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1 September 2002
NEW DATA SHOW CRESTOR® MORE EFFECTIVE THAN ATORVASTATIN ACROSS A WIDE RANGE OF DOSES

AstraZeneca announced today that data presented at the European Society of Cardiology Meeting in Berlin, show that Crestor® (rosuvastatin) consistently achieved a significantly greater reduction in LDL-Cholesterol (LDL-C) levels when compared to atorvastatin across the dose range tested. This marks the first presentation of data demonstrating the superior LDL-C lowering capability of 'Crestor' when compared with atorvastatin across a range of doses. Previously presented data have been individual dose comparisons or titration studies. AstraZeneca also announced the implementation of the GALAXY programme, which is a long-term comprehensive global research initiative to investigate cardiovascular risk reduction with 'Crestor'.

"New data presented today that reaffirm the superior lipid lowering capability of 'Crestor', in addition to the company's plans to conduct further research, through the GALAXY programme, in patients with, or at risk of, cardiovascular disease, demonstrate AstraZeneca's commitment to 'Crestor' a drug which we believe will play an important role in the treatment and management of cardiovascular disease in the future," said Hamish Cameron, MD, Vice President, Cardiovascular Therapy Area.

Previous studies have shown that broadly speaking each doubling of the dose of a statin provides an extra 6 per cent reduction in LDL-C. Results from this study showed that on average 'Crestor' provided an 8.4 percent greater reduction in LDL-C than atorvastatin across the dose ranges compared (p< 0.001). This provides further evidence that 'Crestor' should enable more patients to achieve their guideline LDL-C goal at a lower dose, avoiding the need to double the dose. These positive results further support data from other studies, which clearly showed that at a given dose more patients achieved guideline LDL-C goals with CRESTOR than with atorvastatin.

The data also showed that 'Crestor' had beneficial effects on HDL-Cholesterol (HDL-C) levels. This result, combined with the drug's LDL-C lowering effect, demonstrated that 'Crestor' was consistently more effective than atorvastatin in improving lipid ratios across the dose ranges tested. Improvements in these ratios may offer enhanced potential for cardiovascular risk reduction. Both therapies were well tolerated across all doses, with similar types and incidences of treatment-emergent adverse events.

The global statin market is estimated to be worth more than $14 billion and is growing at a rate of more than 20 per cent. 'Crestor' is the latest of the statin (HMG-CoA reductase inhibitors) class of lipid-lowering drugs, which are used in the treatment of dyslipidaemia. 'Crestor' was submitted simultaneously for regulatory approval in the US and Europe in June 2001, in Japan earlier this year, and in a number of other markets worldwide.

Successfully achieving LDL-cholesterol guideline goals reduces cardiovascular disease (CVD) risk. Cardiovascular disease is the leading cause of mortality worldwide. Over 16.7 million deaths each year are due to CVD, which represents approximately one death every two seconds. In Europe CVD accounts for over 50 per cent of deaths in those aged over 65 years. Superior LDL-C lowering efficacy is important because it could imply greater potential to prevent more cardiovascular events.

The GALAXY research programme is a series of co-ordinated 'Crestor' studies from more than 30 countries around the world. Independent researchers will implement the GALAXY programme, which aims to further address a number of questions including how to slow the progression of 'blocked arteries' or atherosclerosis in patients with diseased arteries; evaluation of optimal treatments; helping more patients reach recommended guideline treatment goals; evaluation of initiatives designed to help patients take their medication more appropriately; to determining how the lives of patients can be improved and prolonged. Currently, 10 studies are ongoing, involving over 9,000 subjects from 20 countries around the world.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca has more than 40 years experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a comprehensive cardiovascular portfolio including Atacand®, Zestril®, Seloken ZOK® /Toprol-XL® and Plendil®. This heritage is complemented by an innovative pipeline including 'Crestor', a highly effective treatment for dyslipidaemia, the first oral direct thrombin inhibitor, Exanta®, and a novel treatment for type 2 diabetes / metabolic syndrome (AZ 242).

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Note to News Editors:

  • Study 033 was a 6-week, randomised, double-blind trial, conducted in dyslipidaemic men and women aged over eighteen years at 41 centres in the US and Canada. Mean percentage changes from baseline to week 6 in lipid measures across the dose range for each drug were assessed by linear-regression analysis using analysis of covariance, where there was a linear dose relationship. In other parameters ANOVA was used for dose-by-dose comparisons.
  • For further information please contact: www.AstraZenecaPressOffice.com

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