“These data underscore the strength of the ‘Crestor’ product profile, and confirm that once approved, this product will be very competitive and, just as importantly, provide patients with highly effective LDL lowering capability,” said Dr. Hamish Cameron, Vice President, Cardiovascular Therapy Area, AstraZeneca.

Superior Efficacy in Getting More Patients to Goal

A pooled-data analysis of three multicentre trials compared the proportion of patients who achieved the Joint European Societies LDL-cholesterol (LDL-C) goal of <3 mmol/L. The results showed that ‘Crestor’ 10 mg achieved significantly greater reductions in LDL-C levels than atorvastatin 10 mg and enabled more patients to reach the recommended LDL-C goal. After 12 weeks of treatment, following a six-week dietary lead-in period, the mean percentage decrease in LDL-C was significantly greater (p<0.001) with ‘Crestor’ (47 percent) compared with the atorvastatin (36 percent). More patients in the ‘Crestor’ group achieved the European LDL-C goal than in the atorvastatin group: 82 percent compared with 51 percent.

In a previously presented analysis (WCC, May 2002) of two other multicentre trials, ‘Crestor’ 10 mg again demonstrated superior LDL-C lowering efficacy and the capability to bring more patients to recommended LDL-C goals (80 percent), this time in comparison with pravastatin 20 mg (16 percent) and simvastatin 20 mg (48 percent).

A third pooled-analysis compared the ability of ‘Crestor’ to enable patients to achieve National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATPIII) LDL-C goals with that of atorvastatin. Pooled data from three trials showed that significantly more (p<0.001) patients receiving 10 mg of ‘Crestor’ achieved their LDL-C goals (76 percent) compared with those receiving 10 mg atorvastatin (53 percent). HDL-C also increased significantly more (p<0.001) with ‘Crestor’ (8.9 percent) than with atorvastatin (5.5 percent).

Complementing these trials which showed the ability of ‘Crestor’ to enable more patients to reach European and US LDL-C target levels, two other presentations demonstrated that more Western hypercholesterolaemic patients achieved Japanese Atherosclerosis Society (JAS) LDL-C targets when treated with ‘Crestor’ than with the atorvastatin, pravastatin or simvastatin.

“The extensive range of data highlighting ‘Crestor’s’ efficacy in producing greater reductions in LDL-C levels and bringing more patients to goal than other statins, is very impressive,” commented Professor Rodolfo Paoletti, Department of Pharmacological Sciences, University of Milan, Italy, the Principal Investigator for one of the trials. “It is particularly satisfying to see that ‘Crestor’ can lower patients’ LDL-cholesterol to reach both European, US and Japanese guidelines at a time when globally, there are still large numbers of patients, on current cholesterol-lowering therapy, not reaching guideline targets.”

Three further presentations highlighted the suitability of ‘Crestor’ for a range of different patient populations – namely, Japanese hypercholesterolaemic patients, post-menopausal women and patients with homozygous familial hypercholesterolaemia.

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.

About AstraZeneca

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 / insulin resistance (AZ 242).