Health Canada Approves New Indication for CRESTOR(R) (ROSUVASTATIN CALCIUM)

Approval based on JUPITER trial which demonstrated reduction of cardiovascular events by nearly half

MISSISSAUGA, ON, March 17 /CNW/ - AstraZeneca announced today that Health Canada has approved CRESTOR (rosuvastatin calcium) to reduce the risk of nonfatal myocardial infarction (heart attack), nonfatal stroke, and coronary artery revascularization in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease.(A)

The new CRESTOR indication for prevention of major cardiovascular events is based on data from the landmark JUPITER trial (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) which demonstrated that CRESTOR 20mg significantly reduced the relative risk of nonfatal heart attack by 65% (p(less than)0.00001)(B), non fatal stroke by 48% (p=0.003)(C), and coronary artery revascularization by 50% (p(less than)0.001)(D) compared to placebo. The primary endpoint of the JUPITER trial demonstrated a 44% reduction in first major cardiovascular events when compared to placebo in patients with low to normal low density lipoprotein cholesterol (LDL-C) and raised high-sensitivity C-reactive protein (hsCRP).(E) This demonstrates unprecedented cardiovascular risk reduction in a large statin outcomes study.

"The JUPITER trial was significant because it challenged previous thinking about cardiovascular disease. The trial demonstrated that even people with low to normal LDL may still be at risk of a cardiovascular event," said Dr. Jacques Genest, Director, Cardiology Division, McGill University Health Centre. "In addition to the benefits we witnessed, when significant LDL lowering was achieved, the JUPITER trial also suggests that people with high hsCRP and two or more risk factors may be able to reduce their risk of cardiovascular events with effective treatments."

Cardiovascular disease is the leading cause of death in Canada,(F) yet nearly one half of all cardiovascular events occur in patients who have low or normal levels of LDL-C, a traditional indicator of cardiovascular risk.(G)

"This indication is important because it provides physicians with greater clarity when determining treatment options for their patients at risk of cardiovascular disease," says Catriona McMahon, Vice President Medical Affairs, AstraZeneca Canada. "AstraZeneca is proud to conduct research such as the JUPITER study because it offers new insights into cardiovascular disease that can ultimately play a role in improving the lives of Canadians."

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 (men (greater than or equal to)50, women (greater than or equal to)60) 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 (58%), low HDL-C (23%), family history of premature coronary heart disease (CHD) (16%) or smoking (12%). hsCRP is a 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 global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.

    
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    (A) AZ Product Monograph, March 9, 2010.
    (B) 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.
    (C) 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.
    (D) Data on file, AstraZeneca Inc. March 2010.
    (E) 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.
    (F) Statistics Canada, Mortality Summary List of Causes 2005. Released
        March 2009; as per 
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm
    (G) 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.
    

For further information: Sarah Rutka, Fleishman-Hillard Canada Inc., [phone] office, [phone] mobile, [email protected]; Lee Rammage, AstraZeneca Canada Inc., [phone] office, [email protected]