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

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

September 07, 2007

    LONDON, Sept. 6 /Xinhua-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 Bjork, Global Medical Science Director for
CRESTOR.

    GRAVITY is a 12-week, open-label, randomized,
parallel-group, multi-center, 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 program, 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 Program.

    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. 

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


    For more information, please contact:

     Ben Strutt, Global PR Manager
     Cardiovascular Therapy Area, AstraZeneca
     Phone:   [phone]
     Mobile:  [phone]
     Email:   [e-mail]
     Website: http://www.AstraZenecaPressOffice.com