First Statin Monotherapy to Achieve Regression of Coronary Atherosclerosis by Angiography in a Major Clinical Study

CHICAGO, March 31 /CNW/ - CRESTOR(R) (rosuvastatin) is the only statin to show regression of coronary atherosclerosis in a major clinical study.(1) That result, which was based on intravascular ultrasound (IVUS) data from the ASTEROID study, has now been expanded upon by quantitative coronary angiography (QCA) measurements obtained during that study. This is the first time that QCA was used to demonstrate regression of atherosclerosis as a result of statin monotherapy. These new data were presented today at the 57th Annual Scientific Session of the American College of Cardiology and showed that rosuvastatin treatment for 24 months reduced LDL-C levels well below traditional goals (1.57 mmol/L), together with significant increases in HDL-C, produced regression by decreasing percent diameter stenosis and improving minimum lumen diameter as measured by QCA in coronary disease patients.

"The QCA analysis of the ASTEROID study offers us additional, consistent insights into the treatment of patients with coronary artery disease," said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, and member of the ASTEROID steering committee. "Both QCA and IVUS techniques confirm that the use of rosuvastatin 40 mg can help achieve regression of coronary atherosclerosis, the underlying cause of heart disease."

ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden) was designed to study the effect of rosuvastatin 40 mg in 507 patients who had undergone coronary angiography and who had evidence of coronary artery disease (CAD). The QCA analysis was a secondary endpoint in the ASTEROID study. Angiograms taken at baseline and at the end of the 2 year study were analysed for changes in the percent diameter stenosis (%DS) and the minimum lumen diameter (MLD) using QCA imaging.

Key findings of this analysis of the 292 patients with matched stenoses (greater than)25% of the lumen diameter at baseline, after taking rosuvastatin 40 mg for 2 years include:

<< - 53.3% reduction in LDL-C (from 3.37 mmol/L to a mean of 1.57 mmol/L) - 13.8% increase in HDL-C (from 1.1 mmol/L to 1.24 mmol/L) - Regression of atherosclerosis occurred in the majority of patients - Over 90% of patients remained clinically stable or had regression (either %DS or MLD) - Significant decrease in percent diameter stenosis (from median 35.7% at baseline to 34.5% at 2 years; mean decrease 1.3%, median decrease 0.5%; p(less than)0.001). Significant increase in minimum lumen diameter (from median 1.62 mm at baseline to 1.67 mm at 2 years; mean increase 0.03 mm, median increase 0.02 mm; p(less than)0.001) - Rosuvastatin 40 mg was well tolerated in this two-year study >>

Atherosclerosis is an underlying cause of heart disease and involves the progressive build-up of plaque - the fatty deposits and other cells - in the inner walls of the arteries. The condition is a consequence of elevated cholesterol and for many it's a silent disease, with no visible signs or symptoms.(2) The disease can begin in early adulthood and continues to progress for the rest of a person's life. Despite the serious nature of atherosclerosis, much is not understood about how it develops and progresses. Several coronary angiography studies have indicated that slowing the progression of atherosclerosis is associated with a decreased risk of CV events.(3)

"We are proud of the research we have been able to conduct as part of our GALAXY program," said Andrew Vieira, MD, Scientific Director Cardiovascular at AstraZeneca Canada. "Studies such as METEOR and ASTEROID not only clearly differentiate rosuvastatin from other treatment options but also reinforce to physicians and their patients the importance of targeting LDL and HDL levels and attacking the build-up of arterial plaque in the fight against coronary artery disease."

In the U.S., based on the METEOR study, rosuvastatin has received an indication as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The rosuvastatin Prescribing Information in Europe has been updated to incorporate data from the METEOR study, in which rosuvastatin demonstrated a positive effect on atherosclerosis in people at low risk of coronary heart disease and with early signs of carotid artery disease as measured by B-mode ultrasound. In Canada, rosuvastatin is not indicated for the regression of coronary atherosclerosis. ASTEROID is a part of AstraZeneca's extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research. Currently, more than 64,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.

CRESTOR has now received regulatory approvals in over 90 countries. Over 12 million patients have been prescribed rosuvastatin worldwide. Data from clinical trials(4) and real world(5,6) use show that the safety profile for rosuvastatin is in line with other marketed statins.

The 40 mg dose is the highest registered dose of rosuvastatin. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In Canada, the recommended starting dose of CRESTOR in most patients is 10 mg orally once daily. The 40 mg dose should only be used in patients who have not achieved their LDL-C goal utilizing the 20 mg dose of rosuvastatin.

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 http://www.astrazeneca.ca.

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(1) Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Erbel R, Tardif JC, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006 295:1556-65
(2) Heart and Stroke Living with Cholesterol: Cholesterol and healthy living http://www.heartandstroke.ca
(3) Rossouw, J Lipid-Lowering Interventions in Angiographic Trials. Am J Cardiol. 1995 76:86C-92C
(4) Shepherd J, Hunninghake DB, Stein EA et al. Safety of rosuvastatin. Am J Cardiol. 2004 94:882-8
(5) 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
(6) 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.

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/For further information: Marlo Taylor, Fleishman-Hillard Canada Inc., (416) 645-3652, marlo.taylor@fleishman.ca

Posted: April 2008

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