD a; Guize, Louis MD a. Cost of care distribution in atrial
        fibrillation patients: The COCAF study. American Heart Journal.
        147(1):121-126, January 2004. Available at:
        http://pt.wkhealth.com/pt/re/amhj/abstract.00000406-200401000-00022.htm;jsessionid=JFPb2sjgTnyR8JVGNpLwpt1WxFn12BgC4vY0LmPWHvP4LLL5TlVY!-1891305337!181195628!8091!-1 .
        Last accessed: 24th October 2008.
    (4) Ringborg A, Nieuwlaat R, Lindgren P, Jönsson B, Fidan D,
        Maggioni AP, Lopez-Sendon J, Stepinska J, Cokkinos DV, Crijns HJ.
        Costs of atrial fibrillation in five European countries: Results from
        the Euro Heart Survey on atrial fibrillation. Europace. 2008
        Apr;10(4):403-11. Epub 2008 Mar 7.
    (5) Wattigney WA, circulation. 2003;108:711-716.
    (6) Fuster V et al. ACC/AHA/ESC Guidelines. European Heart
        Journal 2006; 27: 1979-2030
    (7) Hohnloser S, et al. J Cardiovasc Electrophysiol.
        2008;19:69-73.
Sanofi-aventis http://www.sanofi-aventis.com

Contact:

MEDIA CONTACT: Philippe Barquet, Tel: +33(0)6-70-48-61-28, Email:
philippe.barquet@sanofi-aventis.com . Sanofi-aventis
http://www.sanofi-aventis.com . Media Relations: Tel. :
+33-1-53-77-44-50 - E-mail : MR@sanofi-aventis.com . Investor
Relations : Tel. : +33-1-53-77-45-45 - E-mail : IR@sanofi-aventis.com
.

Plus de actualités: sanofi-aventis Group
Plus de actualités: sanofi-aventis Group