Healthcare Industry News:  rosuvastatin 

Biopharmaceuticals Cardiology

 News Release - June 22, 2006

New Data Shows CRESTOR(R) Helped African American, Hispanic American and South Asian American Patients Significantly Lower LDL-C and Achieve Cholesterol Goals

Results of Three First-ever Large-scale, Prospective Studies Presented Today

WILMINGTON, Del., June 22 (HSMN NewsFeed) -- Data from an analysis of three first-ever large-scale, prospective studies presented today at the International Symposium on Atherosclerosis (ISA) demonstrate that AstraZeneca's CRESTORŽ (rosuvastatin calcium) effectively reduced cholesterol levels in several distinct ethnic populations that have generally been underrepresented in clinical trials -- African American, Hispanic American and South Asian American. The three studies, ARIES (African American Rosuvastatin Investigation of Efficacy and Safety), STARSHIP (STudy Assessing RoSuvastatin in HIspanic Population) and IRIS (Investigation of Rosuvastatin In South Asian Subjects) are all part of AstraZeneca's US GALAXY program which is designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes.

"These ethnic groups represent a significant -- and growing -- sector of the U.S. population and have specific health-related concerns based on genetics, demographic structure and other cultural factors(1)," said Prakash C. Deedwania, M.D., Chief of Cardiology at the Veterans Affairs Central California Health Care System and Professor of Medicine at the University of California, San Francisco, School of Medicine. "The results of ARIES, STARSHIP and IRIS have, for the first time, shown us that we can effectively lower LDL-C or 'bad' cholesterol levels and bring a majority of patients to goal with the 10-mg start dose of CRESTOR in these populations."

ARIES (774 patients), STARSHIP (696) and IRIS (740) were each six-week, randomized, controlled, open-label, multi-center trials designed to evaluate the efficacy of CRESTOR and atorvastatin in various ethnic populations with elevated cholesterol -- African Americans, Hispanic Americans and South Asian Americans, respectively. After a six-week dietary lead-in, patients 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.

Specific results from the studies include:

In ARIES, CRESTOR 10 and 20 mg reduced LDL-C by 37 and 46 percent, compared to 32 and 39 percent at similar doses of atorvastatin (p<0.017). CRESTOR 10 and 20 mg brought 66 and 79 percent of patients to their individual NCEP ATP III cholesterol goals.

The STARSHIP study showed that CRESTOR 10 and 20 mg reduced LDL-C by 45 and 50 percent compared to 36 and 42 percent with atorvastatin 10 and 20 mg (p<0.017). CRESTOR 10 and 20 mg brought 78 and 88 percent of patients to their individual NCEP ATP III cholesterol goals.

Results of the IRIS study demonstrate that CRESTOR 10 mg reduced LDL-C by 45 percent compared to 40 percent with atorvastatin 10 mg (p<0.017). The 50 percent LDL-C reduction seen with CRESTOR 20 mg compared to the 47 percent reduction seen with atorvastatin 20 mg was not statistically significant. CRESTOR 10 and 20 mg brought 79 and 89 percent of patients to their individual NCEP ATP III cholesterol goals.

Both treatments were well-tolerated and had similar safety profiles in the studies.
    Cholesterol in Diverse Populations
    African Americans
       *  Approximately 42 percent of African American men and 47 percent of
          African American women have total blood cholesterol levels of 200
          mg/dL or higher.(2)
       *  Over 12 percent of African American men and 17.4 percent of African
          American women have total blood cholesterol levels of 240mg/dL or
          higher.(2)
       *  An estimated 24.9 percent of this population have never had their
          cholesterol levels checked.(3)

    Hispanic Americans
       *  Among Mexican Americans age 20 and older, 52 percent of men and 45
          percent of women have total blood cholesterol levels of 200 mg/dL or
          higher.(4)
       *  Of these, nearly 17 percent of men and nearly 14 percent of women
          have total cholesterol over 240 mg/dl.(4)
       *  Hispanics are 36 percent less likely than Caucasians to have
          properly controlled cholesterol.(5)

    South Asian Americans
       *  Heart disease is the leading cause of death for South-Asian
          Americans, a population that has more than doubled (106%) in the
          past ten years in the United States.(6)
       *  The prevalence of heart disease is higher in this population as
          compared to Asians and non-Hispanic Whites.(6)
About the GALAXY Program

The ARIES, STARSHIP and IRIS studies are all trials in AstraZeneca's GALAXY Program, which is a large, comprehensive, long-term and evolving global research initiative 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 has recruited over 50,000 subjects in more than 50 countries around the world.

About CRESTOR

CRESTOR (rosuvastatin calcium) 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 has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

Important Safety Information

CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy. Initiation of therapy with 5mg once daily should be considered for Asian patients (having either Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin). The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).

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 world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

(1) Results of 3 North American Trials (ARIES, IRIS, STARSHIP) Comparing Rosuvastatin and Atorvastatin in African Americans, South Asians, and Hispanics. P. Deedwania, K. Ferdinand, R. Lloret, J. Ycas, M. Stein VACCHCS/UCSF, Fresno, CA; Heartbeats Life Center, New Orleans, LA; CV Center of South Florida, Miami, FL; AstraZeneca, Wilmington, DE, USA

(2) American Heart Association. African Americans and Cardiovascular Diseases - Statistics. Dallas, TX.; 2006.

(3) Behavioral Risk Factor Surveillance System prevalence data page. National Center for Chronic Disease Prevention and Health Promotion Web site. Available at: http://apps.nccd.cdc.gov/brfss/race.asp?yr=2005&state=UB&qkey=1488&grp=0. Accessed May 22, 2006.

(4) American Heart Association. Hispanics/Latinos and Cardiovascular - Statistics - 2006 Update. Dallas, TX.; 2006.

(5) American Heart Association. "American Ethnic Groups less likely to have cholesterol controlled." Online. Internet. Available at http://www.americanheart.org/presenter.jhtml?identifier=3026059. Accessed February 15, 2006.

(6) South Asian Public Health Association. A Brown Paper: The Health of South Asians in the United States: Executive Summary. N. Gupta, K. Bhandarkar, A. Gandhi, M. Shah, S. Rao, S. Akram, S. Ivey, B. Bhattacharya, A. Ghosh, R. Gupta, H. P. Mangto, M. Carvalho, N. Islam, N. Zojwalla, M. Khatta, R. Vedanthan, S. Rajpathak, P. Mukherji, L. Groetzinger, J. Gupta, U. D. Upadhyay, M. Rastogi, V. Suthakaran, S. S. Jonnalagadda, S. Diwan, S. Patel. July 2003.


Source: AstraZeneca

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