Older adults might be getting left out of important research and drug development, which could result in inaccurate treatment protocols, according to a report published in the November issue of Circulation: Cardiovascular Quality and Outcomes.
Emphasizing the population of seniors age 85 and older will more than double in the next 25 years, authors cited 2011 research showing 25% of heart failure trials had an “arbitrary upper age exclusion.” Not including the higher age bracket of older adults left out crucial factors such as decreased life expectancy, functional limitations, cognitive impairment, serious concomitant illness or nursing home residence, according to the report.
Researchers suggest such gaps in analysis and the creation of new drugs could have dire consequences, including increased cost, the report said. Women, who make up a majority of older cohorts, are most underrepresented, according to the report.
“It is no surprise that Medicare beneficiaries, almost all of whom have multiple chronic conditions differ significantly from participants in trials used to inform Medicare coverage decisions,” the authors write. “The medical community has suggested elimination of age-based exclusions, justification for exclusion criteria that limit inclusion of older individuals, performance of trials specific to older individuals, and reporting trends to assess inclusion of older adults in clinical trials.”
Although efforts have been made to improve inclusion of other demographic groups in studies, the authors write, research and trials for older adults continues to be lacking. Researchers note a 2014 initiative by Congress, dubbed the Food and Drug Administration Safety and Innovation Act, which required the FDA to report safety and effectiveness of drugs based on sex, age, race and ethnicity, according to the report. Drugs included in the FDA’s snapshots of demographics included Vorapaxar, a thrombin receptor antagonist that when administered along with antiplatelet therapy to patients with cardiovascular disease, led to a minor reduction in cardiovascular outcomes but also increased bleeding, the report stated. At the same time, the FDA’s snapshots of patient demographics did not include enough older individuals, showing no difference noted by patient age, but only 17% of the definitive trial and 9% of the overall drug experience was collected in those 75 years and younger, the report states. Researchers concluded that although 65 years old is an easy cutoff point for drug trials, 75 years old is better and 85 years old is optimal, particularly when considering the risk of bleeding is greater among older patients.
“The well-intentioned consumer FDA snapshots are also profoundly limited by the continued lack of inclusion of older adults on which to base their information,” the authors write.
The report points to efforts by other agencies and organizations that could serve as a good model for better inclusion of older adults, such as targeted and planned enrollment tables required for sex, race and ethnicity in trials at the National Institutes of Health.
“Continuing to simply characterize this geriatric gap for another 25 years will send health care for older adults blindly over the demographic cliff ahead,” researches concluded. “Despite concerns about implementa- tion, cost, and political hurdles, we must learn from progress made for other special populations. It is time to act — we must design and implement mandates, partnerships, and incentives to ensure representation of older adults in the evidence which forms the basis of their care.”
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