Crestor(r) Reduced Risk Of Cardiovascular Events In Women By Nearly Half In New Analysis Of Jupiter

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18th November 2009, 12:34pm - Views: 637






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MEDIA RELEASE PR37145


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

Jupiter Study


ORLANDO, Fla, Nov.18/PRNewswire-AsiaNet/ --


    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: 




    "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

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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.


SOURCE: AstraZeneca


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