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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus	Drug: atorvastatin	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.
Study Start Date :	September 2007
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

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Intervention Details:

Drug: atorvastatin
atorvastatin 40mg, given orally daily for 3 months.
Other Name: Lipitor 40mg

Outcome Measures

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Primary Outcome Measures :

1. decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. lower lipid levels in female lupus patients [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Missouri
The Center for Rheumatic Disease, Allergy, and Immunology
Kansas City, Missouri, United States, 64111

Sponsors and Collaborators

The Center for Rheumatic Disease, Allergy, & Immunology

Saint Luke's Health System

Investigators

Principal Investigator:	Nabih I Abdou, MD, PhD	The Center for Rheumatic Disease, Allergy, and Immunology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nabih I Abdou, MD, PhD, Center for Rheumatic Disease Allergy & Immunology
ClinicalTrials.gov Identifier:	NCT00519363 History of Changes
Other Study ID Numbers:	06-316; Saint; Luke's; Hospital; Grant
First Posted:	August 22, 2007
Last Update Posted:	March 24, 2010
Last Verified:	September 2009

Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Lupus; TLR's; Hyperlipidemia; age eighteen to sixty	female with SLE; SLEDAI, greater than four; LDL cholesterol elevated

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Atorvastatin Calcium; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors