SAN DIEGO, California, February 19 /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 stroke by nearly half (48%; p=0.002), compared to placebo among men and women with elevated hsCRP but low to normal cholesterol levels.
"Stroke is the third most common cause of death in developed countries. Globally around 15 million people have a stroke every year and of these about 5 million die and another 5 million are left permanently disabled, with conditions such as paralysis, cognitive deficits, speech problems, emotional difficulties, daily living problems and pain. Rosuvastatin has previously shown that it can slow the progression of atherosclerosis, which is a major underlying cause of stroke", said Michael Cressman, Director of Clinical Research for CRESTOR. "This analysis of the JUPITER data evaluated rosuvastatin 20 mg across a number of subgroups with notable benefits in higher risk patients including those older than 70 years, cigarette smokers, hypertensives, those with an elevated Framingham risk score, and those with a high-sensitivity C-reactive protein level at or above 5 mg/L at baseline."
There was no increase in the risk of hemorrhagic stroke (P=0.44 vs placebo) in patients treated with rosuvastatin. Rosuvastatin 20 mg was well tolerated in nearly 9,000 patients during the course of the JUPITER study.
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 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).
AstraZeneca 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.
Rosuvastatin is not indicated for the prevention of cardiovascular events, including stroke. 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.
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) 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 elevated high-sensitivity C-reactive protein (hsCRP) and age. 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 programme, 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 Programme.
About CRESTOR (Rosuvastatin):
Studies have previously shown that CRESTOR was the most effective statin at lowering 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 16 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.
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.
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