Home  Media Press releases 2004
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| 10 November 2004 | 2004-11-10T00:00:00.0000000-00:00 |
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CRESTOR™ HELPS MORE AFRICAN AMERICAN PATIENTS WITH HYPERCHOLESTEROLAEMIA ACHIEVE CHOLESTEROL GOALS
Results from the ARIES study presented today at the American Heart Association’s Annual Scientific Sessions demonstrate that CRESTOR 10 and 20mg reduce LDL-cholesterol (LDL-C or “bad” cholesterol) significantly more and raise HDL-cholesterol (HDL-C or “good” cholesterol) more than atorvastatin 10 and 20mg in African Americans with hypercholesterolaemia, and enable more patients to achieve their US NCEP ATP III guideline LDL-C goals.
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Cardiovascular disease (CVD) is estimated to account for approximately a third of all deaths globally and is the leading cause of mortality in the US. African Americans have higher CVD and stroke death rates than Caucasians, and approximately 40 percent of African American men and women age 20 and older have CVD.
"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.”
Results from ARIES, involving 774 African American adults with hypercholesterolaemia, show that at six weeks:
· CRESTOR 10mg reduces LDL-C significantly more than atorvastatin 10mg (-37 percent versus –32 percent, respectively; p<0.017)
· CRESTOR 20mg almost halves LDL-C levels, a significantly greater reduction than with atorvastatin 20mg (-46 percent versus –39 percent, respectively; p<0.017)
· CRESTOR 10mg and 20mg enables 66 percent and 79 percent of patients to achieve their LDL-C goal, compared with atorvastatin 10mg and 20mg (58 percent and 62 percent, respectively)
· CRESTOR 10 and 20mg increases HDL-C by 7.0 percent and 6.5 percent, compared with 5.6 percent and 3.7 percent for atorvastatin 10mg and 20mg, respectively (p<0.017 CRESTOR 10mg versus atorvastatin 20mg)
· CRESTOR 10 and 20mg significantly reduces non-HDL-C compared with atorvastatin 10 and 20mg (-34 percent and –42 percent versus –30 percent and –36 percent, respectively; p<0.017)
· CRESTOR 10 and 20mg reduces total cholesterol significantly more than atorvastatin 10 and 20 mg (-27 percent and –33 percent versus –23 percent and –29 percent, respectively; p<0.017)
· CRESTOR 10mg and 20mg achieved similar results as atorvastatin 10mg and 20mg at lowering patients’ triglyceride levels (-16 and –21 percent versus –17 percent and –20 percent, respectively; n.s.).
Treatments used in the ARIES study were well tolerated.
According to the American Heart Association, approximately 42 percent of the African-American population has high cholesterol, with approximately 45 percent having elevated LDL-C levels. Additionally the National Center for Chronic Disease Prevention and Health Promotion’s Risk Factor Surveillance System (BRFSS) states that an estimated 26 percent of African Americans have never had their cholesterol levels checked. Despite the increased risk of CVD in African Americans, there is evidence that this population is less likely to receive interventional treatments and are generally underrepresented in clinical trials.
The effect of CRESTOR is also being investigated in the first prospective studies of statins in South Asian and Hispanic populations – both are minority populations currently under-represented in clinical trials of statins. The IRIS trial will assess the comparative efficacy and safety of CRESTOR and atorvastatin in Americans of South Asian origin and with hypercholesterolaemia. There is evidence that the symptoms of coronary disease in people of South Asian origin present at an earlier age and that there is a higher frequency of CHD compared to other populations. The STARSHIP trial will assess the efficacy of CRESTOR and atorvastatin in lowering LDL-C in Hispanic subjects with hypercholesterolaemia, the largest minority population in the US. Hispanics have an adverse cardiovascular risk profile with an increased risk of the metabolic syndrome. Further clarification of the role of intervention therapy within both of these minority groups is greatly needed, and results from these trials may have important treatment implications for these high-risk populations.
CRESTOR 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 US and Canada. Over 3.5 million patients have been prescribed CRESTOR and almost 12 million prescriptions have been written worldwide. In the first nine months of 2004, CRESTOR sales reached $596 million. The post-marketing experience supports the favourable benefit:risk profile of CRESTOR and confirms that the safety profile is in line with other currently marketed statins. CRESTOR 10mg 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.
Media Enquiries:
Steve Brown, +44 207 304 5033
Edel McCaffrey, +44 207 304 5034
Investor Enquiries:
Mina Blair, +44 207 304 5084
Jonathan Hunt, +44 207 304 5087
Notes to editors:
· 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. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
· AstraZeneca has more than 40 years’ experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a comprehensive cardiovascular portfolio including CRESTORTM, the first oral direct thrombin inhibitor EXANTA™, ATACAND™, ZESTRIL™, TENORMIN™, SELOKEN ZOK /TOPROL-XL™ and PLENDIL™. This heritage is complemented by an innovative pipeline including a novel treatment for type 2 diabetes / metabolic syndrome, GALIDA™.
· CRESTOR study titles:
ARIES = African American Rosuvastatin Investigation of Efficacy and Safety
IRIS =Investigation of Rosuvastatin In South-Asian Subjects
STARSHIP = STudy Assessing RosuvaStatin in the HIspanic Population
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