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Randomized Controlled Trial
. 2012 Jan;64(1):285-96.
doi: 10.1002/art.30645.

Use of atorvastatin in systemic lupus erythematosus in children and adolescents

L E Schanberg  1 , C Sandborg, H X Barnhart, S P Ardoin, E Yow, G W Evans, K L Mieszkalski, N T Ilowite, A Eberhard, L F Imundo, Y Kimura, E von Scheven, E Silverman, S L Bowyer, M Punaro, N G Singer, D D Sherry, D McCurdy, M Klein-Gitelman, C Wallace, R Silver, L Wagner-Weiner, G C Higgins, H I Brunner, L Jung, J B Soep, A M Reed, J Provenzale, S D Thompson; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Use of atorvastatin in systemic lupus erythematosus in children and adolescents

L E Schanberg et al. Arthritis Rheum. 2012 Jan.

Abstract

Objective: Statins reduce atherosclerosis and cardiovascular morbidity in the general population, but their efficacy and safety in children and adolescents with systemic lupus erythematosus (SLE) are unknown. This study was undertaken to determine the 3-year efficacy and safety of atorvastatin in preventing subclinical atherosclerosis progression in pediatric-onset SLE.

Methods: A total of 221 participants with pediatric SLE (ages 10-21 years) from 21 North American sites were enrolled in the Atherosclerosis Prevention in Pediatric Lupus Erythematosus study, a randomized double-blind, placebo-controlled clinical trial, between August 2003 and November 2006 with 36-month followup. Participants were randomized to receive atorvastatin (n=113) or placebo (n=108) at 10 or 20 mg/day depending on weight, in addition to usual care. The primary end point was progression of mean-mean common carotid intima-media thickening (CIMT) measured by ultrasound. Secondary end points included other segment/wall-specific CIMT measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) level, and SLE disease activity and damage outcomes.

Results: Progression of mean-mean common CIMT did not differ significantly between treatment groups (0.0010 mm/year for atorvastatin versus 0.0024 mm/year for placebo; P=0.24). The atorvastatin group achieved lower hsCRP (P=0.04), total cholesterol (P<0.001), and low-density lipoprotein (P<0.001) levels compared with placebo. In the placebo group, CIMT progressed significantly across all CIMT outcomes (0.0023-0.0144 mm/year; P<0.05). Serious adverse events and critical safety measures did not differ between groups.

Conclusion: Our results indicate that routine statin use over 3 years has no significant effect on subclinical atherosclerosis progression in young SLE patients; however, further analyses may suggest subgroups that would benefit from targeted statin therapy. Atorvastatin was well tolerated without safety concerns.

Trial registration: ClinicalTrials.gov NCT00065806.

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Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram for the Atherosclerosis Prevention in Pediatric Lupus Erythematosus study. CIMT = carotid intima-media thickening; Cr = creatinine; SLE = systemic lupus erythematosus; CK = creatine kinase; AE = adverse event; SAE = serious adverse event.
Figure 2
Figure 2
Difference in progression rates of carotid intima-media thickening (CIMT) in the atorvastatin and placebo treatment groups. Forest plots of the progression rate differences between the atorvastatin and placebo groups are shown for all CIMT outcomes. Whiskers indicate the 95% confidence interval.
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