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** CORONA (COntrolled ROsuvastatin multiNAtional Trial in Heart Failure) is
the first ever multi-national, prospective outcomes study to determine the
impact of statin treatment on heart
failure. The goal of the CORONA study is to determine the effect of
CRESTOR (rosuvastatin calcium) 10 mg on a combined endpoint of
cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke
in patients with chronic heart failure (HF).

** CORONA is a long-term, randomized, double-blind, placebo controlled
study of 5,016 patients to evaluate a 10 mg dose of CRESTOR on
cardiovascular morbidity and mortality and overall survival in patients
with chronic symptomatic systolic heart failure of ischemic etiology
receiving standard treatment.

** The CORONA study is a part of AstraZeneca’s GALAXY Program, which is a
large, comprehensive, long-term and evolving global research initiative
designed to address important unanswered questions in statin research and to investigate
the impact of CRESTOR on cardiovascular risk reduction and patient
outcomes. The GALAXY Program has recruited over 50,000 subjects in more
than 50 countries around the world.

** 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.

** Efficacy and safety information about the use of CRESTOR specifically in
heart failure patients is not included within the approved prescribing
information for CRESTOR.

Heart Failure:

What is it?

– Heart Failure (HF) is a disorder in which an underlying condition,
such as coronary heart disease (CHD), causes the heart to progressively
lose its ability to pump blood efficiently.
– HF, though manageable, is a serious, progressive condition, which can
be fatal that frequently leads to repetitive hospitalizations.
– Symptoms of HF may include: exercise intolerance, fluid retention,
fatigue and shortness of breath.
– HF usually occurs as a result of damage to the heart muscle caused by
a number of risk factors including hypertension, CHD (usually caused by
atherosclerosis), smoking, diabetes and cardiac arrhythmia.

Prevalence

– Approximately 23 million people worldwide are afflicted with Heart
Failure (HF), and 2 million new cases are diagnosed each year worldwide.(1)
– HF is a condition that affects nearly five million Americans and over
400,000 new cases will be diagnosed in the next year.(2)
– HF accounts for 5% of all hospital admissions, and in the US it is the
most common cause of admission in patients over 65 years of age.(3)
– By 2010, CVD is expected to be the number one cause of death in
developing countries.(4)
– The economic impact of HF in the US has been estimated to be
approximately $29.6 billion annually.(5)

Testing

– The functional status of patients with HF is categorized in accordance
with the New York Heart Association (NYHA) Classification. Physicians use
this grading system worldwide in the absence of a clinical test for heart
failure, ranging from class I (mild) to class IV (very severe).(6)

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%).