News Release

CRESTOR® leads in 1st international prospective study of statins in the metabolic syndrome

Peer-Reviewed Publication

Shire Health International

London, United Kingdom, Monday 6 September 2004. New data from the first international prospective study of statin treatment in people with the metabolic syndrome demonstrate that CRESTORTM (rosuvastatin) achieves excellent results in lowering LDL-cholesterol (LDL-C) and raising HDL-C in this important and growing patient population.1 Today's results from the COMETS study, presented at the 40th Annual Meeting of the European Association for the Study of Diabetes (EASD), Munich, Germany, show that CRESTOR 10mg lowers LDL-C and raises HDL-C significantly more than atorvastatin 10mg in patients with the metabolic syndrome and raised LDL-C.1

People with the metabolic syndrome, which affects nearly one in five men and nearly one in four women, are nearly twice as likely to die from cardiovascular disease and their risk of heart attack and stroke is threefold.2 ,3 The term 'metabolic syndrome' describes a clustering of three or more cardiovascular risk factors, including abdominal obesity, elevated triglycerides, low HDL-C (or 'good' cholesterol), hypertension and elevated blood glucose.4 For these 'high risk' patients, lowering LDL-C levels is the primary lipid treatment target to reduce their cardiovascular risk, as highlighted in both the US National Cholesterol Education Programme's Adult Treatment Panel III (US NCEP ATP III) guidelines and the recently revised European Guidelines on Cardiovascular Disease Prevention in Clinical Practice.4-6 Sub-group analyses of long-term studies have also shown that statin treatment in people with the metabolic syndrome can reduce cardiovascular events.7,8

The COMETS study, part of the GALAXY ProgrammeTM, assessed both the effect of CRESTOR 10mg compared to atorvastatin 10mg and placebo at six weeks and, following titration, CRESTOR 20mg and atorvastatin 20mg at 12 weeks. The results in 397 patients with the metabolic syndrome (as defined by the US NCEP ATP III) and raised LDL-C show:

  • CRESTOR 10mg reduces LDL-C significantly more than atorvastatin 10mg at six weeks (-42% and -36%, respectively; p<0.001)1
  • CRESTOR 20mg reduces LDL-C significantly more than atorvastatin 20mg at 12 weeks (-49% vs -43%, respectively; p<0.001)1
  • CRESTOR 10mg significantly increases HDL-C by 9.3% at six weeks, almost double that of atorvastatin 10mg, which raised HDL-C by 4.8% (p<0.01)1 and CRESTOR 20mg increases HDL-C significantly more than atorvastatin 20mg at 12 weeks (10.5% vs 5.7%, respectively; p<0.01).1
  • CRESTOR 10mg and 20mg are as effective as atorvastatin 10mg and 20mg at lowering patients' triglyceride levels (-19% vs -20% at six weeks and -24% vs -24% at 12 weeks, respectively; n.s.).1

    Lead investigator of the COMETS study, Professor Stalenhoef of University Medical Centre Nijmegen, The Netherlands, comments, "With the number of people with the metabolic syndrome increasing, results such as these for CRESTOR are welcomed by the medical community as here we see a treatment that both lowers LDL-C (a key cardiovascular risk factor) with the added benefit of raising HDL-C."

    New data from the MERCURY I study in a subset of 547 patients with type 2 diabetes were also presented at the EASD this week showing that CRESTOR 10mg reduces LDL-C in patients with type 2 diabetes and dyslipidaemia significantly more than atorvastatin at the same dose (47% vs 37%, respectively: p<0.0001).9 In addition, CRESTOR achieves a significantly greater reduction in non-HDL-C compared to atorvastatin (-42% vs -33%, respectively: p<0.0001) and increases HDL-C. 9

    People with type 2 diabetes are three times more likely to die from a heart attack or stroke than people without diabetes with the same cholesterol level and up to 80% of people with type 2 diabetes die from cardiovascular disease.10,11 Recent large-scale study results have shown that aggressive lipid-lowering with statins can lead to a significant reduction in heart disease deaths in patients with type 2 diabetes.12 These new data presented at EASD demonstrate that CRESTOR 10mg is more effective than atorvastatin 10mg at improving the overall lipid profile associated with heart disease risk.

    Commenting on the results, Professor Schuster of Humboldt University Berlin, lead investigator of MERCURY I explains, "Aggressively reducing LDL-C in high risk patients is becoming an increasingly important treatment strategy in the prevention of heart attacks and strokes. These results show that a low dose of CRESTOR can significantly lower LDL-C levels, therefore offering patients with type 2 diabetes an important and highly effective treatment option."

    CRESTOR has now received regulatory approvals in more than 60 countries across five continents and has been launched in over 45 countries worldwide, including 13 European markets, the US and Canada. Over 2.8 million patients have been prescribed CRESTOR and more than 8 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 comparable 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.

