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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
• Collaborator: Saint Luke's Health System
• Treatments: Atorvastatin; Atorvastatin Calcium

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