15th Nov 2006 20:15
New data from the ASTEROID(a) study shows that substantialregression of coronary atheroma is linked to enlargement of the vessellumen. Earlier this year, initial results from ASTEROID (A Study ToEvaluate the Effect of Rosuvastatin On IntravascularUltrasound-Derived Coronary Atheroma Burden) suggested thatsubstantial reductions in LDL-C and increases in HDL- C using CRESTORare associated with the regression of coronary atherosclerosis.2 Thesenew data demonstrate that with intensive lipid therapy, in patientsdemonstrating substantial atheroma regression, enlargement of thelumen accompanied arterial remodeling. Further data provided byORION(b) shows the potential for high and low dose rosuvastatin tohave an impact on plaque composition. Both results were presented forthe first time this week at the American Heart Association's 2006Scientific Session in Chicago. £ Dr Elisabeth Bjork, CRESTOR Medical Science Director atAstraZeneca, said: "The ASTEROID results indicate that substantialregression of atherosclerosis may help improve diseased arteries inhigh risk patients. The results from ASTEROID and ORION, together withthose from the METEOR(c) study, will form the basis of the plannedregulatory submission for an atherosclerosis indication in the firsthalf of 2007." £ These new results from ASTEROID and ORION add to the outstandingCRESTOR efficacy data from its extensive GALAXY clinical trialsprogramme, designed to address important unanswered questions instatin research and to investigate the impact of CRESTOR oncardiovascular risk reduction and patient outcomes. Currently, morethan 55,000 patients have been recruited from 55 countries worldwideto participate in the GALAXY Programme. --ends-- £ For further information please visit:www.AstraZenecaPressOffice.com. £ Notes to Editors: £ (a) ASTEROID, an open-label, single-arm study, used intravascularultrasound (IVUS) imaging to assess atheroma volume in 349 subjectswith angiographic coronary artery disease taking CRESTOR 40 mg for 2years. £ 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, usedMorphology-Enhanced Probabilistic Plaque Segmentation (MEPPS) tosegment and identify carotid plaque composition as depicted byhigh-resolution magnetic resonance imaging (MRI), in 43 subjectsrandomised 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 less than 0.001) £ -- Mean change in artery wall area of 0.54mm(2) (range -0.70 to 1.54) and lumen area of -0.03 mm(2) (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 oncarotid intima-media thickness (IMT) in asymptomatic,hypercholesterolaemic subjects with a low risk of coronary heartdisease (CHD) and sub-clinical evidence of atherosclerotic disease asdetermined by a thickened carotid IMT (maximum IMT greater than 1.2and less than 3.5 mm). The METEOR clinical trial has been completedand the study has been submitted for presentation at the AmericanCollege of Cardiology meeting in March 2007. £ Atherosclerosis occurs when there is a build-up of fatty orfibrous deposits, to form areas called plaques, in the artery wall.The build-up of plaques causes the artery to narrow and this canreduce 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 ofblood 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 84countries across five continents. Over 8.4 million patients have beenprescribed 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 linewith other marketed statins. £ The 40 mg dose is the highest registered dose of CRESTOR. CRESTORshould be used according to the prescribing information, whichcontains recommendations for initiating and titrating therapyaccording to the individual patient profile. In most countries, theusual 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. Copyright Business Wire 2006Related Shares:
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