IRCT2012081110557N1 IRCT 2012-10-02 Vice Chancellor of Research, School of Medicine The efficacy of atorvastatin in treatment of Lupus Comparison the efficacy of atorvastatin with placebo on disease activity in patients with systemic lupus erythematosus 2012-01-21 anticipated 90 Complete https://irct.ir/trial/11045 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study- from the SLE patients who fulfill the American college of Rhueumatology criteria for SLE and visited in rheumatology clinic (Alzahra Hospital, Isfahan University of Medical Sciences)- ninety patients will be recruit by convenience sampling. After that, they will be divided into intervention and control groups by using random number table. The atorvastatin and placebo will be taken from Sobhan Darou Co. and have similar package which label by A or B. The physicians who give them to the patients do not know which of them is atorvastatin or placebo, as well as who analyze the data. 2 Systemic Lupus Erythematosus. Intervention 1: Atorvastatin (20 mg/day) for 3 months. Intervention 2: Placebo (20mg/day) for 3 months. Aim: Statins have shown therapeutic efficacy on autoimmune diseases<br /> 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<br /> months. The primary outcome was change in SLE disease activity index<br /> (SLEDAI). Lipids, ESR, and CRP were assessed as secondary<br /> 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