Positieve resultaten na behandeling met otamixaban van patiënten met acuut coronair syndroom

otamixaban_3dTijdens het ESC congres (European Society of Cardiology) in Barcelona, zijn zondag 30 augustus 2009 de volgende resultaten gepresenteerd
De resultaten van een fase II studie (SEPIA-ACS1/ TIMI-42) tonen een belangrijke bijdrage van otamixaban op het verminderen van het risico op cardiovasculair overlijden, een tweede hartaanval of op andere cardiovasculaire complicaties bij patienten met acuut coronair syndroom*. In de studie is de effectiviteit en de veiligheid van otamixaban vergeleken met de huidige standaardbehandeling van patienten met acuut coronair syndroom (ACS). De resultaten tonen bij de patienten die otamixaban kregen een risicoreductie van 27 tot 42 % op het krijgen van ACS complicaties. De resultaten van de SEPIA-ACS1/ TIMI-42 zijn gepresenteerd tijdens het ESC-congres (European Society of Cardiology) in Barcelona en zijn tevens on-line gepubliceerd in The Lancet. Voor meer informatie verwijzen wij u graag naar bijgaand persbericht afkomstig van Brigham and Women’s Hospital (Harvard Medical School) en naar het volledige Engelstalige persbericht van sanofi-aventis.

* Acuut coronair syndroom (ACS), waaronder hartaanvallen en instabiele angina pectoris (pijn op de borst), is een veel voorkomende doodsoorzaak in de Europese Unie, met meer dan 741.000 sterfgevallen per jaar. Acuut coronair syndroom is een belangrijk gevolg van coronaire atherosclerose, een kransslagaderaandoening, waarbij arterien die het hart voorzien van zuurstof verstopt of vernauwd raken. Het begrip ‘acuut coronair syndroom’ omvat zowel het acute myocardinfarct (AMI) als instabiele angina pectoris (IAP).

Study Shows Otamixaban substantially
Reduced Complications of Invasive
Management of Acute Coronary Syndromes
– 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 –
Paris, France – August 30, 2009 – 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 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.
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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.
*

Bron: Sanofi Aventis

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