AKTUELLE DATEN ZU ANGIOX (BIVALIRUDIN) BEI PATIENTEN MIT HERZINFARKT AUF DEM EUROPCR VORGESTELLT UND ZEITGLEICH IM EUROPEAN HEART JOURNAL VERÖFFENTLICHT
(22.05.2014, Pharma-Zeitung.de) PARIS - Copyright by Business Wire - The Medicines Company
PRÄSPEZIFIZIERTE SUBGRUPPENANALYSE DER EUROMAX-STUDIE VERGLEICHT DIE ANGIOX MONOTHERAPIE GEGENÜBER EINER HEPARIN-MONOTHERAPIE BEI THERAPIEBEGINN BEREITS IM RETTUNGSWAGEN
Im Rahmen der Late Breaking Clinical Trial Sitzung auf dem EuroPCR präsentierte Professor Dr. Uwe Zeymer, Klinikum Ludwigshafen, Deutschland gestern die Daten der zeitgleich im European Heart Journal publizierten Analyse mit dem Titel: “ Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial“ (Bivalirudin ist bei Patienten mit ST-Streckenhebungsmyokardinfarkt, die notfallmäßig für eine primäre perkutane Koronarintervention transportiert werden, der alleinigen Gabe von Heparin und GP IIB/IIIa-Inhibitoren als Notfallbehandlung überlegen: eine präspezifizierte Analyse der EUROMAX Studie)
In der EUROMAX Studie wurden 2.198 Patienten mit ST-Streckenhebungsmyokardinfarkt (STEMI) bereits auf ihrem Transport zur primären perkutanen Koronarintervention (pPCI) untersucht. Dieser Notfalleingriff am Herzen wird durchgeführt, um den thrombotischen Verschluß der Herzkranzarterien, welche die Ursache für den Herzinfarkt sind, zu beheben. Dabei wurde eine Behandlung mit Bivalirudin (Angiox®) oder unfraktioniertem bzw. niedermolekularem Heparin mit optionaler Gabe von Glykoprotein-Inhibitoren (GPI) verglichen. In dieser Studie, deren Ergebnisse 2013 im New England Journal of Medicine veröffentlicht wurden, sindalle prä-spezifizierten Endpunkte erreicht worden.
Der leitende Prüfarzt der EUROMAX-Studie, Professor Dr. med. P. Gabriel Steg, Hôpital Bichat, Paris sagte, "die Ergebnisse dieser präspezifizierten Subgruppenanalyse sind in Einklang mit den Gesamtergebnissen der Studie und belegen, dass die Reduktion des primären Endpunktes und der schweren Blutungen gemäß Protokolldefinition unter Bivalirudin gegenüber Heparin konsistent und unabhängig von der GPI-Anwendung sind. Die bereits bekannte etwas erhöhte Rate an akuten Stentthrombosen um absolut ca. 1 % in der EUROMAX-Gesamtstudie wurde auch in dieser präspezifizierten Analyse beobachtet.”
Nach Aussage des Erstautors und Referenten dieser neuen Analyse, Prof. Dr. med. Uwe Zeymer, Klinikum Ludwigshafen, sind “die Ergebnisse dieser präspezifizierten Subgruppenanalyse konsistent zu den Gesamtergebnissen der Studie. Bivalirudin führt zu signifikant reduzierten Raten des primären Endpunktes und der schweren Blutungskomplikationen – unabhängig davon, ob GPI routinemäßig oder auschließlichen als Notfallbehandlung verwendetwerden.”
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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