Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol

The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

Inclusion Criteria:

• Subjects with an LDL-cholesterol greater than 100 mg/dL
• Patients willing and able to provide signed informed consent

Exclusion Criteria:

• Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
• Patients intolerant of statins
• Patients receiving ezetimibe
• Patients intolerant of ezetimibe
• Patients receiving a niacin preparation
• Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
• Cancer undergoing active treatment
• Creatinine clearance < 50 ml/minute
• Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
• Participation in any clinical study within the last 30 days
• Drug addition or alcohol abuse within the past 6 months
• Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
• Active use of macrolide antibiotics or verapamil
• Consumption of grapefruit juice on a daily basis
• Patients unwilling or unable to provide informed consent
• Patients with poor compliance
• Women of childbearing potential