Development of Age-appropriate Formulations and Doses for Elderly Patients Could Enable Smarter Prescription of Approved Drugs, says GBI Research

Apr 09, 2014
By Applied Clinical Trials Editors

Despite the elderly being the fastest-growing segment of the global population, only a few of their treatments have been clinically trialed in age-appropriate patients, with many of their therapies still not available in suitable formulations and dosages, says business intelligence provider GBI Research.

According to the company’s latest report*, many older people suffer from comorbid conditions and one in three takes at least five drugs or more on a daily basis. This significantly increases the risk of Adverse Drug Events and hospitalization, with up to one third of elderly emergency admissions being drug-related.

GBI Research states that off-label prescriptions are common for older patients, as pre-marketing drug trials often exclude geriatric patients and approved doses are not likely to be appropriate for the elderly.

Antipsychotic medications, for example, are regularly prescribed off-label in up to 80% of care-home patients, to manage delirium, agitation and psychosis resulting from Alzheimer’s disease and schizophrenia. However, these drugs have been associated with an increased risk of diabetes, cerebrovascular events and death, according to the report.

In 2010, the International Conference on Harmonisation (ICH) updated its E7 guidelines, which determined that the number of older patients should be representative of the study population and not limited to 100 patients, as previously indicated. Additionally, ICH E7 recommended that people aged 75 years and older should be incorporated in clinical trials, including those with comorbidities using concomitant therapies.

GBI Research believes that the development of age-appropriate formulations and doses could allow for smarter prescriptions of approved drugs, such as anti-coagulants, anti-diabetic agents, antipsychotics and analgesics in older people. Additionally, new opportunities exist for companies to develop medicines for age-related diseases, including cognitive impairment, sarcopenia and neurodegenerative diseases.

*CBR Pharma: Geriatric Medicine Development - Carving Out New Opportunities to Treat Age-Related Diseases

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