First study to show positive benefit on Atherosclerosis for people with early signs of diseased arteries

    METEOR trial shows CRESTOR slowed progression of atherosclerosis compared
    to baseline in people at low-risk of coronary heart disease (Framingham
    10 year risk (less than)10%)

    TORONTO, March 26 /CNW/ - METEOR is the first study to show a positive
effect on atherosclerosis in people with early signs of carotid artery disease
and low risk of coronary heart disease (CHD). The METEOR study, using
CRESTOR (TM) (rosuvastatin) 40 mg, slowed progression of atherosclerosis
compared to baseline and showed significantly slower progression compared to
placebo over the two year duration of the study.
    Although 75 per cent of individuals are considered to be at
low-to-intermediate risk (based on Framingham criteria), more than 60 per cent
of cardiovascular events occur in this group and sudden coronary deaths often
occur in individuals who are asymptomatic.(1)
    Data presented at the 56th Annual Scientific Session of the American
College of Cardiology (ACC) showed that patients that received 40 mg of
CRESTOR, with increased LDL ('bad') cholesterol levels (mean 4 mol/L) and no
established atherosclerosis, experienced a 0.0014 mm/yr decrease in the mean
maximum carotid intima-media thickness - a marker of atherosclerotic
burden, (2) compared to a progression of 0.0131 mm/yr for those on placebo. In
a clinical trial program investigating the effects on atherosclerosis, CRESTOR
has demonstrated a significant impact on atherosclerosis across the spectrum
of the disease; with METEOR in subjects with early disease and low CHD risk
(Framingham 10 year risk (less than)10%), and ASTEROID, in patients with
established coronary artery disease and a high risk of CHD events.
    "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 dyslipidemia
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 ischemic 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.(3)
    A recently published independent post hoc analysis combining data from
four prospective trials, including ASTEROID, showed that by increasing HDL-C
by more than 7.5 per cent and substantially decreasing LDL-C, a beneficial
effect on atherosclerosis can be achieved.4 In METEOR, CRESTOR was associated
with a 48.8 per cent reduction in LDL-C and an 8.0 per cent increase in HDL-C
(both p-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 translates into beneficial effects on
    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 40 mg in 984
asymptomatic, hypercholesterolemic 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.

    Key findings from METEOR:

    -   CRESTOR achieved a -0.0014 mm/yr change in CIMT at all sites,
        compared to +0.0131 mm/yr with placebo (p(less than)0.0001) - primary
    -   CRESTOR achieved significant regression in the common carotid artery
        (-0.0038 mm/yr vs. +0.0084 mm/yr with placebo (p(less than)0.0001)) -
        secondary endpoint
    -   CRESTOR achieved a +0.0039 mm/yr change in CIMT in the internal
        carotid artery vs. +0.0145 mm/yr with placebo (p=0.023) -
        secondary endpoint
    -   CRESTOR demonstrated a -0.0040 mm/yr change in CIMT in the carotid
        bifurcation (bulb) sites, compared to +0.0172 mm/yr with placebo (p
        (less than)0.0001) - secondary endpoint
    -   These changes were associated with a 48.8 percent reduction in LDL-C
        (p(less than)0.0001) and an 8.0 percent increase in HDL-C (p(less
    -   CRESTOR 40 mg over 2 years was well tolerated during the study

    These new results from METEOR add to the wealth of CRESTOR efficacy data
from its extensive GALAXY clinical trials program5, 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 Program.
    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 trials6 and marketed use7,8 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 Canadian prescribing information, which contains
recommendations for initiating and titrating therapy according to the
individual patient profile. In Canada, the usual recommended starting dose of
CRESTOR is 10 mg once daily. A dose of 40 mg once daily should only be used in
patients with severe hypercholesterolemia who do not achieve their target
treatment on 20 mg and have no predisposing factors for
    CRESTOR is not indicated to arrest or slow the progression of
atherosclerosis in patients for whom lipid lowering is indicated.

    About AstraZeneca Canada

    AstraZeneca is a leading global pharmaceutical company with an extensive
product portfolio spanning six major therapeutic areas: gastrointestinal,
cardiovascular, infection, neuroscience, oncology, and respiratory.
AstraZeneca's Canadian headquarters and packaging facilities are located in
Mississauga, Ontario, with a state-of-the-art drug discovery centre based in
Montreal, Quebec. For more information, visit the company's website at


    DATE OF FEED:   Monday, March 26, 2007

    TIME OF FEED:   11:00 - 11:30 am EDT

    COORDINATES:    Anik F2 C Band
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    (1) Crowse JR et al. Carotid intima-media thickness in low-risk
        individuals with asymptomatic atherosclerosis: baseline data from the
        METEOR study. Current Medical Research and Opinion 2007; 23(3):
    (2) Bots ML. Carotid intima-media thickness as a surrogate marker for
        cardiovascular disease in intervention studies. Curr Med Res Opin.
        2006 22:2181-90
    (3) Bonow, R, Smaha, L, Smith, S et al. The International Burden of
        Cardiovascular Disease: Responding to the Emerging Global Epidemic.
        Circulation 2002;106:1602
    (4) Nicholls SJ, Tuzcu EM, Sipahi I et al. Statins, high-density
        lipoprotein cholesterol, and regression of coronary atherosclerosis
        JAMA 2007 297:499-508
    (5) 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.
    (6) Shepherd J, Hunninghake DB, Stein EA et al. Safety of rosuvastatin.
        Am J Cardiol. 2004 94:882-8
    (7) 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
    (8) 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.

For further information:

For further information: Dara Willis, Fleishman-Hillard Canada Inc.,
(416) 645-8179 office, (416) 836-9272 mobile,

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