Official Title
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Phase
Phase 4Lead Sponsor
University of FloridaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
InflammationIntervention/Treatment
atorvastatin ...Study Participants
108The 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.
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.
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Inclusion Criteria: 18+ years old Normocholesterolemic Exclusion Criteria: Cardiovascular disease or risk equivalents Malignancy Active alcohol abuse Contraindications to statins Interacting drugs Chronic anti-inflammatory drugs
| Event Type | Organ System | Event Term | Atorvastatin |
|---|
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
