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

Purpose

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	Intervention	Phase
Systemic Lupus Erythematosus	Drug: atorvastatin	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Statins

Drug Information available for: Atorvastatin Atorvastatin calcium Atorvastatin calcium trihydrate

U.S. FDA Resources

Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	15
Study Start Date:	September 2007
Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

atorvastatin 40mg, given orally daily for 3 months.

Other Name: Lipitor 40mg

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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519363

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


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
Study First Received:	August 20, 2007
Last Updated:	March 23, 2010
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016