Atherosclerosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
DRUGsimvastatin
Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
DRUGatorvastatin
20 mg atorvastatin once daily for 12 weeks. Tablets
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment. | after 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg will lower LDL-C more than doubling the statin dose as demonstrated by the percentage change from treated baseline in total and LDL-cholesterol after 12 weeks of treatment. | after 12 weeks of treatment |
Outcome results
None listed