Systemic Lupus Erythematosus
Conditions
Keywords
statin, systemic lupus erythematosus, microcirculation
Brief summary
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
Detailed description
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.
Interventions
DRUGatorvastatin
Sponsors
Pfizer
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration) 2. 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. 3. The type and number immunosuppressive agents were not changed in recent one months
Exclusion criteria
1. inability to give informed consent; 2. myositis (CK\>3×normal value); 3. dialysis or serum creatinin\>2.5mg/dL; 4. abnormal liver function (ALT\>3×normal value); 5. pregnant or breastfeeding; 6. life-threatening illness that would interfere with ability to complete the study; 7. current drug or alcohol abuse 8. Already under statin therapy 9. Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the change in SLE-DAI, a validated composite disease activity score. | — |
Secondary
| Measure | 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. | — |
Countries
Taiwan
Contacts
Primary ContactMing-Chi Lu, MD
Outcome results
None listed