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Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations

International Journal of Obesity volume 40, pages 1043–1050 (2016)Cite this article

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Abstract

Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial end-point selection, trial duration, implementation of lifestyle modification therapy and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity.

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Acknowledgements

KDR is supported in part by NCATS award UL1TR000114. JRR is supported in part by NHLBI award: F32HL12785. The authors are grateful to Dr Charles Billington for reviewing and commenting on the manuscript.

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Authors and Affiliations

  1. Department of Pediatrics, University of Minnesota Medical School, and University of Minnesota Masonic Children’s Hospital, Minneapolis, MN, USA

    A S Kelly, C K Fox, A C Gross & J R Ryder

  2. Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA

    A S Kelly

  3. Division of Biostatistics, School of Public Health and Clinical and Translational Science Institute, University of Minnesota, Minneapolis, MN, USA

    K D Rudser

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  1. A S Kelly
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Corresponding author

Correspondence to A S Kelly.

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Competing interests

ASK serves as a consultant for Takeda Pharmaceuticals and Novo Nordisk Pharmaceuticals and is the signatory author for a pediatric obesity clinical trial sponsored by Novo Nordisk Pharmaceuticals; he does not accept personal or professional income for his services. ASK also receives research support from Astra Zeneca Pharmaceuticals in the form of drug/placebo. CKF is a site principal investigator for a pediatric obesity clinical trial sponsored by Novo Nordisk Pharmaceuticals.The remainig authors declare no conflict of interest.

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Kelly, A., Fox, C., Rudser, K. et al. Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations. Int J Obes 40, 1043–1050 (2016). https://doi.org/10.1038/ijo.2016.69

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