New data examines the effect of adding a statin to optimised treatment for patients with advanced heart failure

    ORLANDO, FL, Nov. 5 /CNW/ - New data from the CORONA study presented
today at the American Heart Association 2007 Scientific Sessions showed that
adding a statin to optimised 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.(1)
    Patients taking AstraZeneca's CRESTOR(TM) (rosuvastatin) 10mg experienced
an 8 percent reduction in the combined primary endpoint of cardiovascular
death or myocardial infarction or stroke(1). This benefit was not
statistically significant (p=0.12). 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. This reduction in the primary endpoint was driven
mainly by a decrease in atherosclerotic events, i.e. stroke and myocardial
infarctions (post hoc analysis p=0.05) which is where statins have been proven
to have benefit.(1) In addition, fewer hospitalizations occurred in patients
on CRESTOR compared to placebo, whether due to any cause (p=0.007),
cardiovascular causes (p less than 0.001), for worsening heart failure
    "The results of the CORONA study are important," says Dr. Robert Roberts,
President, Chief Executive Officer and Chief Scientific Officer, University of
Ottawa Heart Institute. "In particular, this study reinforces how critical it
is to recognize and treat atherosclerosis early and appropriately, well before
cardiovascular disease has a chance to escalate to the point of heart
    "The CORONA results represent a major advancement in medical research and
understanding of patients with advanced heart failure, 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 a failing heart muscle damaged beyond repair."
    "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," said
Elisabeth Bjork, Global Medical Science Director for CRESTOR.
    CORONA (COntrolled ROsuvastatin MultiNAtional Study in Heart Failure) was
a long-term, randomised, placebo-controlled study of more than 5,000 patients
with chronic, symptomatic, systolic heart failure (NYHA II-IV) of ischaemic
origin. The study was designed to evaluate the effects of adding CRESTOR 10 mg
to optimised treatment (including multiple medications) on cardiovascular
mortality and morbidity and overall survival in patients who were not
indicated a statin.(1)
    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.(1)
    CORONA is a part of AstraZeneca's extensive GALAXY(2) clinical trials
programme, 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 Programme.
    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.(3) In Canada CRESTOR is approved for use in
hyperlipidemic and dyslipidemic conditions to decrease the elevated total
cholesterol, LDL-C, ApoB, TG and the Total-C/HDL-C ratio and to increase
HDL-C. CRESTOR is not approved for treatment of atherosclerosis or heart

    About AstraZeneca Canada

    AstraZeneca is a leading global pharmaceutical company with an extensive
product portfolio spanning six major therapeutic areas: gastrointestinal,
cardiovascular, infection, neuroscience, oncology, and respiratory.
AstraZeneca's Canadian headquarters and packaging facilities are located in
Mississauga, Ontario, with a state-of-the-art drug discovery centre based in
Montreal, Quebec. For more information, visit the company's website at


    DATE OF FEED:   Monday, November 5, 2007

    TIME OF FEED:   11:00am - 11:30 and again at 14:30 - 15:00 Eastern


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    (1) John Kjekshus, M.D., Ph.D. Rosuvastatin in Older Patients with
        Systolic Heart Failure. This article was published at on
        November 5, 2007. It will appear in the November 29 issue of the New
        England Journal of Medicine.
    (2) Schuster H. The GALAXY Program: an update on studies investigating
        efficacy and tolerability of rosuvastatin for reducing cardiovascular
        risk. Expert Rev Cardiovasc Ther. 2007 5:177-93.
    (3) Shepherd J, et al. Safety of rosuvastatin. American Journal of
        Cardiology 2004; 94: 882-888.

For further information:

For further information: Marlo Taylor, Fleishman-Hillard Canada Inc.,
(416) 645-3652,

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