Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome

We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.

Inclusion Criteria:

• Patients aged between 18 and 75

• Patients with LDL ≥ 100mg/dL

• Patients with metabolic syndrome

  1. IFG: Fasting glucose ≥ 100mg/dL

  2. Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm

  3. 1 or more of the following

     1. Triglyceride ≥ 150mg/dL
     2. HDL-C: men < 40mg/dL, women < 50mg/dL
     3. Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment

Exclusion Criteria:

• uncontrolled hypertension (DBP ≥ 95mmHg)
• taking diabetic drugs or with HbA1c > 8%
• LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
• coronary heart disease or other diseases caused by artherosclerosis
• malignancy within 6 months
• Serum creatinine ≥ 2.0mg/dL
• ALT or AST ≥ ULN*2.5
• CPK ≥ ULN*2
• hypothyroidism