Pediatric Rheumatology

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Use of atorvastatin in systemic lupus erythematosus in children and adolescents†

  1. L. E. Schanberg1,‡,§,*,
  2. C. Sandborg2,‡,
  3. H. X. Barnhart1,
  4. S. P. Ardoin3,¶,
  5. E. Yow1,
  6. G. W. Evans4,‖,
  7. K. L. Mieszkalski1,
  8. N. T. Ilowite5,
  9. A. Eberhard6,
  10. L. F. Imundo7,
  11. Y. Kimura8,††,
  12. E. von Scheven9,
  13. E. Silverman10,
  14. S. L. Bowyer11,
  15. M. Punaro12,
  16. N. G. Singer13,‡‡,
  17. D. D. Sherry14,
  18. D. McCurdy15,§§,
  19. M. Klein-Gitelman16,¶¶,
  20. C. Wallace17,‖‖,
  21. R. Silver18,
  22. L. Wagner-Weiner19,
  23. G. C. Higgins3,
  24. H. I. Brunner20,
  25. L. Jung21,¶¶,
  26. J. B. Soep22,
  27. A. M. Reed23,
  28. J. Provenzale1,†††,
  29. S. D. Thompson20,
  30. Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators

Article first published online: 29 DEC 2011

DOI: 10.1002/art.30645

Issue

Arthritis & Rheumatism

Arthritis & Rheumatism

Volume 64, Issue 1, pages 285–296, January 2012

Additional Information

How to Cite

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. and Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators (2012), Use of atorvastatin in systemic lupus erythematosus in children and adolescents. Arthritis & Rheumatism, 64: 285–296. doi: 10.1002/art.30645

Author Information

  1. 1

    Duke University Medical Center, Durham, North Carolina

  2. 2

    Stanford University School of Medicine, Palo Alto, California

  3. 3

    Nationwide Children's Hospital, Columbus, Ohio

  4. 4

    Wake Forest University School of Medicine, Winston-Salem, North Carolina

  5. 5

    Albert Einstein College of Medicine, Bronx, New York

  6. 6

    Cohen Children's Medical Center, New Hyde Park, New York

  7. 7

    Columbia University Medical Center, New York, New York

  8. 8

    Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, New Jersey

  9. 9

    University of California, San Francisco

  10. 10

    Toronto Hospital for Sick Children, Toronto, Ontario, Canada

  11. 11

    Indiana University School of Medicine, Indianapolis

  12. 12

    Texas Scottish Rite Hospital for Children, Dallas

  13. 13

    University Hospitals Case Medical Center, Cleveland, Ohio

  14. 14

    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  15. 15

    University of California, Los Angeles David Geffen School of Medicine

  16. 16

    Northwestern University Feinberg School of Medicine, Chicago, Illinois

  17. 17

    Seattle Children's Hospital, Seattle, Washington

  18. 18

    Medical University of South Carolina, Charleston

  19. 19

    University of Chicago, Chicago, Illinois

  20. 20

    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

  21. 21

    Creighton University Medical Center, Omaha, Nebraska

  22. 22

    The Children's Hospital, Denver, Colorado

  23. 23

    Mayo Clinic, Rochester, Minnesota

  1. ‡

    Drs. Schanberg and Sandborg contributed equally to this work.

  2. §

    Dr. Schanberg has received consulting fees from Pfizer (less than $10,000).

  3. Dr. Ardoin has received honoraria for serving on the Johnson & Johnson Data Safety Monitoring Board (less than $10,000).

  4. ‖

    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).

  5. ††

    Dr. Kimura has received consulting fees, speaking fees, and/or honoraria from Genentech (more than $10,000).

  6. ‡‡

    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).

  7. §§

    Dr. McCurdy owns stock or stock options in Amgen.

  8. ¶¶

    Drs. Klein-Gitelman and Jung have received consulting fees, speaking fees, and/or honoraria from Genentech (less than $10,000 each).

  9. ‖‖

    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.

  10. †††

    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).

*Department of Pediatrics, Duke University Medical Center, DUMC 3212, Durham, NC 27710

  1. †

    ClinicalTrials.gov identifier: NCT00065806.

  2. ‡

    Drs. Schanberg and Sandborg contributed equally to this work.

  3. §

    Dr. Schanberg has received consulting fees from Pfizer (less than $10,000).

  4. Dr. Ardoin has received honoraria for serving on the Johnson & Johnson Data Safety Monitoring Board (less than $10,000).

  5. ‖

    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).

  6. ††

    Dr. Kimura has received consulting fees, speaking fees, and/or honoraria from Genentech (more than $10,000).

  7. ‡‡

    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).

  8. §§

    Dr. McCurdy owns stock or stock options in Amgen.

  9. ¶¶

    Drs. Klein-Gitelman and Jung have received consulting fees, speaking fees, and/or honoraria from Genentech (less than $10,000 each).

  10. ‖‖

    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.

  11. †††

    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).

Publication History

  1. Issue published online: 29 DEC 2011
  2. Article first published online: 29 DEC 2011
  3. Accepted manuscript online: 26 OCT 2011 03:08PM EST
  4. Manuscript Accepted: 18 AUG 2011
  5. Manuscript Received: 8 FEB 2011

Funded by

  • NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases). Grant Number: N01-AR-2-2265
  • Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis
  • Pfizer
  • NIH (Clinical and Translational Science Award program). Grant Number: UL1-RR-024989

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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.

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