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Clinical question
Is orlistat (Xenical) effective for weight management in obese adolescents?
Bottom line
Orlistat (Xenical), in combination with diet, exercise, and behavioral
modification, improves weight management in obese adolescents. No major
safety issues were identified after 1 year, but further follow-up for
sustained weight management and safety is important.
Reference
Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of
orlistat on weight and body composition in obese adolescents. A randomized
controlled trial. JAMA 2005;293:2873-83.
Study design: Randomized controlled trial (double-blinded)
Setting: Outpatient (any)
Synopsis
These investigators identified 539 adolescents, aged 12 years to 16 years,
who met the criteria for obesity (a body mass index of more than 2 units
above the 95th percentile for age and sex). Participants were randomly
assigned in a double-blind fashion (concealed allocation assignment) to
receive 120 mg orlistat (Xenical) or placebo 3 times daily. All subjects
also received general recommendations for diet, exercise, and behavior
modification. Individuals blinded to treatment group assignment assessed
outcomes. Follow-up occurred for 98% of subjects for 1 year. Approximately
two thirds of adolescents in each group completed the study. The
investigators performed a modified intention-to-treat analysis which
included only patients with a baseline measurement and at least 1
postbaseline efficacy measurement. At 1 year of follow-up, 26.5% of
adolescents in the treatment group versus 15.7% in the placebo group had a
5% decrease in BMI, and 13.3% in the treatment group versus 4.5% in the
placebo group had a 10% decrease in BMI (NNT = 9; 95% CI, 6 - 31 for both).
Weight increased an average of 1.2 pounds with orlistat and 6.9 pounds with
placebo (total cost per pound not gained = $374). Overall, body mass index
decreased 0.55 in the orlistat group and increased 0.31 in the placebo group
(P = .001). Twelve (3.4%) patients taking orlistat and 3 (1.6%) taking
placebo discontinued treatment because of adverse events, most often
problems in the gastrointestinal tract. No major safety issues were
reported. |