Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL

Exclusion Criteria

• •All the following criteria must be answered "No":
• •1. Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;
• •2. Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;
• •3. Patient has untreated or unsuccessfully treated psychiatric disease;
• •4. Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;
• •5. Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
• •6. Patient has a history of any of the following:
• •* active gallbladder disease within the preceding 12 months (cholecystectomy is allowed);
• •* pancreatitis;
• •* liver disease (e.g., hepatitis B and/or C);
• •* persistent uncontrolled or untreated severe hypertension;
• •* Type I or Type II diabetes;
• •* persistent uncontrolled or untreated hypothyroidism;
• •* arterial bleeding;
• •* unstable angina;
• •* myocardial infarction, coronary artery bypass graft surgery, or angioplasty within the preceding 6 months;
• •* stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within the preceding 6 months;
• •* congestive heart failure NYHA class III or IV;
• •* active cancer within the last 5 years or a diagnosis of cancer within the last 5 years (excluding basal cell carcinoma);
• •* fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain or weakness, and/or discontinuation of a statin because of myalgia; and/or
• •* life expectancy \< 2 years.
• •7. Patient has any of the following abnormalities at any of the Screening or Qualification Visits:
• •* CPK elevation \> 3xULN;
• •* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.3xULN;
• •* serum creatinine ≥ 1.5 mg/dL;
• •* creatinine clearance \< 30 mL/min, as calculated using the Cockroft and Gault formula by the central laboratory;
• •* active gout symptoms and/or uric acid level \> 1.3xULN;
• •* and/or active peptic ulcer disease;
• •8. Patient is planning to undergo major surgery within the next 6 months;
• •9. Patient has any health condition or laboratory abnormality that, in the opinion of the Principal Investigator, may be adversely affected by the procedures or medications in this study.