Inflammation
Conditions
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.
Interventions
DRUGAtorvastatin
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Sponsors
American Heart Association
American College of Clinical Pharmacy
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin 80mg of atorvastatin given once daily for 16 weeks | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 27 |
Baseline characteristics
| Characteristic | Atorvastatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Age Continuous | 31.6 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
Mean Change in Level: Week 16-baseline in Ena-78
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
Time frame: 16 weeks after baseline
Population: Power calculation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin 80 MG/Day | Mean Change in Level: Week 16-baseline in Ena-78 | -111.2 pg/ml | Standard Deviation 690.5 |
Comparison: The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.p-value: 0.1595% CI: [-264, 42]t-test, 2 sided