title: Effects of combined ezetimibe and simvastatin therapy as compared with simvastatin alone in patients with type 2 diabetes: a prospective randomized double-blind clinical trial.
abstract: OBJECTIVE
  To assess the effects of inhibited gastrointestinal cholesterol absorption in statin-treated dyslipidemic patients.
  
  
  METHODS
  In a multicenter prospective randomized double-blind placebo-controlled trial, we primarily compared by ANCOVA the effect of 2-month ezetimibe (10 mg/day) or placebo therapy on LDL cholesterol serum levels in 108 type 2 diabetic patients with albuminuria <200 microg/min and total cholesterol concentrations >135 mg/dl despite simvastatin treatment (40 mg/day).
  
  
  RESULTS
  Unlike placebo, ezetimibe decreased LDL cholesterol from 99 +/- 31 to 66 +/- 22 mg/dl, total cholesterol from 162 +/- 36 to 124 +/- 30 mg/dl, and apolipoprotein B from 83 +/- 22 to 64 +/- 18 mg/dl (P < 0.0001 for all changes versus placebo). A total of 72 and 17% of patients on ezetimibe or placebo achieved LDL levels <70 mg/dl, respectively (P < 0.0001). Treatment was well tolerated.
  
  
  CONCLUSIONS
  Adding ezetimibe to simvastatin therapy helps to improve the pro-atherogenic lipoprotein profile in type 2 diabetic patients who fail to reach recommended lipid targets with statin therapy alone.
authors.affiliation: Clinical Research Center for Rare Diseases Aldo & Cele Daccò, Mario Negri Institute for Pharmacological Research, Bergamo, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Ruggenenti
authors.forename: Dario
authors.initials: D
authors.lastname: Cattaneo
authors.forename: Stefano
authors.initials: S
authors.lastname: Rota
authors.forename: Ilian
authors.initials: I
authors.lastname: Iliev
authors.forename: Aneliya
authors.initials: A
authors.lastname: Parvanova
authors.forename: Olimpia
authors.initials: O
authors.lastname: Diadei
authors.forename: Bogdan
authors.initials: B
authors.lastname: Ene-Iordache
authors.forename: Silvia
authors.initials: S
authors.lastname: Ferrari
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Bossi
authors.forename: Roberto
authors.initials: R
authors.lastname: Trevisan
authors.forename: Antonio
authors.initials: A
authors.lastname: Belviso
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001055:Apolipoproteins B / Q000378:metabolism; D001384:Azetidines / Q000627:therapeutic use*; D002784:Cholesterol / Q000378:metabolism; D008078:Cholesterol, LDL / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods*; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D008078:Cholesterol, LDL; D002784:Cholesterol; D019821:Simvastatin; D000069438:Ezetimibe