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New users of low-dose aspirin show a substantially heightened risk of gastric and duodenal ulcers, especially during early treatment initiation.
A large population-based analysis of over 220,000 volunteers has revealed that low-dose aspirin initiation is connected with increased risk of gastric ulcer and duodenal ulcer, particularly in new users, highlighting an important early window of gastrointestinal (GI) risk that may have been underestimated in previous studies.
Low-dose aspirin is widely prescribed for cardiovascular prevention, including secondary prevention of myocardial infarction and stroke, but is also a well-established risk factor for peptic ulcer disease and GI bleeding. Earlier population-based cohort studies may have underestimated this risk because they relied on prevalent-user design, which excludes the initial treatment period when GI adverse events are most likely to occur.
To better assess this risk, the authors analyzed data from two large cohorts—the German ESTHER study (n = 7,737) and the UK Biobank (n = 213,598)—with more than 10 years of follow-up. Using multivariate Cox regression models, the study explored ulcer risk between prevalent users and novel users of low-dose aspirin, focusing on incident gastric and duodenal ulcers.
In the prevalent-user analysis, low-dose aspirin exhibited no prominent association with gastric ulcer risk in either cohort. A weak association with duodenal ulcer was noted in the UK Biobank (hazard ratio [HR]: 1.27), while no statistically significant link was found in the ESTHER cohort (HR: 1.33). However, the new-user design revealed a markedly higher risk of incident peptic ulcers. In the UK Biobank, new users illustrated an increased risk of gastric ulcer (HR: 1.82) and duodenal ulcer (HR: 1.66). In the ESTHER study, the risk was even higher, with an HR of 2.83 for gastric ulcer and 3.89 for duodenal ulcer.
These findings confirm that low-dose aspirin is an independent predictor for peptic ulcer disease, with the highest risk occurring shortly after treatment initiation. The discrepancy between prevalent-user vs. new-user design suggests that earlier studies may have underestimated early GI toxicity associated with aspirin therapy. From a clinical perspective, these results emphasize the importance of risk–benefit assessment prior to commencing low-dose aspirin therapy, especially in those at higher risk of GI complications. Early monitoring for dyspepsia, abdominal pain, and GI bleeding, along with consideration of gastroprotective strategies such as proton pump inhibitors, may help mitigate adverse outcomes.
Alimentary Pharmacology & Therapeutics
Strongly increased risk of gastric and duodenal ulcers among new users of low-dose aspirin: results from two large cohorts with new-user design
Thi Ngoc Mai Nguyen et al.
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