New Clinical Trial Shows CRESTOR(R) Significantly Slowed Progression of Atherosclerosis in People With Early Signs of the Disease |
- Results Presented at the American College of Cardiology 56th Annual
Scientific Sessions -
LONDON, March 29 /PRNewswire/ --
* METEOR (Measuring Effects on intima media Thickness: an Evaluation Of
Rosuvastatin) was a randomized, double-blind, multi-national study
comparing the effects of two years of treatment with CRESTOR(R)
(rosuvastatin calcium) 40mg with placebo on carotid atherosclerosis,
measured as change in carotid intima-media thickness (CIMT), in people
with early signs of the disease.
- John Robert Crouse, III, M.D., Professor of Medicine at Wake Forest
University School of Medicine, Winston-Salem, NC was the principal
investigator for the METEOR study.
- The METEOR study involved 61 clinical sites in eight countries,
including the U.S., Holland, Germany, France, Belgium, Finland,
Norway, and the Czech Republic.
* METEOR was a 24 month study in patients at low risk for coronary heart
disease (CHD) with early signs of atherosclerosis as determined by an
increased CIMT (maximum CIMT greater than or equal to 1.2 and < 3.5 mm).
Additional study population characteristics include:(1)
- Framingham 10-year risk <10% but with minimal evidence of
atherosclerosis (MaxIMT all sites; mean 1.16mm) and modest LDL-C
levels (mean 154 mg/dL)
- HDL-C less than or equal to 60 mg/dL, TG <500 mg/dL
* METEOR demonstrated a slowing of progression of atherosclerosis in
subjects with such early signs of the disease and who are at low
cardiovascular risk. Specific results showed that:
- CRESTOR 40mg significantly slowed progression of atherosclerosis
compared to placebo (MaxIMT at all sites -0.0014 mm/year versus
0.0131 mm/year; p<0.0001)
- Significant progression was observed in the placebo arm compared to
baseline, while there was no significant progression in the CRESTOR
treatment group
-- Effects on maximum carotid intima-media thickness (MaxIMT) were also
seen in the individual carotid artery segments - common carotid
artery (CCA), internal carotid artery (ICA), and the carotid
bifurcation (bulb):(2)
- CCA: -0.0038 vs. +0.0084 mm/year with placebo (p<0.0001)
- ICA: +0.0039 vs. +0.0145 mm/year with placebo (p=0.023)
- Bulb: -0.0040 vs. +0.0172 mm/year with placebo (p<0.0001)
-- Additional effects on mean carotid intima-media thickness were also
seen in the common carotid artery (CCA) segment:(2)
-- CCA: +0.0004 vs. +0.0088 mm/year with placebo (p<0.0001)
-- LDL-C, or "bad" cholesterol, reduced by 48.8 percent, compared to 0.3
percent with placebo (p<0.0001)
- HDL-C, or "good" cholesterol, increased by 8.0 percent, compared to
2.8 percent with placebo (p<0.0001)
- CRESTOR is not indicated for the treatment of atherosclerosis.
* METEOR is one of several studies that formed the basis of AstraZeneca's
application to the FDA for an update to the CRESTOR Prescribing
Information. The submission seeks to expand the use of CRESTOR to
include the treatment of atherosclerosis with the purpose of impacting
the progression of the disease in patients in whom lipid-lowering
therapy is indicated. METEOR and ASTEROID (AStudy To evaluate the
Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary
Atheroma Burden) examined the effect of CRESTOR 40mg on atherosclerosis
in both the carotid and coronary arteries, using two different
ultrasound techniques, across the spectrum of the disease, (i.e. both
early signs and more established disease).
(Photo: http://www.newscom.com/cgi-bin/prnh/20070329/NYTH036 )
* Atherosclerosis is the cause of "hardening" and narrowing of the
arteries. It is caused by the slow buildup of plaque inside the walls of
the arteries. Arteries are blood vessels that carry oxygen-rich blood
from the heart to other parts of the body. The build-up of plaques can
cause the arteries to narrow, which can reduce the blood supply to vital
organs such as the heart and brain, depriving them of oxygen and vital
nutrients.(3)
* METEOR is part of AstraZeneca's GALAXY Program, which is a large,
comprehensive, long-term, and evolving global research initiative
designed to address important unanswered questions in statin research
and to investigate the impact of CRESTOR on cardiovascular risk
reduction and patient outcomes. The GALAXY Program has recruited over
55,000 subjects in more than 75 countries around the world.
* CRESTOR 40mg over two years was well tolerated in the METEOR study. In
this population, the overall frequency of muscle, hepatic and renal
adverse events was similar in rosuvastatin and placebo treated people,
and was consistent with the known safety profile of CRESTOR.
