CRESTOR(TM) Gains New EU Indication to Prevent Major Cardiovascular Events in High Risk Patients

By Astrazeneca, PRNE
Monday, April 26, 2010

LONDON, April 27, 2010 - CRESTOR(TM) (rosuvastatin) has been approved in nineteen countries within
the EU for the prevention of major cardiovascular events in patients who are
at high risk* of having a first cardiovascular event.

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This new indication is based on subgroup data from the landmark JUPITER
study, which evaluated the impact of rosuvastatin 20 mg on reducing major
cardiovascular events in a previously unstudied population. A post-hoc
analysis of this subgroup data showed a significant reduction in the combined
endpoint of heart attacks, strokes and CV deaths amongst the high risk
patients within JUPITER.

"This new indication is a significant milestone and means that
rosuvastatin can now be prescribed to high risk patients to prevent CV events
including heart attacks and strokes," said Michael Cressman, Executive
Director of Clinical Research for CRESTOR. "Clinical studies have previously
shown that rosuvastatin was the most effective statin at lowering LDL-C, had
a significant effect on raising HDL-C and slowed the progression of
atherosclerosis, an underlying cause of cardiovascular disease."

In JUPITER, rosuvastatin 20 mg was well tolerated in nearly 9,000
patients. There was no difference between treatment groups for major adverse
events. There was a small increase in physician reported diabetes which is in
line with data from other large placebo controlled statin trials. This
finding has been reflected in the updated Summary of Product Characteristics
(SmPC).

* high risk patients defined as having a SCORE risk greater than or equal
to 5% or Framingham Risk > 20%

ABOUT JUPITER:

JUPITER was a long-term, randomised, double-blind, placebo-controlled,
large-scale study of 17,802 patients designed to determine if rosuvastatin 20
mg decreased the risk of heart attack, stroke and other cardiovascular events
in patients with low to normal LDL-C but at increased cardiovascular risk as
identified by age and elevated high-sensitivity C-reactive protein (hsCRP).
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 recognised marker of inflammation which is
associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER was stopped early by the Data Safety Monitoring Board due to meeting
pre-defined stopping rules for efficacy in patients treated with CRESTOR.
There was a small increase in physician reported diabetes (2.8% in patients
taking CRESTOR vs. 2.3% in patients taking placebo) observed in the JUPITER
trial.

This new indication is based on a post-hoc analysis described in section
5.1 of the EU SmPC which reads, 'In a post-hoc analysis of a high-risk
subgroup of subjects with a baseline Framingham risk score >20% (1558
subjects) there was a significant reduction in the combined end-point of
cardiovascular death, stroke and myocardial infarction (p=0.028) on
rosuvastatin treatment versus placebo. The absolute risk reduction in the
event rate per 1000 patient-years was 8.8. Total mortality was unchanged in
this high risk group (p=0.193). In a post-hoc analysis of a high-risk
subgroup of subjects (9302 subjects total) with a baseline SCORE risk greater
than or equal to 5% (extrapolated to include subjects above 65 yrs) there was
a significant reduction in the combined end-point of cardiovascular death,
stroke and myocardial infarction (p=0.0003) on rosuvastatin treatment versus
placebo. The absolute risk reduction in the event rate was 5.1 per 1000
patient-years. Total mortality was unchanged in this high risk group
(p=0.076).'

JUPITER is a part of AstraZeneca's extensive GALAXY clinical trials
programme, designed to address important unanswered questions in statin
research. Currently, more than 65,000 patients have been recruited from 55
countries worldwide to participate in the GALAXY Programme.

ABOUT CRESTOR (ROSUVASTATIN):

CRESTOR has now received regulatory approval in over 100 countries. More
than 19 million patients have been prescribed CRESTOR worldwide. Data from
clinical trials and real world use shows that the safety profile for CRESTOR
is in line with other marketed statins. CRESTOR is not indicated to slow the
progression of atherosclerosis within the EU. The rosuvastatin SmPC has also
been updated to include an indication for the treatment of dyslipidaemia in
children and adolescents with heterozygous familial hypercholesterolaemia.
New statin class labeling has also been included relating to depression,
sexual dysfunction, sleep disturbance, oedema, dyspnoea, cough and
interstitial lung disease.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialisation 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.
For more information please visit: www.astrazeneca.com.

    For further information please contact:
    Ben Strutt, Global PR Director, AstraZeneca
    Tel: +44(0)1625-230076
    Mob: +44(0)7919-565990
    Email: ben.strutt@astrazeneca.com

This press release has been made available on worldwide press
communication media for the benefit of correspondents writing for the medical
professional press. Differing national legislation, codes of practice,
medical practice etc mean that you should contact your local AZ press office
to obtain information designed for use in your country.

Ben Strutt, Global PR Director, AstraZeneca, +44(0)1625-230076, Mob: +44(0)7919-565990, ben.strutt at astrazeneca.com

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