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AstraZeneca GmbH

CRESTOR Cuts Risk of Stroke by Nearly Half in JUPITER Study

San Diego, California (ots/PRNewswire)

A new analysis
from the JUPITER study presented today at the International Stroke
Conference (ISC) in San Diego, California, describes details of the
stroke data according to gender, ethnicity and baseline risk factors.
This data adds to the primary analysis of the JUPITER study which
demonstrated that CRESTOR® (rosuvastatin calcium) 20mg significantly
reduced the risk of stroke by nearly half (48%; p=0.002), compared to
placebo among men and women with elevated hsCRP but low to normal
cholesterol levels.
"Stroke is the third most common cause of death in developed
countries. Globally around 15 million people have a stroke every year
and of these about 5 million die and another 5 million are left
permanently disabled, with conditions such as paralysis, cognitive
deficits, speech problems, emotional difficulties, daily living
problems and pain. Rosuvastatin has previously shown that it can slow
the progression of atherosclerosis, which is a major underlying cause
of stroke", said Michael Cressman, Director of Clinical Research for
CRESTOR. "This analysis of the JUPITER data evaluated rosuvastatin 20
mg across a number of subgroups with notable benefits in higher risk
patients including those older than 70 years, cigarette smokers,
hypertensives, those with an elevated Framingham risk score, and
those with a high-sensitivity C-reactive protein level at or above 5
mg/L at baseline."
There was no increase in the risk of hemorrhagic stroke (P=0.44
vs placebo) in patients treated with rosuvastatin. Rosuvastatin 20 mg
was well tolerated in nearly 9,000 patients during the course of the
JUPITER study.
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<0.00001). 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<0.00001).
AstraZeneca expects to file a regulatory submission including the
JUPITER data in the first half of 2009 and if approved, will begin
promotional activities within the approved labeling.
Rosuvastatin is not indicated for the prevention of
cardiovascular events, including stroke. Rosuvastatin should be used
according to the prescribing information, which contains
recommendations for initiating and titrating therapy according to the
individual patient profile. In most countries, the usual recommended
starting dose of rosuvastatin is 10 mg.
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
high-sensitivity C-reactive protein (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 CRESTOR (Rosuvastatin):
Studies have previously shown that CRESTOR 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.
CRESTOR has now received regulatory approval in over 95
countries. Nearly 16 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.
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:
http://www.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. In particular this press release has not been prepared for
use in the USA.

Contact:

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

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