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CRESTOR(R) Reduced CV Risk in Patients Achieving Low LDL-C and hsCRP Targets in New Jupiter Analysis

Orlando, Florida (ots/PRNewswire)

Results from a new
sub-analysis of the JUPITER study show that patients who attained a
dual treatment target of LDL-C <70mg/dL and high-sensitivity
C-reactive protein (hsCRP) <2mg/L with CRESTOR (rosuvastatin) 20mg
achieved a greater reduction in cardiovascular events compared to
placebo than those who did not (65% vs 36%, p=0.033) among men and
women with low to normal cholesterol levels and elevated hsCRP. These
new data were presented at the 58th Annual American College of
Cardiology Scientific Sessions (ACC) in Orlando, Florida, and
published simultaneously in The Lancet.
This analysis was conducted in approximately 15,500 patients, or
87% of the entire JUPITER cohort, representing patients who had LDL-C
and hsCRP values assessed at baseline and one year.
Additional results from this analysis showed:
- Patients who achieved an LDL-C <70 mg/dL experienced a 55% reduction in
      cardiovascular events compared to placebo
    - Patients who achieved a dual treatment target of LDL-C<70 mg/dL and
      hsCRP <1 mg/L achieved a 79% reduction in CV events compared to
      placebo.
"These data further support the benefit of achieving low LDL-C
with rosuvastatin," said Michael Cressman, AstraZeneca's Medical
Science Director for CRESTOR, "Raised LDL-C is one of the major
causes of atherosclerosis, an underlying cause of cardiovascular
disease. Elevated CRP is a recognized marker of inflammation, so this
analysis also suggests that in addition to its lipid lowering
properties, CRESTOR may impact another aspect of atherosclerosis,
inflammation."
Rosuvastatin 20mg was well tolerated in nearly 9,000 patients
during the course of the JUPITER study.
Rosuvastatin is not indicated for the prevention of
cardiovascular events. 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:
Results from the primary analysis of JUPITER (Justification for
the Use of statins in Primary prevention: an Intervention Trial
Evaluating Rosuvastatin), 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
rosuvastatin 20 mg reduced the combined risk of heart attack, stroke
or CV death by nearly half (47%, p<0.00001 vs placebo).
JUPITER 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
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 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 program, 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
Program.
AstraZeneca has previously announced that it 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.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR significantly lowered
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 15 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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  • 19.02.2009 – 22:46

    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 ...