TY - JOUR
T1 - Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents
AU - Maahs, David
AU - Gonzalez De Serna, Daniela
AU - Kolotkin, Ronette L.
AU - Ralston, Shawn
AU - Sandate, Jeffrey
AU - Qualls, Clifford
AU - Schade, David S.
PY - 2006
Y1 - 2006
N2 - 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. Conclusion: In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months.
AB - 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. Conclusion: In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months.
UR - http://www.scopus.com/inward/record.url?scp=33646842569&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646842569&partnerID=8YFLogxK
U2 - 10.4158/EP.12.1.18
DO - 10.4158/EP.12.1.18
M3 - Article
C2 - 16524859
AN - SCOPUS:33646842569
SN - 1530-891X
VL - 12
SP - 18
EP - 28
JO - Endocrine Practice
JF - Endocrine Practice
IS - 1
ER -