Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors

NCT ID: NCT00519363

Last Updated: 2010-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-12-31

Brief Summary

This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.

Detailed Description

Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.

Eligibility critera:

• age 18-60, females, as a marjority of lupus patients are female
• at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
• Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
• LDL cholesterol 100-190mg/dl

Exclusion criteria:

• Pregnancy, and or lactating or wants to get pregnant
• Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
• already on lipid lowering therapy
• already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
• has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

atorvastatin

atorvastatin 40mg, given orally daily for 3 months.

Intervention Type: DRUG

Other Intervention Names

Lipitor 40mg

Eligibility Criteria

Inclusion Criteria

• Age 18-60, female
• have at least four ACR criteria for SLE
• SLEDAI score > 4
• LDL cholesterol level from 100-190mg/dl

Exclusion Criteria

• Pregnant, lactating, or wanting to become pregnant
• unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
• already on lipid lowering therapy
• participating in another lupus study
• on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
• has a diagnosis of myositis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Luke's Health System

OTHER

Sponsor Role: collaborator

The Center for Rheumatic Disease, Allergy, & Immunology

OTHER

Sponsor Role: lead

Responsible Party

Center for Rheumatic Disease Allergy & Immunology

Principal Investigators

Nabih I Abdou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Center for Rheumatic Disease, Allergy, and Immunology

Locations

The Center for Rheumatic Disease, Allergy, and Immunology

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

Saint

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Identifier Source: secondary_id

Luke's

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Hospital

Identifier Type: -

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Grant

Identifier Type: -

Identifier Source: secondary_id

06-316

Identifier Type: -

Identifier Source: org_study_id