NCT00519363

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	atorvastatin	atorvastatin 40mg, given orally daily for 3 months.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2007-08-22
• Last updated: 2010-03-24

Locations

1 site across 1 country: United States