Data presented at AHA Scientific Sessions adds to body of evidence
highlighting unique benefits of CRESTOR across the spectrum of
atherosclerosis disease progression
ORLANDO, FL, Nov. 7 /CNW/ - New analysis of the METEOR (Measuring Effects
on intima media Thickness: an Evaluation Of Rosuvastatin) trial presented
today showed CRESTOR(TM) (rosuvastatin) 40mg slowed the progression of carotid
intima-media thickness (CIMT) in patients at varying levels of risk for
cardiovascular disease while all placebo treated subjects exhibited
significantly higher progression rates.
This new analysis was conducted in subjects defined by the Framingham
risk assessment tool as having less than two or two or more risk factors (RF)
with either thinner or thicker CIMT (less than 1.749 mm (median) vs. greater
than or equal to 1.749 mm). Results demonstrated that CRESTOR significantly
slowed the progression of CIMT in all four subgroups (all p less than 0.02)
compared to placebo treated subjects who all exhibited significantly higher
progression rates. These data were presented at the American Heart Association
Scientific Sessions in Orlando, Florida.
"The METEOR trial continues to provide important information regarding
the effects of CRESTOR on atherosclerotic progression in subjects with various
degrees of risk based on conventional risk factors and carotid artery wall
thickness," said John R. Crouse, III, M.D., lead investigator and Professor of
Endocrinology at Wake Forest University School of Medicine, Winston-Salem, NC.
The analysis showed that CRESTOR, when compared with placebo, slows
progression of carotid atherosclerosis in subjects at relatively low risk of
cardiovascular disease (less than 2RF + Thinner CIMT; 0.0007mm/yr v.
0.0123mm/yr with placebo and less than 2RF + Thicker CIMT; -0.0012mm/yr v.
0.0116mm/yr with placebo). Furthermore, those with more risk factors and those
with greater baseline thickness in the CRESTOR-treated group exhibited a
greater trend toward regression or a greater negative slope (2+RF + Thinner
CIMT; -0.0013mm/yr v. 0.0144mm/yr with placebo and 2+RF + Thicker CIMT;
-0.0071mm/yr v. 0.015mm/yr with placebo).
A further analysis presented earlier at AHA Scientific Sessions
demonstrated CRESTOR significantly reduced CIMT progression after 12 months
with a rate of 0.0032 mm/yr compared with 0.0133 mm/yr for placebo
(p=0.049). This analysis evaluated the shortest time period at
which differences in atherosclerosis progression rates were detectable after
initiating CRESTOR therapy. Data showed that aggressive LDL-C lowering with
CRESTOR exerts a beneficial effect on atherosclerosis during the first year of
treatment, which parallels the timing of event rate reduction seen in clinical
trials. Additional results include:
- Differences in CIMT progression rates between the CRESTOR and placebo
groups were apparent after six months: 0.0023 mm/yr and 0.0106 mm/yr,
- After 18 months, the difference in CIMT progression rates between
CRESTOR and placebo increased: -0.0009 mm/yr and 0.0131 mm/yr,
respectively (p less than 0.0001).
- After 24 months, CIMT progression between the CRESTOR and placebo
groups increased further; -0.0014 mm/yr and 0.0131 mm/yr,
respectively (p less than 0.0001).
Ultrasound assessments were made at 12 carotid artery sites at baseline
and every 6 months up to two years. In these analyses, the same statistical
method was applied to the data cut at 6 months, 1 year, and 18 months, in
addition to the analysis of all data at two years.
Atherosclerosis occurs when there is a build-up of fatty or fibrous
deposits, known as plaques, in the artery wall. Plaques cause the artery to
narrow, and can reduce the blood supply to the heart, brain, and other vital
organs, resulting in symptoms such as angina or transient ischaemic attacks.
Plaques can also rupture and lead to the formation of a thrombus, which can
result in a sudden, complete blockage of blood flow. In the heart, this
blockage causes a heart attack; in the brain, it causes a stroke.
Atherosclerosis is a progressive disease and the main cause of cardiovascular
disease-the number one killer worldwide(1).
