Use of atorvastatin in systemic lupus erythematosus in children and adolescents

L. E. Schanberg; 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

doi:10.1002/art.30645

Use of atorvastatin in systemic lupus erythematosus in children and adolescents

L. E. Schanberg, 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. WallaceR. Silver, L. Wagner-Weiner, G. C. Higgins, H. I. Brunner, L. Jung, J. B. Soep, A. M. Reed, J. Provenzale, S. D. Thompson

Rheumatology

Research output: Contribution to journal › Article › peer-review

105 Scopus citations

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.

Original language	English (US)
Pages (from-to)	285-296
Number of pages	12
Journal	Arthritis and rheumatism
Volume	64
Issue number	1
DOIs	https://doi.org/10.1002/art.30645
State	Published - Jan 2012

ASJC Scopus subject areas

Immunology and Allergy
Rheumatology
Immunology
Pharmacology (medical)

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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., ... Thompson, S. D. (2012). Use of atorvastatin in systemic lupus erythematosus in children and adolescents. Arthritis and rheumatism, 64(1), 285-296. https://doi.org/10.1002/art.30645

Schanberg, LE, Sandborg, C, Barnhart, HX, Ardoin, SP, Yow, E, Evans, GW, Mieszkalski, KL, Ilowite, NT, Eberhard, A, Imundo, LF, Kimura, Y, Von Scheven, E, Silverman, E, Bowyer, SL, Punaro, M, Singer, NG, Sherry, DD, McCurdy, D, Klein-Gitelman, M, Wallace, C, Silver, R, Wagner-Weiner, L, Higgins, GC, Brunner, HI, Jung, L, Soep, JB, Reed, AM, Provenzale, J & Thompson, SD 2012, 'Use of atorvastatin in systemic lupus erythematosus in children and adolescents', Arthritis and rheumatism, vol. 64, no. 1, pp. 285-296. https://doi.org/10.1002/art.30645

@article{2177c0ecf0094e078ae3c17fb7e6abbd,

title = "Use of atorvastatin in systemic lupus erythematosus in children and adolescents",

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.",

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

year = "2012",

month = jan,

doi = "10.1002/art.30645",

language = "English (US)",

volume = "64",

pages = "285--296",

journal = "Arthritis and rheumatism",

issn = "0004-3591",

publisher = "John Wiley and Sons Ltd",

number = "1",

}

TY - JOUR

T1 - Use of atorvastatin in systemic lupus erythematosus in children and adolescents

AU - Schanberg, L. E.

AU - Sandborg, C.

AU - Barnhart, H. X.

AU - Ardoin, S. P.

AU - Yow, E.

AU - Evans, G. W.

AU - Mieszkalski, K. L.

AU - Ilowite, N. T.

AU - Eberhard, A.

AU - Imundo, L. F.

AU - Kimura, Y.

AU - Von Scheven, E.

AU - Silverman, E.

AU - Bowyer, S. L.

AU - Punaro, M.

AU - Singer, N. G.

AU - Sherry, D. D.

AU - McCurdy, D.

AU - Klein-Gitelman, M.

AU - Wallace, C.

AU - Silver, R.

AU - Wagner-Weiner, L.

AU - Higgins, G. C.

AU - Brunner, H. I.

AU - Jung, L.

AU - Soep, J. B.

AU - Reed, A. M.

AU - Provenzale, J.

AU - Thompson, S. D.

PY - 2012/1

Y1 - 2012/1

N2 - 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.

AB - 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.

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Use of atorvastatin in systemic lupus erythematosus in children and adolescents

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