Use of atorvastatin in systemic lupus erythematosus in children and adolescents
Open Access
- 26 October 2011
- journal article
- research article
- Published by Wiley in Arthritis & Rheumatism
- Vol. 64 (1), 285-296
- https://doi.org/10.1002/art.30645
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.Keywords
This publication has 52 references indexed in Scilit:
- Atherosclerotic vascular events in a multinational inception cohort of systemic lupus erythematosusArthritis Care & Research, 2010
- Systemic lupus erythematosus and the risk of cardiovascular disease: Results from the nurses' health studyArthritis Care & Research, 2009
- The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trialsBMJ, 2009
- Premature atherosclerosis in pediatric systemic lupus erythematosus: Risk factors for increased carotid intima‐media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohortArthritis & Rheumatism, 2009
- Adolescent onset of lupus results in more aggressive disease and worse outcomes: results of a nested matched case–control study within LUMINA, a multiethnic US cohort (LUMINA LVII)Lupus, 2008
- Adherence to MedicationNew England Journal of Medicine, 2005
- Carotid Intima-Media Thickness Measurements in Intervention StudiesStroke, 2003
- A review on the diagnosis, natural history, and treatment of familial hypercholesterolaemiaAtherosclerosis, 2003
- Prevalence and risk factors of carotid plaque in women with systemic lupus erythematosusArthritis & Rheumatism, 1999
- An in vitro study of the effects of lovastatin on human fetal brain cellsNeurotoxicology and Teratology, 1995