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Use of atorvastatin in systemic lupus erythematosus in children and adolescents

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

Arthritis and rheumatism, 2012-01, Vol.64 (1), p.285-296

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Use of atorvastatin in systemic lupus erythematosus in children and adolescents
Autor: Schanberg, L. E. ; Sandborg, C. ; Barnhart, H. X. ; Ardoin, S. P. ; Yow, E. ; Evans, G. W. ; Mieszkalski, K. L. ; Ilowite, N. T. ; Eberhard, A. ; Imundo, L. F. ; Kimura, Y. ; von Scheven, E. ; Silverman, E. ; Bowyer, S. L. ; Punaro, M. ; Singer, N. G. ; Sherry, D. D. ; McCurdy, D. ; Klein-Gitelman, M. ; Wallace, C. ; Silver, R. ; Wagner-Weiner, L. ; Higgins, G. C. ; Brunner, H. I. ; Jung, L. ; Soep, J. B. ; Reed, A. M. ; Provenzale, J. ; Thompson, S. D.
Assuntos: Adolescent ; Anticholesteremic Agents - therapeutic use ; Atherosclerosis ; Atherosclerosis - complications ; Atherosclerosis - diagnosis ; Atherosclerosis - prevention & control ; Atorvastatin ; Biological and medical sciences ; Carotid Intima-Media Thickness ; Child ; Cholesterol ; Disease Progression ; Diseases of the osteoarticular system ; Double-Blind Method ; Female ; Heptanoic Acids - therapeutic use ; Humans ; Lipids - blood ; Lupus ; Lupus Erythematosus, Systemic - blood ; Lupus Erythematosus, Systemic - complications ; Lupus Erythematosus, Systemic - drug therapy ; Male ; Medical sciences ; Pediatrics ; Pyrroles - therapeutic use ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Treatment Outcome ; Young Adult
É parte de: Arthritis and rheumatism, 2012-01, Vol.64 (1), p.285-296
Notas: NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases) - No. N01-AR-2-2265
ark:/67375/WNG-2LNZF8MP-4
Pfizer
ClinicalTrials.gov identifier: NCT00065806.
istex:48841073CC7DE15317627B300FEE974DDDE873E5
ArticleID:ART30645
Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis
NIH (Clinical and Translational Science Award program) - No. UL1-RR-024989
ClinicalTrials.gov
identifier: NCT00065806.
Dr. Schanberg has received consulting fees from Pfizer (less than $10,000).
Dr. Ardoin has received honoraria for serving on the Johnson & Johnson Data Safety Monitoring Board (less than $10,000).
Mr. Evans has received consulting fees from ImagePace and AstraZeneca (less than $10,000 each) and has received honoraria from Merck/Schering‐Plough (less than $10,000).
Dr. Kimura has received consulting fees, speaking fees, and/or honoraria from Genentech (more than $10,000).
Dr. Singer has received consulting fees, speaking fees, and/or honoraria from Pfizer, UCB, and NovelMed Therapeutics (less than $10,000 each) and has received honoraria for service on the Pfizer Drug Safety Monitoring Board (less than $10,000).
Dr. McCurdy owns stock or stock options in Amgen.
Drs. Klein‐Gitelman and Jung have received consulting fees, speaking fees, and/or honoraria from Genentech (less than $10,000 each).
Dr. Wallace has received a grant from Pfizer for the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project in Juvenile Idiopathic Arthritis.
Dr. Provenzale has received consulting fees, speaking fees, and/or honoraria from Bayer, Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceuticals, and Theradex (less than $10,000 each).
Drs. Schanberg and Sandborg contributed equally to this work.
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Descrição: 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.
Editor: Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Idioma: Inglês

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