EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)

In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.

Patients with simvastatin 20 mg or atorvastatin 10 mg were randomized to (1) double statin dose (to 40 mg simvastatin or 20 mg atorvastatin) or (2) switch to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks.

• Drug: ezetimibe (+) simvastatin
  Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
  Other Names:

  • MK0653A
  • Vytorin®
  • INEGY™
• Drug: simvastatin
  Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
  Other Names:

  • MK0733
  • Zocor®
• Drug: atorvastatin
  20 mg atorvastatin once daily for 12 weeks. Tablets

• Active Comparator: 1
  Arm 1: Active comparator
  Interventions:

  • Drug: simvastatin
  • Drug: atorvastatin
• Experimental: 2
  Arm 2: Drug
  Intervention: Drug: ezetimibe (+) simvastatin

Inclusion Criteria:

• Patient is male or female 18 years of age.
• Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
• lipid values while on statin monotherapy treatment: LDL-C level of > 2.5 mmol/L to * 5.0 mmol/L, triglycerides < 4.0 mmol/L and total cholesterol < 7.0 mmol/L.
• Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.

Exclusion Criteria:

• Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
• Patients who have been treated with any other investigational drug within 3 months of Visit 1.
• Patients who are pregnant or lactating.
• Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.