Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

• In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Triglycerides [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in TC/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Non-HDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Apo B/Apo A-I Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

• Cardiovascular Disorder
• Diabetes Mellitus

• Drug: ezetimibe (+) simvastatin
  ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
  Other Name: Vytorin
• Drug: simvastatin 40 mg or atorvastatin 20 mg
  simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
  Other Name: Lipitor, Zocor
• Drug: Rosuvastatin
  rosuvastatin 10 mg tablets, taken once daily for six weeks.
  Other Name: Crestor
• Drug: atorvastatin 10 mg or simvastatin 20 mg
  All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
  Other Name: Lipitor, Zocor

• Experimental: Ezetimibe/simvastatin
  Interventions:

  • Drug: ezetimibe (+) simvastatin
  • Drug: atorvastatin 10 mg or simvastatin 20 mg
• Active Comparator: Doubling statin dose
  Interventions:

  • Drug: simvastatin 40 mg or atorvastatin 20 mg
  • Drug: atorvastatin 10 mg or simvastatin 20 mg
• Active Comparator: Rosuvastatin
  Interventions:

  • Drug: Rosuvastatin
  • Drug: atorvastatin 10 mg or simvastatin 20 mg

Inclusion Criteria:

• Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
• Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
• Patient is willing to remain abstinent or use birth control for the duration of the study
• Patient has Diabetes Mellitus with cardiovascular disease

Exclusion Criteria:

• Patient has sensitivity to certain common statin drugs
• Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
• Patient consumes more than 2 alcoholic drinks per day
• Patient is pregnant or breast-feeding
• Patient has been treated with other investigational drugs within 30 days of first visit
• Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin
• Patient has congestive heart failure
• Patient has uncontrolled high blood pressure
• Patient has kidney disease
• Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
• Patient has diabetes mellitus that is not well controlled
• Patient is human immunodeficiency virus (HIV) positive
• Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
• Patient is currently taking therapies that would increase the risk of muscle weakness
• Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
• Patient is currently taking psyllium or other fiber-based laxatives