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 CRESTOR
TM(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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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Nothing in life is to be feared. It is only to be understood.
-- Marie Curie