Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions.
OBJECTIVE
To study the safety, tolerability, and potential efficacy of orlistat in adolescents with obesity and its comorbid conditions.


METHODS
We studied 20 adolescents (age, 14.6 +/- 2.0 years; body mass index, 44.1 +/- 12.6 kg/m(2)). Subjects were evaluated before and after taking orlistat (120 mg three times daily) and a multivitamin for 3 months. Subjects were simultaneously enrolled in a 12-week program emphasizing diet, exercise, and strategies for behavior change.


RESULTS
Participants who completed treatment (85%) reported taking 80% of prescribed medication. Adverse effects were generally mild, limited to gastrointestinal effects observed in adults, and decreased with time. Three subjects required additional vitamin D supplementation despite the prescription of a daily multivitamin containing vitamin D. Weight decreased significantly (-4.4 +/- 4.6 kg, p < 0.001; -3.8 +/- 4.1% of initial weight), as did body mass index (-1.9 +/- 2.5 kg/m(2); p < 0.0002). Total cholesterol (-21.3 +/- 24.7 mg/dL; p < 0.001), low-density lipoprotein-cholesterol (-17.3 +/- 15.8 mg/dL; p < 0.0001), fasting insulin (-13.7 +/- 19.0 microU/mL; p < 0.02), and fasting glucose (-15.4 +/- 7.4 mg/dL; p < 0.003) were also significantly lower after orlistat. Insulin sensitivity, assessed by a frequently sampled intravenous glucose-tolerance test, improved significantly (p < 0.02).


CONCLUSIONS
We conclude that, in adolescents, short-term treatment with orlistat, in the context of a behavioral program, is well-tolerated and has a side-effect profile similar to that observed in adults, but its true benefit versus conventional therapy remains to be determined in placebo-controlled trials.
McDuffie
Jennifer R
JR
Unit on Growth and Obesity, Developmental Endocrinology Branch, National Institute of Child Health and Human Development, NIH, Bethesda, Maryland 20892, USA. Mcduffj@mail.nih.gov
Calis
Karim A
KA
Uwaifo
Gabriel I
GI
Sebring
Nancy G
NG
Fallon
Erica M
EM
Hubbard
Van S
VS
Yanovski
Jack A
JA
D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D005215:Fasting; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007328:Insulin / Q000097:blood; D007783:Lactones / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D009765:Obesity / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000077403:Orlistat; D010865:Pilot Projects; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage; D014815:Vitamins / Q000008:administration & dosage; D015431:Weight Loss
D001786:Blood Glucose; D008078:Cholesterol, LDL; D007328:Insulin; D007783:Lactones; D014815:Vitamins; D014807:Vitamin D; D000077403:Orlistat; D002784:Cholesterol