New data from the ASTEROID(a) study shows that substantial regression of coronary atheroma is linked to enlargement of the vessel lumen. Earlier this year, initial results from ASTEROID (A Study ToEvaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden) suggested that substantial reductions in LDL-C and increases in HDL- C using CRESTOR are associated with the regression of coronary atherosclerosis.2 These new data demonstrate that with intensive lipid therapy, in patients demonstrating substantial atheroma regression, enlargement of the lumen accompanied arterial remodeling. Further data provided by ORION(b) shows the potential for high and low dose rosuvastatin to have an impact on plaque composition. Both results were presented for the first time this week at the American Heart Association's 2006 Scientific Session in Chicago.
Dr Elisabeth Björk, CRESTOR Medical Science Director at AstraZeneca, said: "The ASTEROID results indicate that substantial regression of atherosclerosis may help improve diseased arteries in high risk patients. The results from ASTEROID and ORION, together with those from the METEOR(c) study, will form the basis of the planned regulatory submission for an atherosclerosis indication in the first half of 2007."
These new results from ASTEROID and ORION add to the outstanding CRESTOR efficacy data from its 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 55,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
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Notes to Editors:
(a) ASTEROID, an open-label, single-arm study, used intravascular ultrasound (IVUS) imaging to assess atheroma volume in 349 subjects with angiographic coronary artery disease taking CRESTOR 40 mg for 2 years.
Key findings from ASTEROID:1
- Percent atheroma volume (PAV) reduced -0.8 percent and total atheroma volume (TAV) reduced -6.8 percent
- Atheroma volume reductions accompanied by reductions in lumen volume of 3.1 percent and EEM volume of 4.7 percent
- Atheroma regression accompanied by 3.9 percent reduction in EEM and no change in lumen volumes
- Substantial regression of atheroma accompanied by 3.2 percent reduction in EEM, but also a 3.5 percent increase in lumen
- Plaque progression accompanied by 5.8 percent reduction in EEM and 9.1 percent reduction in lumen
(b) ORION, a 24-month, randomised, double-blind study, used Morphology-Enhanced Probabilistic Plaque Segmentation (MEPPS) to segment and identify carotid plaque composition as depicted by high-resolution magnetic resonance imaging (MRI), in 43 subjects randomised to low or high dose rosuvastatin therapy.
Key findings from ORION:3
- Low and high dose rosuvastatin reduced LDL-C by 39 and 58 percent, respectively (p<0.001)
- Mean change in artery wall area of 0.54mm2 (range -0.70 to 1.54) and lumen area of -0.03 mm2 (range -1.31 to 1.39)
- High dose rosuvastatin reduced portion of vessel wall comprised by the lipid-rich necrotic core by 32.7 percent
(c) METEOR is a randomised, double-blind, placebo-controlled, international study to evaluate the effect of CRESTOR 40mg/day on carotid intima-media thickness (IMT) in asymptomatic, hypercholesterolaemic subjects with a low risk of coronary heart disease (CHD) and sub-clinical evidence of atherosclerotic disease as determined by a thickened carotid IMT (maximum IMT >1.2 and <3.5 mm). The METEOR clinical trial has been completed and the study has been submitted for presentation at the American College of Cardiology meeting in March 2007.
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 a sudden, complete blockage of blood flow. In the heart, this causes a heart attack and in the brain, this causes a stroke.
CRESTOR has now received regulatory approvals in more than 84 countries across five continents. Over 8.4 million patients have been prescribed CRESTOR worldwide, and from clinical trials, marketed use, the recently published National Lipid Association safety evaluation, and early pharmacoepidemiology data, the safety profile 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 5 or 10mg.
1. SJ Nicholls, I Sipahi, A Colagiovanni, K Wolski, P Schoenhagen, T Crowe, JS Raichlen, VA Cain, S Kapadia, EM Tuzcu and SE Nissen. Arterial Wall Remodeling in Response to Atheroma Regression with Very Intensive Lipid Lowering: Insights from the ASTEROID trial. Presented at: American Heart Association; 15th November, 2006; Chicago, Illinois. USA.
2. Nissen SE et al. Effect of Very High-Intensity Statin Therapy on Regression of Coronary Atherosclerosis: The ASTEROID Trial. JAMA. 2006;295:1556-1565.
3. HR Underhill, TS Hatsukami, JS Raichlen, J Waterton, F Liu, WS Kerwin, T Saam, B Chu, N Takaya, XQ Zhao, W Hamar, C Yuan. Morphology-Enhanced Probabilistic Plaque Segmentation Identifies Regression of the Lipid-Rich Portion of Carotid Plaques after 2 Years of Rosuvastatin Therapy. Presented at: American Heart Association; 12th November, 2006. Chicago, Illinois, USA.
