New Data Examines the Effect of Adding a Statin...
ORLANDO, Florida, November 5 /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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