First Statin Monotherapy to Achieve Regression ...

LONDON, March 31 /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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