An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
研究概览
简要总结
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
- •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
- •The SLE-DAI score should have been stable for at least two weeks prior to screening.
- •The type and number immunosuppressive agents were not changed in recent one months
排除标准
- •inability to give informed consent;
- •myositis (CK>3×normal value);
- •dialysis or serum creatinin>2.5mg/dL;
- •abnormal liver function (ALT>3×normal value);
- •pregnant or breastfeeding;
- •life-threatening illness that would interfere with ability to complete the study;
- •current drug or alcohol abuse
- •Already under statin therapy
- •Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
结局指标
主要结局
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
次要结局
- 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.