ORLANDO, Fla., Nov. 5 /PRNewswire-FirstCall/ -- New data from the
CORONA study presented today at the American Heart Association 2007
Scientific Sessions showed that adding a statin to optimized heart failure
treatment did not significantly improve the prognosis for patients with
advanced heart failure because it could not reverse or prevent the
deterioration of a failing heart.
Patients taking AstraZeneca's CRESTOR(R) (rosuvastatin calcium) 10 mg
experienced an 8 percent reduction in the combined primary endpoint of
cardiovascular death, myocardial infarction or stroke, which was not
statistically significant (p=0.12). This reduction was primarily driven by
a decrease in atherosclerotic events, i.e. stroke and myocardial
infarctions (post hoc analysis, nominal p=0.05), where statins have been
proven to have benefit. In this study the majority of deaths were due to
sudden death, or non-ischemic causes, which did not appear to be impacted
by statin therapy. In addition, significantly fewer hospitalizations
occurred in patients on CRESTOR compared to placebo, whether due to any
cause (p=0.007), cardiovascular causes (p<0.001), or for worsening heart
failure (p=0.01).
"The CORONA results represent a major advancement in medical research
and understanding of patients with advanced heart failure, as it appears
they clearly differ from patients without heart failure in their response
to statin treatment," said lead investigator Prof. John Kjekshus,
Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway.
"We added a highly effective statin on top of an optimal treatment regimen.
Our findings suggest the major cause of death in these patients was likely
not to be related to atherosclerotic events, where benefit with statins in
non-heart failure patients has been demonstrated, but instead may have been
caused by the deterioration of failing heart muscle damaged beyond repair.
CORONA underscores the need for early intervention in the progression of
atherosclerosis to prevent one of its worst consequences, heart failure."
"The CORONA study was a novel and challenging study and demonstrates
our commitment to advancing medical knowledge by investigating the effects
of CRESTOR in challenging patient populations with unmet medical need. The
CORONA study included patients with advanced heart failure on optimal
treatment who were not candidates for statin therapy in the view of the
investigators and which sought to answer the question of whether or not
statins provide additional benefit or might even be harmful in this
population. As a result of this study, AstraZeneca has provided new
scientific information to help answer these important questions", said
Elisabeth Bjork, Global Medical Science Director for CRESTOR.
CORONA (COntrolled ROsuvastatin MultiNAtional Study in Heart Failure)
was a long-term, randomized, placebo-controlled study of more than 5,000
patients with chronic, symptomatic, systolic heart failure (NYHA II-IV) of
ischemic origin, whom investigators felt did not need lipid-lowering
therapy. The study was designed to evaluate the effects of adding CRESTOR
10 mg to optimized treatment for heart failure on cardiovascular mortality
and morbidity and overall survival.
CRESTOR 10 mg was well tolerated in over 2,500 patients during the
study, with a safety profile similar to placebo. The frequency and type of
adverse events were comparable in all treatment groups throughout the
study. CORONA was conducted in 21 countries.
CORONA 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.
CRESTOR has now received regulatory approvals in over 90 countries.
Over 11 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.
About CRESTOR
CRESTOR is a once-daily prescription statin medication indicated for
use as an adjunct to diet in the treatment of various lipid disorders
including primary hypercholesterolemia, mixed dyslipidemia and isolated
hypertriglyceridemia, available in a 5-, 10-, 20-, and 40-mg dose. 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. For more complete prescribing information, please
visit: http://www.crestor.com.
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 $26.47
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare
business with more than 12,000 employees. For nearly three decades,
AstraZeneca has offered drug assistance programs side by side with its
medicines, and over the past five years, has provided over $3 billion in
savings to more than 1 million patients throughout the US and Puerto Rico.
AstraZeneca has been named one of the "100 Best Companies for Working
Mothers" by Working Mother magazine and is the only large pharmaceutical
company named to FORTUNE magazine's 2007 list of "100 Best Companies to
Work For." In 2006, for the fifth consecutive year, Science magazine named
AstraZeneca a "Top Employer" on its ranking of the world's most respected
biopharmaceutical employers.
For more information about AstraZeneca, please visit:
http://www.astrazeneca-us.com.
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Related links:
http://www.astrazeneca-us.com
http://www.crestor.com
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CONTACT:
Michele Pelkowski, +1-302-885-4055,
Michele.Pelkowski@astrazeneca.com, Julia Walker, +1-302-885-5172,
Julia.Walker@astrazeneca.com, both of AstraZeneca LP
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