Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations.
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.
Department of Pediatrics, University of Minnesota Medical School, and University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.|Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
A S
AS
Kelly
Department of Pediatrics, University of Minnesota Medical School, and University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.
C K
CK
Fox
Division of Biostatistics, School of Public Health and Clinical and Translational Science Institute, University of Minnesota, Minneapolis, MN, USA.
K D
KD
Rudser
Department of Pediatrics, University of Minnesota Medical School, and University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.
A C
AC
Gross
Department of Pediatrics, University of Minnesota Medical School, and University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.
J R
JR
Ryder
D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015992:Body Mass Index; D002648:Child; D037001:Directive Counseling / Q000639:trends; D000077270:Exenatide; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008687:Metformin / Q000627:therapeutic use; D063766:Pediatric Obesity / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D010455:Peptides / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D040242:Risk Reduction Behavior; D014688:Venoms / Q000627:therapeutic use; D015431:Weight Loss / Q000187:drug effects
D019440:Anti-Obesity Agents; D007004:Hypoglycemic Agents; D010455:Peptides; D014688:Venoms; D008687:Metformin; D000077270:Exenatide