AstraZeneca Announces First Patient Enrolled in Head-to-Head Comparison of CRESTOR/Ezetimibe With Simvastatin/Ezetimibe

London (ots/PRNewswire) - AstraZeneca today announced enrolment of
the first patient in the new GRAVITY study (Gauging the lipid effects
of RosuvAstatin plus ezetimibe Versus sImvastatin plus ezetimibe
TherapY). GRAVITY is a clinical trial examining the impact on
LDL-cholesterol ('bad' cholesterol) levels in patients with
hypercholesterolaemia and coronary heart disease following a
treatment regimen with lower doses of CRESTOR plus ezetimibe,
compared to higher doses of simvastatin plus ezetimibe (in a fixed
dose combination marketed as Vytorin(TM) or Inegy(TM)). Ezetimibe is
a cholesterol absorption inhibitor and this study is AstraZeneca's
first head-to-head comparison of CRESTOR/ezetimibe with
simvastatin/ezetimibe.

CRESTOR provides comprehensive dyslipidaemia management, offering
the most effective LDL-C reduction of any statin available, with the
additional benefit of raising HDL across the dose range.

In a previous clinical trial, EXPLORER, CRESTOR 40mg with
ezetimibe 10mg helped high risk patients achieve unprecedented levels
of LDL-C reduction of up to 70% compared to 57% with CRESTOR alone.

"GRAVITY will, for the first time, examine the effects of adding
ezetimibe to low dose CRESTOR and to simvastatin in a head-to-head
clinical trial setting, to see which of these treatment options
achieves the greatest LDL-C lowering benefits. We expect these
results to firmly establish CRESTOR as the best statin upon which to
base any combination therapy for patients with dyslipidaemia," said
Elisabeth Björk, Global Medical Science Director for CRESTOR.

GRAVITY is a 12-week, open-label, randomised, parallel-group,
multicentre, Phase IIIb study of 800 patients to compare the efficacy
and safety of CRESTOR (rosuvastatin) 10mg and 20mg in combination
with ezetimibe 10mg and simvastatin 40mg and 80mg in combination with
ezetimibe 10mg in patients with hypercholesterolaemia and coronary
heart disease (CHD) or a CHD risk equivalent, atherosclerosis or a
10-year CHD Risk of >20%. Complete results are due in 2009.

GRAVITY is a part of AstraZeneca's extensive GALAXY clinical
trials programme, designed to address important unanswered questions
in statin research and to investigate the impact of CRESTOR on
cardiovascular risk reduction and patient outcomes. Currently, more
than 69,300 patients have been recruited from 55 countries worldwide
to participate in the GALAXY Programme.

CRESTOR has now received regulatory approvals in over 90 countries
across five continents. 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.

The 40 mg dose is the highest registered dose of CRESTOR. CRESTOR
should be used according to the prescribing information, which
contains recommendations for initiating and titrating therapy
according to the individual patient profile. In most countries, the
usual starting dose of CRESTOR is 5mg or 10mg. The 40mg dose should
be reserved for patients with severe hypercholesteraemia at high
cardiovascular risk.

Note to Editors

This press release has been made available on worldwide press
communication media for the benefit of correspondents writing for the
medical professional press. Differing national legislation, codes of
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use in the USA.

For further information please visit:
http://www.AstraZenecaPressOffice.com

ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Ben Strutt, Global PR Manager, Cardiovascular Therapy Area,
AstraZeneca, Tel: +44-1625-230076, Mob: +44-7919-565990, Email:
ben.strutt@astrazeneca.com


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