New Data Examines the Effect of Adding a Statin to Optimised Treatment for Patients with Advanced Heart Failure

New Data Examines the Effect of Adding a Statin to Optimised Treatment for Patients with Advanced Heart Failure

November 05, 2007

    ORLANDO, Fla., Nov. 5 /Xinhua-PRNewswire/ -- 

    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.

    Patients taking AstraZeneca's CRESTOR(TM)
(rosuvastatin) 10mg experienced an 8 percent reduction
(p=0.12) in the combined primary endpoint of cardiovascular
death or myocardial infarction or stroke, which was not
statistically significant. This reduction was primarily
driven 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. 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, 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, 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
whom investigators felt did not need lipid-lowering
therapy.

    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 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.

    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 FTSE4 Good Index.

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in the USA.

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http://www.astrazeneca.com 

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    For more information, please contact:

     Ben Strutt
     AstraZeneca, Global PR Manager
     Cardiovascular Therapy Area
     Tel:   [phone]
     Mob:   [phone]
     Email: [e-mail]