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Targets in New Jupiter Analysis
Results from a new sub-analysis of the JUPITER study show that patients
who attained a dual treatment target of LDL-C <70mg/dL and high-sensitivityC-reactive protein (hsCRP) <2mg/L with CRESTOR (rosuvastatin) 20mg achieved agreater reduction in cardiovascular events compared to placebo than those who
did not (65% vs 36%, p=0.033) among men and women with low to normal
cholesterol levels and elevated hsCRP. These new data were presented at the
58th Annual American College of Cardiology Scientific Sessions (ACC) in
Orlando, Florida, and published simultaneously in The Lancet. This analysis was conducted in approximately 15,500 patients, or 87% of
the entire JUPITER cohort, representing patients who had LDL-C and hsCRP
values assessed at baseline and one year. Additional results from this analysis showed:
- Patients who achieved an LDL-C <70 mg/dL experienced a 55% reduction in cardiovascular events compared to placebo - Patients who achieved a dual treatment target of LDL-C<70 mg/dL and hsCRP <1 mg/L achieved a 79% reduction in CV events compared to placebo. "These data further support the benefit of achieving low LDL-C with
rosuvastatin," said Michael Cressman, AstraZeneca's Medical Science Director
for CRESTOR, "Raised LDL-C is one of the major causes of atherosclerosis, an
underlying cause of cardiovascular disease. Elevated CRP is a recognized
marker of inflammation, so this analysis also suggests that in addition to
its lipid lowering properties, CRESTOR may impact another aspect of
atherosclerosis, inflammation." Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the
course of the JUPITER study. Rosuvastatin is not indicated for the prevention of cardiovascular
events. 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. ABOUT JUPITER: Results from the primary analysis of JUPITER (Justification for the Use
of statins in Primary prevention: an Intervention Trial Evaluating
Rosuvastatin), 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 alsoshowed that rosuvastatin 20 mg reduced the combined risk of heart attack,
stroke or CV death by nearly half (47%, p<0.00001 vs placebo).
JUPITER 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 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. AstraZeneca has previously announced that it 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. 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. Nearly
15 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
(ORLANDO, Fl., Mar. 30 AsiaNet=연합뉴스)<저 작 권 자(c)연 합 뉴 스. 무 단 전 재-재 배 포 금 지.>
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