Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

University of Florida

Status and phase: Completed; Phase 4

Conditions: Inflammation

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00361283

0435278B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

atorvastatin

Other group

Description:

80mg of atorvastatin given once daily for 16 weeks

Treatment:

Drug: Atorvastatin