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

The Center for Rheumatic Disease, Allergy, & Immunology

Status and phase

Completed

Phase 2

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00519363

Saint

06-316

Luke's

Grant

Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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