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

London (ots/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 Björk, 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-naïve 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-naïve 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.

Contact:

For further information please contact: Ben Strutt, Global PR
Manager, Cardiovascular Therapy Area, AstraZeneca, Tel:
+44(0)1625-230076, Mob: +44(0)7919-565990, Email:
ben.strutt@astrazeneca.com.

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