Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
研究概览
简要总结
This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.
详细描述
Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.
Eligibility critera:
- age 18-60, females, as a marjority of lupus patients are female
- at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
- Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
- LDL cholesterol 100-190mg/dl
Exclusion criteria:
- Pregnancy, and or lactating or wants to get pregnant
- Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
- already on lipid lowering therapy
- already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
- has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-60, female
- •have at least four ACR criteria for SLE
- •SLEDAI score > 4
- •LDL cholesterol level from 100-190mg/dl
排除标准
- •Pregnant, lactating, or wanting to become pregnant
- •unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
- •already on lipid lowering therapy
- •participating in another lupus study
- •on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
- •has a diagnosis of myositis
结局指标
主要结局
decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
时间窗: 3 months
次要结局
- lower lipid levels in female lupus patients(3 months)