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CRESTOR(R) Reduced Risk of Cardiovascular Events in Women by Nearly Half in New Analysis of Jupiter Study

Orlando, Florida, November 17 (ots/PRNewswire)

JUPITER, which used
CRESTOR 20 mg, is the first statin study to demonstrate a reduction
in the risk of cardiovascular (CV) events in women without
established cardiovascular disease (CVD). In this new analysis of
6,801 women from the JUPITER study, rosuvastatin 20 mg reduced CV
events by 46% in women without CVD but at increased risk of a
cardiovascular event, as identified by age and elevated hsCRP
(p=0.002 vs placebo). This analysis also showed a 42% reduction in CV
events for men without established CVD (p<0.001 vs placebo). These
data were presented today at the American Heart Association Annual
Scientific Sessions in Orlando, Florida.
To view the Multimedia News Release, please click:
http://multivu.prnewswire.com/mnr/astrazeneca/41126/
"Nearly twice as many women die of heart attacks, strokes and
other cardiovascular diseases as from all forms of cancer, including
breast cancer," said Michael Cressman, AstraZeneca's Director of
Clinical Research for CRESTOR. "Women have been an understudied
population in statin outcomes trials and until now there has been
limited evidence that women can benefit from statin therapy."
    Also presented at AHA today were two additional analyses of JUPITER data:
    - Patients who achieved very low LDL-C (< 50 mg/dL) with rosuvastatin 20
      mg achieved a significant 63% reduction in CV events (p<0.0001 vs.
      placebo) and a 51% greater reduction in CV events than patients not
      achieving such a low LDL-C (p=0.003). Current treatment guidelines
      recommend aggressive LDL-C goals for appropriate patients based on the
      results from outcome trials, however there has been uncertainty about
      the possible side effects that could be associated with achieving very
      low LDL-C levels. In this new analysis of 4,100 patients, the safety
      profile of rosuvastatin was similar among patients who achieved very
      low LDL-C levels and those who did not.
    - Treatment with rosuvastatin 20 mg significantly reduced the risk of CV
      events by 32% (p=0.028 vs placebo) in 5,466 patients with Impaired
      Fasting Glucose (IFG) at baseline and by 49% in patients with Normal
      Fasting Glucose (NFG) at baseline (p<0.001 vs placebo). IFG can be an
      early sign that a patient will develop diabetes, and many people with
      IFG do become diabetic, which in turn places them at increased
      cardiovascular risk.
The results from all three JUPITER analyses are consistent with
findings from the primary JUPITER analysis which showed that
rosuvastatin 20 mg significantly reduced cardiovascular events by a
dramatic 44 percent compared to placebo in patients at increased
cardiovascular risk as identified by age and elevated hsCRP. In
JUPITER, the safety profile for rosuvastatin 20 mg in nearly 9,000
patients, including 3,426 women, was consistent with what has been
observed previously in CRESTOR clinical trials. There was a small
increase in physician reported diabetes consistent with data from
other large placebo controlled statin trials.
AstraZeneca filed a regulatory submission including the JUPITER
data in the first half of 2009.
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 is a part of AstraZeneca's extensive GALAXY clinical
trials program, 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
Program.
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. More than 17 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, AstraZeneca, Tel: +44(0)1625-230076, Mob:
+44(0)7919-565990, Email: ben.strutt@astrazeneca.com

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