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6 May 2002
CRESTOR™ DATA AT WORLD CONGRESS OF CARDIOLOGY REINFORCE STRONG PRODUCT PROFILE

Data were presented from two comparative studies involving a total of nearly 1,000 patients with hypercholesterolaemia. In both studies, changes in LDL-C levels (a major risk-factor for the development of CHD) and achievement of ATP-III LDL-C goals were assessed after a 12-week treatment period in patients receiving ‘Crestor’ 5 or 10mg compared with patients receiving pravastatin 20mg or simvastatin 20mg. The two studies were planned to enable the data to be analysed together.

In these studies, ‘Crestor’ produced significantly greater reductions in LDL-C, compared with pravastatin and simvastatin. For those patients who started on ‘Crestor’ 10mg, the average reduction in LDL-C was 48 per cent, compared with only 27 per cent on pravastatin and 36 per cent on simvastatin (p< 0.001).

The data presented today also show that 86 per cent of all patients (including high-risk patients with clinically evident coronary heart disease, peripheral vascular disease or diabetes) who received ‘Crestor’ 10mg achieved LDL-C goal, according to the ATP-III guidelines, compared with 49 per cent of patients on pravastatin 20mg and 64 per cent of patients on simvastatin 20mg.

In announcing the results of the trials, Professor Philip Barter, Royal Adelaide Hospital, Australia said, “The critical challenge for clinicians throughout the world is to get their patients to their LDL-C goals. With currently available therapies, there are still many patients who are unable to achieve the recommended goals. New agents like ‘Crestor’ give us the opportunity to take on that challenge. There is no doubt that this new statin will enable us to get more patients to cholesterol goals that we ever could before.”

In addition to LDL-C lowering and numbers of patients reaching target LDL-C goals, these data also show that ‘Crestor’ 10mg increases HDL-C (which protects against the development of CHD) more than pravastatin 20mg or simvastatin 20mg (9 per cent increase on ‘Crestor’ 10mg, versus only 6 per cent with pravastatin 20mg or simvastatin 20mg, p<0.05).

Further data presented today compare the efficacy of ‘Crestor’ with atorvastatin, pravastatin and simvastatin in helping patients achieve LDL-C goals over a 52-week period, with upward dose-titration if required. The results show that more patients treated with ‘Crestor’ are able to achieve ATP II LDL-C goals at their starting dose than patients treated with atorvastatin, pravastatin and simvastatin and that fewer upward dose-titration steps are required from 10mg ‘Crestor’ for a similar proportion of patients to reach goals than from 10mg atorvastatin.

These data also confirm the results of the phase II dose ranging programme, in which ‘Crestor’ demonstrated dose-dependent reductions in LDL-C of up to 65 per cent.

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.

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 new highly effective treatment for dyslipidaemia, the first oral direct thrombin inhibitor, Exanta®, and a novel treatment for type 2 diabetes / insulin resistance (AZ 242).

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Note to News Editors:

  • In May 2001, the NCEP guidelines, which provide guidance to prescribers in their treatment of people with cholesterol disorders and cardiovascular disease, were revised. The guidelines have become more inclusive by expanding the definitions for those considered to be at high risk for heart disease (by assessing LDL-C levels, presence or absence of CHD, other forms of atherosclerotic disease and/or other major risk factors) and those who would benefit from statin therapy. The guidelines also focus on other risk factors for CHD including high triglyceride levels, low HDL-C (another risk factor for the development of CHD) levels and poor nutrition.

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