A landmark two-year study demonstrated that CRESTORTM (rosuvastatin) reversed plaque build-up in the arteries of patients with evidence of coronary artery disease. This is the first time a statin has demonstrated regression of atherosclerosis in a major clinical study. Data presented from ASTEROID, at the 55th Annual Scientific Session of the American College of Cardiology (ACC) show that plaque build-up in patients’ arteries was reduced by between seven and nine per cent. These significant changes were achieved with CRESTOR and were associated with significant reductions in LDL-C or ‘bad’ cholesterol (53 per cent, p<0.001) and increases in HDL-C or ‘good’ cholesterol (15 per cent, p<0.001).
“Multiple clinical studies have clearly documented that CRESTOR provides better LDL-C lowering and significant increases in HDL-C compared to other statins, establishing it as an important, effective and well tolerated treatment. The data from this study - demonstrating that CRESTOR regressed plaque in the arteries of four out of five patients - is an important new finding. We see this as underscoring the benefits of aggressively managing cholesterol levels, both LDL and HDL, to reduce the burden of atherosclerosis,” said Dr Howard Hutchinson, Vice President of Clinical Research for AstraZeneca.
“We designed the GALAXY clinical programme to confirm the hypothesis that CRESTOR has a positive impact on atherosclerosis and cardiovascular events. The results from ASTEROID represent an exciting step towards confirming our hypothesis,” added Dr Hutchinson.
Atherosclerosis results when a build-up of cholesterol, inflammatory cells and fibrous tissue forms areas in the artery wall called plaques. If these plaques rupture they can block blood flow to critical organs like the heart or the brain, and can lead to heart attack or stroke.
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). The plaque volume in the target coronary artery was measured at the initial catheterisation and again after two years of treatment. ASTEROID used intravascular ultrasound (IVUS) imaging to measure the effect on the change in plaque volume compared to baseline in the target vessel.
Key findings of the study in the 349 patients with evaluable IVUS data include:
- 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)
- Significant regression occurred in all patient subgroups including men and women, and older and younger patients
- CRESTOR 40 mg was well tolerated in the two-year study
CRESTOR is indicated for the treatment of lipid disorders. CRESTOR is not indicated for atherosclerosis. The 40mg 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 5 or 10mg.
With over 40 million prescriptions written, CRESTOR has been prescribed to more than six million patients and has a safety profile in line with that of other marketed statins.
-Ends-
13 March 2006
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Notes to editors:
Intravascular Ultrasound (IVUS) is an invasive method of imaging arteries using high frequency sound waves that are transmitted and received inside the vessel being examined. It enables measurement of the volume of atheroma within the wall of the arteries by combining a series of cross-sectional images of the vessel over a predefined length. IVUS is acknowledged as being among the most rigorously quantitative methodologies for assessing atheroma burden.
ASTEROID is part of AstraZeneca’s GALAXY Programme, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. The GALAXY Program has recruited over 50,000 subjects in more than 50 countries around the world.
CRESTOR and the GALAXY Programme are trade marks of the AstraZeneca group of companies