Study demonstrates risk of cardiovascular disease cut by nearly half among women

JUPITER ANAYLSIS - Reduced first major cardiovascular events by 46% in women

TORONTO, Nov. 17 /CNW/ - A new analysis of the JUPITER trial, released today at the American Heart Association meeting in Orlando, Florida, demonstrates that CRESTOR (rosuvastatin calcium) 20mg reduced first major cardiovascular events by 46% (p=0.002 vs placebo) compared to placebo in women with low to normal LDL-C and raised hsC-reactive protein (hsCRP).(1) These results suggest that seemingly healthy Canadian women may be saved from heart attacks, strokes, or even death if they are screened for elevated hsCRP and successfully lower their cholesterol levels, even when their cholesterol levels are considered normal. The results of the JUPITER study are particularly important because it involved the largest number of women in a primary prevention trial for cardiovascular disease.

Cardiovascular disease is the leading cause of death in Canadian women and is no longer considered a "man's disease." In fact, women are more likely than men to die of a heart attack or stroke. Women are also ten times more likely to die from cardiovascular disease than from any other disease and six times more likely to die from a heart attack or stroke than from breast cancer.(2)

"Until now, we've had limited information about the benefits of primary prevention in women," said Dr. Jacques Genest, Director, Cardiology Division, McGill University Health Centre. "The results of the JUPITER trial demonstrate that women can reduce their risk of cardiovascular events with effective treatments such as rosuvastatin 20mg."

Nearly one half of all cardiovascular events occur in people who are apparently healthy and who have low or normal levels of low density lipoprotein cholesterol (LDL-C), a traditional indicator of cardiovascular risk.(3) hsCRP is a type of protein naturally produced in the body that is thought to be a marker of inflammation and increased risk of cardiovascular and other diseases.

Initial results from JUPITER, originally presented in November 2008 at the American Heart Association's Annual Scientific Sessions and published by the New England Journal of Medicine, showed rosuvastatin 20mg significantly reduced major cardiovascular (CV) events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by 44% compared to placebo (p(less than)0.00001).(4) These results also showed that for patients in the trial taking rosuvastatin 20mg the combined risk of heart attack, stroke or CV death was reduced by nearly half (47%, p(less than)0.00001).(5)

There were 6,801 female participants (38.2% of the entire study population of 17,802) randomized to receive either rosuvastatin 20mg once daily or placebo.

CRESTOR is indicated as an adjunct to diet in the treatment of high cholesterol. The 40mg dose is the highest approved dose of CRESTOR. CRESTOR is not indicated for atherosclerosis or for the reduction of mortality and morbidity. CRESTOR should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In Canada, the recommended starting dose of CRESTOR in most patients is 10 mg orally once daily.

With over 160 million prescriptions written worldwide, CRESTOR has been prescribed to more than 15 million patients and has a safety profile in line with that of other marketed statins.

ABOUT JUPITER:

JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated hsCRP and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.

JUPITER is a part of AstraZeneca's extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.ca.

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    (1) Abstract 1426: Rosuvastatin for the Primary Prevention of
        Cardiovascular Events in Women With Elevated hsCRP and Low LDLC: Sex-
        Specific Outcomes From the JUPITER Trial Circulation, Nov 2009;
        120: S500 - S501.
    (2) Cardiovascular Health. Women's Health Matters. Accessed on October
        29. Available at
        http://www.womenshealthmatters.ca/centres/cardio/index.html.
    (3) Ridker PM, Rifai N, Clearfield M, Downs J, Weis SE, Miles JS, Gotto
        A. Measurement of C-reactive Protein for the Targeting of Statin
        Therapy in the Primary Prevention of Acute Coronary Events. N Engl J
        Med 2001;344:1959-1965.
    (4) Ridker Paul M, et al. Rosuvastatin to Prevent Vascular Events in Men
        and Women with Elevated C-Reactive Protein. N Engl J Med 2008;
        359: 2195-2207.
    (5) Ridker Paul M, et al. Rosuvastatin to Prevent Vascular Events in Men
        and Women with Elevated C-Reactive Protein. N Engl J Med 2008;
        359: 2195-2207.

For further information: Sarah Rutka, Fleishman-Hillard Canada Inc., (416) 645-8191 office, (647) 291-1058 mobile, sarah.rutka@fleishman.ca; Lee Rammage, AstraZeneca Canada Inc., (416) 560-9850 mobile, lee.rammage@astrazeneca.com