An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

Phase 2

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00432354
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Study Timeline

• Study First Submitted: 2007-02-06
• Study First Submitted QC: 2007-02-06
• Study First Posted: 2007-02-07
• Status Verified: 2007-03
• Study Start: 2007-03
• Last Update Submitted: 2007-03-19
• Last Update Posted: 2007-03-20
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Buddhist Dalin Tzu Chi General Hospital; 🇨🇳 Chia-Yi, Taiwan

Dalin Tzu Chi General Hospital; 🇨🇳 Chia-yi, Taiwan

Buddhist Dalin Tzu Chi General Hospital

🇨🇳Chia-Yi, Taiwan

Ming-Chi Lu, MD

Principal Investigator