Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Atorvastatin; Atorvastatin Calcium; Pravastatin

Criteria

Inclusion Criteria:

• Males or females without child bearing potential aged 21-80 years

• Fasting low-density lipoprotein (LDL) level > 120mg/dL.

• Either known to be diabetic or have at least 3 components of metabolic syndrome that are defined below:

• Hypertension defined as blood pressure (BP) > 140 systolic or > 90 mmHg diastolic, or stable medical therapy for documented hypertension;

• Fasting glucose > 110 mg/dL;

• Waist > 40 inches in males, and > 35 inches in females;

• Triglycerides > 150mg/dL; or

• High-density lipoprotein (HDL) cholesterol < 40 mg/dL in males and < 50 mg/dL in females.

• Able to provide written informed consent

• Non-smoker

Exclusion Criteria:

• On any oral antioxidants or lipid lowering medications in the previous 8 weeks

• Age < 21 or > 80 years

• Premenopausal females with potential for pregnancy

• LDL cholesterol level < 120 mg/dl

• Initiation or change in dose of any concomitant medical therapy within 2 months before the study

• Uncontrolled hypertension with BP > 180 mmHg systolic and > 120 mmHg diastolic

• Current smoker

• Previous intolerance or allergy to statins

• Acute infection in previous 4 weeks

• History of substance abuse

• Uninterpretable Brachial Artery Reactivity Study

• Current neoplasm

• Chronic renal failure (creatinine > 2.5 mg/dL) or liver failure (liver enzymes > 2X normal)

• Acute coronary syndrome, heart failure, cerebrovascular accident (CVA), or coronary intervention within 3 months

• Known aortic stenosis, hypertrophic cardiomyopathy, or symptomatic heart failure.

• Inability to give informed consent

• Inability to return to Emory for follow-up