BARCELONA, August 31 /PRNewswire/ -- A new analysis from the JUPITER study showed that CRESTOR(R) (rosuvastatin) 20mg reduced the composite primary end point of major cardiovascular (CV) events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by 39% (p<0.001), compared to placebo in elderly patients with low to normal cholesterol levels and elevated high-sensitivity C-reactive protein (hsCRP). This analysis was conducted in 5,695 patients aged 70 years or older. These results are consistent with the CV risk reduction seen across all patients taking rosuvastatin in the primary JUPITER analysis. This new analysis was presented today at the European Society of Cardiology (ESC) meeting in Barcelona, Spain.
Additional results from this analysis showed that treatment with CRESTOR:
- Reduced the combined risk of cardiovascular death, heart attack and
stroke by nearly 40% (p=0.004 vs placebo)
- Reduced the risk of heart attack by 45% (p=0.046 vs placebo) and of
stroke by 45% (p=0.023 vs placebo)
- Reduced the need for hospitalisation for arterial revascularisation or
unstable angina by 49% (p=0.003 vs placebo)
- Treatment effects, relative to placebo, were generally comparable in
both the elderly (aged 70 or older) and younger patient groups
"This analysis is important because it provides physicians with further evidence that CRESTOR can significantly reduce the risk of major CV events in elderly patients at higher risk of cardiovascular disease," said Michael Cressman, AstraZeneca's Director of Clinical Research for CRESTOR. "This adds to the previously published JUPITER data which showed that treatment with rosuvastatin 20mg resulted in notable benefits in a number of higher risk patient subgroups including cigarette smokers, hypertensives, and those with an elevated Framingham risk score."
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 a dramatic 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).
Rosuvastatin 20mg was well-tolerated in nearly 9,000 patients, including 2,878 patients aged 70 or older, during the course of the JUPITER study.
AstraZeneca filed a regulatory submission with the US Food and Drug Administration (FDA), including the JUPITER data, in the first half of 2009.
ABOUT JUPITER:
JUPITER was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20mg 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.
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.
For further information please contact: Ben Strutt, Global PR Director, AstraZeneca, Tel: +44-1625-230076, Mob: +44-7919-565990, Email: ben.strutt@astrazeneca.com
