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 Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Drug: Atorvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: atorvastatin; 80mg of atorvastatin given once daily for 16 weeks	Drug: Atorvastatin; atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: American Heart Association; American College of Clinical Pharmacy
• Investigators: Principal Investigator: Reginald Frye, PharmD, PhD, University of Florida College of Pharmacy

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: August 4, 2006
• First Submitted That Met QC Criteria: August 4, 2006
• First Posted (Estimate): August 8, 2006

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: April 16, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Inflammation; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 0435278B