Melbourne, Australia—For years, observational studies have raised the possibility that daily low-dose aspirin can reduce fractures and serious falls in healthy older people. A new study adds the question: At what cost?

Falls and fractures are frequent and can be devastating to the health and quality of life of the elderly, according to a recent report in the Journal of the American Medical Association Internal Medicine.

The international study involving Australian and U.S. researchers, including the Mayo Clinic, sought to determine if daily low-dose aspirin (100 mg) reduces the risk of fractures or serious falls (fall-related hospital presentations) in healthy older men and women.

The substudy of the double-blind, randomized, placebo-controlled ASPREE-FRACTURE trial involved older adult men and women in 16 major sites across southeastern Australia. Between 2010 and 2014, 16,703 healthy (i.e., free of cardiovascular disease, dementia, or physical disability), community-dwelling volunteers aged 70 years or older were recruited to participate in the ASPREE trial. Data were analyzed from October 17, 2019, to August 31, 2022. Participants had a median age of 74 years, and 55% were women.

The participants in the intervention group received a daily dose of oral 100-mg enteric-coated aspirin, while the control group received a daily identical enteric-coated placebo tablet.

The researchers were primarily looking for the occurrence of any fracture, with a serious fall resulting in hospitalization being the secondary outcome.

The study noted that 2,865 fractures and 1,688 serious falls occurred over the median follow-up of 4.6 years. “While there was no difference in the risk of first fracture between the intervention and control participants (hazard ratio, 0.97; 95% CI, 0.87-1.06; P = .50), aspirin was associated with a higher risk of serious falls (total falls 884 vs 804; incidence rate ratio, 1.17; 95% CI, 1.03-1.33; P = .01),” the authors reported. “Results remained unchanged in analyses that adjusted for covariates known to influence fracture and fall risk.”

The substudy reached the conclusion that “the failure of low-dose aspirin to reduce the risk of fractures while increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, white older adult population.”

“The clinical significance of these results relates to the large percentage of the older population who are both at risk of fracture and are taking aspirin for the prevention of cardiovascular and cerebrovascular disease,” the researchers pointed out. “Despite promising findings from both in vitro and observational studies, aspirin does not reduce the risk of fractures in healthy older people and is unlikely either to increase or decrease the community burden of fractures.”

The authors added that the results were somewhat surprising, noting, “The increase in serious falls observed among those randomized to aspirin was not anticipated and might have resulted from either an increased tendency to fall or more substantial nonfracture injuries sustained as a consequence of falling. It was originally hypothesized that aspirin may decrease falls by slowing physical decline by reducing cardiovascular and cerebrovascular events through antiplatelet effects and/or reducing cognitive decline by protecting against Alzheimer disease and/or vascular dementia—well-known fall risk factors. Recent studies by the ASPREE group show that daily low-dose aspirin did not reduce the risk of dementia, mild cognitive impairment, or cognitive decline. This may partially explain why this trial found no protective effect of aspirin on fall risk.”

While the risk of serious falls increased, that was not accompanied by an increase in fractures. The researchers advised that only 10% to 15% of falls in older people are accompanied by fractures. “More likely, it may have resulted from more extensive bleeding or bruising after a fall leading to a need for more medical attention,” the researchers added. “Alternatively, an increase in the tendency to fall may have resulted from other aspirin-induced morbidities such as anemia. The greater risk of falls in the aspirin group was not attributable to any identified subgroup.”

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