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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atorvastatin|atorvastatin 40mg, given orally daily for 3 months.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower lipid levels in female lupus patients |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, TLR's, Hyperlipidemia, age eighteen to sixty, female with SLE, SLEDAI, greater than four, LDL cholesterol elevated