Effects of Sibutramine Treatment in Obese Adolescents

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Abstract
Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy. To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program. 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002. 33 U.S. outpatient clinics. 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. 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%. Body mass index, waist circumference, body weight, fasting lipid and glycemic variables, safety, and tolerability. 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 ≤ 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]). 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. 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. *For members of the Sibutramine Adolescent Study Group, see the Appendix.