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DVR8410.1177/1479164111418136Averna et al.Diabetes and Vascular Disease Research
Original Article
Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome
Diabetes & Vascular Disease Research 8(4) 262–270 © Merck Sharp & Dohme Corp., USA 2011 Reprints and permission: sagepub. co.uk/journalsPermissions.nav DOI: 10.1177/1479164111418136 dvr.sagepub.com
Maurizio Averna1, Luc Missault2, Helena Vaverkova3, Michel Farnier4, Margus Viigimaa5, Qian Dong6, Arvind Shah6, Amy O Johnson-Levonas6, William Taggart6 and Philippe Brudi6
Abstract Metabolic syndrome (MetS) is a clustering of atherosclerotic coronary heart disease risk factors. This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg in a cohort of 618 high-risk hypercholesterolaemic patients with (n=368) and without (n=217) MetS who had previously been on statin monotherapy. Patients were randomised 1:1 to double-blind ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg for 6 weeks. Least squares mean percent change from baseline and 95% confidence intervals in lipid efficacy parameters were calculated for the population and within subgroups. Treatment with ezetimibe/simvastatin was significantly more effective than rosuvastatin at lowering low-density lipoprotein cholesterol, total cholesterol, non- high-density lipoprotein cholesterol, and apolipoprotein B (all p40% of adults over 60 years of age in the United States had the MetS.1 An updated NHANES 1999–2000 analysis demonstrated that there was a continued increase, up to 27%, in the age-adjusted prevalence of MetS.2 Components of the MetS include abdominal obesity, atherogenic dyslipidaemia, hypertension, insulin resistance, prothrombotic state, and proinflammatory state. Although it has not been possible thus far to determine how each of these factors individually contributes to coronary heart disease (CHD), together they accentuate the risk in the presence of reduced levels of high-density lipoprotein cholesterol (HDL-C).3
Expert organisations, such as the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III, have developed guidelines that recommend reducing elevated levels of low-density lipoprotein cholesterol (LDL-C) as the primary therapeutic target for reducing the 1Dipartimento
di Medicina Clinica e Patologie Emergenti, Policlinico Paolo Giaccone, Università di Palermo, Palermo, Italy 2St Jan Hospital, Department of Cardiology, Bruges, Belgium 33rd Department of Internal Medicine, Medical Faculty, University Hospital Olomouc, Olomouc, Czech Republic 4Point Medical, Dijon, France 5Tallinn University of Technology, North-Estonia Regional Hospital, Tallinn, Estonia 6Merck, Whitehouse Station, New Jersey, USA Corresponding author: Maurizio Averna, Professor of Internal Medicine, Department of Clinical Medicine and Emerging Diseases, University of Palermo-Medical School, Via del Vespro 141, 90127-Palermo, Italy. Email:
[email protected]
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Averna et al. risk of CHD in patients with the MetS.4,5 These guidelines also recommended management of the MetS by reversing obesity and increasing physical activity.5 Ezetimibe, an inhibitor of intestinal cholesterol absorption, significantly lowers LDL-C, modestly decreases triglycerides (TG), and raises HDL-C levels.6 When combined with simvastatin, the two drugs provide complementary improvements in the atherogenic lipid profile of patients with hyperlipidaemia.7,8 Rosuvastatin represents the most potent statin currently available in terms of both the lower statin dosage and LDL-C lowering. Many studies have evaluated the effects of lipid-altering drugs in patients with the MetS.9-16 However, it is unclear whether MetS status is a better predictor of atherosclerotic CHD risk than an assessment of its individual components. Given the lack of clarity of whether the dyslipidaemia in patients with the MetS truly represents a distinctly different clinical entity than the dyslipidaemia in patients without MetS, it is clinically relevant to know how hyperlipidaemic patients respond to lipid-altering therapies, with or without meeting the criteria for the diagnosis of MetS. This post-hoc analysis was undertaken to examine the effects of ezetimibe/simvastatin compared with rosuvastatin in dyslipidaemic patients with and without the MetS. Patients in the study had been on previous statin monotherapy, but had not achieved the target LDL-C levels prescribed in the NCEP ATP III guidelines.5 The differences between the two treatments for their various lipid-altering effects were evaluated. Also evaluated were the odds ratio of high-risk patients achieving LDL-C levels of
