Effects of sibutramine treatment in obese adolescents: A randomized trial

Robert I. Berkowitz, Ken Fujioka, Stephen R. Daniels, Alison G. Hoppin, Stanford Owen, Arlette Perry, Melinda S. Sothern, Cheryl L. Renz, Mark A. Pirner, Julia K. Walch, Olga Jasinsky, Ann C. Hewkin, Vicky A. Blakesley

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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. Design: 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002. Setting: 33 U.S. outpatient clinics. Participants: 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. Interventions: 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%. Measurements: 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/m 2 [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 ≤ 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]). Limitations: 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.

Original languageEnglish
Pages (from-to)81-90
Number of pages10
JournalAnnals of Internal Medicine
Volume145
Issue number2
StatePublished - Jul 18 2006

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sibutramine
Placebos
Behavior Therapy
Body Mass Index
Body Weight
Therapeutics
Weights and Measures
Metabolome
Pediatric Obesity
Waist Circumference
Insurance Benefits
Ambulatory Care Facilities

ASJC Scopus subject areas

  • Medicine(all)

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Berkowitz, R. I., Fujioka, K., Daniels, S. R., Hoppin, A. G., Owen, S., Perry, A., ... Blakesley, V. A. (2006). Effects of sibutramine treatment in obese adolescents: A randomized trial. Annals of Internal Medicine, 145(2), 81-90.

Effects of sibutramine treatment in obese adolescents : A randomized trial. / Berkowitz, Robert I.; Fujioka, Ken; Daniels, Stephen R.; Hoppin, Alison G.; Owen, Stanford; Perry, Arlette; Sothern, Melinda S.; Renz, Cheryl L.; Pirner, Mark A.; Walch, Julia K.; Jasinsky, Olga; Hewkin, Ann C.; Blakesley, Vicky A.

In: Annals of Internal Medicine, Vol. 145, No. 2, 18.07.2006, p. 81-90.

Research output: Contribution to journalArticle

Berkowitz, RI, Fujioka, K, Daniels, SR, Hoppin, AG, Owen, S, Perry, A, Sothern, MS, Renz, CL, Pirner, MA, Walch, JK, Jasinsky, O, Hewkin, AC & Blakesley, VA 2006, 'Effects of sibutramine treatment in obese adolescents: A randomized trial', Annals of Internal Medicine, vol. 145, no. 2, pp. 81-90.
Berkowitz RI, Fujioka K, Daniels SR, Hoppin AG, Owen S, Perry A et al. Effects of sibutramine treatment in obese adolescents: A randomized trial. Annals of Internal Medicine. 2006 Jul 18;145(2):81-90.
Berkowitz, Robert I. ; Fujioka, Ken ; Daniels, Stephen R. ; Hoppin, Alison G. ; Owen, Stanford ; Perry, Arlette ; Sothern, Melinda S. ; Renz, Cheryl L. ; Pirner, Mark A. ; Walch, Julia K. ; Jasinsky, Olga ; Hewkin, Ann C. ; Blakesley, Vicky A. / Effects of sibutramine treatment in obese adolescents : A randomized trial. In: Annals of Internal Medicine. 2006 ; Vol. 145, No. 2. pp. 81-90.
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AU - Owen, Stanford

AU - Perry, Arlette

AU - Sothern, Melinda S.

AU - Renz, Cheryl L.

AU - Pirner, Mark A.

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AU - Blakesley, Vicky A.

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N2 - 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. Design: 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002. Setting: 33 U.S. outpatient clinics. Participants: 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. Interventions: 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%. Measurements: 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/m 2 [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 ≤ 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]). Limitations: 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.

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