* The 40mg dose of CRESTOR is reserved only for those patients who have
not achieved their LDL-C goal utilizing the 20mg dose of CRESTOR once
daily. The usual recommended starting dose for CRESTOR is 10mg. CRESTOR
is not indicated for the treatment of atherosclerosis.
About CRESTOR
CRESTOR is a once-daily prescription statin medication indicated for
use as an adjunct to diet in the treatment of various lipid disorders
including primary hypercholesterolemia, mixed dyslipidemia and isolated
hypertriglyceridemia, available in a 5-, 10-, 20-, and 40-mg dose. CRESTOR
has not been determined to prevent heart disease, heart attacks, or
strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the
usual recommended starting dose of CRESTOR is 10 mg. However, initiation of
therapy with 5 mg once daily should be considered for patients requiring
less aggressive LDL-C reductions or who have predisposing factors for
myopathy, and for special populations such as patients taking cyclosporine,
Asian patients, and patients with severe renal insufficiency. For patients
with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid
targets, a 20-mg starting dose may be considered. AstraZeneca licensed
worldwide rights to CRESTOR from the Japanese pharmaceutical company
Shionogi & Co., Ltd.
Important Safety Information
CRESTOR is contraindicated in patients with active liver disease or
unexplained persistent elevations of serum transaminases, in women who are
pregnant or may become pregnant, and in nursing mothers. It is recommended
that liver function tests be performed before and at 12 weeks following
both the initiation of therapy and any elevation of dose, and periodically
(e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute
renal failure secondary to myoglobinuria have been reported with CRESTOR
and with other drugs in this class. The 40-mg dose of CRESTOR is reserved
only for those patients who have not achieved their LDL-C goal utilizing
the 20-mg dose of CRESTOR once daily. When initiating statin therapy or
switching from another statin therapy, the appropriate CRESTOR starting
dose should first be utilized, and only then titrated according to the
patient's individualized goal of therapy. The benefit of further
alterations in lipid levels by the combined use of rosuvastatin with
fibrates or niacin should be carefully weighed against the potential risks
of this combination. Combination therapy with rosuvastatin and gemfibrozil
should generally be avoided. CRESTOR should be prescribed with caution in
patients with predisposing factors for myopathy, such as renal impairment,
advanced age, and inadequately treated hypothyroidism. Patients should be
advised to promptly report unexplained muscle pain, tenderness, or
weakness, particularly if accompanied by malaise or fever. CRESTOR is
generally well-tolerated. Adverse reactions have usually been mild and
transient. The most frequent adverse events thought to be related to
CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%),
abdominal pain (1.3%) and nausea (1.3%).(4)
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
FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare
business with more than 12,000 employees. For nearly three decades,
AstraZeneca has offered drug assistance programs side by side with its
medicines, and over the past five years, has provided over $3 billion in
savings to more than 1 million patients throughout the US and Puerto Rico.
AstraZeneca has been named one of the "100 Best Companies for Working
Mothers" by Working Mother magazine and is the only large pharmaceutical
company named to FORTUNE magazine's 2007 list of "100 Best Companies to
Work For." In 2006, for the fifth consecutive year, Science magazine named
AstraZeneca a "Top Employer" on its ranking of the world's most respected
biopharmaceutical employers.
For more information about AstraZeneca, please visit: http://www.astrazeneca-
us.com
For further information contact:
Michele Pelkowski
Associate Director PR, CRESTOR
302-885-4055
Michele.Pelkowski@astrazeneca.com
CRESTOR is a registered trademark of the AstraZeneca group of companies.
(1) Carotid Intima Media Thickness in Low-Risk Individuals with
Asymptomatic Atherosclerosis: Baseline Data from the METEOR Study --
John R. Crouse, III, Diederick E. Grobbee, Daniel H. O'Leary, Michiel
L. Bots, Greg W. Evans, Mike K. Palmer, Ward A. Riley, Joel S.
Raichlen, METEOR Investigators. Curr Med Res Opin. 2007;23:641-648.
(2) Effect of Rosuvastatin on Progression of Carotid Intima Media
Thickness in Low-Risk Individuals: Results of the METEOR Trial -- John
R. Crouse, III, Diederick E. Grobbee, Daniel H. O'Leary, Michiel L.
Bots, Greg W. Evans, Mike K. Palmer, Ward A. Riley, Joel S. Raichlen,
METEOR Investigators.
(3) National Heart, Lung and Blood Institute: "What is
atherosclerosis?"
http://www.nhlbi.nih.gov/health/dci/Diseases/Atherosclerosis/Atherosclerosi
s_W hatIs.html. Accessed March 13, 2007.
(4) DA-CRS-01
SOURCE AstraZeneca
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Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20070329/NYTH036
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Michele Pelkowski, Associate Director PR,
CRESTOR, +1-302-885- 4055, Michele.Pelkowski@astrazeneca.com, of
AstraZeneca
