title: The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia.
abstract: OBJECTIVE
  To compare the effects of simvastatin alone versus simvastatin plus ezetimibe on small dense low-density lipoprotein cholesterol (sdLDL-C) concentration in subjects with primary hypercholesterolemia.
  
  
  METHODS
  Patients with LDL-C levels above those recommended by the National Cholesterol Education Program Adult Treatment Panel III were randomized to open-label simvastatin 40 mg (n = 50) or simvastatin/ezetimibe 10/10 mg as a fixed combination (n = 50) daily. LDL particle size (estimated by electrophoresis), sdLDL-C levels, and lipid profile were blindly assessed at baseline and 3 months.
  
  
  BACKGROUND
  clinicaltrials.gov NCT00932620.
  
  
  RESULTS
  Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg decreased total cholesterol (-31% and -36%, respectively), LDL-C (-43% and -49%, respectively), triglycerides (-17% and -19%, respectively), non-high-density lipoprotein cholesterol (non-HDL-C; -40% and -46%, respectively), large LDL-C (-40 and -44%, respectively) and sdLDL-C levels (-42% and -46%, respectively, all p < 0.000 vs baseline) and increased LDL particle size (+0.5% and +0.7%, respectively, both p < 0.05 vs baseline). The changes in total cholesterol, LDL-C and non-HDL-C were greater in the simvastatin/ezetimibe group (all p < 0.05). Changes in triglycerides, large LDL-C, sdLDL-C levels and LDL particle size were similar in the two groups. In multivariate analysis, baseline sdLDL-C and triglyceride levels, but not the choice of treatment, were significantly and independently correlated with the changes in sdLDL-C levels.
  
  
  CONCLUSIONS
  The combination of simvastatin 10 mg plus ezetimibe 10 mg is similarly effective to simvastatin 40 mg in improving sdLDL-C concentration and LDL particle size in subjects with primary hypercholesterolemia.
authors.affiliation: Department of Internal Medicine, School of Medicine, University of Ioannina, Ioannina 45110, Greece.
authors.forename: Matilda
authors.initials: M
authors.lastname: Florentin
authors.forename: Evangelos N
authors.initials: EN
authors.lastname: Liberopoulos
authors.forename: Elisavet
authors.initials: E
authors.lastname: Moutzouri
authors.forename: Christos V
authors.initials: CV
authors.lastname: Rizos
authors.forename: Alexandros D
authors.initials: AD
authors.lastname: Tselepis
authors.forename: Moses S
authors.initials: MS
authors.lastname: Elisaf
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000494:pharmacology; D001384:Azetidines / Q000008:administration & dosage* / Q000494:pharmacology; D008078:Cholesterol, LDL / Q000097:blood* / Q000737:chemistry / Q000187:drug effects*; D004338:Drug Combinations; D000069438:Ezetimibe; D005260:Female; D005500:Follow-Up Studies; D006115:Greece; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D010316:Particle Size; D019821:Simvastatin / Q000008:administration & dosage* / Q000494:pharmacology
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D004338:Drug Combinations; D019821:Simvastatin; D000069438:Ezetimibe