Comparison the efficacy of atorvastatin with placebo on disease activity in patients with systemic lupus erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
Aim: Statins have shown therapeutic efficacy on autoimmune diseases
such as rheumatoid arthritis and multiple sclerosis. In the current study,we aimed to evaluate the effects of atorvastatin on systemic lupus erythematosus (SLE) disease activity. Methods: In this double-blind randomized clinical trial, 90 patients with SLE were consented and randomized to receive atorvastatin, 20 mg/day or placebo for three
months. The primary outcome was change in SLE disease activity index
(SLEDAI). Lipids, ESR, and CRP were assessed as secondary
endpoints. Analysis was done by ‘Intention to Treat’ (ITT) and ‘Treatment Completed Analysis’ (TCA). Results: Demographic features, baseline characteristics and distribution of medications of the two groups were not significantly different. Seven patients were lost to follow-up in each group. Mean SLEDAI score at baseline in both groups was 3 ± 0.5. By CTA and ITT, mean SLEDAI scores decreased to 1.7 ± 0.4 and 2.6 ± 0.5, respectively, in the atorvastatin group and 3 ± 0.4 and 3 ± 0.5 in the control group, respectively. In both conditions, the difference between the two groups after intervention was significant (P
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16 years 至 75 years（—）
- 性别
- All
入选标准
- •Inclusion Criteria: 1- Diagnosis of systemic lupus Erythematosus according to American college of rheumatology criteria, 2- No allergy to atorvastatin, 3- No cyclophosphamide use in last three months, 4- No current use of prednisolone (=0.5mg/kg/day) or equivalent dose from other corticosteroids, 5- No current use of cyclosporine, 6- Serum creatinine < 2mg/dl, 7- ALT< 2 x normal, 8- Negative pregnancy test for female patients, 9- No history of hepatitis 10- No history of myositis
排除标准
- •1- Missing of the patients (do not come back for follow up, discontinue the medication), 2- Irregular drug intake, 3- Intolerance to atorvastatin, 4- Need to cyclophosphamide during the study, 5- Need to prednisolone ( =0.5mg/kg/day) or equivalent dose from other corticosteroids during the study, 6- Need to Cysclosporine during the study, 7- Rising of ALT > 2x normal, 8- Unexplained myalgia during the study