Three‐Month Tolerability of Orlistat in Adolescents with Obesity‐Related Comorbid Conditions

McDuffie, Jennifer R; Calis, Karim A.; Uwaifo, Gabriel I.; Sebring, Nancy G.; Fallon, Erica M.; Hubbard, Van S.; Yanovski, Jack A.

doi:10.1038/oby.2002.87

Cited by 152 publications

(89 citation statements)

References 53 publications

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“…For orlistat, published reports conclude repeatedly that it is 'well tolerated' [17][18][19]. However, published trial data show that although persistence with orlistat for Ն3 months in clinical trials was markedly greater than in our data, gastrointestinal side-effects were reported in >50%.…”

Section: Comparison With the Literaturecontrasting

confidence: 53%

“…However, gastrointestinal adverse events were reported by 50% of those taking orlistat [18]. A detailed study of the tolerability of taking orlistat together with a comprehensive behavioural and dietetic programme in 20 adolescents over 3 months found that 85% completed 3 months on orlistat, but that 50-60% reported a combination of unpleasant gastrointestinal side-effects [17]. In an early small open-label randomized controlled trial, gastrointestinal side-effects were reported in all 22 adolescents receiving orlistat, of whom seven (32%) dropped out of the trial during the first month of the trial due to side-effects attributable to orlistat [20].…”

Section: Comparison With the Literaturementioning

confidence: 99%

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Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

Viner

Hsia

Neubert

et al. 2009

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The antiobesity drugs sibutramine and orlistat are not licensed for use in children and adolescents in the UK or USA.• Clinical trials suggest antiobesity drugs are effective and well‐tolerated in obese adolescents. WHAT THIS STUDY ADDS • Prescribing of unlicensed antiobesity drugs in children and adolescents has increased significantly in the past 8 years.• Most prescribed antiobesity drugs in children and adolescents are rapidly discontinued before patients can see clinical benefit, suggesting they are poorly tolerated or poorly efficacious.AIMS The international childhood obesity epidemic has driven increased use of unlicensed antiobesity drugs, whose efficacy and safety are poorly studied in children and adolescents. We investigated the use of unlicensed antiobesity drugs (orlistat, sibutramine and rimonabant) in children and adolescents (0–18 years) in the UK.METHODS Population‐based prescribing data from the UK General Practice Research Database between 1 January 1999 and 31 December 2006.RESULTS A total of 452 subjects received 1334 prescriptions during the study period. The annual prevalence of antiobesity drug prescriptions rose significantly from 0.006 per 1000 [95% confidence interval (CI) 0.0007, 0.0113] in 1999 to 0.091 per 1000 (95% CI 0.07, 0.11) in 2006, a 15‐fold increase, with similar increases seen in both genders. The majority of prescriptions were made to those ≥14 years old, although 25 prescriptions were made for children <12 years old. Orlistat accounted for 78.4% of all prescriptions; only one patient was prescribed rimonabant. However, approximately 45% of the patients ceased orlistat and 25% ceased sibutramine after only 1 month. The estimated mean treatment durations for orlistat and sibutramine were 3 and 4 months, respectively.CONCLUSIONS Prescribing of unlicensed antiobesity drugs in children and adolescents has dramatically increased in the past 8 years. The majority are rapidly discontinued before patients can see weight benefit, suggesting they are poorly tolerated or poorly efficacious when used in the general population. Further research into the effectiveness and safety of antiobesity drugs in clinical populations of children and adolescents is needed.

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Section: Comparison With the Literaturecontrasting

confidence: 53%

Section: Comparison With the Literaturementioning

confidence: 99%

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

Viner

Hsia

Neubert

et al. 2009

Brit J Clinical Pharma

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“…In the US, the Food and Drug Administration (FDA) has approved orlistat for children aged 12-18 y in 2003 using a limited documentation with a maximum of 20 subjects in each study indicating the same side-effect profile as in adults. [53][54][55] However, until more extensive safety and efficacy data are available, medications for weight loss should be used only on an experimental basis in adolescents and children.…”

Section: Treatment Based On Psychotherapy Techniquesmentioning

confidence: 99%

New insights into the field of children and adolescents’ obesity: the European perspective

