Fluvastatin/fenofibrate vs. simvastatin/ezetimibe in patients with metabolic syndrome: different effects on LDL-profiles.
BACKGROUND
Patients with metabolic syndrome (MS) and type 2 diabetes (T2DM) show increased risk for coronary artery disease. Lipoprotein metabolism is characterized by elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C) and predominance of atherogenic small, dense low-density lipoprotein (sdLDL), while low-density lipoprotein (LDL) cholesterol is only slightly elevated.


METHODS
Multicentre, randomized, open-label cross-over study investigating the effect of combination of fluvastatin/fenofibrate (80/200 mg) (F&F) on LDL-subfractions compared with combination of simvastatin/ezetimibe (20/10 mg) (S&E) in patients with MS/T2DM.


RESULTS
Seventy-five patients were randomized, 69 completed the study and LDL-subfractions of 56 patients were analysed. Thirty-eight out of 56 patients (68%) showed a profile dominated by sdLDL. In these, TG and total cholesterol (TC) were elevated compared with non-sdLDL patients. In all patients, reduction of TC and LDL cholesterol (LDL-C) by S&E was stronger than by F&F. The increase of HDL-C was stronger with S&E in the non-sdLDL group, whereas in the sdLDL group, there was no difference between treatments. In non-sdLDL patients, there was no effect on TG or LDL-radius. However, in the sdLDL group, F&F was more effective in reducing TG and increased LDL radius, whereas S&E reduced LDL radius even further.


CONCLUSIONS
S&E is more efficient in reducing TC and LDL-C. This is also true for HDL-C increase in non-sdLDL patients. However, in patients with sdLDL, F&F was more efficient in reducing TG and increasing LDL radius.
Winkler
K
K
University Medical Center Freiburg, Freiburg, Germany. karl.winkler@uniklinik-freiburg.de
Schewe
T
T
Pütz
G
G
Odünc
N
N
Schäfer
G
G
Siegel
E
E
Geisen
U
U
Abletshauser
C
C
Hoffmann
M M
MM
D000924:Anticholesteremic Agents / Q000008:administration & dosage; D001384:Azetidines / Q000008:administration & dosage; D008078:Cholesterol, LDL / Q000187:drug effects*; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000517:prevention & control; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage; D000077340:Fluvastatin; D006801:Humans; D007211:Indoles / Q000008:administration & dosage; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D019821:Simvastatin / Q000008:administration & dosage; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D000077340:Fluvastatin; D019821:Simvastatin; D000069438:Ezetimibe; D011345:Fenofibrate