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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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