ORLANDO, Fla., Nov. 7 /PRNewswire-FirstCall/ -- A new analysis
presented today from METEOR (Measuring Effects on intima media Thickness:
an Evaluation Of Rosuvastatin) showed CRESTOR(R) (rosuvastatin calcium) 40
mg slowed the progression of carotid intima-media thickness (CIMT) in four
patient populations at varying levels of risk for cardiovascular disease.
The sub- study was conducted in subjects defined by the Framingham risk
assessment tool as having less than two or two or more risk factors (RF)
and either thinner or thicker CIMT (<1.749 mm [median] vs. Greater Than or
Equal To 1.749 mm). Results demonstrated that CRESTOR significantly slowed
the progression of CIMT in all four subgroups (all p<0.02), compared to
placebo treated subjects who all exhibited significantly higher progression
rates. These data were presented at the American Heart Association
Scientific Sessions in Orlando, Florida.
The new analysis showed that CRESTOR, when compared with placebo, slows
progression of carotid atherosclerosis in subjects at relatively low risk
for cardiovascular disease (<2RF + Thinner CIMT; 0.0007 mm/yr v. 0.0123
mm/yr with placebo and <2RF + Thicker CIMT; -0.0012 mm/yr v. 0.0116 mm/yr
with placebo). Furthermore, those with more RFs and those with greater
baseline thickness in the CRESTOR-treated group exhibited a greater trend
toward regression or a greater negative slope (2+RF + Thinner CIMT; -0.0013
mm/yr v. 0.0144 mm/yr with placebo and 2+RF + Thicker CIMT; -0.0071 mm/yr
v. 0.015 mm/yr with placebo).
"The METEOR trial continues to provide important information regarding
the effects of CRESTOR on atherosclerotic progression in subjects with
various degrees of risk based on conventional risk factors and carotid
artery wall thickness," said John R. Crouse, III, M.D., lead investigator
and Professor of Medicine at Wake Forest University School of Medicine,
Winston-Salem, NC.
Atherosclerosis is a progressive disease that typically begins in early
adulthood and progresses as people grow older. Those with risk factors for
coronary heart disease, such as those included in the Framingham risk
assessment tool, have an increased risk of atherosclerosis. These risk
factors include age, high LDL cholesterol, low HDL cholesterol, high blood
pressure, and smoking. Earlier this year, METEOR demonstrated that CRESTOR
significantly slowed progression of atherosclerosis
(http://www.astrazeneca.com/pressrelease/5317.aspx) in subjects with early
signs of the disease and who are at low cardiovascular risk.(1)
A second analysis presented earlier at AHA Scientific Sessions
demonstrated CRESTOR reduced CIMT progression after 12 months with a rate
of 0.0032 mm/yr compared with 0.0133 mm/yr for placebo (p=0.049). This
analysis evaluated the shortest time period at which differences in
atherosclerosis progression rates were detectable after initiating CRESTOR
therapy. Additional results include:
-- Differences in CIMT progression rates between the CRESTOR and placebo
groups were apparent after six months: 0.0023 mm/yr and 0.0106 mm/yr,
respectively (p=0.36).
-- After 18 months, the difference in CIMT progression rates increased:
-0.0009 mm/yr and 0.0131 mm/yr, respectively (p<0.0001).
-- After 24 months, the difference in CIMT progression between the CRESTOR
and placebo groups increased further; -0.0014 mm/yr and 0.0131 mm/yr,
respectively (p<0.0001).
Ultrasound assessments were made at 12 carotid artery sites at baseline
and every 6 months up to two years. In these analyses, the same statistical
method was applied to the data cut at 6 months, 1 year, and 18 months, in
addition to the analysis of all data at two years.(2)
METEOR (Measuring Effects on intima media Thickness: an Evaluation Of
Rosuvastatin) was a 24-month, randomized, double-blind, placebo-controlled,
international study to evaluate the effect of CRESTOR 40 mg in 984
asymptomatic, hypercholesterolemic patients with a low risk for CHD
(Framingham ten-year risk <10%) and evidence of sub-clinical
atherosclerotic disease as determined by a thickened carotid artery wall
(maximum CIMT Greater Than or Equal To 1.2 and <3.5 mm). METEOR is the only
placebo controlled study to demonstrate a slowing of progression of
atherosclerosis in subjects with early signs of the disease and at low
cardiovascular risk.
The effects of CRESTOR on atherosclerosis have now been studied among
different populations using three key techniques -- CIMT (METEOR), IVUS
(ASTEROID), and MRI (ORION). These three studies formed the basis of
AstraZeneca's application to the FDA for an update to the CRESTOR
Prescribing Information.
METEOR, ASTEROID and ORION are part of AstraZeneca's GALAXY Program, 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. Another GALAXY trial, JUPITER, which is currently
underway, is the first study of its kind designed to investigate the
effects of a statin medication on the reduction of cardiovascular morbidity
and mortality among 15,000 individuals with normal to low cholesterol
levels and elevated C- reactive protein (CRP) levels. To date, the GALAXY
Program has recruited more than 69,000 subjects in more than 55 countries
around the world.
About Atherosclerosis
Atherosclerosis occurs when there is a build-up of fatty or fibrous
deposits, known as plaques, in the artery wall. Plaques cause the artery to
narrow, and can reduce the blood supply to the heart, brain, and other
vital organs, resulting in symptoms such as angina or transient ischemic
attacks. Plaques can also rupture and lead to the formation of a thrombus,
which can result in a sudden, complete blockage of blood flow. In the
heart, this blockage causes a heart attack; in the brain, it causes a
stroke. Atherosclerosis is a progressive disease and the main cause of
cardiovascular disease -- the No.1 killer worldwide.
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. For more complete prescribing information, please
visit: http://www.crestor.com.
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%).
About AstraZeneca
AstraZeneca (NYSE: AZN) 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.
Subscribe to AstraZeneca's RSS feed at:
http://www.astrazeneca-us.com/subscribe_RSS.asp .
(1) Reference Original METEOR Abstract from ACC
(2) Reference METEOR Abstract 1
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.crestor.com
http://www.prnewswire.com/comp/985887.html /
CONTACT:
Christopher Sampson, +1-302-885-8908,
Christopher.Sampson@astrazeneca.com, or Michele Pelkowski,
+1-302-885-4055, Michele.Pelkowski@astrazeneca.com, both of
AstraZeneca LP
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