Eligible subjects were men and women, aged from 18 to 75 years, with a body mass index (BMI) ranging from 25 to 40 kg/m2 and pre-diabetes (impaired glucose tolerance or impaired fasting glucose). Entry criteria required triglyceride levels ≤ 350 mg/dl and LDL cholesterol ≤ 200 mg/dl, stable blood pressure and no evidence of cardiovascular, hepatic or renal diseases. Subjects were not taking anti-inflammatory agents or others interfering with lipid or glucose metabolism. Eligible participants were recruited from June 2005 to May 2006. Two-hundred-ninety subjects with weight excess, with or without family history of diabetes, were screened for the interventional protocol and 50 with impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) were randomly assigned to 2 groups that would receive ezetimibe 10 mg/d (n = 25) or simvastatin 20 mg/d (n = 25), preceded by a 2-week run-in period. Monotherapies were maintained for 12 weeks; thereafter the drugs were combined in each group for an additional 12-week period. All participants received individual counseling for a healthy lifestyle and had monthly visits. Treatment was to be discontinued prematurely if transaminases exceeded 3 times the upper limit of reference or creatine phosphokinase (CPK) 10 times, but no subject met these criteria. One of the ezetimibe group dropped out due to non-compliance.