ORLANDO, Florida, November 17 /PRNewswire/ -- JUPITER, which used CRESTOR 20 mg, is the first statin study todemonstrate a reduction in the risk of cardiovascular (CV) events in womenwithout established cardiovascular disease (CVD). In this new analysis of6,801 women from the JUPITER study, rosuvastatin 20 mg reduced CV events by46% in women without CVD but at increased risk of a cardiovascular event, asidentified by age and elevated hsCRP (p=0.002 vs placebo). This analysis alsoshowed a 42% reduction in CV events for men without established CVD (p<0.001vs placebo). These data were presented today at the American HeartAssociation Annual Scientific Sessions in Orlando, Florida.
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"Nearly twice as many women die of heart attacks, strokes and othercardiovascular diseases as from all forms of cancer, including breastcancer," said
Also presented at AHA today were two additional analyses of JUPITER data:
- Patients who achieved very low LDL-C (< 50 mg/dL) with rosuvastatin 20mg 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 alow LDL-C (p=0.003). Current treatment guidelines recommend aggressive LDL-Cgoals for appropriate patients based on the results from outcome trials,however there has been uncertainty about the possible side effects that couldbe associated with achieving very low LDL-C levels. In this new analysis of4,100 patients, the safety profile of rosuvastatin was similar among patientswho achieved very low LDL-C levels and those who did not.
- Treatment with rosuvastatin 20 mg significantly reduced the risk of CVevents by 32% (p=0.028 vs placebo) in 5,466 patients with Impaired FastingGlucose (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 apatient 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 findingsfrom the primary JUPITER analysis which showed that rosuvastatin 20 mgsignificantly reduced cardiovascular events by a dramatic 44 percent comparedto placebo in patients at increased cardiovascular risk as identified by ageand elevated hsCRP. In JUPITER, the safety profile for rosuvastatin 20 mg innearly 9,000 patients, including 3,426 women, was consistent with what hasbeen observed previously in CRESTOR clinical trials. There was a smallincrease in physician reported diabetes consistent with data from other largeplacebo controlled statin trials.
AstraZeneca filed a regulatory submission including the JUPITER data inthe 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 20mg decreased the risk of heart attack, stroke and other cardiovascular eventsin patients with low to normal LDL-C but at increased cardiovascular risk asidentified by age and elevated high-sensitivity C-reactive protein (hsCRP).The majority of patients had at least one other risk factor includinghypertension, low HDL-C, family history of premature coronary heart disease(CHD) or smoking. hsCRP is a recognised marker of inflammation which isassociated with an increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca's extensive GALAXY clinical trialsprogram, designed to address important unanswered questions in statinresearch. Currently, more than 65,000 patients have been recruited from 55countries 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 ofatherosclerosis, an underlying cause of cardiovascular disease. CRESTOR hasnow received regulatory approval in over 95 countries. More than 17 millionpatients have been prescribed CRESTOR worldwide. Data from clinical trialsand real world use shows that the safety profile for CRESTOR is in line withother marketed statins.
ABOUT ASTRAZENECA
AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacturing and marketing of meaningful prescriptionmedicines and supplier for healthcare services. AstraZeneca is one of theworld's leading pharmaceutical companies with healthcare sales of US$ 31.6billion and is a leader in gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infectious disease medicines. For more informationabout AstraZeneca, please visit: www.astrazeneca.com.
Press Contact: Ben Strutt Global PR Director AstraZeneca Tel: +44(0)1625-230076 Mob: +44(0)7919-565990 ben.strutt@astrazeneca.comPR Newswire
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