Donnees sur angiox (bivalirudine injectable) dans l'infarctus du myocarde presentées au congrès euro-pcr et publiées dans l'european heart journal
Hier, lors de la session des “Late Breaking Clinical Trial” du congrès Euro-PCR, et en publication simultanée dans l'European Heart Journal, le Professeur Uwe Zeymer de l'hôpital de Ludwigshafen, Allemagne, a présenté une communication intitulée : « La bivalirudine est supérieure à l'héparine seule avec utilisation en « bailout » d'inhibiteurs de glycoprotéine (GP) IIb/IIIa chez des patients ayant un infarctus du myocarde avec sus-décalage du segment ST (STEMI) et transportés d'urgence pour bénéficier d'une angioplastie primaire : une analyse pré-spécifiée de l'étude EUROMAX. »
L'étude EUROMAX a étudié 2198 patients avec infarctus du myocarde (STEMI) qui ont été transportés en urgence vers une procédure cardiaque (angioplastie primaire) qui visait à reperfuser les artères coronaires occluses par un caillot sanguin - la cause sous-jacente de l'infarctus du myocarde. Le traitement avec la bivalirudine (Angiox) a été comparé à de l'héparine non fractionnée ou une héparine de bas poids moléculaire avec une utilisation optionnelle d'inhibiteurs de GP IIb/IIIa. Comme reporté l'année dernière dans le New England Journal of Medicine, cet essai a atteint tous ses critères pré-spécifiés.
L'auteur principal et rapporteur de cette nouvelle analyse, le Pr Uwe Zeymer, de l'hôpital de Ludwigshafen en Allemagne, précise : « les résultats de cette analyse pré-spécifiée de sous-groupe sont cohérents avec l'ensemble des résultats cliniques d'études. L'utilisation de bivalirudine se traduit par des taux significativement moindres sur le critère principal et les saignements majeurs quelque soit l'utilisation en routine ou « bailout » d'inhibiteurs de GP IIb/IIIa. »
L'investigateur principal de l'étude EUROMAX, le Professeur P. Gabriel Steg de Hôpital Bichat à Paris précise : « les résultats de cette analyse pré-spécifiée de sous-groupe sont en phase avec l'ensemble des données d'études et montrent que les réductions sur le critère principal et les saignements majeurs observés avec la bivalirudine par rapport à l'héparine sont cohérents quelque soit l'utilisation des inhibiteurs de GP IIb/IIIa. Cependant, l'augmentation absolue de 1% des thromboses aiguës de stent dans l'étude EUROMAX était également observée dans cette analyse prévue a priori. »
About Angiox/Angiomax
In the United States, bivalirudin is marketed under the trade name Angiomax® and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA. Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
In Europe, bivalirudin is marketed under the trade name Angiox® and is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
About EUROMAX
EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg per kilogram per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no-reflow.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
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