The efficacy of atorvastatin in treatment of Lupus

Phase 2

Conditions: Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus

Registration Number: IRCT2012081110557N1

Lead Sponsor: Vice Chancellor of Research, School of Medicine

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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