Methods: A randomized, double-blind, placebo-controlled clinical trial was carried out in 12 obese, dyslipidaemic patients, independently of their basal insulin sensitivity. At the beginning of the study, a metabolic profile was measured, and insulin sensitivity estimated using the euglycaemic-hyperinsulinaemic clamp technique. The volunteers were randomly assigned to receive ezetimibe (10 mg/day in the morning) or placebo for a period of 90 days. After intervention, a similar metabolic profile was measured and a second clamp study was performed.

Results: Ezetimibe administration for 90 days decreased total (6.0 ± 0.5 vs. 4.2 ± 0.9 mmol/L, p = 0.011) and low-density lipoprotein (4.0 ± 0.7 vs. 2.2 ± 0.8 mmol/L, p=0.003) cholesterol concentrations without modification of insulin sensitivity (3.0 ± 0.6 vs. 2.9 ± 0.7 mg/kg/min, p = 0.345).

Conclusions: Ezetimibe significantly decreased total cholesterol and low-density lipoprotein cholesterol concentrations without affecting insulin sensitivity in obese and dyslipidaemic patients.