title: Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial.
abstract: OBJECTIVE
  This secondary analysis from the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial examines the effects of lowering low-density lipoprotein cholesterol (LDL-C) with statins alone versus statins plus ezetimibe on common carotid artery intima-media thickness (CIMT) in patients with type 2 diabetes and no prior cardiovascular event.
  
  
  BACKGROUND
  It is unknown whether the addition of ezetimibe to statin therapy affects subclinical atherosclerosis.
  
  
  METHODS
  Within an aggressive group (target LDL-C <or=70 mg/dl; non-high-density lipoprotein cholesterol <or=100 mg/dl; systolic blood pressure <or=115 mm Hg), change in CIMT over 36 months was compared in diabetic individuals >40 years of age receiving statins plus ezetimibe versus statins alone. The CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups (target LDL-C <or=100 mg/dl; non-high-density lipoprotein cholesterol <or=130 mg/dl; systolic blood pressure <or=130 mm Hg).
  
  
  RESULTS
  Mean (95% confidence intervals) LDL-C was reduced by 31 (23 to 37) mg/dl and 32 (27 to 38) mg/dl in the aggressive group receiving statins plus ezetimibe and statins alone, respectively, compared with changes of 1 (-3 to 6) mg/dl in the standard group (p < 0.0001) versus both aggressive subgroups. Within the aggressive group, mean CIMT at 36 months regressed from baseline similarly in the ezetimibe (-0.025 [-0.05 to 0.003] mm) and nonezetimibe subgroups (-0.012 [-0.03 to 0.008] mm) but progressed in the standard treatment arm (0.039 [0.02 to 0.06] mm), intergroup p < 0.0001.
  
  
  CONCLUSIONS
  Reducing LDL-C to aggressive targets resulted in similar regression of CIMT in patients who attained equivalent LDL-C reductions from a statin alone or statin plus ezetimibe. Common carotid artery IMT increased in those achieving standard targets. (Stop Atherosclerosis in Native Diabetics Study [SANDS]; NCT00047424).
authors.affiliation: National Heart, Lung, and Blood Institute, Bethesda, Maryland.
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Fleg
authors.forename: Mihriye
authors.initials: M
authors.lastname: Mete
authors.forename: Barbara V
authors.initials: BV
authors.lastname: Howard
authors.forename: Jason G
authors.initials: JG
authors.lastname: Umans
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Roman
authors.forename: Robert E
authors.initials: RE
authors.lastname: Ratner
authors.forename: Angela
authors.initials: A
authors.lastname: Silverman
authors.forename: James M
authors.initials: JM
authors.lastname: Galloway
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Henderson
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Weir
authors.forename: Charlton
authors.initials: C
authors.lastname: Wilson
authors.forename: Mario
authors.initials: M
authors.lastname: Stylianou
authors.forename: Wm James
authors.initials: WJ
authors.lastname: Howard
mesh_terms: D000924:Anticholesteremic Agents / Q000627:therapeutic use; D001384:Azetidines / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002340:Carotid Artery Diseases / Q000188:drug therapy* / Q000473:pathology; D017536:Carotid Artery, Common / Q000187:drug effects* / Q000473:pathology; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects; D048909:Diabetes Complications / Q000188:drug therapy* / Q000473:pathology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000473:pathology; D018450:Disease Progression; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D017539:Tunica Intima / Q000187:drug effects; D017540:Tunica Media / Q000187:drug effects
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D015415:Biomarkers; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069438:Ezetimibe