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 <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

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

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 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

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

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

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]

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

volume in the most diseased 10mm segment of the target vessel (p<0.001)

- second primary endpoint

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

and a 15% increase in HDL-C (p<0.001)

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

[2] Bonow, R, Smaha, L, Smith, S et al. The International Burden of

[3] Nicholls SJ, Tuzcu EM, Sipahi I et al. Statins, high-density

[4] Schuster H. The GALAXY Program: an update on studies investigating

[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

[7] Goettsch WG, Heintjes EM, Kastelein JJ et al. Results from a

[8] Nissen SE, Nicholls SJ, Sipahi I et al. Effect of very high-intensity

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,[email protected]/

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

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