From the publishers of The New England Journal of Medicine

Save time and stay informed. Our physician-editors offer you clinical perspectives on key research and news.

  1. Home>
  2. Specialties>
  3. Cardiology>
  4. Summary and Comment

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.

Your Remark:

Reader Remarks are intended to encourage lively discussion of clinical topics with your peers in the medical community. Please consider this when composing your remark.

Fields marked with an * are required.

Name as you'd like it to appear:

Submitting a comment indicates you have read and agreed to the remark guidelines and declare:*

PRIVACY: We will not use your email address, submitted for a comment, for any other purpose nor sell, rent, or share your e-mail address with any third parties. Please see our Privacy Policy.

 

CLEAR erases anything you've added in any part of the form. CONTINUE allows you to check your entire post (and edit it if necessary) before submitting.

To ensure that your Reader Remark is not formatted as one long paragraph, precede new paragraphs with either a blank line or an indentation.

Search

Advanced

Article Tools

Reader Remarks

Sign-In

Forgot your password?

New to Journal Watch?

E-mail Alerts

Delivered to your inbox.
Tailored to your interests. Free.

Sign Up Now!

Journal Watch Newsletters

Available in 13 specialties with convenient delivery and 10 free online CME exams.

Subscribe Now!

Copyright © 2005. Massachusetts Medical Society. All rights reserved.