News Release

Outstanding efficacy of Crestor (TM) in treating range of patient populations at risk of CVD

Peer-Reviewed Publication

Shire Health International

London, UK, 25 October 2004. New data presented today from several studies involving more than 5,000 patients provide further evidence of the outstanding efficacy of CRESTORTM (rosuvastatin) in treating key cardiovascular disease (CVD) risk factors in patients with dyslipidaemia and either atherosclerosis, coronary artery disease, type 2 diabetes or the metabolic syndrome.1-5

Results from five studies (DISCOVERY, COMETS, MERCURY I, URANUS, RADAR) presented at the XV International Symposium on Drugs Affecting Lipid Metabolism (DALM) demonstrate that CRESTOR is superior to atorvastatin in improving lipid profiles associated with an increased cardiovascular risk in a number of patient populations with dyslipidaemia.1-5 Results from MERCURY I and DISCOVERY also show that CRESTOR, at the usual start dose of 10mg, enables more patients achieve their US NCEP ATP III and European LDL-C goals, respectively, compared to atorvastatin 10mg, thereby avoiding the need to titrate to higher doses.1,3

In current clinical practice, LDL-C is the most widely recognised target for lowering patients' cardiovascular risk.6,7 Guideline cholesterol goals are an important tool to assist physicians in the management of cardiovascular disease worldwide. Recently revised evidence-based guidelines set a series of targets for LDL-C reduction, which vary according to the overall risk category of the patient; the higher the patient's risk of cardiovascular events, such as heart attack or stroke, the lower the LDL-C goal.7 However, many patients are not achieving their recommended LDL-C treatment guideline goals, suggesting that more intensive management with effective statin therapy is required.8,9 Results from one study of the global DISCOVERY Programme*, involving 911 'high risk' patients with hypercholesterolaemia, demonstrate that more patients achieve the European LDL-C guideline goal of <3mmol/L (115mg/dL) with CRESTOR 10mg compared to atorvastatin 10mg (83% vs. 68%, respectively; p<0.001) and at least seven out of 10 patients treated with CRESTOR 10mg achieve the more challenging goal of <2.5 mmol/L (100mg/dL), compared to five out of 10 with atorvastatin 10mg (73 vs. 53%, respectively; p<0.001).1

Professor Philip Barter, The Heart Research Institute, Sydney, Australia, and lead author of the MERCURY I sub-study, commented, "These data further establish CRESTOR as consistently effective across the spectrum of patients at risk of CVD. Physicians can be confident that, with CRESTOR, they have an improved treatment option for 'at risk' patients at the starting dose of 10mg and a product with a tolerability profile similar to other statins."

Further data presented at DALM, demonstrate that CRESTOR is also effective in a range of patient populations at improving other CVD risk factors, including apolipoproteins,2-4 which are recognised by physicians as powerful predictors of coronary heart disease (CHD).10 Raised levels of apolipoprotein A-I (Apo A-I) are linked to an increase in HDL-cholesterol levels (HDL-C or 'good' cholesterol) and expert opinion believes total apolipoprotein B (Apo B) to be a better predictor of relative risk for CHD than LDL-C, therefore providing a further logical therapeutic target in the fight against heart disease.10

Results from COMETS, a study of 397 patients with dyslipidaemia and the metabolic syndrome, demonstrate that:

  • At six weeks, CRESTOR 10mg is significantly more effective than atorvastatin 10mg in lowering Apo B levels (-34 vs. -31%, respectively; p<0.05), raising Apo A-I levels (5.9 vs.1.2%, respectively; p<0.001) and improving the Apo B:Apo A-I ratio (-37 vs. -31%, respectively; p<0.001)2
  • At 12 weeks, CRESTOR 20mg is also significantly more effective than atorvastatin 20mg in lowering Apo B levels (-41 vs. -36%, respectively; p<0.01), raising Apo A-I levels (6.2 vs. 3.2, respectively; p<0.05) and improving the Apo B:Apo A-I ratio (-44 vs. –38%, respectively; p<0.001).2

    These findings are also supported by results from MERCURY I (involving 3,140 patients with dyslipidaemia and atherosclerosis, coronary artery disease or type 2 diabetes)3 and URANUS (involving 469 patients with dyslipidaemia and type 2 diabetes),4 providing further evidence that CRESTOR is effective in improving the apolipoprotein profile in a range of 'at risk' patient groups.

    CRESTOR has now received regulatory approvals in 65 countries across five continents and has been launched in over 50 countries worldwide, including 13 European markets, the US and Canada. Over 3 million patients have been prescribed CRESTOR and more than 10 million prescriptions have been written worldwide. The post-marketing experience supports the favourable benefit:risk profile of CRESTOR and confirms that the safety profile is similar to other currently marketed statins. CRESTOR 10mg is the usual recommended start dose for patients new to statin treatment and also for those switching to CRESTOR from other statins regardless of prior dose.

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    AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

    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 CRESTORTM , the first oral direct thrombin inhibitor EXANTATM , ATACANDTM , ZESTRILTM , TENORMINTM , SELOKEN ZOK /TOPROL-XLTM and PLENDILTM . This heritage is complemented by an innovative pipeline including a novel treatment for type 2 diabetes / metabolic syndrome, GALIDATM .


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