This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe
10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian
population with primary hypercholesterolemia.
Inclusion Criteria:
- Subjects must have an LDL-C concentration >= 3. 3 mmol/L (130 mg/dL) to <= 4. 9 mmol/L
(190 mg/dL) using the Freidewald calculation.
- Subjects must have triglyceride concentrations of < 3. 99 mmol/L (350 mg/dL).
- Subjects must have two or more coronary heart disease risk factors listed below:
- Current cigarette smoking
- Hypertension (BP >= 140/90 mmHg or on antihypertensive medication)
- Low HDL cholesterol (< 40 mg/dL)
- Family history of premature CHD (CHD in male first degree relative < 55 years;
CHD in female first degree relative < 65 years)
- Age (Men >= 45 years; women >= 55 years)
- Subject must be currently taking atorvastatin 10 mg daily and by history has taken 80%
of daily doses for the 6 weeks prior to participating.
- Subjects must have liver transaminases (ALT, AST) < 50% above the upper limit of
normal, with no active liver disease, and CK < 50% above the upper limit of normal.
- Subjects must have maintained a cholesterol lowering diet, exercise program, and
stable weight for at least 4 weeks prior to the study and be willing to continue the
same diet and exercise program during the study.
- Women receiving hormonal therapy, including hormone replacement, any estrogen
antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose
and regimen for at least 8 weeks and be willing to continue the same regimen for the
duration of the study.
Exclusion Criteria:
- Subjects who meet any of the following criteria will be excluded:
- Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2.
- Consume > 14 alcoholic drinks per week.
- Women who are pregnant or nursing.
- Congestive heart failure defined by NYHA as Class III or IV.
- Uncontrolled cardiac arrhythmia.
- Coronary heart disease (CHD).
- Unstable or severe peripheral artery disease within 3 months of participating
- Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm
Hg or diastolic > 100 mm Hg.
- Type I or Type II diabetes mellitus.
- Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to
hypothyroidism.
- Impaired renal function (creatinine > 2. 0 mg/dL) or nephrotic syndrome.
- Known HIV positive.
- Cancer within the past 5 years (except for successfully treated basal and squamous
cell carcinomas).
- History of mental instability, drug/alcohol abuse within the past 5 years, or major
psychiatric illness not adequately controlled and stable on pharmacotherapy.
- Subjects who are on any of the following concomitant medications:
- Subjects who are on medications that are potent inhibitors of CYP3A4, including
cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or
clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of
grapefruit juice (> 1 quart/day).
- Subjects who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day)
- Subjects who are on over the counter lipid lowering agents such as fish oils, garlic
and cholestin
- Subjects who are on oral corticosteroids, unless used as replacement therapy for
pituitary/adrenal disease and the subject is on a stable regimen for at least 6
weeks.
- Subjects who are currently using psyllium, other fiber-based laxatives, and/or any
other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have
not been on a stable regimen for at least 5 weeks and who do not agree to remain on
this regimen throughout the study.
- Subject who are currently using orlistat or sibutramine.
