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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519363
• Other study ID #: 06-316
• Secondary ID: SaintLuke'sHospi
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 20, 2007
• Last updated: March 23, 2010
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: The Center for Rheumatic Disease, Allergy, & Immunology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• atorvastatin
atorvastatin 40mg, given orally daily for 3 months.

Locations

Country	Name	City	State
United States	The Center for Rheumatic Disease, Allergy, and Immunology	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Rheumatic Disease, Allergy, & Immunology	Saint Luke's Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.		3 months
Secondary	lower lipid levels in female lupus patients		3 months