Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis|
- Mean Change in Level: Week 16-baseline in Ena-78 [ Time Frame: 16 weeks after baseline ] [ Designated as safety issue: No ]We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
|Study Start Date:||June 2004|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
80mg of atorvastatin given once daily for 16 weeks
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Other Name: Lipitor
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.
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Reginald Frye, PharmD, PhD||University of Florida College of Pharmacy|