title: Impact sibutramine therapy in children with hypothalamic obesity or obesity with aggravating syndromes.
abstract: OBJECTIVE
  Behavioral treatment of children suffering from hypothalamic obesity or uncomplicated obesity in combination with syndromes that aggravate this condition has proven to be ineffective. The combination of comorbidities and severe obesity lower the quality of these children's lives drastically. The present goal was to determine whether treatment with sibutramine has a beneficial effect on such children.
  
  
  METHODS
  A double-blind, placebo-controlled, cross-over study (20 + 20 wk), followed by a 6-month open phase, was performed. The primary indicator of efficacy was the body mass index (BMI) sd score (SDS) value, which was analyzed using an ANOVA repeated-measures design [intention to treat (ITT)]. The 50 children (7-20 yr of age) involved included 22 with hypothalamic obesity and 28 with uncomplicated obesity plus aggravating syndromes. Forty-five patients completed the first phase, and 42 participated in the entire study.
  
  
  RESULTS
  The group that initially received the placebo demonstrated an insignificant decrease (-0.06) in BMI SDS during this treatment but a significant decrease (-0.68; P < 0.001) when treated with sibutramine. The other group demonstrated a reduction in their BMI SDS of -0.72 during administration of sibutramine and a rebound of +0.43 when placed on the placebo (P < 0.001 in both cases). The response of children with hypothalamic obesity was also significant but was less pronounced than that of children with nonhypothalamic obesity. During the open phase, a continuous reduction in weight was observed. The treatment was tolerated well.
  
  
  CONCLUSIONS
  The clinically and statistically significant weight reduction caused by sibutramine in this short-term study indicates that treatment of hypothalamic and syndromal obesity with this drug may be beneficial.
authors.affiliation: Department of Pediatrics and the National Childhood Obesity Centre, B57, Karolinska University Hospital, Huddinge, S-141 86 Stockholm, Sweden.
authors.forename: Pernilla
authors.initials: P
authors.lastname: Danielsson
authors.forename: Annika
authors.initials: A
authors.lastname: Janson
authors.forename: Svante
authors.initials: S
authors.lastname: Norgren
authors.forename: Claude
authors.initials: C
authors.lastname: Marcus
mesh_terms: D015502:Absorptiometry, Photon; D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007027:Hypothalamic Diseases / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D000928:Antidepressive Agents; D003503:Cyclobutanes; C058254:sibutramine