et al. 2004

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EDITOR'S NOTE:The problem of childhood obesity is accelerating throughout the world. The following is a position paper from The European Childhood Obesity Group (ECOG) that outlines the nature of the problem of childhood obesity along with treatment and prevention methods available today. The paucity of literature on prevention and treatment of obesity in children as documented in this paper points out the need for much additional research on obesity in children. OBJECTIVES: The awareness of childhood obesity as a major health problem and an uncontrolled worldwide epidemic has to be increased in the society. DESIGN: In order to improve the quality of the health care and to minimize the cost it is important to investigate and standardize pediatric obesity prevention and treatment and to adapt to social and cultural aspects. RESULTS: Obesity is the result of excess body fat. The different norms and definitions in Europe and the US is described and clarified. However, the available methods for the direct measurement of body fat are not easily used in daily practice. For this reason, obesity is often assessed by means of indirect estimates of body fat, that is, anthropometrics. There are essentially six relevant levels, which could be involved in prevention of child and adolescent obesity: family (child, parents, siblings, etc), schools, health professionals, government, industry and media. Evidence-based health promotion programs has to be given a high priority. Government should encourage media increase information about healthy nutrition and to avoid the marketing of unhealthy foods including sweet drinks, for example, in TV. Many different approaches of treatments of obesity have been investigated, including diet, exercise, behavioral therapy, surgery, and medication. None have been found to be effective enough as sole tools in children. This has led to focus on multidisciplinary programs especially involving families. Behavioral cognitive therapy is effective in treating childhood obesity as is family therapy. Surgery and drug treatment cannot be recommended without additional research. Clinicians should consider the various factors that can influence body composition. CONCLUSION: It is important to know and to follow nutritional factors, energy intake and composition of the diet, nutrition and hormonal status, food preferences and behavior, and the influence of non-nutritional factors. We recommend that obesity should be the major priority both in the health care system, on the scientific level and for future political actions.

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“…Clinical trials in adults lasting up to 2 years have not reported serious side effects. 48 Recent studies in obese adolescents 49 and prepubertal children 50 indicate that short-term Orl treatment is well-tolerated by children and has a side effect profile similar to that observed in adults. Side effects are generally mild, are limited to gastrointestinal effects such as flatulence and oily leakage, and decrease with time.…”

Section: Discussionmentioning

confidence: 99%

Effective oral treatment of unconjugated hyperbilirubinemia in Gunn rats

et al. 2005

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We sought to develop an oral treatment for unconjugated hyperbilirubinemia. In the Gunn rat model of unconjugated hyperbilirubinemia, dietary supplementation with the lipase inhibitor orlistat (Orl) or with calcium phosphate (CaP) decreases plasma unconjugated bilirubin (UCB) levels. We determined whether Orl, CaP, or their combination is superior to phototherapy, the conventional treatment, and whether the effects of Orl and CaP are influenced by dietary fat content. Gunn rats were treated with Orl (200 mg/kg chow), CaP (20 g/kg chow), Orl ؉ CaP, or continuous phototherapy (19 W/cm 2 /nm) during a low-fat (LF) diet (13 energy%) or high-fat (HF) diet (35 energy%). Plasma UCB and fecal fat excretion were measured before, during, and/or at the end of treatment. Orl treatment for 2 weeks (HF diet) reduced plasma UCB concentrations similar to phototherapy (؊34% and ؊28%, respectively); the combination of both was more effective than either treatment alone (؊48%; P < .001). After 3 weeks of a HF diet, plasma UCB was 46% lower compared with the LF diet (P < .001). Plasma UCB concentrations were negatively correlated with fecal fat excretion (r ‫؍‬ ؊0.96; P < .001). Irrespective of dietary fat content, 3 weeks of combined treatment (Orl ؉ CaP) decreased plasma UCB by approximately 50% (P < .01) and was more effective than phototherapy (P < .05) at the intensity provided. C rigler-Najjar disease is characterized by a permanent unconjugated hyperbilirubinemia due to absent (type I) or decreased (type II) activity of the hepatic enzyme bilirubin-UDP-glucuronosyltransferase. 1 Severe unconjugated hyperbilirubinemia can lead to bilirubin encephalopathy, kernicterus, and death. 2,3 Phenobarbital treatment can usually control unconjugated hyperbilirubinemia in Crigler-Najjar type II patients via residual enzyme induction. 4,5 Phenobarbital is not effective in Crigler-Najjar disease type I, however, so these patients have to undergo daily phototherapy, which has considerable disadvantages. Phototherapy becomes less effective with age, probably due to skin alterations, 6,7 a decrease in the surface area to body mass ratio, 8 and a diminishing compliance to the intensive phototherapy regimen, which may take up to 12 hours per day. 6 To prevent irreversible brain damage due to kernicterus, many patients with CriglerNajjar disease type I undergo liver transplantation in their second decade. 9,10 We sought to develop an alternative treatment for unconjugated hyperbilirubinemia based on oral administration and with equal or higher efficacy than phototherapy. The oral treatment strategy used in the present study is based on reducing the reabsorption of UCB 11,12 through intestinal capture. Reabsorption of UCB can contribute substantially to the pathogenesis

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Three‐Month Tolerability of Orlistat in Adolescents with Obesity‐Related Comorbid Conditions

Cited by 152 publications

References 53 publications

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

New insights into the field of children and adolescents’ obesity: the European perspective

Effective oral treatment of unconjugated hyperbilirubinemia in Gunn rats

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