title: Atorvastatin effect on systemic lupus erythematosus disease activity: a double-blind randomized clinical trial.
abstract: 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.
authors.affiliation: Department of Rheumatology, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran, a_fatemi@med.mui.ac.ir.
authors.forename: Alimohammad
authors.initials: A
authors.lastname: Fatemi
authors.forename: Mahdi
authors.initials: M
authors.lastname: Moosavi
authors.forename: Zahra
authors.initials: Z
authors.lastname: Sayedbonakdar
authors.forename: Ziba
authors.initials: Z
authors.lastname: Farajzadegan
authors.forename: Mehdi
authors.initials: M
authors.lastname: Kazemi
authors.forename: Abbas
authors.initials: A
authors.lastname: Smiley
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D008055:Lipids / Q000097:blood; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D006538:Heptanoic Acids; D008055:Lipids; D011758:Pyrroles; D002097:C-Reactive Protein; D000069059:Atorvastatin