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


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.
Stojakovic
T
T
Medical University of Graz, A-8036 Graz, Austria. tatjana.stojakovic@medunigraz.at
de Campo
A
A
Scharnagl
H
H
Sourij
H
H
Schmölzer
I
I
Wascher
T C
TC
März
W
W
D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001055:Apolipoproteins B / Q000097:blood; D001384:Azetidines / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002784:Cholesterol / Q000097:blood*; D003327:Coronary Disease / Q000097:blood* / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008074:Lipoproteins / Q000097:blood*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D015415:Biomarkers; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D008074:Lipoproteins; D008077:Lipoproteins, LDL; D000077340:Fluvastatin; D002784:Cholesterol; D000069438:Ezetimibe