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

    ###
    For further information please visit: www.AstraZenecaPressOffice.com or contact:

    Rachael Wood, Global PR Manager, Cardiovascular Therapy Area, AstraZeneca
    Tel: +44 (0) 1625 519514
    Mobile: +44 (0) 7980 669242
    Email: rachael.wood@astrazeneca.com
    or
    Ellie Goss, Shire Health International
    Tel: +44 (0) 20 7471 1519
    Mobile : +44 (0) 7747 803217
    Email: ellie.goss@shirehealthinternational.com

    Notes to editors:
    The CRESTOR GALAXY ProgrammeTM
    The GALAXY Programme is a large, comprehensive, long-term, and evolving global research initiative sponsored by AstraZeneca to investigate cardiovascular risk reduction and patient outcomes with CRESTOR. Please refer to the GALAXY media backgrounders for more information on the GALAXY Programme and each of the individual GALAXY Programme studies.

    The Metabolic Syndrome
    The term 'the metabolic syndrome' is used to describe a number of risk factors for cardiovascular disease that are clustered together in some people. Each risk factor alone conveys increased cardiovascular disease risk but, in combination, they enhance the patients' risk of heart attack, stroke, type 2 diabetes and death.2,3,13,14 Currently, there is no globally accepted definition of the metabolic syndrome. The World Health Organization (WHO) and the US National Cholesterol Education Programme's Adult Treatment Panel III (NCEP ATP III) have both defined the metabolic syndrome. The NCEP ATP III guidelines state that patients with three or more of the following risk factors are clinically identified as having the metabolic syndrome:4

    Risk Factor Defining Level
    Abdominal obesity§ Men§ Women Waist circumference >102cm (>40 inches) >88cm (>35 inches)
    Triglycerides >150mg/dL (170mmol/L)
    HDL-cholesterol § Men§ Women <40mg/dL (0.9mmol/L) <50mg/dL (1.3mmol/L)
    High blood pressure >130/>85mmHg
    Elevated fasting glucose ³110mg/dL (6.11mmol/L)

    Non-HDL-C
    Non-HDL-C is calculated routinely as the amount of total cholesterol minus the amount of HDL-C. Therefore, non-HDL-C is important as it refers to all the atherogenic lipoprotein fractions.15 High levels of these are an important factor in the development of atherosclerosis.

    Other AstraZeneca Diabetes News
    AstraZeneca is committed to the research and development of innovative treatments designed to decrease the risk, prevalence and impact of CVD, including type 2 diabetes. To this end, AstraZeneca is researching new treatment options for type 2 diabetes, including a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist, which is currently in Phase III development, called GALIDATM (tesaglitazar).

    For more information please refer to the media backgrounders, 'CRESTOR', 'The metabolic syndrome', 'Type 2 diabetes', 'MERCURY I study', 'GALAXY Programme' and 'GALAXY Programme studies', which can be found on: www.AstraZenecaPressOffice.com

    References:
    1. Stalenhoef AFH, et al. A COmparative study with rosuvastatin in subjects with METabolic Syndrome: results of the COMETS study. 40th Annual Meeting of the European Association for the Study of Diabetes, Munich, Germany 2004.
    2. Ford ES, et al. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. Journal of the American Medical Association 2002; 287:356-9.
    3. Isomaa B, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care 2001; 24:683-9.
    4. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001; 285:2486-2497. Also available on-line:
    http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm
    5. de Backer G et al. European guidelines on cardiovascular disease prevention in clinical practice. European Heart Journal 2003; 24:1601-10. 6. Grundy SM, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation 2004;110:227-39.
    7. Sattar N, et al. Metabolic syndrome with and without C-reactive protein as a predictor of coronary heart disease and diabetes in the West of Scotland Coronary Prevention Study. Circulation 2003;108:414-19.
    8. Pyorala K, et al. Reduction of cardiovascular events by simvastatin in nondiabetic coronary heart disease patients with and without the metabolic syndrome: subgroup analyses of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 2004;27(7):1735-40.
    9. Schuster H, et al. Effects of rosuvastatin and atorvastatin on plasma lipids in type 2 diabetes patients in the MERCURY I study. 40th Annual Meeting of the European Association for the Study of Diabetes, Munich, Germany 2004.
    10. Website of International Diabetes Federation. Facts & Figures. Did you know? 11. Kirpichnikov D, Sowers JR. Diabetes mellitus and diabetes-associated vascular disease. Trends Endocrinol Metab 2001;12:225-30.
    12. Colhoun HM, et al. The Collaborative Atorvastatin Diabetes Study (CARDS). Effectiveness of lipid lowering for the primary prevention of major cardiovascular events in diabetes. Abstract 15-1B presented at 64th session of the American Diabetes Association. June 4-8, 2004. Orlando, Florida, US
    13. Kaplan NM. The deadly quartet: upper body obesity, glucose intolerance, hypertrigylceridemia and hypertension. Archives of Internal Medicine 1989; 149:1514-20.
    14. Meigs JB. Epidemiology of the metabolic syndrome, 2002. American Journal of Managed Care 2002; 8:S283-92.
    15. Cui Y, et al. Non-high-density lipoprotein cholesterol level as a predictor of cardiovascular disease mortality. Archives of Internal Medicine 2001; 161:1413-9.


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