ORLANDO, Fla., March 29 /PRNewswire-FirstCall/ -- Results from a new sub-
analysis of the JUPITER study show that patients with low to normal
cholesterol levels and elevated high sensitivity C-reactive protein (hsCRP)
who attained a dual treatment target of LDL-C <70mg/dL and hsCRP <2mg/L with
CRESTOR(R) (rosuvastatin calcium) 20mg achieved a greater reduction in
cardiovascular events compared to placebo than those who did not (65% vs 36%;
p=0.033). These new data were presented at the 58th Annual American College of
Cardiology Scientific Sessions (ACC) in Orlando, Florida, and published
simultaneously in The Lancet.
This analysis was conducted in approximately 15,500 patients, or 87% of
the entire JUPITER cohort, representing patients who had LDL-C and hsCRP
values assessed at baseline and one year.
Additional results from this analysis showed:
-- Patients who achieved an LDL-C <70 mg/dL experienced a 55% reduction in
cardiovascular events compared to placebo
-- Patients who achieved a dual treatment target of LDL-C<70 mg/dL and
hsCRP <1 mg/L achieved a 79% reduction in CV events compared to placebo
"JUPITER demonstrated the effect of rosuvastatin on cardiovascular
morbidity and mortality," said Alex Gold, MD, Executive Director, Clinical
Development, AstraZeneca US. "In this analysis, patients treated with
rosuvastatin who achieved low levels of LDL-C and hsCRP had a greater
reduction in cardiovascular events."
Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the
course of the JUPITER study.
ABOUT JUPITER:
Results from the primary analysis of JUPITER (Justification for the Use
of statins in Primary prevention: an Intervention Trial Evaluating
Rosuvastatin), originally presented in November 2008 at the American Heart
Association's Annual Scientific Sessions, and published by the New England
Journal of Medicine, evaluated the impact of rosuvastatin 20mg on reducing
major cardiovascular (CV) events (combined risk of myocardial infarction,
stroke, arterial revascularization, hospitalization for unstable angina, or
death from CV causes).
JUPITER was a long-term, randomized, double-blind, placebo-controlled,
large-scale study of 17,802 patients designed to determine if rosuvastatin 20
mg decreases the risk of heart attack, stroke and other major cardiovascular
events in patients with low to normal LDL-C but at increased cardiovascular
risk as identified by age and elevated high-sensitivity C-reactive protein
(hsCRP). The majority of patients had at least one other risk factor including
hypertension, low HDL-C, family history of premature coronary heart disease
(CHD) or smoking. hsCRP is a recognized marker of inflammation which is
associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca's extensive GALAXY clinical trials
program, designed to address important unanswered questions in statin
research. Currently, more than 69,000 patients have been recruited from 55
countries worldwide to participate in the GALAXY Program.
AstraZeneca has previously announced that it expects to file a regulatory
submission including the JUPITER data in the first half of 2009 and if
approved will begin promotional activities within the approved labeling.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR significantly lowered LDL-C,
had a significant effect on raising HDL-C and slowed the progression of
atherosclerosis, the build-up of plaque in the arteries.
CRESTOR has now received regulatory approval in over 90 countries. More
than 13 million patients have been prescribed CRESTOR worldwide. Data from
clinical trials and real world use shows that the safety profile for CRESTOR
is in line with other marketed statins.
IMPORTANT SAFETY INFORMATION:
CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C,
LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in adult patients
with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated
as an adjunct to diet to slow the progression of atherosclerosis as part of a
treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not
approved to prevent cardiovascular morbidity and mortality.
CRESTOR is contraindicated in patients with a known hypersensitivity to
any component of this product, in patients with active liver disease, which
may include unexplained persistent elevations of hepatic transaminase levels,
in women who are pregnant or may become pregnant, and in nursing mothers.
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported with HMG-CoA reductase inhibitors, including
CRESTOR. These risks can occur at any dose level, but are increased at the
highest dose (40 mg).
CRESTOR should be prescribed with caution in patients with predisposing
factors for myopathy (eg, age Greater Than or Equal to 65 years, inadequately
treated hypothyroidism, renal impairment). The risk of myopathy during
treatment with CRESTOR may be increased with concurrent administration of some
other lipid-lowering therapies (fibrates or niacin), gemfibrozil,
cyclosporine, or lopinavir/ritonavir.
Therapy with CRESTOR should be discontinued if markedly elevated CK levels
occur or myopathy is diagnosed or suspected. All patients should be advised to
promptly report unexplained muscle pain, tenderness, or weakness, particularly
if accompanied by malaise or fever. It is recommended that liver enzyme 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.
Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or
withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in
patients who consume substantial quantities of alcohol.
CRESTOR 40 mg should be used only for those patients not achieving their
LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from
another statin should begin treatment with CRESTOR at the appropriate starting
dose.
In the controlled clinical trials database, the most common adverse
reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%),
asthenia (2.5%), and nausea (2.2%).
Please see accompanying full Prescribing Information. If you have any
questions concerning CRESTOR, please contact AstraZeneca at 1-800-237-8898.
CRESTOR is a registered trademark of the AstraZeneca group of companies.
ABOUT ASTRAZENECA:
AstraZeneca (NYSE: AZN) is engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and in the
supply of healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with global healthcare sales of $ 31.6 billion and is
a leader in gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infectious disease medicines. In the United States, AstraZeneca
is a $13.5 billion dollar healthcare business.
For more information about AstraZeneca in the US or our AZ&Me(TM)
Prescription Savings programs, please visit: www.astrazeneca-us.com.
