Monday, November 2, 2009
INTRODUCTION
This Article is an addendum to the Guideline on Clinical Investigation of Medicinal Products used in Weight Control for Adults. It provides guidance on the clinical investigation of medicinal products used in weight control in the paediatric population and should be read in conjunction with the Annex I to Directive 2001/83/EC, as amended, and with relevant European or ICH guidelines for conducting clinical trials, as outlined in the adult guideline.
The prevalence of child obesity is increasing rapidly on a global scale. It is a serious issue with many health and social consequences that often continue into adulthood. Obesity occurs when an individual takes in more energy than they expend although some people may be genetically more susceptible than others. The rise in obesity has been too rapid to be solely attributable to genetic factors and thus must reflect changes in eating patterns and levels of physical activity. It is especially prevalent in industrialised countries where sedentary lifestyles are commonly coupled with high consumption of convenience foods.
Obesity is associated with a range of co-morbidities including type 2 diabetes or hyperinsulinaemia, hypertension, dyslipidaemia and social and psychological problems including stigmatisation, discrimination and prejudice. Coronary heart disease, cancers and joint and bone pain are comorbidities that are well documented in adult obesity, with coronary heart disease being the most common cause of premature death among obese people. Less clear are the links between cancer and obesity. The evidence is strongest for colon cancer where the risk is nearly three times higher in obese men and women.
As childhood obesity frequently continues into adulthood as described above, obesity in childhood is a risk factor for all of the above disease states in later life.
1. DEFINITION OF OBESITY IN CHILDREN
A wide variety of definitions for childhood obesity are in use, but a universally employed definition does not, however, exist. The body mass index (BMI = bodyweight (kilograms)/ (height [metres²]) is widely used in adult populations and a 30 kg/m² cut-off point is recognised internationally as a definition of adult obesity.
However, in children the situation is more complex as the BMI changes substantially with age. BMI cut-offs based on pooled international data that link the accepted adult cut-off points (a BMI of 25 Kg/m2 for overweight and 30 Kg/m2 for obesity) to cut-off points related to age and sex for children should be used to define overweight and obesity in the paediatric population Primary obesity is obesity due to primary causes including lifestyle and dietary habits coupled with lack of adequate physical activity. Secondary obesity refers to obesity where there may be an underlying medical condition such as genetic disorders, endocrine disorders or metabolic disorders.
2. AGE CLASSIFICATION
The ICH guidance Article on clinical investigation of medicinal products in the paediatric
population uses the following categorisation for age classification of paediatric patients:
Ages are defined in completed days, months, or years:
- preterm newborn infants;
- term newborn infants (0 to 27 days);
- infants and toddlers (28 days to 23 months)
- children (2 to 11 years);
- adolescents (12 to 16-18 years (dependent on region)).
- Pre-pubertal: age 6 years old to onset of puberty as defined by a Tanner score of 2.
- Post-pubertal: post-puberty to age 18 years.
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