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

London (ots/PRNewswire)

CRESTOR(TM) (rosuvastatin) is
the only statin to show regression of coronary atherosclerosis in a
major clinical study. 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 a statin monotherapy
has achieved regression of atherosclerosis using coronary
angiographic data in a major clinical trial. 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 to LDL-C levels well below 70 mg/dL, 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 data from these two imaging techniques used in the ASTEROID
study, which measured different parameters and were focused on
different segments of the coronary arteries, demonstrate similar
improvements by QCA and IVUS and are consistent with regression of
atherosclerosis with rosuvastatin," said Professor Christie M.
Ballantyne, cardiologist at Baylor College of Medicine and the
Methodist DeBakey Heart and Vascular Center in Houston, Texas, and
lead author of the QCA analysis. Michael Cressman, AstraZeneca's
Global Medical Science Director for CRESTOR added, "These data
provide confirmation that, in patients with coronary artery disease
rosuvastatin 40 mg can 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 >25% of the lumen diameter at baseline, after taking
rosuvastatin 40 mg for 2 years include:
  • 53.3% reduction in LDL-C (from 131.5 mg/dL to a mean of 61.1 mg/dL)
  • 13.8% increase in HDL-C (from 42.8 mg/dL to 48.3 mg/dL)
  • 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<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<0.001)
  • Regression of atherosclerosis occurred in the majority of patients
  • Over 90% of patients remained clinically stable or had regression (either %DS or MLD)
  • Rosuvastatin 40 mg was well tolerated in this two-year study
Atherosclerosis is the 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. 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.
"The results from ASTEROID and METEOR, in addition to the
subsequent label updates in the United States and Europe, based on
METEOR, have clearly differentiated rosuvastatin from other treatment
options," said Michael Cressman, Global Medical Science Director for
CRESTOR. "These data also add to the research carried out as part of
the GALAXY programme to validate the approach of targeting LDL and
HDL levels in order to attack the build-up of arterial plaque, the
fundamental cause of heart disease. This will be further investigated
in the ongoing SATURN trial, which will compare the impact of
rosuvastatin 40 mg and atorvastatin 80 mg on the progression of
atherosclerosis in patients with coronary artery disease."
In the U.S., based on the METEOR study, rosuvastatin has been
approved 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.
ASTEROID is a part of AstraZeneca's extensive GALAXY clinical
trials programme, 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 and real world 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 is not indicated for the regression of coronary
atherosclerosis. Rosuvastatin 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
rosuvastatin is 10 mg. 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
AstraZeneca is a major international healthcare business engaged
in research, development, manufacturing and marketing of prescription
pharmaceuticals and supplier for healthcare services. AstraZeneca is
one of the world's leading pharmaceutical companies with healthcare
sales of  US$29.55 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection
product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index.
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Contact:

For further information please contact: Ben Strutt, Global PR
Manager, Cardiovascular Therapy Area, AstraZeneca, Tel:
+44(0)1625-230076, Mob: +44(0)7919-565990, Email:
ben.strutt@astrazeneca.com.

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