Two New Studies Provide Real World Data on Cardiovascular Events in CRESTOR Users

Two New Studies Provide Real World Data on Cardiovascular Events in CRESTOR Users

October 23, 2007

    LONDON, Oct. 23 /Xinhua-PRNewswire/ -- Data from two
observational studies of over 470,000 patients taking
statins in routine clinical practice investigating the
incidence of cardiovascular events in patients taking
CRESTOR(TM) (rosuvastatin) and other statins were presented
today at the International Society for Pharmacoeconomics and
Outcomes Research (ISPOR) 10th Annual European Congress in
Dublin.

    The results from one study with a median duration of
therapy of eleven months suggest that patients taking
CRESTOR (mean dose 11mg) had significantly fewer
cardiovascular events compared to patients taking
simvastatin (mean dose 22mg) and pravastatin (mean dose
34mg) and a favourable trend towards fewer cardiovascular
events compared to patients taking atorvastatin (mean dose
17mg).  The results from the other study showed that
CRESTOR users had a similar incidence of cardiovascular
events to users of other statins at a median duration of
therapy of 100 days, however amongst patients who were on
statin therapy for nine months or longer the incidence of
events was significantly lower in CRESTOR users.  These
studies have limitations typical of observational
research.

    "These pharmacoepidemiological studies add to the
extensive knowledge we have gathered through the CRESTOR
clinical trials program, which continues to show that
CRESTOR offers outstanding effects on lowering LDL-C with
the additional benefit of raising HDL-C," said
Elisabeth Bjork, CRESTOR Medical Science Director at
AstraZeneca.

    The first study conducted in the Netherlands, compared
the differences in incidences of hospitalisations for
cardiovascular events -- including fatal and non-fatal
ischaemic heart disease and stroke- between users of
selected statins (rosuvastatin, simvastatin, atorvastatin,
pravastatin).  76,147 statin-naive patients from the PHARMO
Institute database, who had not experienced cardiovascular
events in the preceding year were followed for up to two
years, with a median duration of therapy of eleven months.

    In this study, the incidence of hospitalisation for
cardiovascular events was significantly lower (28%, RR 0.72
(95 percent CI 0.56-0.94)) in patients taking CRESTOR
compared with those taking other statins (simvastatin,
atorvastatin, or pravastatin).  Mean statin doses were
CRESTOR 11mg, atorvastatin 17mg, simvastatin 22mg, and
pravastatin 34mg.  When individually compared to other
statin groups, the incidence of cardiovascular events in
CRESTOR users was:

    -- 40% lower than pravastatin users (0.60 (95%CI
0.45-0.80)) significant

    -- 29% lower than simvastatin users (0.71 (95%CI
0.54-0.94)) significant

    -- 17% lower than atorvastatin users (0.83 (95%CI
0.63-1.10)) not 
       significant

    The second study conducted in the US, assessed real
world effectiveness of statins by comparing the incidence
of fatal and non-fatal cardiovascular events (hospital
cardiovascular death, heart attack, unstable angina,
coronary revascularization, stroke, and carotid
revascularization) in users of CRESTOR versus users of
other statins.  395,039 statin-naive patients from the
Thomson Healthcare's MarketScan research database were
followed for up to two years and four months, with a median
duration of therapy of 100 days.  Mean dose of CRESTOR was
11 mg and was lower than the other statins.

    In this study, CRESTOR patients had a similar incidence
of cardiovascular events to patients taking other statins
for 90 days or more, or for 180 days or more (greater than
or equal to 90 days exposure, HR=0.97, (95 percent
CI=0.86-1.09); greater than or equal to 180 days, HR=0.91,
(95 percent CI=0.78-1.06)).  However, when patients
remained on therapy for at least nine months, patients
taking CRESTOR had a significantly lower incidence of
cardiovascular events (20% lower, HR 0.80 (95 percent CI
0.64-1.00)) than patients taking other statins.

    CRESTOR is indicated for the treatment of lipid
disorders.  CRESTOR has now received regulatory approvals
in more than 90 countries.  More than 11 million patients
have been prescribed CRESTOR worldwide.  Data from clinical
trials(1) and marketed use(2),(3) show that the safety
profile for CRESTOR is in line with other marketed
statins.

    CRESTOR should be used according to the prescribing
information, which contains recommendations for initiating
and titrating therapy according to individual patient
profiles.  In most countries, the usual recommended
starting dose of CRESTOR is 10mg.

    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
USD26.47 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.  For more information about
AstraZeneca, please visit: http://www.astrazeneca.com

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    (1) Shepherd J, Vidt DG et al. Safety of rosuvastatin:
update on 16,876 rosuvastatin-treated patients in a
multinational clinical trial program.  Cardiology 2007
107:433-43

    (2) McAfee AT, Ming EE, Seeger JD et al. The
comparative safety of rosuvastatin: a retrospective matched
cohort study in over 48,000 initiators of statin therapy. 
Pharmacoepidemiol Drug Saf. 2006 15:444-53

    (3) Goettsch WG, Heintjes EM, Kastelein JJ et al.
Results from a rosuvastatin historical cohort study in more
than 45,000 Dutch statin users, a PHARMO study. 
Pharmacoepidemiol Drug Saf. 2006 15:435-43.


    For more information, please contact:

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