Three‐Month Tolerability of Orlistat in Adolescents with Obesity‐Related Comorbid Conditions

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Abstract
Objective:To study the safety, tolerability, and potential efficacy of orlistat in adolescents with obesity and its comorbid conditions.Research Methods and Procedures:We studied 20 adolescents (age, 14.6 ± 2.0 years; body mass index, 44.1 ± 12.6 kg/m2). Subjects were evaluated before and after taking orlistat (120 mg three times daily) and a multivitamin for 3 months. Subjects were simultaneously enrolled in a 12‐week program emphasizing diet, exercise, and strategies for behavior change.Results:Participants who completed treatment (85%) reported taking 80% of prescribed medication. Adverse effects were generally mild, limited to gastrointestinal effects observed in adults, and decreased with time. Three subjects required additional vitamin D supplementation despite the prescription of a daily multivitamin containing vitamin D. Weight decreased significantly (−4.4 ± 4.6 kg,p< 0.001; −3.8 ± 4.1% of initial weight), as did body mass index (−1.9 ± 2.5 kg/m2;p< 0.0002). Total cholesterol (−21.3 ± 24.7 mg/dL;p< 0.001), low‐density lipoprotein‐cholesterol (−17.3 ± 15.8 mg/dL;p< 0.0001), fasting insulin (−13.7 ± 19.0 μU/mL;p< 0.02), and fasting glucose (−15.4 ± 7.4 mg/dL;p< 0.003) were also significantly lower after orlistat. Insulin sensitivity, assessed by a frequently sampled intravenous glucose‐tolerance test, improved significantly (p< 0.02).Discussion:We conclude that, in adolescents, short‐term treatment with orlistat, in the context of a behavioral program, is well‐tolerated and has a side‐effect profile similar to that observed in adults, but its true benefit versus conventional therapy remains to be determined in placebo‐controlled trials.