Effects of sibutramine treatment in obese adolescents - A randomized trial
Effects of sibutramine treatment in obese adolescents - A randomized trial
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DOI：
10.7326/0003-4819-145-2-200607180-00005
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发表时间：
2006-07-18
影响因子：
39.2
通讯作者：
Blakesley, Vicky A.
中科院分区：
文献类型：
--
作者：
Berkowitz, Robert I.;Fujioka, Ken;Blakesley, Vicky A.
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/m(2).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% Cl, -3.5 to -2.2 kg/m(2)]) and body weight (-8.4 kg [Cl, -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
