An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Buddhist Tzu Chi General Hospital
Updated on 7 November 2020
immunosuppressive agents
immunosuppression
proteinuria
nephritis

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 IdentifierNCT00432354
SponsorBuddhist Tzu Chi General Hospital
Last Modified on7 November 2020

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