Orlistat treatment in obese prepubertal children: a pilot study

Acta Paediatr. 2003 Jun;92(6):666-70. doi: 10.1080/08035250310002353.


Aim: This study investigated orlistat treatment in obese prepubertal children with regard to tolerance, safety and psychological well-being.

Methods: 11 healthy, severely obese prepubertal children (age 8.3-12.3 y, body mass index standard deviation score 5.3-9.2) were recruited for a 12 wk open treatment. Before, during and after treatment, the participants were investigated by psychological evaluation, blood chemistry, and parameters reflecting obesity and fat mass.

Results: The participants were able to comply with the treatment, as indicated by pill counts and self reports, and expressed a desire to continue the treatment after the study period. Gastrointestinal side effects were mild and tolerable. No negative effects on psychological or physical well-being were detected, and the psychological evaluation demonstrated increased avoidance of fattening food, body shape preoccupation and oral control (p = 0.011). The median weight loss was 4.0 kg (range -12.7 to +2.5 kg, p = 0.016) and was highly correlated to decreased fat mass (regression coefficient 0.953, p < 0.01).

Conclusion: This pilot study indicates that obese prepubertal children were able to reduce their fat intake to avoid gastrointestinal side effects. Thus, orlistat may be suitable as a component in behaviour-modification programmes for obese children, and the results prompt a placebo-controlled investigation of its effectiveness in promoting weight loss.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Anthropometry
  • Anti-Obesity Agents / pharmacology
  • Anti-Obesity Agents / therapeutic use*
  • Child
  • Female
  • Gonadotropins / blood
  • Humans
  • Lactones / pharmacology
  • Lactones / therapeutic use*
  • Lipids / blood
  • Liver / drug effects
  • Liver / enzymology
  • Male
  • Obesity / drug therapy*
  • Obesity / psychology
  • Orlistat
  • Patient Compliance*
  • Pilot Projects


  • Anti-Obesity Agents
  • Gonadotropins
  • Lactones
  • Lipids
  • Orlistat