Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents.
OBJECTIVE
To evaluate the efficacy of orlistat to enhance weight loss in obese adolescents.


METHODS
The study was a 6-month randomized, double-blind, placebo-controlled trial to compare the effects of orlistat (120 mg orally 3 times a day) and placebo on reduction of body mass index (BMI). Forty adolescents between 14 and 18 years of age with a mean BMI of 40 kg/m2 entered the protocol between December 2002 and February 2003. Study subjects stayed overnight in the General Clinical Research Center, during which dietary records were reviewed and lifestyle recommendations were given. The study participants received either orlistat (120 mg orally 3 times a day) or placebo and were assessed monthly for 6 months. At 0, 3, and 6 months, fasting laboratory tests were performed. The primary end point was the change in BMI from baseline to 6 months. Secondary outcomes included changes in weight, lean body mass, and results of blood chemistry studies.


RESULTS
No statistically significant difference was noted between the 2 study groups for decrease in BMI from baseline to 6 months (P = 0.39). The decrease in BMI within the orlistat group (-1.3 +/- 1.6 kg/m2; P = 0.04) and within the placebo group (-0.8 +/- 3.0 kg/m2; P = 0.02), however, was statistically significant. Laboratory measurements did not differ between the 2 groups. In comparison with the placebo group, the orlistat group had increased adverse events, primarily gastrointestinal symptoms and findings.


CONCLUSIONS
In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months.
Maahs
David
D
Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado 80262, USA.
de Serna
Daniela Gonzalez
DG
Kolotkin
Ronette L
RL
Ralston
Shawn
S
Sandate
Jeffrey
J
Qualls
Clifford
C
Schade
David S
DS
D000293:Adolescent; D019440:Anti-Obesity Agents / Q000008:administration & dosage*; D015992:Body Mass Index; D004032:Diet; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015444:Exercise; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007783:Lactones / Q000008:administration & dosage*; D008297:Male; D009765:Obesity / Q000175:diagnosis / Q000188:drug therapy*; D000077403:Orlistat; D011336:Probability; D011788:Quality of Life; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat