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Nycomed contributes with more than 4,200 European patients leading to completion of ACUITY, a global landmark trial within acute coronary syndromes.
Nycomed and its US collaborator, The Medicines Company, announced today the completion of patient enrolment in the 13,800 patient global phase III ACUITY trial. This randomised clinical trial evaluates the thrombin-specific anticoagulant Angiox® (bivalirudin) replacing the combination of heparin (either unfractionated heparin or enoxaparin) and glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes (ACS) presenting to the emergency department.
ACUITY has been conducted at 450 clinical trial sites in 17 countries worldwide with European sites contributing to the overall enrolment with more than 4,800 patients. Nycomed, the main European distributor of Angiox®, has been the key driver and co-sponsor of the trial in Europe.
"The enrolment of over 13,800 patients with acute coronary syndromes into the ACUITY trial in just over two years is an incredible achievement and a testament to the importance of improving the otherwise poor prognosis in these high-risk patients," said ACUITY's Principal Investigator, Gregg W. Stone, MD, Professor of Medicine and Director of Cardiovascular Research and Education at Columbia University Medical Center's Center for Interventional Vascular Therapy and Vice- Chairman of the Cardiovascular Research Foundation. "We are hopeful that the results of this landmark trial will establish a new standard of care for patients with unstable coronary artery disease."
The first announcement of ACUITY results is expected at the American College of Cardiology Annual Scientific Session in March 2006. Results are also expected to be published in a leading peer-reviewed journal.
"Previous data show there is a need for a safer alternative to heparin for patients with ACS," said Alejandra Mørk, SVP International Product Development at Nycomed. "In the previous Angiox® trial REPLACE-2, we have seen favourable outcomes in patients with high risk characteristics, and we therefore anticipate that the ACUITY trial will support the use of Angiox® in ACS." She continued: "Whether or not patients undergo percutaneous coronary interventions, we believe Angiox® will provide patients with a safe and effective treatment option to unfractionated heparin or enoxaparin in combination with glycoprotein IIb/IIIa inhibitors."
Today, cardiovascular disease is the leading cause of death in Europe and in the western world as a whole. Alone in the European Union, cardiovascular disease each year causes the death of more than 1.5 million people and is a major threat to the quality of life for many others. Ischemic heart disease patients are subject to chest pain that results from a range of conditions, from unstable angina to acute myocardial infarction. The severe onset of these cardiac conditions is collectively referred to as Acute Coronary Syndromes (ACS).
About Angiox® and ACUITY
Angiox® (bivalirudin) – US trade name Angiomax® – is a thrombin-specific anticoagulant currently indicated for use in patients undergoing percutaneous coronary interventions (PCI). In clinical trials, bivalirudin has demonstrated reductions in both ischaemic events and bleeding complications. Reductions that remain evident even in high-risk patients.
ACUITY (Acute Catheterisation and Urgent Intervention Triage strategY) evaluates the use of Angiox®, replacing heparins, starting in the emergency department or critical care unit and continued through the cardiac catheterisation laboratory. The control arm of ACUITY comprises of patients treated with the heparins combined with glycoprotein IIb/IIIa inhibitors, which are intravenous anti-platelet agents. In the other two arms of the trial, Angiox® is evaluated both as mono-therapy and in combination with glycoprotein IIb/IIIa inhibitors.
About Nycomed
Nycomed is a pharmaceutical company dedicated to meeting needs in Europe. The company provides hospital products throughout the region and general practitioner and pharmacy medicines in selected markets.
New products are sourced through licensing agreements with research companies. Here Nycomed provides late-stage clinical development, registration and marketing.
Headquartered in Roskilde, Denmark, the company employs about 3,000 people throughout Europe and Russia/CIS. Nycomed is privately owned and had a 2004 revenue of € 644.6 million.
For more information visit www.nycomed.com
For further information
Alejandra Mørk, SVP International Product Development
Phone: (+45) 46 77 11 11
Christoffer Jensen, VP Communications
Phone: (+45) 46 77 11 12
Mobile: (+45) 22 43 69 44 |
