Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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atorvastatin

80mg of atorvastatin given once daily for 16 weeks

Group Type OTHER

Atorvastatin

Intervention Type DRUG

atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

Interventions

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Atorvastatin

atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes