Low-dose aspirin is frequently prescribed for routine use in older people not only for possible cardiac protection but also to reduce bone fragility and to slow the loss of bone mass.1,2 But a recent study in Australia indicates that such use of this drug might not help, and could even hurt by increasing the risk of a serious fall.
Noting that falls and fractures are not uncommon in the aging population, this study sought to further examine the effects of aspirin in healthy older men and women.
The study, a double-blind, randomized, placebo-controlled trial looked at older adult men and women in 16 major sites across southeastern Australia.3
The ASPREE-FRACTURE substudy was part of the Australian component of the ASPREE trial. Between 2010 and 2014, healthy community-dwelling volunteers 70 years or older were recruited to participate in the trial. Eligible participants needed to have authorization from their medical practitioners and to adhere to a 4-week run-in medication trial. Participants were randomized. Data were analyzed from October 17, 2019, to August 31, 2022.
Participants in the intervention group received a daily dose of oral 100-mg (low-dose) enteric-coated aspirin. The control group received a daily identical enteric-coated placebo tablet.
The researchers sought to document the occurrence of any fracture. The secondary outcome was to document any serious fall resulting in hospital presentation.
Recruitment included. 16,703 people with a median (interquartile range) age of 74 (72-78) years. Of the total participants, 55% were women. Numbers for the study group versus control group were 8322 versus 8381.
Over a median follow-up of 4.6 years, there were 2865 documented fractures and 1688 serious falls. The researchers demonstrated no difference between the intervention and control participants in the risk of first fracture (hazard ratio, 0.97; 95% confidence interval [CI], 0.87-1.06; P = 0.50). However, 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 = 0.01). Covariates known to influence fracture and fall risk were considered and results remained unchanged.
The authors concluded that, in this substudy of a randomized clinical trial, the failure of low-dose aspirin to reduce the risk of fractures while increasing the risk of serious falls indicates that this drug provides little favorable benefit in a healthy, White, older adult population. Future studies looking to expand this research should look at a more diverse group of participants.
Trial registration: This substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).
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