TY - JOUR
T1 - Effects of sibutramine treatment in obese adolescents
T2 - A randomized trial
AU - Berkowitz, Robert I.
AU - Fujioka, Ken
AU - Daniels, Stephen R.
AU - Hoppin, Alison G.
AU - Owen, Stanford
AU - Perry, Arlette C.
AU - Sothern, Melinda S.
AU - Renz, Cheryl L.
AU - Pirner, Mark A.
AU - Walch, Julia K.
AU - Jasinsky, Olga
AU - Hewkin, Ann C.
AU - Blakesley, Vicky A.
PY - 2006/7/18
Y1 - 2006/7/18
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.
AB - 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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U2 - 10.7326/0003-4819-145-2-200607180-00005
DO - 10.7326/0003-4819-145-2-200607180-00005
M3 - Article
C2 - 16847290
AN - SCOPUS:33746664768
VL - 145
SP - 81
EP - 90
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 2
ER -
