This study was designed to assess whether co-administration of ezetimibe 10 mg with
atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with
atorvastatin 10 mg alone for reducing LDL-concentrations.
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Inclusion Criteria:
- Male and non-pregnant female subjects, who demonstrated willingness to participate
and comply with procedures by signing informed consent, and who were >=18 years and
<=75 years of age, were eligible to participate if they had: a baseline LDL-C
concentration >=3. 3 mmol/L (130 mg/dL) to <=4. 9 mmol/L (190 mg/dL); a baseline
triglyceride concentration of <3. 99 mmol/L (350 mg/dL); a documented history of
coronary heart disease (CHD); a stable weight history for 4 weeks prior to baseline;
completion of the designated washout periods for all prohibited medications; and did
not fulfill any of the exclusion criteria for the study.
Exclusion Criteria:
- Body Mass Index of >=30 kg/m^2 at baseline (increased to 35 kg/m^2 in protocol
amendment 1
- Liver transaminase (ALT, AST) >1. 5 times the upper limit of normal and with no active
liver disease at baseline
- Evidence of current myopathy (excluding subjects with CK >1. 5 times above the upper
limit of normal at baseline
- Clinical lab tests (CBC, blood chemistries, urinalysis) results outside the normal
range or unacceptable to the investigator at baseline
- Type II diabetes mellitus that was poorly controlled (HbA1c>9%), newly diagnosed, or
changed their anti-diabetic therapy within 3 months of baseline
- Type I diabetes mellitus and not on a stable insulin regimen for 3 months prior to
baseline or who had a recent history of repeated hypoglycaemia or unstable glycaemic
control
- Known hypersensitivity to HMG-CoA reductase inhibitors
- Alcohol consumption >14 units (women)/21 units (men) (unit = 0. 5 pint of beer or
wine, or single measure of spirits)
- Pregnancy, lactation, or any condition or situation which, in the opinion of the
investigator, posed a risk to the subject or interfered with participation in this
study.
- Any of the following medical conditions: HIV positive; congestive heart failure
defined by NYHA as Class III or IV; uncontrolled cardiac arrhythmia; MI, acute
coronary insufficiency, CABG, or angioplasty within 3 months of baseline; unstable or
severe peripheral artery disease within 3 months of baseline; newly diagnosed or
unstable angina pectoris at baseline; uncontrolled hypertension with systolic blood
pressure >100 mm Hg at baseline; uncontrolled endocrine or metabolic disease known to
influence serum lipids or lipoproteins; impaired renal function or nephritic syndrome
at baseline; disorders of the hematological, gastrointestinal, or central nervous
systems; diseases other than hyperlipidaemia or coronary heart disease that would
have interfered with study evaluations; and cancer.
- Drug abuse or emotional or intellectual problems;
- Use of certain drugs, food, or other agents known to alter cholesterol levels or to
cause pharmacokinetic interactions with either ezetimibe or atorvastatin