Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease

Completed

Phase N/A Results N/A

Eligibility Criteria

- INCLUSION CRITERIA:
- Age 21 or older
- Not taking a statin or other lipid-lowering drug and no history of statin use
- Two or more risk factors as listed below:
- Age (men greater than or equal to 45 years, women greater than or equal to 55 years)
- Hypertension (BP greater than or equal to 140/90 or on antihypertensive medication)
- Cigarette smoking
- Coronary heart disease equivalents (includes diabetes mellitus, abdominal aortic aneurysm, peripheral vascular disease, carotid artery disease)
- Prior stroke or transient ischemic attack
- Family history of premature coronary heart disease (CHD): CHD in male first degree relative less than 55 years or CHD in female first degree relative less than 65 years
- Total cholesterol greater than or equal to 240mg/dL and/or LDL cholesterol greater than or equal to 160 mg/dL
- Low HDL cholesterol (less than 40 mg/dL)
Note: A high HDL cholesterol (greater than 60 mg/dL) counts as a negative risk factor: its presence removes one risk factor from the total counts.
EXCLUSION CRITERIA
- Current or past history of statin use
- Assessed need for immediate statin treatment by subject's primary care physician
- Current use of an investigational drug as part of another research protocol
- Chronic or active liver disease
- Chronic or active muscle disease
- Alcohol abuse
- Prior myocardial infarct
- Heart failure
- Uncontrolled arrhythmias
- Any clinically important hematological or biochemical abnormality on routine screening
- Recent history of cancer
- Pregnant women or breast-feeding women
- Concomitant use of the following medications, including drugs that strongly inhibit CYP3A54: nicotinic acid, gemfibrozil, clofibrate, fenofibrate, verapamil, mibefradil, cyclcosporin, nefazodone, fluoxetine, paroxetine, ketoconazole, itraconazole, cimetadine, clarithromycin, erythromycin, protease inhibitors, NSAIDs, celebrex