Randomized, Double-Blind, Placebo-Controlled Trial of Orlistat for Weight Loss in Adolescents

doi:10.4158/EP.12.1.18

Endocrine Practice

Volume 12, Issue 1, January–February 2006, Pages 18-28

https://doi.org/10.4158/EP.12.1.18 Get rights and content

ABSTRACT

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. (Endocr Pract. 2006;12:18-28)

Section snippets

INTRODUCTION

The prevalence of obesity has increased in America and worldwide. Data from 1999 to 2000 indicate that 15.5% of children and adolescents ages 12 to 19 years in the United States were overweight (defined as body mass index [BMI] > 95th percentile) and a further 20% were classified as at risk (defined as a BMI between the 85th and 95th percentiles for age and sex) (1). Furthermore, the rate of development of obesity is increasing. Data from the first 3 years of the National Health and Nutrition

Study Participants

Overall, 40 subjects were enrolled in this study in a randomized, double-blind manner. Subjects were recruited from our pediatric population as well as from other pediatricians in private practice in Albuquerque. This broad recruitment strategy ensured a clinically relevant population in need of therapy for obesity. All subjects were between the ages of 14 and 18 years old and had a BMI that exceeded the 85th percentile for age and sex. Exclusion criteria included known secondary causes for

Participant Flow

Forty-three subjects were screened to participate in the study, of whom 40 were enrolled and 20 each randomized to receive either orlistat or placebo (Fig. 1). In the orlistat group, 16 of the 20 subjects who were enrolled completed the 6-month study. Reasons for withdrawal from the study in the orlistat group included the following: adverse effects in 2 subjects, lack of parental support in 1 subject, and suicide in 1 subject who was under a psychiatrist’s care. In the placebo group, 18 of the

DISCUSSION

Obesity continues to increase worldwide and more so in certain ethnicities. Especially disturbing are the increasing prevalence and degree of obesity in America’s youth. Obesity is linked with a variety of serious health-care problems. Early onset of obesity will likely lead to earlier development and longer duration of obesity-related morbidities, such as diabetes, and premature mortality (22). In the current study, the mean BMI was 40 kg/m² and the mean age was 15.8 years, indicating an early

ACKNOWLEDGMENT

This research was supported by grants from the University of New Mexico Department of Pediatrics Research Committee; the Research Allocation Committee, University of New Mexico; and the University of New Mexico GCRC (National Institutes of Health, National Center for Research Resources GCRC grant M01-RR00997). We thank Rob Annett, PhD, for reviewing the QOL questionnaires, the GCRC nursing and dietary staff, and Carolyn King for secretarial support.

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Original ArticleRandomized, Double-Blind, Placebo-Controlled Trial of Orlistat for Weight Loss in Adolescents

ABSTRACT

Objective

Methods

Results

Conclusion

Section snippets

INTRODUCTION

Study Participants

Participant Flow

DISCUSSION

ACKNOWLEDGMENT

Prev Med.

Lancet.

Prevalence and trends in overweight among US children and adolescents, 1999-2000

JAMA.

Overweight children and adolescents: description, epidemiology, and demographics

Pediatrics.

Extent of overweight among US children and adolescents from 1971 to 2000

Int J Obes Relat Metab Disord.

Long-term morbidity and mortality of overweight adolescents: a follow-up of the Harvard Growth Study of 1922 to 1935

N Engl J Med.

Health-related quality of life of severely obese children and adolescents

JAMA.

How effective are traditional dietary and exercise interventions for weight loss?

Med Sci Sports Exerc.

Interventions for treating obesity in children

Cochrane Database Syst Rev.

Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions

Obes Res.

Orlistat treatment in obese prepubertal children: a pilot study

Acta Paediatr.

Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial [erratum in JAMA. 1999;281:1174]

JAMA.

Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity

Obes Res.

Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults

Arch Intern Med.

Original Article
Randomized, Double-Blind, Placebo-Controlled Trial of Orlistat for Weight Loss in Adolescents