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Crestor (Rosuvastatin) Appears To Helps More African-American Patients Achieve Cholesterol Goals

NEW ORLEANS, LA -- November 16, 2004 -- New data from the first large-scale prospective study of statins in African Americans with hypercholesterolaemia demonstrate the excellent efficacy of Crestor™ (rosuvastatin) in this important, currently undertreated1,2, patient group at risk of developing coronary heart disease (CHD). Results from the ARIES study3 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.4

"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, under treated 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 bad cholesterol in this population using rosuvastatin (Crestor) compared to atorvastatin, using equal doses of each."

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.5 African Americans have higher CVD and stroke death rates than Caucasians, and approximately 40% of African American men and women age 20 and older have CVD.6

Results from ARIES, involving 774 African American adults with hypercholesterolaemia, show that at six weeks:3
· Crestor 10mg reduces LDL-C significantly more than atorvastatin 10mg (-37% versus -32%, respectively; p<0.017)
· Crestor 20mg almost halves LDL-C levels, a significantly greater reduction than with atorvastatin 20mg (-46% versus -39%, respectively; p<0.017)
· Crestor 10 and 20mg enables 66% and 79% of patients to achieve their LDL-C goal, compared with atorvastatin 10mg and 20mg (58% and 62%, respectively)
· Crestor 10 and 20mg increases HDL-C by 7.0% and 6.5%, compared with 5.6% and 3.7% for atorvastatin 10 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% and -42% versus -30% and -36%, respectively; p<0.017)
· Crestor 10 and 20mg reduces total cholesterol significantly more than atorvastatin 10 and 20 mg (-27% and -33% versus -23% and -29%, respectively; p<0.017)
· Crestor 10 and 20mg achieved similar results as atorvastatin 10 and 20mg at lowering patients' triglyceride levels (-16 and -21% versus -17% and -20%, 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.7 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 has never had their cholesterol levels checked.8 Despite the increased risk of CVD in African Americans, there is evidence that this population is less likely to receive interventional treatments9-11 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 underrepresented 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 age12,13 and that there is a higher frequency of CHD compared to other populations.14 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.15 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 3.4 million patients have been prescribed Crestor and 11 million prescriptions have been written worldwide. 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.

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)

Cardiovascular Disease
The term cardiovascular disease (CVD) refers to a wide range of disorders affecting the heart and blood vessels. CVD can be sub-divided into the following diseases:
· Coronary heart disease (CHD) (e.g. heart attacks and angina)
· Cerebrovascular disease (e.g. strokes and transient ischaemic attacks)
· Peripheral vascular disease (e.g intermittent claudication).
CVD is estimated to account for approximately a third of all deaths globally and is the leading cause of mortality in Europe and the US. Over 16.7 million deaths each year are due to CVD (more than 45,000 deaths every day, and almost 32 deaths each minute).5 In Europe, about half of all deaths from CVD are from CHD and nearly one-third are from stroke.16

Recommended LDL-C targets
LDL-C (low density lipoprotein cholesterol) - also known as 'bad cholesterol' - is recognised as a major contributor to the development of atherosclerosis, whereas HDL-C (high density lipoprotein cholesterol) - also known as 'good cholesterol' - inhibits the atherosclerotic process.

The National Cholesterol Education Program Adult Treatment Panel III (ATP III) LDL-C goals for LDL are as follows:4
CHD* and CHD risk equivalents** <2.6 mmol/L (100 mg/dL)
Multiple (2+) risk factors† <3.5 mmol/L (130 mg/dL)
Zero to 1 risk factor <4.2 mmol/L (160 mg/dL)
*Includes a history of myocardial infarction, unstable angina, stable angina, coronary artery procedures, and clinical evidence of myocardial ischemia.
**Includes clinical forms of non-coronary atherosclerotic vascular disease (peripheral arterial disease, abdominal aortic aneurysm, clinical carotid artery disease, diabetes, and multiple (2 or more) risk factors with 120 year risk for major coronary events (myocardial infarction + coronary death) =20%
†Multiple (2 or more) risk factors with 10-year risk for major coronary events =20%. ATP III modifies intensity of LDL-lowering therapy required to achieve the goals of therapy according to 10-year risk for CHD.

References:
1. Foster P, Jackson M. Distribution of lipoprotein phenotypes, cholesterol, and lipids in inner-city blacks. Journal of the National Medical Association 1993;85:211-15.
2. Nieto FJ, Alonso, J, Chambless LE, et al. Population awareness and control of hypertension and hypercholesterolemia. The Atherosclerosis Risk in Communities study. Archives of Internal Medicine 1995;155(7):677-84.
3. Ferdinand KC, Clark LT, Neal RC, et al. Efficacy of statin therapy in African American patients with hypercholesterolemia: Results from the ARIES Trial. Abstract Presented at American Heart Association Scientific Sessions, New Orleans, Louisiana, 2004.
4. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Journal of American Medical Association 2001; 285:2486-2497. Also available on-line: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm
5. World Health Report 2003. World Health Organization. http://www.who.int
6. American Heart Association. Facts About African-American Heart Health. http://www.americanheart.org
7. American Heart Association. Cholesterol Statistics. http://www.americanheart.org
8. National Center for Chronic Disease Prevention and Health Promotion. Risk Factor Surveillance System. Prevalence Data 2003. http://apps.nccd.cdc.gov/brfss/race.asp?cat=CA&yr=2003&qkey=1487&state=US
9. Ford ES, Cooper RS. Racial/ethnic differences in health care utilization of cardiovascular procedures: a review of the evidence. Health Services Research. 1995;30:237-252.
10. Giles WH, Anda RF, Casper ML, et al. Race and sex differences in rates of invasive cardiac procedures in U.S. hospitals. Archives of Internal Medicine. 1995;155:318-324.
11. Curry C. In: Livingston IL, ed. Handbook of black American health: the mosaic of conditions, issues, policies, and prospects. Westport, CT: Greenwood Press, 1994:24-32.
12. Hughes LO, Wojciechowski AP, Raftery EB. Relationship between plasma cholesterol and coronary artery disease in Asians. Atherosclerosis 1990;83:15-20.
13. McKeigue PM, Ferrie JE, Pierpoint T, et al. Association of early-onset coronary heart disease in South Asian men with glucose intolerance and hyperinsulinemia. Circulation 1993;87:152-161.
14. Enas AE. Coronary artery disease in Indians (CADI) study. Asian Am Pac Isl J Health 1998;6(1):54-60.
15. Ford E, Giles W H, Dietz, W H. Prevalence of the Metabolic Syndrome Among US Adults. Findings from the Third National Health and Nutrition Examination Survey. Journal of American Medical Association 2002;287(3):356-59.
16. European Cardiovascular Disease Statistics, 2000 Edition, British Heart Foundation. http://www.bhf.org.uk


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