Healthcare Industry News: rosuvastatin
News Release - March 25, 2007
First Study to Show Positive Benefit on Atherosclerosis for People With Early Signs of Diseased ArteriesMETEOR Trial Shows CRESTOR Slowed Progression of Atherosclerosis in People at Low-Risk of Coronary Heart Disease (Framingham 10 Year Risk (less than)10%)
LONDON, March 25 (Healthcare Sales & Marketing Network) - METEOR is the first study to show a positive effect on atherosclerosis in people with early signs of carotid artery disease and at low risk of coronary heart disease (CHD). The METEOR study, using CRESTOR(TM) (rosuvastatin) 40mg, resulted in subjects showing a significantly slower rate of progression of atherosclerosis when compared to placebo. When assessed vs. baseline, no significant progression was observed in the 40 mg rosuvastatin arm over the two-year duration of the study while significant progression vs. baseline was observed in the placebo arm.
Data presented at the 56th Annual Scientific Session of the American College of Cardiology (ACC) showed that the CRESTOR 40mg patients, with moderately increased LDL ('bad') cholesterol levels (mean 154 mg/dL) and no established atherosclerosis, experienced a 0.0014 mm/yr decrease in the mean maximum carotid intima-media thickness - a marker of atherosclerotic burden(1), compared to a progression of 0.0131 mm/yr for those on placebo (p(less than)0.0001). CRESTOR 40 mg was well tolerated during the 2 years of the study.
With completion of this study, CRESTOR has now been studied across the atherosclerosis disease spectrum, first with ASTEROID which included patients with established coronary artery disease and at a high risk of CHD events and now with METEOR, which evaluated CRESTOR in asymptomatic subjects with early disease and at low CHD risk.
"It's exciting to see that by using rosuvastatin we can potentially slow or even stop the disease progression in people with relatively modest atherosclerosis," said lead investigator John R. Crouse, III, M.D., Professor of Medicine and Public Health Sciences and Associate Director of the Wake Forest University School of Medicine (WFUSM) General Clinical Research Centre. "METEOR provides evidence that the effect of rosuvastatin on dyslipidaemia translates into a beneficial effect on the progression of atherosclerosis."
Atherosclerosis occurs when there is a build-up of fatty or fibrous deposits, to form areas called plaques, in the artery wall. The build-up of plaques causes the artery to narrow and this can reduce the blood supply to vital organs such as the heart and brain, resulting in symptoms such as angina or transient ischaemic attacks. Plaques can also rupture leading to thrombus formation, which can result in a sudden, complete blockage of blood flow. In the heart, this causes a heart attack and in the brain, this causes a stroke. Atherosclerosis is a progressive disease and the main cause of cardiovascular disease - the number one killer worldwide(2).
A recently published independent post hoc analysis combining data from four prospective trials, including ASTEROID, showed that by substantially both decreasing LDL-C and increasing HDL-C by more than 7.5 percent, a beneficial effect on atherosclerosis can be achieved(3). In METEOR, CRESTOR was associated with a 48.8 percent reduction in LDL-C and an 8.0 percent increase in HDL-C (both p(less than)0.0001 vs placebo). These results are consistent with the above finding and provide additional confirmation that the lowering of LDL-C and raising of HDL-C offered by CRESTOR translate into beneficial effects on atherosclerosis.
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 40mg in 984 asymptomatic, hypercholesterolaemic patients with a low risk of coronary heart disease (Framingham ten year risk (less than)10%) and evidence of sub-clinical atherosclerotic disease as determined by a thickened carotid artery wall (maximum intima media thickness (IMT) (greater than)1.2 and (less than)3.5 mm). METEOR used B-mode ultrasound imaging to assess and measure change in mean maximum IMT of 12 vessel sites in the carotid artery. The study evaluated low risk subjects not indicated for statin therapy to permit inclusion of a comparative placebo arm.
Currently, CRESTOR is indicated for the treatment of lipid disorders. The results from the METEOR study, supported by data from the ASTEROID study and including the ORION trial, formed the basis of the atherosclerosis regulatory submissions filed in the European Union and the United States in January 2007. These submissions seek to expand the use of CRESTOR to include the treatment of atherosclerosis with the purpose of impacting the progression of the disease in patients in whom lipid-lowering therapy is indicated.
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 and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, more than 63,000 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 9 million patients have been prescribed CRESTOR worldwide. Data from clinical trials(5) and marketed 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 the individual patient profile. In most countries, the usual recommended starting dose of CRESTOR is 10mg. The 40mg dose should only be used in patients who have not achieved their LDL-C goal utilizing the 20mg dose of CRESTOR.
Notes to Editors:
1) 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 40mg in 507 patients who had undergone coronary angiography and who had evidence of coronary artery disease (CAD).
Key findings from ASTEROID include(8)
- 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 10mm 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 endpoint
- 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)
2) 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.
(1) Bots ML. Carotid intima-media thickness as a surrogate marker for cardiovascular disease in intervention studies. Curr Med Res Opin. 2006 22:2181-90
(2) Bonow, R, Smaha, L, Smith, S et al. The International Burden of Cardiovascular Disease: Responding to the Emerging Global Epidemic. Circulation 2002; 106:1602
(3) Nicholls SJ, Tuzcu EM, Sipahi I et al. Statins, high-density lipoprotein cholesterol, and regression of coronary atherosclerosis JAMA 2007 297:499-508
(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 15:444-53
(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.
(8) 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
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