New Orleans, November 9 (ots/PRNewswire)
- New data from the JUPITER
study demonstrated that CRESTOR(R) (rosuvastatin calcium) 20 mg
significantly reduced major cardiovascular (CV) events (defined in
this study as the 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<0.001)
among men and women with elevated hsCRP but low to normal cholesterol
Results also showed that for patients in the trial taking
- the combined risk of heart attack, stroke or CV death was
reduced by nearly half (47%, p<0.001).
- risk of heart attack was cut by more than half (54%,p<0.001).
- risk of stroke was cut by nearly half (48%, p=0.002).
- total mortality was significantly reduced by 20% (p=0.02).
These results were accompanied by a median LDL-C reduction of
50% (p<0.001) resulting in an on-treatment median LDL-C of 55 mg/dL.
On the basis of the data, if the results are projected over a
period of 5 years, 25 patients would need to be treated to prevent
one major cardiovascular event (NNT=25).
The JUPITER results will be presented today at the American Heart
Association Scientific Sessions and were simultaneously published
online by the New England Journal of Medicine.
"These results provide new information about CRESTOR's effects on
CV risk. The JUPITER trial confirmed that CRESTOR dramatically
reduces LDL-C cholesterol levels and has now demonstrated a nearly
50% reduction in the risk of heart attack and stroke in a population
of patients who had elevated hsCRP but low to normal cholesterol
levels," said Howard Hutchinson, Chief Medical Officer for
AstraZeneca. "As is appropriate, the medical community, regulators,
and guideline committees will now carefully consider these data and
any implications for treating patients."
As previously guided, 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
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.
Rosuvastatin 20 mg was well tolerated in nearly 9,000 patients
during the course of the study. There was no difference between
treatment groups for major adverse events, including cancer or
myopathy. There was a small increase in physician reported diabetes
consistent with data from other large placebo controlled statin
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
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
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
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
AstraZeneca is a major international healthcare business engaged
in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of $29.55 billion and leading positions in sales of
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infection products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4 Good Index.
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