MEDIA RELEASE PR35894
Study Shows Otamixaban Substantially Reduced Complications of Invasive Management
of Acute Coronary Syndromes
PARIS, August 30 /PRNewswire-AsiaNet/--
- SEPIA-ACS Multiple-dose Phase II Results Showing 27- 42% Risk Reduction
in ACS Complications Presented in Plenary Session of European Society of
Cardiology Congress and Published in The Lancet
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
that the investigational anti-Xa intravenous anticoagulant otamixaban reduced
by 27 to 42 percent the odds of the composite primary endpoint of death,
myocardial infarction, urgent revascularization or rescue GPIIb/IIIa use in 4
out of the 5 otamixaban tested doses, versus standard UFH/eptifibatide
combination in [non-ST] ACS patients suitable for invasive strategy. The
results of the SEPIA-ACS1/ TIMI-42 were presented today at the plenary
session of the Annual European Society of Cardiology congress in Barcelona
and simultaneously published online in The Lancet.
Otamixaban is a first in class, rapid onset antithrombotic
compound, acting as a direct selective inhibitor of factor Xa. Otamixaban is
originating from Sanofi-aventis world-class thrombosis research portfolio and
is currently in phase IIb clinical development phase.
"The data show that intermediate dosages of otamixaban may
offer substantial reduction in major coronary complications in patients
presenting with acute coronary syndrome, with bleeding rate comparable to
current therapy," said Dr Marc Sabatine, MD, MPH, an Investigator in the TIMI
Study Group and a cardiologist at Brigham and Women's Hospital, Harvard
Medical School. "This research is addressing an important medical need, by
potentially significantly improving outcomes of ACS patients undergoing PCI
while simplifying the treatment pattern of the acute management phase of the
disease." he added.
The double-blind phase II SEPIA-ACS1/ TIMI-42 study randomized
3241 patients from 36 countries in 6 treatment arms. The study assessed the
efficacy and safety of five different doses of otamixaban versus the standard
unfractionated heparin plus Glycoprotein IIb/IIIa inhibitor (eptifibatide),
on background of standard dual antiplatelet therapy, in patients with
high-risk non-ST-elevation acute coronary syndromes. SEPIA-ACS1 study showed
that otamixaban displayed clinically meaningful activity on the primary
endpoint from the threshold dose of 0.070 mg/kg/h, the second tested dose,
with a consistent antithrombotic effect up to the 5th highest tested dosage.
The lowest studied dosage was prematurely stopped due to insufficient
activity, based on recommendation by an independent data monitoring board.
Moreover a combined analysis of the intermediate doses (0.105 and 0.140
mg/kg/h) of otamixaban arms showed that otamixaban reduced by approximately
46 percent (p=0.0198) the risk of the composite of death or a second
myocardial infarction, a predefined study secondary efficacy endpoint.
The potent antithrombotic effect of otamixaban was also
accompanied with a dose-dependent bleeding profile. Combined intermediate
otamixaban dosages showed a safety profile not statistically different with
regard to TIMI major or minor bleeding through 7 days, in comparison to UFH
and GPIIb/IIIa inhibitor comparator (RR 1.20, 95% CI 0.64-2.27, p=0.5634).
"The SEPIA-ACS1 trial is providing very encouraging results
for a new and more effective treatment approach," said Marc Cluzel, MD Senior
Vice President Research and Development Sanofi-aventis. "We aim, on the basis
of these findings to address through our development program remaining
patients', practionners' and payers' needs for management of ACS."
Acute Coronary Syndromes is a general term used to regroup
clinical symptoms related to acute myocardial ischemia. ACS represents an
area of important medical need, as despite use of several antithrombotic
therapies, death and myocardial infarction still occur in 5 to 8% of patients
in the following week after an initial event.
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).
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SOURCE: Sanofi-aventis
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