AstraZeneca Announces First Patient Enrolled in Head-to-Head Comparison of CRESTOR/Ezetimibe With Simvastatin/Ezetimibe
06/09/2007 16:30
PR Newswire
LONDON, September 6 /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
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.
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Contact: Ben Strutt, Global PR Manager, Cardiovascular Therapy Area, AstraZeneca, Tel: +44-1625-230076, Mob: +44-7919-565990, Email: ben.strutt@astrazeneca.com