Introduction
Little is known about use of medication for obesity in children and adolescents in the UK, particularly use in primary care. Orlistat is currently the only licensed antiobesity drug (AOD) in the UK since sibutramine was withdrawn due to concerns about cardiovascular safety.1 2 However, the most commonly used drug for obesity in children and young people (CYP) is metformin, an antidiabetes drug used off-licence to treat the metabolic sequelae of obesity in CYP, although not formally classed as an AOD.3 4 Both orlistat and metformin appear to offer small benefits for body mass index (BMI) loss in CYP; systematic reviews show small reductions in BMI compared with placebo, orlistat by 0.83 kg/m2 5 and metformin by 1.4 kg/m2 (at 6–12 months and 6 months, respectively).6
In the UK, the National Institute for Health and Care Excellence (NICE) guidance recommends community-based lifestyle modification programmes as the first tier of weight management for childhood obesity, with pharmacotherapy as a second-line treatment.2 Their guidance, summarised in box 1, only covers use of orlistat, which they state should be prescribed only in exceptional circumstances for those with obesity-related comorbidities (life-threatening in those under 12 years of age) and only prescribed by teams with expertise in these conditions.
Summary of 2014National Institute for Health and Care Excellence guidance for prescribing of orlistat to children and young people
1.8.4—Drug treatment is not generally recommended for children younger than 12 years.
1.8.5—In children younger than 12 years, drug treatment may be used only in exceptional circumstances, if severe comorbidities are present. Prescribing should be started and monitored only in specialist paediatric settings.
1.8.6—In children aged 12 years and older, treatment with orlistat is recommended only if physical comorbidities (such as orthopaedic problems or sleep apnoea) or severe psychological comorbidities are present. Treatment should be started in a specialist paediatric setting, by multidisciplinary teams with experience of prescribing in this age group.
1.8.7—Do not give orlistat to children for obesity unless prescribed by a multidisciplinary team with expertise in drug monitoring, psychological support, behavioural interventions, interventions to increase physical activity and interventions to improve diet.
1.8.8—Drug treatment may be continued in primary care, for example, with a shared care protocol if local circumstances and/or licensing allow.
1.9.2—Adults and children: If there is concern about micronutrient intake adequacy, a supplement providing the reference nutrient intake for all vitamins and minerals should be considered, particularly for vulnerable groups such as older people (who may be at risk of malnutrition) and young people (who need vitamins and minerals for growth and development).
1.9.11—If orlistat is prescribed for children, a 6-month to 12-month trial is recommended, with regular review to assess effectiveness, adverse effects and adherence.
Randomised trial data on orlistat and metformin come from specialist clinical settings and largely from outside the UK. Very little is known about how these AODs are prescribed and used in actual practice. Pharmacoepidemiology studies of AOD prescribing in primary care in the UK show increasing use of AODs, but also high levels of drug discontinuation, with approximately half the prescriptions of orlistat not being continued beyond 1 month.5 The one qualitative study examining adolescent use of AOD showed frequent cessation by families independent of their doctors, usually because the perceived advantages did not outweigh the medication side effects that they endured with often minimal professional support.7 These data suggest that the effectiveness of AOD in ‘real life’ settings may be considerably less than shown in trials, and suggest a need to identify strategies to improve the effectiveness of AODs for CYP.
We undertook a questionnaire survey of general practitioners (GPs) prescribing AODs to CYP to better understand their use in primary care in the UK. We sought to characterise patient demographics, quantify adherence to NICE guidance and identify primary care perceptions of AOD with the long-term aim of optimising AOD prescribing and efficacy.