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Orlistat for Obese Teens?

A 1-year trial of this weight-loss drug elucidates the potential short-term benefits and drawbacks of use in adolescents.

Orlistat is a gastrointestinal-tract lipase inhibitor approved by the FDA to treat obesity in adults and, on the basis of preliminary data from a randomized multicenter trial, in adolescents (http://www.fda.gov/cder/foi/label/2003/20766se5-018_xenical_lbl.pdf). That manufacturer-funded trial, now formally published, enrolled 539 obese adolescents (age 12–16) who received orlistat (120 mg, 3 times daily; 357 patients) or placebo (182 patients) for 1 year. All participants had body-mass indexes 2 kg/m² above the U.S. 95th percentile for age and sex, and all were assigned to a low-calorie diet, exercise, and behavioral therapy during the study. The trial-completion rate was about 65% in each group, but nearly all participants had at least one follow-up assessment and were included in the analyses.

Significant BMI declines occurred in both groups by 3 months. At 1 year, the BMI change from baseline was +0.31 kg/m² in the placebo group and –0.55 kg/m² in the orlistat group (a significant difference), and BMI declines of >5% and >10% were significantly more common with orlistat than with placebo. Both groups of growing adolescents gained weight during the study (mean, +3.14 kg with placebo vs. +0.53 kg with orlistat, P<0.001); the two groups had similar gains in fat-free body mass, but the orlistat group experienced a much greater loss of fat mass than did the placebo group. Most cardiovascular risk-factor changes were similar between the two groups.

Orlistat did not adversely affect bone-mineral content or growth patterns. Adverse GI events occurred in both groups but were much more common with orlistat, occurring in about half of recipients.

Comment: In this small, 1-year randomized trial in obese adolescents, orlistat was associated with significantly less weight gain than was placebo. Despite the small absolute size of the weight-gain advantage (<3.0 kg) and orlistat's substantial rate of GI side effects, the drug might be appropriate for well-chosen obese adolescents who are enrolled in comprehensive obesity-management programs with adequate support and supervision. Further studies must examine orlistat's long-term effects on cardiovascular risk and on growth in adolescents.

— JoAnne M. Foody, MD

Published in Journal Watch Cardiology July 15, 2005

Citation(s):

Chanoine J-P et al. Effect of orlistat on weight and body composition in obese adolescents: A randomized controlled trial. JAMA 2005 Jun 15; 293:2873-83.

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