Childhood Obesity in the United Kingdom 89aged less than 12 years are initiated, studies should first be carried out in
adolescents aged 12-16 years old. Only once drugs have been shown to be safe
in this age group can they then be investigated in children under 12 years old.
Furthermore, due to changes in linear growth in children, the FDA
recommends change in BMI should be the primary efficacy parameter of
obesity drugs in children, as opposed to weight loss [42].
There is currently only a narrow range of pharmacological treatment
options available for childhood obesity. There are several reasons for this,
including a lack of good quality trial data and ethical considerations regarding
clinical trials involving children. There has also been debate regarding specific
weights for drug dosing in paediatric obesity, and several drugs have already
been taken off the market due to their side effects, as we will discuss below
[43].
In the UK, the use of drug therapy for childhood obesity is closely
regulated. According to the National Institute of Health and Care Excellence
(NICE) guidelines, drug therapy in children should only be considered if
weight modification programmes have failed [44]. In children less than 12
years old, pharmacotherapy is only recommended in exceptional
circumstances and if the child has severe co-morbidities. In children over 12
years old, NICE recommends drug therapy only if the child has severe
psychological or physical co-morbidities (for example, orthopaedic problems
or sleep apnoea). Orlistat is the only drug recommended by NICE for
paediatric obesity. In all cases, drug therapy must be initiated and monitored
by specialist paediatricians, working within highly experienced
multidisciplinary teams. In cases where Orlistat is prescribed for children,
NICE recommends an initial trial period of 6-12 months. Within this period
the child must be reviewed regularly to assess the effectiveness of the drug
therapy, monitor any adverse effects, and assess the child and family’s
adherence to the treatment. In children over 12 years old drug treatment may
be continued in primary care where local circumstances, e.g., shared protocols,
and licensing allow [44].
Scottish Intercollegiate Guidelines Network (SIGN) guidelines regarding
pharmacological treatment in young people recommend Orlistat only for
severely obese adolescents, with a BMI greater or equal to the 99.6th centile,
with co morbidities, or those with very severe to extreme obesity who are
attending a specialist clinic [45].^ Again, SIGN like NICE, recommends regular
reviews throughout the period of use, to assess effectiveness and monitor for
any adverse effects.