NCT00432354

An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	atorvastatin

Timeline

• Start date: 2007-03-01
• Completion: 2009-03-01
• First posted: 2007-02-07
• Last updated: 2007-03-20

Locations

2 sites across 1 country: Taiwan