Orlistat Helps Manage Weight in Teens
As more children and teenagers are tipping the scales into overweight andobesity, some are searching for pharmacological approaches to help fight theepidemic. A clinical study reported in the June 15 JAMA suggests thatorlistat (Xenical, Roche) is safe and effective as part of a weight-managementtreatment program for obese adolescents.
Orlistat, a gastrointestinal tract lipase inhibitor, reduces dietary fatabsorption by about 30%. Although its safety profile in adults is well known,the drug is not labeled for use in adolescents. The 54-week double-blindclinical trial included 539 obese adolescents who were followed at 32 centersin the U.S. and Canada. They were 12–16 years old and two or more unitsabove the 95th percentile of age- and sex-matched body mass index (BMI).
Three hundred fifty-seven participants took 120 mg orlistat three timesdaily for 1 year, while 182 control subjects were given placebo. Allparticipants were prescribed a mildly hypocaloric diet, deriving 30% ofcalories from fat, and advised to exercise. They also received behavioraltherapy. Outcome measures included changes in BMI, waist and hipcircumferences, weight, lipid measurements, and glucose and insulin responseto an oral glucosechallenge.
Although both groups initially lost weight, by the end of the study periodthose who had taken orlistat decreased BMI an average of 0.55 units whilepatients on placebo gained an average of 0.31 units. Combined with exerciseand behavioral therapy, orlistat significantly improved weight managementwithout negatively affecting the building of lean body mass typically seenduring adolescence.
No safety issues were raised during the clinical trial, although thosereceiving orlistat had more adverse gastrointestinal events.
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