TABLE 1.

Exclusion criteria

All Subjects Included in the Study Did Not Meet Any of the Following Exclusion Criteria:
Women
Non-Caucasian
Excessive obesity defined as BMI above 35 kg/m2, rounded to the nearest whole number
LDL-C >190 mg/dl at screening
Fasting TGs >400 mg/dl at screening
Diabetes mellitus, defined as a fasting glucose >7 mM, or taking diabetic therapy at screening
History of symptomatic cardiovascular disease including angina pectoris, acute myocardial infarction, or peripheral arterial disease including intermittent claudication
History of symptomatic cerebrovascular disease, including cerebrovascular hemorrhage, transient ischemic attack, or carotid endarterectomy
A current smoker or have smoked in the preceding 12 months
Consume >10 g of alcohol (equivalent to one 100 ml glass of table wine) per day
Have received statins, fibric acid derivatives, bile acid sequestrants, cholesterol absorption inhibitors (including ezetimibe), or nicotinic acid >500 mg per day in the previous year
Have uncontrolled hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg). Patients may have their hypertension controlled with a calcium channel blocker but must not receive treatment with a diuretic, beta-blocker, angiotensin converting enzyme inhibitor, or angiotensin II receptor blocker . If the patient has previously received treatment with these therapies, they must have been discontinued at least 2 months previously.
Any conditions that cause secondary dyslipidemia or increase the risk of statin therapy including alcoholism, autoimmune disease, nephrotic syndrome, uremia, any viral hepatitis clinically active within 12 months before study entry, obstructive hepatic or biliary disease, dysglobulinemia or macroglobulinemia, multiple myeloma, glycogen storage disease, porphyria, and uncontrolled hypothyroidism or hyperthyroidism. Controlled thyroid disease [normal serum thyroid stimulating hormone and stable therapy for at least 3 months] is permitted.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase
Liver injury as indicated by serum transaminase levels (alanine aminotransferase/serum glutamic pyruvic transaminase, aspartate aminotransaminase/serum glutamic oxaloacetic transaminase) >3 × upper limit of the reference range (ULRR).
Impaired renal function as indicated by serum creatinine levels >1.5 × ULRR at screening or estimated glomerular filtration rate (eGFR) by Cockroft formula <60 ml/min.
History of any muscle disease or unexplained elevation (>3 × ULRR) of serum creatine kinase
Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of the study drug, including the following: history of major gastrointestinal tract surgery (e.g., gastrectomy, gastroenterostomy or small bowel resection), gastritis or inflammatory bowel disease, current active ulcers, or gastrointestinal or rectal bleeding
Current obstruction of the urinary tract or difficulty in voiding likely to require intervention during the course of the study
Severe acute illness or severe trauma in the preceding 3 months
Evidence of symptomatic heart failure (New York Heart Association class III or IV): significant heart block or cardiac arrhythmia
History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats/min at rest. Patients whose electrophysiological instability is controlled with a pacemaker or implantable cardiac device are eligible.
History of drug abuse
History of allergy or intolerance to medication (including statins)
Current or recent (within 1 week) use of supplements or medications known to alter lipid metabolism including soluble fiber (including >2 teaspoons Metamucil or psyllium-containing supplement per day) or other dietary fiber supplements, fish oils containing omega-3 oils, “fat blockers” (e.g., orlistat), or other products at the discretion of the investigator
Any forbidden concomitant medication
Within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health
Participation in any clinical trial with an investigational drug in the past 3 months preceding study entry
Forfeit their freedom by administrative or legal award or who are under guardianship