Clinical trial NCT00519363: Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
Official title: Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
TLR's
Hyperlipidemia
age eighteen to sixty
female with SLE
SLEDAI, greater than four
LDL cholesterol elevated
Lead sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
Sponsor class: OTHER
Collaborators: name: Saint Luke's Health System
First posted: 2007-08-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
timeFrame: 3 months
Secondary outcomes:
measure: lower lipid levels in female lupus patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Center for Rheumatic Disease, Allergy, and Immunology
state: Missouri
Study officials:
affiliation: The Center for Rheumatic Disease, Allergy, and Immunology
name: Nabih I Abdou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: