Atorvastatin effect on systemic lupus erythematosus disease activity: a double-blind randomized clinical trial

We aimed to evaluate the therapeutic effects of atorvastatin on systemic lupus erythematosus disease activity index (SLEDAI). Ninety patients with SLE were consented and randomized to receive either atorvastatin, 20 mg/day, or placebo for 3 months. The primary outcome was change in SLEDAI. Lipids, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were assessed as secondary end points. Analysis was done by "intention to treat" (ITT) as the primary analysis and "treatment completed analysis" (TCA) as the supplementary analysis. Demographic features, baseline characteristics, and distribution of medications were not significantly different between the two groups. Mean SLEDAI score at baseline in both groups was 3 ± 0.5. By TCA and ITT, mean SLEDAI scores decreased to 1.7 ± 0.4 and 2.7 ± 0.5, respectively, in the atorvastatin group and 3 ± 0.4 and 3 ± 0.5, respectively, in the control group. The difference between the two groups after intervention was significant by TCA (P < 0.05) and nonsignificant by ITT analysis (P = 0.1). The effect of atorvastatin therapy on lupus activity was inconclusive.