Low-dose aspirin has been hypothesized to decrease the risk of falls by reducing acute thrombotic cardiovascular events and cognitive decline by protecting against vascular dementia or Alzheimer’s disease. However, in contradiction to this assumption, results of the ASPREE-FRACTURE trial published in JAMA Internal Medicine show that aspirin does not decrease the risk of fractures but instead it increases the risk of serious falls in adults over 70 years of age, which require hospital admission.^1,2

The multicenter ASPREE-FRACTURE trial, a substudy of the  the Aspirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial, was conducted by a team of researchers from the US and Australia. The trial examined the impact of 100 mg of enteric-coated aspirin daily on the risk of fracture (non-osteoporotic), which was the primary outcome or serious falls necessitating hospitalization, which was the secondary outcome of the study in healthy older men and women. None of the participants had any heart disease, dementia or physical disability at baseline. The control group was given an identical enteric-coated placebo tablet daily. The ASPREE trial had recruited 16,703 subjects between 2010 and 2014, aged 70 years or older; more than half (55%) of them were women. The ASPREE-FRACTURE trial however involved only the participants from Australia. The analysis of data was done from mid-October 2019 through to August 2022.

Over the follow-up period of 4.6 years (median), 2865 fractures and 1688 serious falls occurred. The two groups did not differ with regard to the risk of first fracture (hazard ratio 0.97). However, the risk of serious falls was higher among the participants who received aspirin. The total number of serious falls was greater in the aspirin group at 884 vs 804 in the placebo group with an incidence rate ratio of 1.17. These observations continued to be significant even after adjusting for confounding variables such as age, alcohol and medications.

The findings of this substudy show that low-dose aspirin not only failed to reduce the risk of fractures, it also increased the risk of serious falls, which the authors note “adds to evidence that this agent provides little favorable benefit in a healthy older adult population.”¹ These observations are significant because most older patients, which formed the study population in this trial, are on aspirin to prevent cardiovascular disease and are a high risk group for fractures.

References

1. Barker AL, et al. Daily low-dose aspirin and risk of serious falls and fractures in healthy older people: a substudy of the ASPREE randomized clinical trial. JAMA Intern Med. 2022 Nov 7. doi: 10.1001/jamainternmed.2022.5028.
2. https://www.medpagetoday.com/geriatrics/generalgeriatrics/101629, November 7, 2022.