econdary analysis of ASPREE Trial shows
By Miriam E. Tucker
Low-dose aspirin reduces the risk for type- 2 diabetes among older adults and slows the increase in fasting glucose levels over time, new research finds. The data come from a secondary analysis of ASPREE, a double-blind, placebo-controlled trial of healthy adults aged 65 years or older, showing that 100 mg of aspirin taken daily for about five years did not provide a cardiovascular benefit but did significantly raise the risk for bleeding.
This new analysis shows that individuals taking aspirin had a 15% lower risk for developing type 2 diabetes and that the medication slowed the rate of increase in fasting plasma glucose, compared with placebo, during follow-up. However, lead author Sophia Zoungas, MBBS, PhD, head of the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia, says, “Major prescribing guidelines now recommend older adults take daily aspirin only when there is a medical reason to do so, such as after a heart attack… Although these new findings are of interest, they do not change the clinical advice about aspirin use in older people at this time.”
Nonetheless, she told Medscape Medical News, “At this time, our findings are exploratory but ignite the debate of the important role that anti-inflammatory approaches may play in preventing diabetes. Further work is currently underway to understand which subpopulations may be better targeted and to understand the balance of risk vs benefit.”
The results are scheduled to be presented at the upcoming meeting of the European Association for the Study of Diabetes, taking place October 2-6 in Hamburg, Germany.
New Findings Not Robust Enough to Change Current Practice
Asked to comment, Debabrata Mukherjee, MD, told Medscape Medical News, “Given the post hoc secondary nature of the analysis, the findings should be considered hypothesis generating and not definitive. At this time, based on prospective randomized studies, the risks of aspirin outweigh the benefits for aspirin in older adults.”
Among those studies was another ASPREE sub-study showing failure of low-dose aspirin to reduce fracture risk while increasing the risk for serious falls, and two other trials, ARRIVE and ASCEND, also showing that harms of aspirin outweigh the benefits in people with cardiovascular risk but not diabetes, and in those with diabetes, respectively, said Mukherjee, professor and chair of the Department of Internal Medicine at Texas Tech University Health Sciences Center at El Paso.
And, Mukherjee noted, in 2019 the American College of Cardiology updated its practice guidelines to say that low-dose aspirin should not be administered on a routine basis for the primary prevention of atherosclerotic cardiovascular disease in adults over age 70. In 2021, the American Diabetes Association seconded that recommendation in its Standards of Care.
Asked whether these newest findings might change current practice for any higher-risk subgroup, such as people with pre-diabetes, Mukherjee replied, “Unless there is a prospective randomized trial that validates these findings in those with prediabetes, the findings should not change practice. There are also no data [showing] that another antiplatelet agent would be indicated or would be beneficial. Instead, I would recommend lifestyle changes including regular exercise and a healthy diet to minimize risk of diabetes.
The 16,209 ASPREE participants were community-dwelling and did not have diabetes, cardiovascular disease, or dementia at baseline. They were randomized in a 1:1 ratio to receive 100 mg/d of enteric-coated aspirin or placebo. Over a median follow-up of 4.7 years, the proportions developing type 2 diabetes were 5.7% with aspirin vs 6.6% with placebo, giving a hazard ratio of 0.85 (P = .01).The annual rate of increase in fasting plasma glucose over the follow-up period was slowed by 0.006 mmol/L with aspirin compared with placebo, also a significant difference (P = .004). According to Zoungas, “The potential for anti-inflammatory agents like aspirin to prevent type 2 diabetes or improve glucose levels needs further study.”
The ASPREE trial was supported by the US National Institutes of Health, the National Health and Medical Research Council of Australia, Monash University, and the Victorian Cancer Agency. Zoungas and Mukherjee have no disclosures. The European Association for the Study of Diabetes 2023 Annual Meeting; is scheduled for October 2-6, 2023; Hamburg, Germany. Abstract 175.
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