London (ots/PRNewswire) - AstraZeneca (LSE: AZN) (NYSE: AZN) today
announced the launch of a new clinical trial, SATURN, designed to
measure the impact of CRESTOR(TM) (rosuvastatin) 40 mg and
atorvastatin (Lipitor(R)) 80 mg on the progression of
atherosclerosis in high risk patients. SATURN will compare the
effects of these two statins on the ability to decrease progression
or induce regression of atherosclerosis, the main cause of
cardiovascular disease, following two years of treatment in patients
with coronary artery disease.
"The impact on atherosclerosis has been studied previously in
separate clinical trials involving rosuvastatin and atorvastatin,"
said Elisabeth Bjork, Global Medical Science Director for CRESTOR,
"This study, for the first time, will provide physicians with
important information to better understand how these two statins
compare when treating dyslipidaemic patients with advanced
SATURN, (Study of Coronary Atheroma by InTravascular Ultrasound:
Effect of Rosuvastatin Versus AtorvastatiN), is a 104-week,
parallel-group, multicentre, double-blind, Phase IIIb intravascular
ultrasound (IVUS) imaging study of approximately 1,300 patients at
170 centres worldwide. The first patient will be enrolled later this
month and the study is expected to complete in 2011. SATURN is part
of AstraZeneca's extensive GALAXY clinical trials programme, designed
to address important unanswered questions in statin research and to
investigate the impact of rosuvastatin on control of lipids,
atherosclerosis and cardiovascular morbidity and mortality.
Currently, more than 63,000 patients have been recruited from 55
countries worldwide to participate in the GALAXY Programme.
"Two major studies in the GALAXY programme have already
demonstrated the significant impact of rosuvastatin 40mg on
atherosclerosis across the disease spectrum. The ASTEROID study was
the first to show regression of coronary atherosclerosis in patients
with established disease, and the METEOR study showed that
rosuvastatin can also slow or delay the progression of carotid
atherosclerosis in patients with early signs of the disease. The
results of the SATURN study will provide additional information on
how best to treat patients with the very serious condition of
advanced atherosclerosis," said Elisabeth Bjork, "we believe the data
from this study will underscore the benefits of intensively managing
cholesterol levels with rosuvastatin, both LDL-C and HDL-C, to reduce
the burden of atherosclerosis."
Data from other atherosclerosis trials in the GALAXY programme,
METEOR and ASTEROID, have demonstrated that intensive treatment with
rosuvastatin 40mg results in effective lipid management and
beneficial effects across the atherosclerotic disease spectrum;
- METEOR was the first study to show that rosuvastatin
demonstrated a positive effect on atherosclerosis in people at low
risk of coronary heart disease (CHD) and with early signs of carotid
artery disease as measured by B-mode ultrasound.
- ASTEROID demonstrated that rosuvastatin regressed
atherosclerosis as measured by intravascular ultrasound (IVUS) in
high risk patients with evidence of coronary artery disease by
In the U.S., based on the METEOR study, rosuvastatin has been
approved as an adjunct to diet to slow the progression of
atherosclerosis in patients with elevated cholesterol. The
rosuvastatin Prescribing Information in Europe has been updated to
incorporate data from the METEOR study.
CRESTOR has now received regulatory approvals in over 90
countries. Over 11 million patients have been prescribed rosuvastatin
worldwide. Data from clinical trials and real world use shows that
the safety profile for rosuvastatin is in line with other marketed
The 40 mg dose is the highest registered dose of rosuvastatin.
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 10mg. The 40mg
dose should only be used in patients who have not achieved their
LDL-C goal utilizing the 20mg dose of rosuvastatin.
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 $26.47 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. For
more information about AstraZeneca, please visit:
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