An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
- 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.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432354
|Buddhist Dalin Tzu Chi General Hospital|
|Chia-Yi, Taiwan, 622|
|Dalin Tzu Chi General Hospital|
|Chia-yi, Taiwan, 622|
|Study Chair:||Ning-Sheng Lai, MD., Ph.D.||Vice President of Buddhist Dalin Chi Tzu General Hospital|