An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
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- STATUS
- Recruiting
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- participants needed
- 40
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- sponsor
- Buddhist Tzu Chi General Hospital
Summary
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
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.
Details
| Condition | SYSTEMIC LUPUS ERYTHEMATOSUS |
|---|---|
| Treatment | Atorvastatin |
| Clinical Study Identifier | NCT00432354 |
| Sponsor | Buddhist Tzu Chi General Hospital |
| Last Modified on | 7 November 2020 |
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