nidhi.saxena@xcelloninstitute.com
Clinical Trials in
Geriatrics
Nidhi Saxena
Xcellon Institute
nidhi.saxena@xcelloninstitute.com
Introduction
Those aged 65 years or above
Increase in prevalence of large number of physical
and health related problems with age
Increased use of prescription and non-prescription
drug
Long duration of treatment and poly-pharmacy is
common in elderly
Altered physiological function altering the response
of drugs.
Drug used to treat condition where increased age
is a risk factor, older people should be
oversampled in studies designed to test there
efficacy
nidhi.saxena@xcelloninstitute.com
Fact
Elderly population are under-represented in trials
of treatments for conditions that predominantly
affect older people.
Limited data available for geriatrics from studies,
resulting in a late recognition of serious side effects
eg. benoxaprofen (Opren) was withdrawn from
the market after the report of death of 5 elderly
patients.
According to the Guidelines-
Trials of the efficacy of interventions need to
cover the age groups who are affected
nidhi.saxena@xcelloninstitute.com
Polypharmacy
Multiple drug prescription is common in elderly.
Reasons:
Prevalence of many diseases is age related and several
may co-exist in the same patient
Adequate response from single drug is not possible
Increased utilization of fixed dose drug combination for
the optimum management of a number of conditions.
To counteract or minimize the risk of side effects.
Patient are also being targeted by pharmaceutical
companies (direct-to- consumer advertising)
nidhi.saxena@xcelloninstitute.com
Interactions in relation to
multiple drug prescribing
ADRs are common in the elderly
Multiple drug prescription
Drug to drug interactions
Inappropriate drug combination
Drug interactions represent a change in either the
magnitude or the duration of action
This may enhance or reduce the efficacy of one or
both of the drugs or a new effect may appear
Intera