First Head to Head Study Comparing Crestor(TM) and Lipitor(R) Effects on the Treatment...

First Head to Head Study Comparing Crestor(TM) and Lipitor(R) Effects on the
Treatment of Atherosclerosis

LONDON, Jan. 15 /PRNewswire/ -- AstraZeneca 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 atherosclerosis."
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 coronary angiography.

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 statins.
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.
About AstraZeneca
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:
http://www.astrazeneca.com
SOURCE AstraZeneca

Ben Strutt, Global PR Manager, Cardiovascular Therapy Area, AstraZeneca,
+44(0)1625-230076, cell: +44(0)7919-565990, or ben.strutt@astrazeneca.com