ASTEROID研究数据汇集了CRESTOR(TM)对血管重塑的作用

美国商业资讯2006年11月13日伦敦消息——

ASTEROID(a)研究的最新数据显示，冠状动脉粥样硬化斑块的明显消退与扩张血管腔有关。今年初，ASTEROID（血管内超声评定罗素他汀对冠状动脉粥样硬化效果研究）的最初研究结果认为，使用CRESTOR大幅降低LDL-C（低密度脂蛋白胆固醇）和提高HDL- C（高密度脂蛋白胆固醇）与冠状动脉粥样硬化斑块消退有关。2　这些最新的研究数据显示，进行强化的血脂治疗，患者的动脉粥样硬化斑块明显消退，血管重塑时血管腔扩张。ORION(b)研究项目提供的进一步数据显示，大剂量及小剂量使用罗素他汀进行治疗，可能会对动脉粥样硬化斑块的成份产生影响。这两项研究结果均于本周首次提交给了在芝加哥举行的美国心脏学会2006年科学大会。

阿斯利康公司（AstraZeneca）CRESTOR医学总监Elisabeth Bjork博士说：“ASTEROID研究结果显示，动脉粥样硬化斑块的明显消退可能会有助于改善高风险患者病变动脉的功能。ASTEROID和ORION的研究结果，结合METEOR(c)的研究结果，将为计划于2007年上半年送审的动脉粥样硬化征兆打下了基础。”

ASTEROID和ORION的这些最新研究成果，以及CRESTOR在其广泛的GALAXY临床试验中获得的卓越的临床疗效数据，主要是用来解决目前在他汀类药物研究中还没有解决的一些重要问题，并调查CRESTOR对降低心血管疾病患病风险的影响及疗效。目前，来自全球55个国家的5.5万多名患者已经应征参与了该GALAXY项目。

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致编者：

（a）ASTEROID是一项开放性标记的单独机构研究项目，在这项研究中，使用了血管内超声（IVUS）成像技术对349位冠状动脉粥样硬化患者的粥样硬化面积进行了评估，这些患者均服用了2年每天剂量为40毫克的CRESTOR。

ASTEROID研究的主要成果：（1）

——动脉粥样斑块体积百分比（PAV）减少了－0.8%，总粥样斑块体积百分比（TAV）减少了－6.8%

——动脉粥样斑块体积缩小的同时，血管腔面积缩小了3.1%，EEM面积缩小了4.7%

——动脉粥样斑块消退的同时，EEM面积缩小了3.9%，血管腔面积未发生变化　

——动脉粥状斑块明显退化的同时，EEM面积缩小了3.2%，血管腔面积增加了3.5%

——动脉粥样斑块进展的同时，EEM面积缩小了5.8%，血管腔面积缩小了9.1%

（b）ORION是一项为期两年的随机双盲研究，采用了MEPPS的方法，对随机抽取的43名服用小剂量或大剂量罗素他汀的患者，分割鉴定由高清晰度的磁共振成像（MRI）确定的颈动脉粥化斑块的成份，

ORION研究的主要成果：（3）

——服用小剂量及大剂量罗素他汀可分别减少39%和58%的LDL-C（P值小于0.001）

——这就是说动脉血管壁面积变化了0.54平方毫米（范围从-0.70到1.54），血管腔面积变化了-0.03平方毫米（范围从-1.31到1.39）

——大剂量服用罗素他汀可以减少32.7%的由高血脂坏死中心形成的血管壁

（c）METEOR研究是一项随机双盲式安慰剂控制的国际化研究，以评估每天服用40毫克CRESTOR对低风险冠心病（CHD ）患者以及由变厚的颈动脉内中膜厚度（IMT）（最大大于1.2毫米，小于3.5毫米）确定的动脉粥化硬化症亚临床症状的患者的颈动脉内中膜厚度的影响。METEOR临床试验已经完成，这项研究的成果已经提交给将于2007年3月举行的American College of Cardiology会议。

当一个人过度肥胖或纤维状物质堆积在血管壁形成斑块时，就会患动脉粥样硬化症。动脉粥样硬化斑块形成后将会导致血管腔变窄，减少对身体一些重要器官，如心脏和大脑的供血量，从而导致如心胶痛或短暂性缺血性症状等病症。动脉粥样硬化斑块还会发生破裂，进而阻塞血管，导致血液循环的突然中断。如果这种情况发生在心脏血管，就会引发心脏病，如果这种情况发生在大脑血管就会引发中风。

目前，CRESTOR已经获得了全球超过84个国家相关机构的批准。全球840多万名患者已经使用上了CRESTOR，从临床试验、市场销售、National Lipid Association最近公布的安全评测以及早期的药物流行病学数据来看，该药物的安全性达到了市场上其他他汀类药物的安全标准。

每天40毫克的剂量是CRESTOR的最大可用剂量。应根据说明书合理使用CRESTOR，说明书中根据不同患者个体的情况推荐了最初的和滴定法测量的治疗方案。在大多数国家，CRESTOR推荐的起始用量通常为每天5毫克或10毫克。

1、SJ Nicholls、I Sipahi、A Colagiovanni、K Wolski、P Schoenhagen、T Crowe、JS Raichlen、VA Cain、S Kapadia、EM Tuzcu和SE Nissen。采用强化降脂方法对动脉粥样硬化症的治疗，重塑动脉血管壁：ASTEROID试验得出的观点。已提交给：美国心脏学会（American Heart Association）。美国，伊利诺斯州芝加哥，2006年11月15日。

2、Nissen SE et al。为消退冠状动脉粥样硬化斑块进行的高强度他汀类药物治疗：ASTEROID试验。JAMA。2006年，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。采用MEPPS方法，对服用2年的罗素他汀进行治疗的患者，鉴定颈动脉粥样硬化斑块高血脂成份的消退情况。已提交给：美国心脏学会，美国伊利诺斯州芝加哥，2006年11月12日。

联系方式：AstraZeneca Ben Strutt 全球公共关系经理，心血管疾病治疗领域 电话：+44 (0) 1625 230076 电子信箱：ben.strutt@astrazeneca.com

(BW)(ASTRAZENECA)(AZN)(AZN.L)(AZN.ST) Substantial Regression of Atherosclerosis May Help Improve Diseased Arteries

ASTEROID data highlights effect of CRESTOR(TM) on arterial remodeling

LONDON--(BUSINESS WIRE)--Nov. 13, 2006--

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 To Evaluate 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 Bjork, 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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For further information please visit:　www.AstraZenecaPressOffice.com　.

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 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 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 greater than 1.2 and less than 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.

CONTACT: AstraZeneca Ben Strutt Global PR Manager, Cardiovascular Therapy Area Tel: +44 (0) 1625 230076 Email: ben.strutt@astrazeneca.com