Differential effects of fluvastatin alone or in combination with ezetimibe on lipoprotein subfractions in patients at high risk of coronary events

• Published in: European journal of clinical investigation Vol. 40; no. 3; pp. 187 - 194
• Main Authors: Stojakovic, T., De Campo, A., Scharnagl, H., Sourij, H., Schmölzer, I., Wascher, T. C., März, W.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-03-2010; Wiley-Blackwell
• Subjects: Aged; Anticholesteremic Agents - therapeutic use; Apolipoproteins B - blood; Atherogenic lipoprotein phenotype; Atherosclerosis (general aspects, experimental research); Azetidines - therapeutic use; Biological and medical sciences; Biomarkers - blood; Blood and lymphatic vessels; Cardiology. Vascular system; Cholesterol - blood; Coronary Disease - blood; Coronary Disease - drug therapy; Coronary heart disease; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Drug Therapy, Combination; Ezetimibe; Fatty Acids, Monounsaturated - therapeutic use; Female; fluvastatin; General aspects; Heart; Humans; Indoles - therapeutic use; lipopoprotein subfractions; Lipoproteins - blood; Lipoproteins, LDL - blood; Male; Medical sciences; Middle Aged; Prospective Studies; type 2 diabetes; Endocrinopathy; Type 2 diabetes; High risk; Ezetimibe; Cardiovascular disease; Lipoprotein; Hypocholesterolemic agent; Vascular disease; Fluvastatin; HMG-CoA reductase inhibitor; Atherosclerosis; Human; Drug combination; Enzyme; Coronary artery; Enzyme inhibitor; Metabolic diseases; Patient; Statin derivative; Coronary heart disease; Medicine; Phenotype; lipopoprotein subfractions; Hydroxymethylglutaryl-CoA reductase; Atherogenic lipoprotein phenotype; Oxidoreductases; Antilipemic agent
• ISSN: 0014-2972; 1365-2362
• DOI: 10.1111/j.1365-2362.2009.02249.x

Eur J Clin Invest 2010; 40 (3): 187–194
Background  Ezetimibe, a cholesterol‐absorption inhibitor, significantly lowers low‐density lipoprotein cholesterol (LDL‐C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. The objective of the study was to examine the effects of fluvastatin plus ezetimibe on lipoprotein subfractions in patients with type 2 diabetes and/or coronary heart disease.
Materials and methods  Ninety patients with LDL‐C between 100 and 160 mg dL−1 were enrolled in this prospective, randomized, single‐blind, single‐centre study. A total of 84 patients were treated with either fluvastatin 80 mg (n = 28) alone or in combination with ezetimibe 10 mg (n = 56) for 12 weeks to determine the effects on lipids, apolipoproteins and LDL subfractions by equilibrium density gradient ultracentrifugation. This study is registered with ClinicalTrials.gov, number NCT00814723.
Results  Total cholesterol, LDL‐C and apolipoprotein B were significantly more reduced in the combined therapy group. High density lipoproteins increased in the fluvastatin‐only group and decreased in the combined therapy group. There was a significant difference between the two groups in buoyant and intermediate, but not in dense LDL particles.
Conclusions  Addition of ezetimibe to fluvastatin resulted in a further reduction of buoyant and intermediate, but not of dense LDL compared with fluvastatin alone.