Studies in Support of Special Populations

6. Studies in Elderly People

The elderly population will increase significantly over coming years. This means that the management of medicines for geriatric populations is an important issue. The use of medicines in this population requires special consideration due to the frequent occurrence of underlying diseases, use of concomitant medicines and the consequent risk of medicines interaction.

Not all potential differences that can occur in the geriatric population can be predicted from non-geriatric populations. This might include differences in:

  • pharmacokinetics  - what the body does to the medicine
  • pharmacodynamics - what the medicine does to the body
  • disease-medicine interactions - interactions between the medicine and existing diseases
  • medicine interactions - interactions between the tested medicine and other medicines the patient takes
  • clinical response - the effect of the medicine on the disease.

The elderly patients are far more likely to have multiple illnesses and to be receiving multiple medicines.  Therefore, to assess the benefit-risk balance of a medicine that will be used in the geriatric population, elderly patients should be represented in clinical trials.