Wilmington, DE, (March 18, 2003) -- AstraZeneca today announced initiation of a long-term clinical study to examine whether the company's investigational statin CRESTOR® (rosuvastatin calcium) can reduce the risk of major cardiovascular events in patients. The new study is part of the GALAXY Program, a large, comprehensive, long-term and evolving global research initiative related to cardiovascular risk reduction.
The JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) is the first study of its kind designed to evaluate the effect of statin therapy on the reduction of cardiovascular morbidity and mortality among individuals with average or normal LDL-cholesterol levels and elevated C-reactive protein (CRP) levels.
CRP is a protein whose levels increase when there is inflammation in the body. Elevated CRP levels may indicate a risk of future heart attack up to eight years in advance, even if cholesterol levels are low. The Centers for Disease Control and Prevention (CDC) and American Heart Association (AHA) released the first CRP testing guidelines in January 2003. The guidelines focus on patients who have a moderate risk for heart disease and are designed to help doctors determine if the patient needs treatment with medication. Recent estimates suggest that 25 million healthy middle-aged Americans who have normal cholesterol levels have elevated CRP levels.
"C-reactive protein is rapidly becoming an important indicator of cardiovascular risk," says Dr. Paul Ridker, MD, MPH, Director of the Center of Cardiovascular Disease Prevention, Brigham and Women's Hospital, Boston, and lead investigator of the JUPITER study. "The JUPITER study will allow us to determine the effects of CRESTOR on patients with low LDL-cholesterol and elevated CRP levels. These patients do not currently qualify for treatment based on current cholesterol guidelines, therefore this study will help us determine if CRESTOR can prevent cardiovascular events among men and women with elevated CRP levels."
The JUPITER study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study of an estimated 15,000 patients. The primary objective of the study is to investigate whether long-term treatment with CRESTOR compared to placebo will decrease the rate of major cardiovascular events among individuals with LDL-C (<130 mg/dL) and elevated levels of CRP (=2.0 mg/L) who may be at vascular risk on the basis of an enhanced inflammatory response.
Two other studies in the GALAXY Program that have already begun, METEOR and ASTEROID, are investigating the effects of CRESTOR on atherosclerosis reflected by thickening of the arterial walls.
The objective of METEOR (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin) is to evaluate CRESTOR on the progression of carotid atherosclerosis by measuring intima media thickness (IMT) in low risk, asymptomatic, hypercholesterolemic subjects with sub-clinical evidence of atherosclerosis as determined by thickened carotid artery walls. This randomized, double-blind, placebo-controlled study started in August 2002 and will enroll more than 800 patients worldwide.
The objective of ASTEROID (A Study To evaluate the Effect of Rosuvastatin On Intravascular ultrasound-Derived coronary atheroma burden) is to use intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to assess the effects of CRESTOR on the regression of coronary atherosclerosis in patients with coronary artery disease who require coronary angiography. This open-label, non-comparative study started in November 2002 and will enroll more than 400 patients worldwide.
A third study within the GALAXY Program, AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular hemodialysis: an Assessment of survival and cardiovascular events) has also started. AURORA is the first ever global, randomized, placebo-controlled study to examine the role of statin therapy in patients with end-stage renal disease undergoing chronic hemodialysis treatment.
The GALAXY Program
The GALAXY Program is designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, 2 studies have completed and 9 are ongoing and more than 19,000 patients have been recruited from 23 countries worldwide.
About CRESTOR®
CRESTOR belongs to the class of lipid-lowering medications called HMG-CoA reductase inhibitors, or "statins." AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd. AstraZeneca filed a new drug application (NDA) for rosuvastatin in June 2001 with the U.S. Food and Drug Administration.
About AstraZeneca
AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $9.3 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit www.astrazeneca-us.com