Magazin
2009-02-19
San Diego, California (ots/PRNewswire) - A new analysisfrom the JUPITER study presented today at the International StrokeConference (ISC) in San Diego, California, describes details of thestroke data according to gender, ethnicity and baseline risk factors.This data adds to the primary analysis of the JUPITER study whichdemonstrated that CRESTOR® (rosuvastatin calcium) 20mg significantlyreduced the risk of stroke by nearly half (48%; p=0.002), compared toplacebo among men and women with elevated hsCRP but low to normalcholesterol levels.
"Stroke is the third most common cause of death in developedcountries. Globally around 15 million people have a stroke every yearand of these about 5 million die and another 5 million are leftpermanently disabled, with conditions such as paralysis, cognitivedeficits, speech problems, emotional difficulties, daily livingproblems and pain. Rosuvastatin has previously shown that it can slowthe progression of atherosclerosis, which is a major underlying causeof stroke", said Michael Cressman, Director of Clinical Research forCRESTOR. "This analysis of the JUPITER data evaluated rosuvastatin 20mg across a number of subgroups with notable benefits in higher riskpatients including those older than 70 years, cigarette smokers,hypertensives, those with an elevated Framingham risk score, andthose with a high-sensitivity C-reactive protein level at or above 5mg/L at baseline."
There was no increase in the risk of hemorrhagic stroke (P=0.44vs placebo) in patients treated with rosuvastatin. Rosuvastatin 20 mgwas well tolerated in nearly 9,000 patients during the course of theJUPITER study.
Initial results from JUPITER, originally presented in November2008 at the American Heart Association's Annual Scientific Sessions,and published by the New England Journal of Medicine, showedrosuvastatin 20mg significantly reduced major cardiovascular (CV)events (combined risk of myocardial infarction, stroke, arterialrevascularization, hospitalization for unstable angina, or death fromCV causes) by 44 % compared to placebo (p<0.00001). These resultsalso showed that for patients in the trial taking rosuvastatin 20mgthe combined risk of heart attack, stroke or CV death was reduced bynearly half (47%, p<0.00001).
AstraZeneca expects to file a regulatory submission including theJUPITER data in the first half of 2009 and if approved, will beginpromotional activities within the approved labeling.
Rosuvastatin is not indicated for the prevention ofcardiovascular events, including stroke. Rosuvastatin should be usedaccording to the prescribing information, which containsrecommendations for initiating and titrating therapy according to theindividual patient profile. In most countries, the usual recommendedstarting dose of rosuvastatin is 10 mg.
About JUPITER:
JUPITER (Justification for the Use of statins in Primaryprevention: an Intervention Trial Evaluating Rosuvastatin) was along-term, randomized, double-blind, placebo-controlled, large-scalestudy of 17,802 patients designed to determine if rosuvastatin 20 mgdecreases the risk of heart attack, stroke and other majorcardiovascular events in patients with low to normal LDL-C but atincreased cardiovascular risk as identified by elevatedhigh-sensitivity C-reactive protein (hsCRP) and age. The majority ofpatients 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 isassociated with an increased risk of atherosclerotic cardiovascularevents.
JUPITER is a part of AstraZeneca's extensive GALAXY clinicaltrials programme, designed to address important unanswered questionsin statin research. Currently, more than 69,000 patients have beenrecruited from 55 countries worldwide to participate in the GALAXYProgramme.
About CRESTOR (Rosuvastatin):
Studies have previously shown that CRESTOR was the most effectivestatin at lowering LDL-C, had a significant effect on raising HDL-Cand slowed the progression of atherosclerosis, an underlying cause ofcardiovascular disease.
CRESTOR has now received regulatory approval in over 95countries. Nearly 16 million patients have been prescribed CRESTORworldwide. Data from clinical trials and real world use shows thatthe safety profile for CRESTOR is in line with other marketedstatins.
About AstraZeneca
AstraZeneca is a major international healthcare business engagedin the research, development, manufacturing and marketing ofmeaningful prescription medicines and supplier for healthcareservices. AstraZeneca is one of the world's leading pharmaceuticalcompanies with healthcare sales of US$ 31.6 billion and is a leaderin 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 presscommunication media for the benefit of correspondents writing for themedical professional press. Differing national legislation, codes ofpractice, medical practice etc mean that you should contact yourlocal AZ press office to obtain information designed for use in yourcountry. In particular this press release has not been prepared foruse in the USA.
ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Ben Strutt, Global PR Director, Cardiovascular Therapy Area, AstraZeneca, Tel: +44(0)1625-230076, Mob: +44(0)7919-565990, Email: ben.strutt@astrazeneca.com
CRESTOR Cuts Risk of Stroke by Nearly Half in JUPITER Study
"Stroke is the third most common cause of death in developedcountries. Globally around 15 million people have a stroke every yearand of these about 5 million die and another 5 million are leftpermanently disabled, with conditions such as paralysis, cognitivedeficits, speech problems, emotional difficulties, daily livingproblems and pain. Rosuvastatin has previously shown that it can slowthe progression of atherosclerosis, which is a major underlying causeof stroke", said Michael Cressman, Director of Clinical Research forCRESTOR. "This analysis of the JUPITER data evaluated rosuvastatin 20mg across a number of subgroups with notable benefits in higher riskpatients including those older than 70 years, cigarette smokers,hypertensives, those with an elevated Framingham risk score, andthose with a high-sensitivity C-reactive protein level at or above 5mg/L at baseline."
There was no increase in the risk of hemorrhagic stroke (P=0.44vs placebo) in patients treated with rosuvastatin. Rosuvastatin 20 mgwas well tolerated in nearly 9,000 patients during the course of theJUPITER study.
Initial results from JUPITER, originally presented in November2008 at the American Heart Association's Annual Scientific Sessions,and published by the New England Journal of Medicine, showedrosuvastatin 20mg significantly reduced major cardiovascular (CV)events (combined risk of myocardial infarction, stroke, arterialrevascularization, hospitalization for unstable angina, or death fromCV causes) by 44 % compared to placebo (p<0.00001). These resultsalso showed that for patients in the trial taking rosuvastatin 20mgthe combined risk of heart attack, stroke or CV death was reduced bynearly half (47%, p<0.00001).
AstraZeneca expects to file a regulatory submission including theJUPITER data in the first half of 2009 and if approved, will beginpromotional activities within the approved labeling.
Rosuvastatin is not indicated for the prevention ofcardiovascular events, including stroke. Rosuvastatin should be usedaccording to the prescribing information, which containsrecommendations for initiating and titrating therapy according to theindividual patient profile. In most countries, the usual recommendedstarting dose of rosuvastatin is 10 mg.
About JUPITER:
JUPITER (Justification for the Use of statins in Primaryprevention: an Intervention Trial Evaluating Rosuvastatin) was along-term, randomized, double-blind, placebo-controlled, large-scalestudy of 17,802 patients designed to determine if rosuvastatin 20 mgdecreases the risk of heart attack, stroke and other majorcardiovascular events in patients with low to normal LDL-C but atincreased cardiovascular risk as identified by elevatedhigh-sensitivity C-reactive protein (hsCRP) and age. The majority ofpatients 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 isassociated with an increased risk of atherosclerotic cardiovascularevents.
JUPITER is a part of AstraZeneca's extensive GALAXY clinicaltrials programme, designed to address important unanswered questionsin statin research. Currently, more than 69,000 patients have beenrecruited from 55 countries worldwide to participate in the GALAXYProgramme.
About CRESTOR (Rosuvastatin):
Studies have previously shown that CRESTOR was the most effectivestatin at lowering LDL-C, had a significant effect on raising HDL-Cand slowed the progression of atherosclerosis, an underlying cause ofcardiovascular disease.
CRESTOR has now received regulatory approval in over 95countries. Nearly 16 million patients have been prescribed CRESTORworldwide. Data from clinical trials and real world use shows thatthe safety profile for CRESTOR is in line with other marketedstatins.
About AstraZeneca
AstraZeneca is a major international healthcare business engagedin the research, development, manufacturing and marketing ofmeaningful prescription medicines and supplier for healthcareservices. AstraZeneca is one of the world's leading pharmaceuticalcompanies with healthcare sales of US$ 31.6 billion and is a leaderin 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 presscommunication media for the benefit of correspondents writing for themedical professional press. Differing national legislation, codes ofpractice, medical practice etc mean that you should contact yourlocal AZ press office to obtain information designed for use in yourcountry. In particular this press release has not been prepared foruse in the USA.
ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Ben Strutt, Global PR Director, Cardiovascular Therapy Area, AstraZeneca, Tel: +44(0)1625-230076, Mob: +44(0)7919-565990, Email: ben.strutt@astrazeneca.com
AstraZeneca
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