Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention description(s): atorvastatin 40mg, given orally daily for 3 months.
Other intervention name(s): Lipitor 40mg
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus; TLR's; Hyperlipidemia; age eighteen to sixty; female with SLE; SLEDAI, greater than four; LDL cholesterol elevated