New Crestor® data in African-American patients with high cholesterol
First-ever large-scale, prospective study in African Americans with high cholesterol levels demonstrates Crestor helped patients achieve cholesterol goals
NEW ORLEANS (November 9, 2004) -- New data presented today at the American Heart Association's Annual Scientific Sessions showed that AstraZeneca's CRESTOR® (rosuvastatin calcium) at 10 and 20 mg reduced LDL-C or "bad" cholesterol by 37 and 46 percent, compared to 32 and 39 percent at similar doses with atorvastatin in African-American patients. CRESTOR also brought more patients in this study to National Cholesterol Education Program Adult Treatment Panel III (ATP III) LDL-C goals than atorvastatin at milligram-equivalent doses of 10 and 20 mg. ARIES (African American Rosuvastatin Investigation of Efficacy and Safety) is the first-ever large-scale, prospective trial exclusively designed to compare the effects of statins in African-American patients, who have generally been underrepresented in clinical trials.
"As an African American physician who treats a large number of African-American patients, the ARIES trial represents an opportunity to demonstrate the efficacy and safety of statins in this high-risk, undertreated and underserved population," said Dr. Keith C. Ferdinand, clinical cardiologist and medical director of Heartbeats Life Center and the lead investigator for ARIES. "ARIES is the first trial to demonstrate superiority in lowering LDL-cholesterol (bad cholesterol) in this population using rosuvastatin (CRESTOR) compared to atorvastatin, comparing equal doses of each."
ARIES is a six-week, randomized, controlled, open-label, multi-center trial designed to evaluate the efficacy of CRESTOR and atorvastatin in African Americans with elevated cholesterol. After a six-week dietary lead-in, 774 African-American adults with hypercholesterolemia were randomized to one of four open-label treatments for six weeks: CRESTOR 10 or 20 mg or atorvastatin 10 or 20 mg. Results showed CRESTOR 10 and 20 mg reduced LDL-C by 37 and 46 percent respectively compared with 32 and 39 percent for atorvastatin at the same dosages (p<0.017). The data also showed that 66 and 79 percent of the patients treated with CRESTOR 10 and 20 mg respectively reached their NCEP ATP III cholesterol goals compared to 58 and 62 percent for the patients treated with atorvastatin 10 and 20 mg respectively. Treatments used in the ARIES study were well tolerated.
Additional data from ARIES demonstrated:
CRESTOR 10 and 20 mg increased HDL-C by 7 and 6.5 percent compared with 5.6 and 3.7 percent with atorvastatin 10 and 20 mg. CRESTOR 10 mg produced significantly greater increases than 20 mg of atorvastatin (p<0.017)
CRESTOR 10 and 20 mg reduced non-HDL-C by 34 and 42 percent compared with 30 and 36 percent for atorvastatin at the same dosages (p<0.017)
CRESTOR 10 and 20 mg reduced total cholesterol by 27 and 33 percent compared with 23 and 29 percent for atorvastatin 10 and 20 mg (p<0.017)
African Americans and Elevated Cholesterol
According to the American Heart Association, approximately 42 percent of the African-American population has high cholesterol, and an estimated 45 percent has elevated LDL-C levels. Additionally, according to the National Center for Chronic Disease Prevention and Health Promotion's Risk Factor Surveillance System (BRFSS), an estimated 26 percent of the African-American population has never had their cholesterol levels checked.
About CRESTOR CRESTOR® (rosuvastatin calcium) has now received regulatory approvals in 65 countries across five continents and has been launched in over 50 countries worldwide, including 19 European markets, the United States and Canada. Over 3.4 million patients have been prescribed CRESTOR and 11 million prescriptions have been written worldwide. The post-marketing experience supports the favorable benefit:risk profile of CRESTOR and confirms that the safety profile is in line with other currently marketed statins.
The ARIES study is a specialized trial included in AstraZeneca's GALAXY Program, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. The GALAXY program also includes two additional first-ever prospective trials exclusively designed to compare the effects of statins in various ethnic populations: the IRIS trial (Investigation of Rosuvastatin In South-Asian Subjects) and the STARSHIP trial (STudy Assessing RosuvaStatin in the HIspanic Population). Currently, three studies in the GALAXY Program have completed and 14 studies are ongoing; in total, the studies have recruited over 40,000 subjects in more than 50 countries around the world.
CRESTOR is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR 10 mg is the usual recommended start dose for patients new to statin treatment and also for those switching to CRESTOR from other statins regardless of prior dose. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
In clinical studies, CRESTOR was generally well-tolerated. The most common side effects are muscle pain, constipation, weakness, stomach pain and nausea. These are usually mild and tend to go away. Doctors will perform blood tests before and during treatment with CRESTOR to monitor for liver function. Patients are encouraged to tell their doctor if they are taking any medications, including cyclosporine, warfarin, gemfibrozil or antacids. CRESTOR is not right for everyone, including women who are nursing, pregnant, or who may become pregnant, or anyone with liver problems. Unexplained muscle pain, tenderness or weakness could be a sign of a rare but serious side effect and should be reported to a doctor right away. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes.
Full prescribing and product information for CRESTOR is available by calling the AstraZeneca Information Center at 1-800-236-9933 or by visiting www.crestor.com.
About AstraZeneca AstraZeneca 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 world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.