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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. 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/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]). 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.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Berkowitz RI,Fujioka K,Daniels SR,Hoppin AG,Owen S,Perry AC,Sothern MS,Renz CL,Pirner MA,Walch JK,Jasinsky O,Hewkin AC,Blakesley VA,Sibutramine Adolescent Study Group.

doi

10.7326/0003-4819-145-2-200607180-00005

subject

Has Abstract

pub_date

2006-07-18 00:00:00

pages

81-90

issue

eissn

0003-4819

issn

1539-3704

pii

145/2/81

journal_volume

145

pub_type

杂志文章,多中心研究,随机对照试验

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Effects of sibutramine treatment in obese adolescents: a randomized trial.