First Study to Show Positive Benefit on Atherosclerosis for People With Early Signs of Diseased Arteries



    METEOR Trial Shows CRESTOR Slowed Progression of Atherosclerosis in
    People at Low-Risk of Coronary Heart Disease (Framingham 10 Year Risk
    (less than)10%)

    LONDON, March 25 /CNW/ - METEOR is the first study to show a positive
effect on atherosclerosis in people with early signs of carotid artery disease
and at low risk of coronary heart disease (CHD). The METEOR study, using
CRESTOR(TM) (rosuvastatin) 40mg, resulted in subjects showing a significantly
slower rate of progression of atherosclerosis when compared to placebo. When
assessed vs. baseline, no significant progression was observed in the 40 mg
rosuvastatin arm over the two-year duration of the study while significant
progression vs. baseline was observed in the placebo arm.
    Data presented at the 56th Annual Scientific Session of the American
College of Cardiology (ACC) showed that the CRESTOR 40mg patients, with
moderately increased LDL ('bad') cholesterol levels (mean 154 mg/dL) and no
established atherosclerosis, experienced a 0.0014 mm/yr decrease in the mean
maximum carotid intima-media thickness - a marker of atherosclerotic
burden(1), compared to a progression of 0.0131 mm/yr for those on placebo
(p(less than)0.0001). CRESTOR 40 mg was well tolerated during the 2 years of
the study.
    With completion of this study, CRESTOR has now been studied across the
atherosclerosis disease spectrum, first with ASTEROID which included patients
with established coronary artery disease and at a high risk of CHD events and
now with METEOR, which evaluated CRESTOR in asymptomatic subjects with early
disease and at low CHD risk.
    "It's exciting to see that by using rosuvastatin we can potentially slow
or even stop the disease progression in people with relatively modest
atherosclerosis," said lead investigator John R. Crouse, III, M.D., Professor
of Medicine and Public Health Sciences and Associate Director of the Wake
Forest University School of Medicine (WFUSM) General Clinical Research Centre.
"METEOR provides evidence that the effect of rosuvastatin on dyslipidaemia
translates into a beneficial effect on the progression of atherosclerosis."
    Atherosclerosis occurs when there is a build-up of fatty or fibrous
deposits, to form areas called plaques, in the artery wall. The build-up of
plaques causes the artery to narrow and this can reduce the blood supply to
vital organs such as the heart and brain, resulting in symptoms such as angina
or transient ischaemic attacks. Plaques can also rupture leading to thrombus
formation, which can result in a sudden, complete blockage of blood flow. In
the heart, this causes a heart attack and in the brain, this causes a stroke.
Atherosclerosis is a progressive disease and the main cause of cardiovascular
disease - the number one killer worldwide(2).
    A recently published independent post hoc analysis combining data from
four prospective trials, including ASTEROID, showed that by substantially both
decreasing LDL-C and increasing HDL-C by more than 7.5 percent, a beneficial
effect on atherosclerosis can be achieved(3). In METEOR, CRESTOR was
associated with a 48.8 percent reduction in LDL-C and an 8.0 percent increase
in HDL-C (both p(less than)0.0001 vs placebo). These results are consistent
with the above finding and provide additional confirmation that the lowering
of LDL-C and raising of HDL-C offered by CRESTOR translate into beneficial
effects on atherosclerosis.
    METEOR (Measuring Effects on intima media Thickness: an Evaluation Of
Rosuvastatin) was a 24-month, randomised, double-blind, placebo-controlled,
international study to evaluate the effect of CRESTOR 40mg in 984
asymptomatic, hypercholesterolaemic patients with a low risk of coronary heart
disease (Framingham ten year risk (less than)10%) and evidence of sub-clinical
atherosclerotic disease as determined by a thickened carotid artery wall
(maximum intima media thickness (IMT) (greater than)1.2 and (less than)3.5
mm). METEOR used B-mode ultrasound imaging to assess and measure change in
mean maximum IMT of 12 vessel sites in the carotid artery. The study evaluated
low risk subjects not indicated for statin therapy to permit inclusion of a
comparative placebo arm.
    Currently, CRESTOR is indicated for the treatment of lipid disorders. The
results from the METEOR study, supported by data from the ASTEROID study and
including the ORION trial, formed the basis of the atherosclerosis regulatory
submissions filed in the European Union and the United States in January 2007.
These submissions seek 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.
    These new results from METEOR add to the wealth of CRESTOR efficacy data
from its extensive GALAXY clinical trials programme(4), designed to address
important unanswered questions in statin research and to investigate the
impact of CRESTOR on cardiovascular risk reduction and patient outcomes.
Currently, more than 63,000 patients have been recruited from 55 countries
worldwide to participate in the GALAXY Programme.
    CRESTOR has now received regulatory approvals in over 90 countries across
five continents. Over 9 million patients have been prescribed CRESTOR
worldwide. Data from clinical trials(5) and marketed use(6)(7), shows that the
safety profile for CRESTOR is in line with other marketed statins.
    The 40 mg dose is the highest registered dose of CRESTOR. CRESTOR 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 CRESTOR is 10mg. The 40mg dose should only be used in patients who
have not achieved their LDL-C goal utilizing the 20mg dose of CRESTOR.

