An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.

Detailed Description
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Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending. Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE. Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration) Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening. The type and number immunosuppressive agents were not changed in recent one months Exclusion Criteria: inability to give informed consent; myositis (CK>3×normal value); dialysis or serum creatinin>2.5mg/dL; abnormal liver function (ALT>3×normal value); pregnant or breastfeeding; life-threatening illness that would interfere with ability to complete the study; current drug or alcohol abuse Already under statin therapy Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atorvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the change in SLE-DAI, a validated composite disease activity score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint was the improvement of microcirculation evaluated by Raynaud's condition score and nailfold capillaroscopy in the beginning and end of the atorvastatin. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, systemic lupus erythematosus, microcirculation