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.
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.
Ruggenenti
Piero
P
Clinical Research Center for Rare Diseases Aldo & Cele Daccò, Mario Negri Institute for Pharmacological Research, Bergamo, Italy.
Cattaneo
Dario
D
Rota
Stefano
S
Iliev
Ilian
I
Parvanova
Aneliya
A
Diadei
Olimpia
O
Ene-Iordache
Bogdan
B
Ferrari
Silvia
S
Bossi
Antonio C
AC
Trevisan
Roberto
R
Belviso
Antonio
A
Remuzzi
Giuseppe
G
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
D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D008078:Cholesterol, LDL; D002784:Cholesterol; D019821:Simvastatin; D000069438:Ezetimibe