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European Heart Journal Advance Access published online on September 5, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi482
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received May 23, 2005
Revised August 5, 2005
Accepted August 11, 2005

Clinical research

A COmparative study with rosuvastatin in subjects with METabolic Syndrome: results of the COMETS study

Anton F.H. Stalenhoef 1*, Christie M. Ballantyne 2, Cinzia Sarti 3, Jan Murin 4, Serena Tonstad 5, Helen Rose 6, and Wim Wilpshaar 6

1 Department of Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
2 Department of Medicine, Baylor College of Medicine, Houston, TX, USA
3 Department of Epidemiology and Health Promotion, National Public Health Institute, Helsinki, Finland
4 1st Internal Department, University Hospital, Bratislava, Slovakia
5 Department of Preventive Medicine, Ullevål University Hospital, Oslo, Norway
6 Clinical Science, AstraZeneca, Macclesfield, UK

* To whom correspondence should be addressed.
Anton F.H. Stalenhoef, E-mail: a.stalenhoef{at}aig.umcn.nl


  Abstract

Aims The efficacy and safety of rosuvastatin, atorvastatin, and placebo were compared in patients with the metabolic syndrome.

Methods and results Patients with the metabolic syndrome with low-density lipoprotein cholesterol (LDL-C) ≥3.36 mmol/L (130 mg/dL) and multiple risk factors conferring a 10-year coronary heart disease risk score of >10% were randomized (2:2:1) to receive rosuvastatin 10 mg, atorvastatin 10 mg, or placebo for 6 weeks. Subsequently, the rosuvastatin 10 mg and placebo groups received rosuvastatin 20 mg and the atorvastatin 10 mg group received atorvastatin 20 mg for 6 weeks. LDL-C was reduced significantly more in patients receiving rosuvastatin 10 mg when compared with those receiving atorvastatin 10 mg at 6 weeks [intention-to-treat (ITT) population by randomized treatment: 41.7 vs. 35.7%, P < 0.001; ITT population by as-allocated treatment: 42.7 vs. 36.6%, P < 0.001]. Significant LDL-C reductions were also observed in patients receiving rosuvastatin when compared with those receiving atorvastatin at 12 weeks (48.9 vs. 42.5%, P < 0.001). More patients achieved LDL-C goals with rosuvastatin when compared with atorvastatin. Rosuvastatin increased high-density lipoprotein cholesterol significantly more than atorvastatin. Treatments were well tolerated.

Conclusion At equivalent doses, rosuvastatin had a significantly greater effect than atorvastatin in lowering LDL-C and improving the lipid profile and was well tolerated in patients with the metabolic syndrome.

Keywords: Metabolic syndrome; Statins; Low-density lipoprotein cholesterol.
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