Arixtra, (fondaparinux sodium) GlaxoSmithKline’s anti-thrombotic product is found as effective as with the commonly used Lovenox/Clexane (enoxaparin) for the primary composite endpoint of preventing death, myocardial infarction, and refractory ischaemia at 9 days (incidence of 5.9% and 5.8%, respectively) in patients with acute coronary syndromes (ACS), according to the results from the clinical trial.
The patients in the study experienced at least one of the three components of the primary endpoint. Furthermore, Arixtra was associated with a 47% (p< 0.001) reduction in major bleeding vs. Lovenox/Clexane (2.1% and 4.0% incidence, respectively) in this study.
Organization to Assess Strategies for Ischaemic Syndromes (OASIS 5), a landmark head-to-head trial, evaluated more than 20,000 patients with ACS, and was presented today at the European Society of Cardiology (ESC) meeting in Stockholm, Sweden.
"The OASIS 5 findings demonstrate that Arixtra is likely an effective anti-thrombotic drug in many patients with ACS already receiving aspirin and clopidogrel,” said Dr. Salim Yusuf, principal investigator of the study, and professor of medicine, McMasterUniversityand Hamilton Heath Sciences, Ontario, Canada.
Arixtra is not currently approved in the EU or US for patients with Acute Coronary Syndromes.
Previous studies have shown that newer anti-thrombotics can substantially reduce the risk of heart attacks in patients; however, this is often accompanied by an increased risk of major bleeding.5 A need remains for effective therapies in ACS with a lower incidence of major bleeding. Bleeding rates of Arixtra in OASIS 5 coupled with similar efficacy to therapy with Lovenox/Clexane, a low molecular weight heparin, demonstrated a strong risk:benefit profile for Arixtra in this study.
“Results from OASIS 5 soundly demonstrate that Arixtra, a trusted medicine in venous thrombosis, may offer tremendous potential clinical benefits in the treatment of Acute Coronary Syndromes,” Dr. Lawson Macartney, senior vice-president, Cardiovascular and Metabolic Medicine Development Centre, GlaxoSmithKline said adding, “GSK is excited that this product can address an unmet medical need and we look forward to submitting these data to Regulatory Authorities worldwide for review so that we may bring the product to physicians and patients for use in ACS.”
Arixtra is the first in a new class of anti-thrombotics that selectively inhibits Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin, a protease in blood that facilitates blood clotting.