    
    Notes to Editors:

    1) ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On
       Intravascular Ultrasound-Derived Coronary Atheroma Burden) was a
       104-week, open label, single-arm, blinded endpoint study designed to
       study the effect of CRESTOR 40mg in 507 patients who had undergone
       coronary angiography and who had evidence of coronary artery disease
       (CAD).

    Key findings from ASTEROID include(8)

    -   CRESTOR brought about a 0.79% (median) reduction in percent atheroma
        volume in the entire target vessel (p(less than)0.001) - first
        primary endpoint

    -   CRESTOR brought about a 9.1% (median) reduction in total atheroma
        volume in the most diseased 10mm segment of the target vessel
        (p(less than)0.001) - second primary endpoint

    -   CRESTOR brought about a 6.8% (median) reduction in total atheroma
        volume in the entire target vessel (p(less than)0.001) - secondary
        endpoint

    -   These changes were associated with a 53% reduction in LDL-C
        (p(less than)0.001) and a 15% increase in HDL-C (p(less than)0.001)
    

    2) ORION (Outcome of Rosuvastatin Treatment on Carotid Artery Atheroma: a
    Magnetic Resonance Imaging ObservatioN) was the first study to use
    advanced, high resolution MRI to investigate the effect of a statin -
    CRESTOR - on the change in the composition of plaques in the carotid
    artery wall. Forty-three (43) patients with moderate
    hypercholesterolemia and established carotid atherosclerosis were
    treated with either CRESTOR low dose (5 mg) or high dose (40/80 mg)
    for two years.

    References

    (1) Bots ML. Carotid intima-media thickness as a surrogate marker for
    cardiovascular disease in intervention studies. Curr Med Res Opin.
    2006 22:2181-90

    (2) Bonow, R, Smaha, L, Smith, S et al. The International Burden of
    Cardiovascular Disease: Responding to the Emerging Global Epidemic.
    Circulation 2002; 106:1602

    (3) Nicholls SJ, Tuzcu EM, Sipahi I et al. Statins, high-density
    lipoprotein cholesterol, and regression of coronary atherosclerosis
    JAMA 2007 297:499-508

    (4) Schuster H. The GALAXY Program: an update on studies investigating
    efficacy and tolerability of rosuvastatin for reducing cardiovascular
    risk. Expert Rev Cardiovasc Ther. 2007 5:177-93.

    (5) Shepherd J, Hunninghake DB, Stein EA et al. Safety of rosuvastatin.
    Am J Cardiol. 2004 94:882-8

    (6) McAfee AT, Ming EE, Seeger JD et al. The comparative safety of
    rosuvastatin: a retrospective matched cohort study in over
    48,000 initiators of statin therapy. Pharmacoepidemiol Drug Saf.
    2006 15:444-53

    (7) Goettsch WG, Heintjes EM, Kastelein JJ et al. Results from a
    rosuvastatin historical cohort study in more than 45,000 Dutch statin
    users, a PHARMO study. Pharmacoepidemiol Drug Saf. 2006 15:435-43.

    (8) Nissen SE, Nicholls SJ, Sipahi I et al. Effect of very high-intensity
    statin therapy on regression of coronary atherosclerosis: the
    ASTEROID trial. JAMA 2006 295:1556-65

    AstraZeneca (NYSE:   AZN , LSE: AZN)

    This press release has been made available on worldwide press
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Strutt, Global PR Manager, Cardiovascular Therapy Area, AstraZeneca, Tel:
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