METEOR (Measuring Effects on intima media Thickness: an Evaluation Of
Rosuvastatin) was a 24-month, randomised, double-blind, placebo-controlled,
international study to evaluate the effect of CRESTOR 40 mg in 984
asymptomatic, hypercholesterolaemic patients with a low risk of CHD
(Framingham ten-year risk less than 10%) and evidence of sub-clinical
atherosclerotic disease as determined by a thickened carotid artery wall
(maximum CIMT greater than or equal to 1.2 and less than 3.5 mm). METEOR data
presented earlier this year were the first to show a positive effect on
atherosclerosis in this patient population(2).
CRESTOR is indicated for the treatment of lipid disorders. The results
from the METEOR study, supported by data from the ASTEROID(3) and ORION
trials, formed the basis of the atherosclerosis regulatory submissions filed
in the European Union and the United States in January 2007. The CRESTOR
(rosuvastatin) Prescribing Information in Europe was updated to incorporate
data from the METEOR study in section 5.1 of the SmPC in July 2007.
These new results from METEOR add to the wealth of CRESTOR efficacy data
from its extensive GALAXY clinical trials programme(4), designed to address
important unanswered questions in statin research. Currently, more than 69,000
patients have been recruited in over 55 countries worldwide to participate in
the GALAXY Programme.
CRESTOR has now received regulatory approvals in over 90 countries. More
than 11 million patients have been prescribed CRESTOR worldwide. Data from
clinical trials(5) and real world use(6)(7) 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 individual
patient profiles. In most countries, the usual recommended starting dose of
CRESTOR is 10 mg. The 40 mg dose should only be used in patients who have not
achieved their LDL-C goal with the 20 mg dose of CRESTOR. Consult the CRESTOR
product monograph for all contraindications, warnings and precautions
concerning the use of the 40 mg dose. In Canada CRESTOR is not approved for
the treatment of arthrosclerosis.
Notes to Editors:
(*) ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On
Intravascular Ultrasound-Derived Coronary Atheroma Burden) was a
104-week, open label, single-arm, blinded endpoint study designed to
study the effect of CRESTOR 40 mg in 507 patients who had undergone
coronary angiography and who had evidence of coronary artery disease
Key findings from ASTEROID include:
- CRESTOR brought about a 0.79% (median) reduction in percent
atheroma volume in the entire target vessel (p less than 0.001) -
first primary endpoint
- CRESTOR brought about a 9.1% (median) reduction in total atheroma
volume in the most diseased 10 mm segment of the target vessel
(p less than 0.001) - second primary endpoint
- CRESTOR brought about a 6.8% (median) reduction in total atheroma
volume in the entire target vessel (p less than 0.001) - secondary
- These changes were associated with a 53% reduction in LDL-C
(p less than 0.001) and a 15% increase in HDL-C
(p less than 0.001)
(xx)ORION (Outcome of Rosuvastatin Treatment on Carotid Artery
Atheroma: a Magnetic Resonance Imaging ObservatioN) was the first
study to use advanced, high resolution MRI to investigate the effect
of a statin - CRESTOR - on the change in the composition of plaques
in the carotid artery wall. Forty-three (43) patients with moderate
hypercholesterolemia and established carotid atherosclerosis were
treated with either CRESTOR low dose (5 mg) or high dose (40/80 mg)
for two years.
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(1) Bonow, R, Smaha, L, Smith, S et al. The International Burden of
Cardiovascular Disease: Responding to the Emerging Global Epidemic.
(2) Crouse JR, et. al. Effect of rosuvastatin on progression of carotid
intima-media thickness in low-risk individuals with subclinical
atherosclerosis (The METEOR Trial). JAMA, 2007; 297: 1344-1353.
(3) Nissen SE, Nicholls SJ, Sipahi I et al. Effect of very high-intensity
statin therapy on regression of coronary atherosclerosis: the
ASTEROID trial. JAMA 2006 295:1556-65
(4) Schuster H. The GALAXY Program: an update on studies investigating
efficacy and tolerability of rosuvastatin for reducing cardiovascular
risk. Expert Rev Cardiovasc Ther. 2007 5:177-93.
(5) Shepherd J, Hunninghake DB, Stein EA et al. Safety of rosuvastatin.
Am J Cardiol. 2004 94:882-8
(6) 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
(7) 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 further information:
For further information: Marlo Taylor, Fleishman-Hillard Canada Inc.,
(416) 645-3652, email@example.com