ASTRAZENECA PRESENTS NEW DATA DEMONSTRATING
CRESTOR® REDUCED
C-REACTIVE PROTEIN LEVELS IN AFRICAN AMERICAN PATIENTS
--CRESTOR reduced CRP in African-American patients
by up to 20 percent--
(AANEWSWIRE)ORLANDO, FL (March 8, 2005)
- New ARIES (African American Rosuvastatin Investigation
of Efficacy and Safety) data presented today at the
American College of Cardiology's Annual Meeting (ACC)
show that AstraZeneca's CRESTOR® (rosuvastatin
calcium) at 10 and 20 mg reduced levels of C-Reactive
Protein (CRP) by 14 and 19 percent respectively while
atorvastatin 10 and 20 mg reduced CRP levels by 8
and 15 percent, respectively. In a subgroup analysis
performed in patients with elevated CRP, CRESTOR reduced
this biomarker of inflammation by 20 and 20 percent
at the 10 and 20 mg doses respectively, while atorvastatin
reduced CRP by 12 and 20 percent respectively. CRP
is a protein in the body whose level increases when
there is inflammation of blood vessels.
"An increasing number of cardiologists
believe that CRP may be an important, yet often ignored,
diagnostic tool," said Dr. Keith C. Ferdinand,
clinical cardiologist and medical director of Heartbeats
Life Center and the lead investigator for ARIES. "Through
the ARIES trial, we have important new information
about the changes caused by CRESTOR on this potentially
critical biomarker in African-Americans."
The ARIES study was the first-ever large-scale,
prospective trial exclusively designed to compare
the effects of statins in African-American patients.
ARIES was a six-week, randomized, controlled, open-label,
multi-center trial designed to evaluate the efficacy
of CRESTOR and atorvastatin in African Americans with
elevated cholesterol. After a six-week dietary lead-in,
774 African-American adults with hypercholesterolemia
were randomized to one of four open-label treatments
for six weeks: CRESTOR 10 or 20 mg or atorvastatin
10 or 20 mg. Results showed CRESTOR 10 and 20 mg reduced
CRP by 14 and 19 percent (20 mg only; p<0.01 versus
baseline) respectively, and 8 and 15 percent (20 mg
only; p<0.01 versus baseline) for atorvastatin
at the same dosages in patients with elevated LDL
or "bad" cholesterol (>160 and <300
mg/dL) and triglyceride levels (<400 mg/dL). The
data also showed that in patients with baseline CRP
>2.0 mg/L, CRESTOR reduced CRP by 20 and 21 percent
(p<0.01 versus baseline) at the 10 and 20 mg doses,
12 and 20 percent (20 mg only; p<0.01 versus baseline)
with atorvastatin at the same dosages respectively.
Treatments used in the ARIES study were well tolerated.
In addition to ARIES, there are a number
of studies underway to examine the effects of statin
therapy on patients with elevated CRP. One study,
called JUPITER (Justification for the Use of statins
in Primary prevention: an Intervention Trial Evaluating
Rosuvastatin), is ongoing and will investigate the
effect of CRESTOR in the primary prevention of cardiovascular
events in patients with normal to low cholesterol
levels but elevated CRP.
Additional Studies
Presented at ACC:
Ezetimibe Added to Rosuvastatin for Severely Hypercholesterolemic
Patients: this substudy assessed the effects of CRESTOR
on low-density lipoprotein cholesterol and CRP; results
showed that the addition of ezetimibe 10 mg to rosuvastatin
40 mg brought 52% of patients to the LDL-C goal of
<100 mg/dL. The addition of ezetimibe to rosuvastatin
produced further reductions in CRP. NCEP Evaluation
ProjecT Utilizing Novel E-Technology (NEPTUNE II):
designed to estimate the probability of achieving
ATP III cholesterol goals among treated dyslipidemic
patients; An analysis was performed to investigate
the implications of new recommendations by NCEP, specifically
the classification of patients at very high risk and
the new optional LDL-C treatment target of <70
mg/dl; results concluded a large proportion of patients
with cardiovascular disease would be classified as
very high risk, whereas a small minority of this population
has a LDL-C level that meets the new optional goal,
indicating a need for more aggressive treatment.
About CRESTOR
CRESTOR (rosuvastatin calcium) is a once-daily prescription
medication for use as an adjunct to diet in the treatment
of various lipid disorders including primary hypercholesterolemia,
mixed dyslipidemia and isolated hypertriglyceridemia.
It is a member of the statin (HMG-CoA reductase inhibitors)
class of drug therapy. CRESTOR has not been determined
to prevent heart disease, heart attacks, or strokes.
For patients with hypercholesterolemia and mixed dyslipidemia,
the usual recommended starting dose of CRESTOR is
10 mg. However, initiation of therapy with 5 mg once
daily should be considered for patients requiring
less aggressive LDL-C reductions or who have predisposing
factors for myopathy, and for special populations
such as patients taking cyclosporine, Asian patients,
and patients with severe renal insufficiency. For
patients with marked hypercholesterolemia (LDL-C >190
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%).
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: www.astrazeneca-us.com
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