<AsiaNet> First Study to Show Positive Benefit on Atherosclerosis for People

With Early Signs of Diseased Arteries

(LONDON, March 25 AsiaNet=연합뉴스)

- METEOR Trial Shows CRESTOR Slowed Progression of Atherosclerosis in

People at Low-Risk of Coronary Heart Disease (Framingham 10 Year Risk <10%)

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<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<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 <10%) and evidence of

sub-clinical atherosclerotic disease as determined by a thickened carotid

artery wall (maximum intima media thickness (IMT) >1.2 and <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<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<0.001)

- second primary endpoint

-- CRESTOR brought about a 6.8% (median) reduction in total atheroma

volume in the entire target vessel (p<0.001) - secondary endpoint

-- These changes were associated with a 53% reduction in LDL-C (p<0.001)

and a 15% increase in HDL-C (p<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

This press release has been made available on worldwide press

communication media for the benefit of correspondents writing for the medical

professional press. Differing national legislation, codes of practice,

medical practice etc mean that you should contact your local AZ press office

to obtain information designed for use in your country. In particular this

press release has not been prepared for use in the USA.

SOURCE: AstraZeneca

CONTACT: Ben Strutt, Global PR Manager,

Cardiovascular Therapy Area, AstraZeneca,

+44-(0)-1625-230076,ben.strutt@astrazeneca.com/

Website: http://www.AstraZenecaPressOffice.com/

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