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

This study has been completed.
Sponsor:
Collaborator:
Saint Luke's Health System
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:
NCT00519363
First received: August 20, 2007
Last updated: March 23, 2010
Last verified: September 2009
  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:


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

Ages Eligible for Study:   18 Years to 60 Years
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
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

No publications provided

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014