title: Effects of sibutramine treatment in obese adolescents: a randomized trial.
abstract: BACKGROUND
  Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy.
  
  
  OBJECTIVE
  To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program.
  
  
  METHODS
  12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002.
  
  
  METHODS
  33 U.S. outpatient clinics.
  
  
  METHODS
  498 participants 12 to 16 years of age with a body mass index (BMI) that was at least 2 units more than the U.S. weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2.
  
  
  METHODS
  Site-specific behavior therapy plus 10 mg of sibutramine or placebo. Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%.
  
  
  METHODS
  Body mass index, waist circumference, body weight, fasting lipid and glycemic variables, safety, and tolerability.
  
  
  RESULTS
  Seventy-six percent of patients in the sibutramine group and 62% of patients in the placebo group completed the study. The estimated mean treatment group difference at month 12 (linear mixed-effects model) favored sibutramine for change from baseline in BMI (-2.9 kg/m2 [95% CI, -3.5 to -2.2 kg/m2]) and body weight (-8.4 kg [CI, -9.7 to -7.2 kg]) (P < 0.001 for both). The sibutramine group had greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity (P < or = 0.001 for all). The rate of tachycardia was greater with sibutramine vs. placebo (12.5% vs. 6.2%; difference, 6.3 percentage points [CI, 1.0 to 11.7 percentage points]) but did not lead to increased withdrawal (2.4% vs. 1.5%; difference, 0.9 percentage point [CI, -1.7 to 3.5 percentage points]).
  
  
  CONCLUSIONS
  The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the sibutramine and placebo groups, respectively, did not complete follow-up.
  
  
  CONCLUSIONS
  Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.
authors.affiliation: The Behavioral Health Center, The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. berkowitz@email.chop.edu
authors.forename: Robert I
authors.initials: RI
authors.lastname: Berkowitz
authors.forename: Ken
authors.initials: K
authors.lastname: Fujioka
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Daniels
authors.forename: Alison G
authors.initials: AG
authors.lastname: Hoppin
authors.forename: Stanford
authors.initials: S
authors.lastname: Owen
authors.forename: Arlette C
authors.initials: AC
authors.lastname: Perry
authors.forename: Melinda S
authors.initials: MS
authors.lastname: Sothern
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Renz
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pirner
authors.forename: Julia K
authors.initials: JK
authors.lastname: Walch
authors.forename: Olga
authors.initials: O
authors.lastname: Jasinsky
authors.forename: Ann C
authors.initials: AC
authors.lastname: Hewkin
authors.forename: Vicky A
authors.initials: VA
authors.lastname: Blakesley
mesh_terms: D000293:Adolescent; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D001521:Behavior Therapy; D001794:Blood Pressure; D001827:Body Height; D015992:Body Mass Index; D002648:Child; D003131:Combined Modality Therapy; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009765:Obesity / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D011674:Pulse; D012741:Sexual Maturation; D013610:Tachycardia / Q000139:chemically induced; D015431:Weight Loss
chemical_list: D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine