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New Study on Effects of CRESTOR on Carotid Atherosclerosis
Presented at European Atherosclerosis Society Congress
- First of its kind ORION Study examines effects of statin therapy on plaque
composition using high-resolution MRI -
PRAGUE, Czech Republic, April 24 /PRNewswire-FirstCall/ -- New data presented
today from ORION (Outcome of Rosuvastatin treatment on carotid artery atheroma:
a magnetic resonance Imaging ObservatioN) showed that CRESTOR 5 mg and 40 mg
reduced the proportion of lipid-rich necrotic core (LRNC) in the most diseased
area of atherosclerotic plaques by 17.6% (p=NS) and 35.5% (p=0.006),
respectively. The ORION study was designed to assess and visualize the effect
of CRESTOR on the composition of atherosclerotic plaques using advanced,
non-invasive and high-resolution magnetic resonance imaging (MRI) techniques.
These data were presented at the 75th European Atherosclerosis Society Congress
(EAS).
"Atherosclerosis occurs when there is a build up of fatty or fibrous deposits
to form areas called plaques in the artery wall," said Thomas Hatsukami,
Professor of Surgery at the University of Washington School of Medicine and
assistant chief of vascular surgery in the VA Puget Sound Health Care System
and principal investigator of the ORION study. "Prior studies have used
imaging to examine changes in the size of plaque in response to statin therapy.
The ORION study is novel in that we used advanced MRI techniques to not only
measure the size of atherosclerotic carotid arteries, but also changes in the
composition of the plaque following two years of treatment with rosuvastatin."
In ORION, 35 patients with moderate hypercholesterolemia and established
carotid atherosclerosis were treated with either CRESTOR 5 mg (N=15) or 40 mg
(N=20) for two years. The findings from ORION showed that CRESTOR 5 mg and 40
mg reduced LDL-C from baseline by 39 percent and 58 percent, respectively
(p190
mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered.
AstraZeneca licensed worldwide rights to CRESTOR from the Japanese
pharmaceutical company Shionogi & Co., Ltd.
Important Safety Information
CRESTOR is contraindicated in patients with active liver disease or unexplained
persistent elevations of serum transaminases, in women who are pregnant or may
become pregnant, and in nursing mothers. It is recommended that liver function
tests be performed before and at 12 weeks following both the initiation of
therapy and any elevation of dose, and periodically (e.g., semiannually)
thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported with CRESTOR and with other drugs in this
class. The 40-mg dose of CRESTOR is reserved only for those patients who have
not achieved their LDL-C goal utilizing the 20 mg dose of CRESTOR once daily.
When initiating statin therapy or switching from another statin therapy, the
appropriate CRESTOR starting dose should first be utilized, and only then
titrated according to the patient's individualized goal of therapy. The
benefit of further alterations in lipid levels by the combined use of
rosuvastatin with fibrates or niacin should be carefully weighed against the
potential risks of this combination. Combination therapy with rosuvastatin and
gemfibrozil should generally be avoided. CRESTOR should be prescribed with
caution in patients with predisposing factors for myopathy, such as renal
impairment, advanced age, and inadequately treated hypothyroidism. Patients
should be advised to promptly report unexplained muscle pain, tenderness, or
weakness, particularly if accompanied by malaise or fever. CRESTOR is
generally well-tolerated. Adverse reactions have usually been mild and
transient. The most frequent adverse events thought to be related to CRESTOR
were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain
(1.3%) and nausea (1.3%).
A full copy of the prescribing information for CRESTOR is available at
http://www.astrazeneca-us.com/pi/crestor.pdf or by calling 1-877-420-7249.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the world's
leading pharmaceutical companies with healthcare sales of over $21.4 billion
and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology and neuroscience products. In the United States,
AstraZeneca is a $9.6 billion healthcare business with more than 12,000
employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global)
as well as the FTSE4Good Index. For more information about AstraZeneca, please
visit: http://www.astrazeneca-us.com/.
DATASOURCE: AstraZeneca
CONTACT: Kellie Caldwell of AstraZeneca LP, +1-302-885-1435,
Web site: http://www.astrazeneca-us.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html