To evaluate the availability of medication studies enrolling patients that are 80 years of age and older.

Evaluation of Medication Studies Enrolling Patients Aged 80 Years and Older

Nipa Patel PharmD Candidate 2013 * Marilyn N. Bulloch PharmD, BCPS

•A search was conducted using PubMed, Google, and Google Scholar to identify studies of older people and their inclusion in clinical studies involving medication use. • Pertinent references of identified articles were also included. Keywords searched:

• 80 years and older,• Octogenarians,• Nonagenarian• Octogenarians/ nonagenarian + medication,• Octogenarians/ nonagenarian + warfarin,• Octogenarians/ nonagenarian + benzodiazepines,• Octogenarians/ nonagenarian + beta blockers,• Octogenarians + calcium channel blockers,• Octogenarians +iron, • Octogenarians +triptans,• Octogenarians +depression• Octogenarians +heart failure.• Hypertension• Diabetes• Chronic obstructive pulmonary diseases (COPD)• Stroke

Search Limits• Humans• Clinical Trials• Age of 80 years and older. • No restriction was set on any specific languages• Excluded oncology studies

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• Evidence regarding efficacy and safety of medication use in patients 80 years and older is limited.

• The majority of the studies identified enrolled small numbers of patients 80 years of age and older

• The most common disease states studied were cardiac disorders and strokes which a common concern in the geriatric population

• The most common drug class studied was antiarrhythmic which is also a common concern geriatric population.

• More studies concentrating on the inclusion of older patients are required for the proper understanding of safety and efficacy of medications in these patients.

In the United States, the older population is currently the fastest growing age group, and this trend is expected to continue for many decades. Usually geriatrics have a higher disease burden compared to younger adults. Among the geriatrics, heart disease, cancer, stroke, chronic obstructive pulmonary diseases, diabetes, and pneumonia and influenza are some of the most common disease states. A dramatic reductions in old age mortality has been seen through out the years. During the last 10 years, life expectancy has increased and the number of centenarians has doubled or more in most developed countries. If life expectancy continues to rise at the same rate as during the last 160 years. It has been estimated that about 50% of people born in the beginning of this century will live to see their 100th birthday.

Approximately one-third of all prescription drugs are used by geriatric patients, despite the fact that this group represents only about 13% of the US population. An average geriatric American uses 4-5 prescription drugs and 2 over-the-counter medications daily. Patients who are frail or in a nursing home use an average of 7-8 medications per day. There are many effective treatments for conditions that affect the geriatrics.

Though geriatrics are the largest users of medications, many medications are not satisfactorily evaluated in patients aged 80 years and older during pre-market studies. As a result, the data assessing benefit versus risk estimation, and dose adjustment requirements in patients over the age of 80 years is limited.

INTRODUCTION

RESULTS

OBJECTIVE

METHODS RESULTS

CONCLUSION

DISCLOSURES

Table 1: Characteristics of Clinical Studies Enrolling Patients Aged ≥ 80 Years

Studies Identified 16

Prospective Trials 13 (81%)

Retrospective Trials 3/16

Gender¶ 66% Female

Average Age╪ 73.8 (2-100)

Trials only with patients >80 year of age (n=10)

83.47 years (80-100 years)

Trials including patients < 80 years of age (n=3)

63.45 years (2-95 years)

¶ Gender was only provided in 14 or 16 studies evaluated╪ Average age was only provided in 13 of 16 studies evaluated

•All authors: nothing to disclose.•Reference available on request.