Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
- Registration Number
- NCT00361283
- Lead Sponsor
- University of Florida
- Brief Summary
The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.
- Detailed Description
All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 18+ years old
- Normocholesterolemic
- Cardiovascular disease or risk equivalents
- Malignancy
- Active alcohol abuse
- Contraindications to statins
- Interacting drugs
- Chronic anti-inflammatory drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description atorvastatin Atorvastatin 80mg of atorvastatin given once daily for 16 weeks
- Primary Outcome Measures
Name Time Method Mean Change in Level: Week 16-baseline in Ena-78 16 weeks after baseline We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States