safety of orlistat

Safety and Efficacy of Orlistat in African American and Caucasian Children and Adolescents with Obesity-Related Comorbid Conditions

Presented by Nancy Sebring and Patti Riggs at the NIH

Review by Ann McMeans, MS, RD, LD

Currently, there are no drugs approved for use with obese children, hence the reason for the study. The study began with a 6-month open label pilot with all children on Orlistat. The second phase is a randomized double blind placebo controlled study.

Protocol Description:

Subjects : BMI greater than 95^th%ile, age 12-17, evidence of obesity related

problems (i.e. apnea, increased insulin production)

Screening: H&P, 7 day food record to assess usual intake

Seven day initial admission where many studies are done (i.e. sleep study,

GTT, body comp, 72 hour fecal fat, RMR)

On discharge 10 kids start as a group--Orlistat 120mg P.O. TID, MVI, 20% calorie deficit

Behavioral modification program

Parents group

Results: 1^st group @ month four: 3 drop outs, wt loss 0-45 pounds, some adverse GI affects. Have not started 2^nd group yet.

This study is looking at fat preferences and whether participant’s preferences for fat will change with Orlistat. The study also looks at the effect of Orlistat on the absorption of beta-carotene in children and adolescents.