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.

Research design and 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.

Trial registration: ClinicalTrials.gov NCT00157482.