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Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents.

Publication ,  Journal Article
Maahs, D; de Serna, DG; Kolotkin, RL; Ralston, S; Sandate, J; Qualls, C; Schade, DS
Published in: Endocr Pract
2006

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.

Duke Scholars

Published In

Endocr Pract

DOI

ISSN

1530-891X

Publication Date

2006

Volume

12

Issue

1

Start / End Page

18 / 28

Location

United States

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Risk Assessment
  • Reference Values
  • Quality of Life
  • Probability
  • Orlistat
  • Obesity
  • Male
  • Lactones
 

Citation

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Chicago
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MLA
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Maahs, D., de Serna, D. G., Kolotkin, R. L., Ralston, S., Sandate, J., Qualls, C., & Schade, D. S. (2006). Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Endocr Pract, 12(1), 18–28. https://doi.org/10.4158/EP.12.1.18
Maahs, David, Daniela Gonzalez de Serna, Ronette L. Kolotkin, Shawn Ralston, Jeffrey Sandate, Clifford Qualls, and David S. Schade. “Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents.Endocr Pract 12, no. 1 (2006): 18–28. https://doi.org/10.4158/EP.12.1.18.
Maahs D, de Serna DG, Kolotkin RL, Ralston S, Sandate J, Qualls C, et al. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Endocr Pract. 2006;12(1):18–28.
Maahs, David, et al. “Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents.Endocr Pract, vol. 12, no. 1, 2006, pp. 18–28. Pubmed, doi:10.4158/EP.12.1.18.
Maahs D, de Serna DG, Kolotkin RL, Ralston S, Sandate J, Qualls C, Schade DS. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Endocr Pract. 2006;12(1):18–28.

Published In

Endocr Pract

DOI

ISSN

1530-891X

Publication Date

2006

Volume

12

Issue

1

Start / End Page

18 / 28

Location

United States

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Risk Assessment
  • Reference Values
  • Quality of Life
  • Probability
  • Orlistat
  • Obesity
  • Male
  • Lactones