What's different about older people.

Older people can be regarded as a marginalised group within society from a number of perspectives including that of health. When it comes to the use of medication older people have suffered from a double whammy. Not only are they more at risk from the adverse effects of drugs but also their involvement in clinical trials has been limited so that rational prescribing both to maximise benefit and to reduce risk has been problematic. Their special problems have been recognised formerly by the Department of Health in its NSF for Older People [National Service Framework for Older People. Department of Health, London (2001a)], [Medicines and Older People. Implementing medicines-related aspects of the NSF for Older People. Department of Health (2001b)]. Early studies focussed on compliance, the avoidance of poly-pharmacy and the high prevalence of adverse effects of drugs and the reasons for this. Studies in long-stay patients showed dramatic differences in pharmacokinetics between such older people and young healthy volunteers. Initially such differences were ascribed to age alone and the overall message became "start low and go slow". Studies in healthy older people then revealed that age differences in drug metabolism were, as a rule, not so marked although clearance of renally excreted drugs was reduced in line with the age associated decline in renal function. Including older people in clinical trials poses challenges. Many traditional trialists do not have ready access to older people, co-morbidity and poly-pharmacy are common and most people feel reluctant to ask older people to take part in complex and potentially hazardous trials. Concern about compliance is unwarranted. Adverse events may be more serious. Thus in a younger patient postural hypotension may make a subject unsteady but in an older subject the unsteadiness may lead to a fall, the fall to a fracture, and the fracture to poor recovery. The choice of end-points is crucial. Although reduction of clinical events is clearly important, effects on quality of life become more important as natural life expectancy reduces. Although regulatory bodies state that they now evidence of effectiveness in older people before registration there are still many examples of arbitrary and illogical upper age limits in clinical trials.