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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519363
First Posted: August 22, 2007
Last Update Posted: March 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Saint Luke's Health System
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
  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
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.

Resource links provided by NLM:


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:
    Drug: atorvastatin
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 20, 2007
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