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

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.