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The goal of this activity is for learners to be better able to describe the associations of low-dose aspirin with gastric and duodenal ulcer incidence among persons starting and persons continuing low-dose aspirin therapy, according to an analysis using multivariate Cox regression models in the German ESTHER study and the UK Biobank with > 10 years' follow-up.
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CME / ABIM MOC / CE Released: 7/22/2022
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Aspirin (acetylsalicylic acid) inhibits platelet aggregation through an irreversible acetylation process. Low daily doses of 75 to 325 mg are used in early treatment of myocardial infarction and unstable angina and in primary and secondary cardiovascular disease (CVD) prevention.
Adverse effects (AEs) may include increased risk for peptic ulcer disease. Chronic use of aspirin was linked to 2- to 4-fold increased risk for upper gastrointestinal (GI) events, which may be an underestimate, as 80% of endoscopy-confirmed gastroduodenal ulcer cases are asymptomatic.
New users of low-dose aspirin -- but not "prevalent" users -- have a significantly increased risk of developing gastric and duodenal ulcers, a finding that highlights the importance of weighing the risks and benefits of starting low-dose aspirin therapy, researchers said.
Before starting a low-dose aspirin regimen, "a careful weighing of risks and benefits is recommended," wrote Ben Schöttker, PhD, with the German Cancer Research Center in Heidelberg, and colleagues. Once low-dose aspirin therapy is started, monitoring for AEs is recommended to ensure safe long-term use, they added.
The study was published in the July issue of Alimentary Pharmacology and Therapeutics.
Although low-dose aspirin has been shown to be a risk factor for peptic ulcer disease, previous cohort studies may have underestimated the risk because the researchers did not employ a new-user design, the investigators noted. This is important because GI bleeding occurs more often early after initiation of low-dose aspirin therapy than in later years.
Schöttker and colleagues evaluated associations between low-dose aspirin and the occurrence of gastric and duodenal ulcers in both prevalent users and new users. (In this study, "prevalent users" are persons who were taking low-dose aspirin at baseline and had generally been taking aspirin for some time before study follow-up began.) Data for the study were derived from 7737 participants in the German ESTHER study and 213,598 from the UK Biobank with more than 10 years of follow-up.
In prevalent users, low-dose aspirin was not significantly associated with gastric ulcers in either cohort. There was a weak statistically significant association with duodenal ulcer in the UK Biobank (HR 1.27 [95% CI: 1.07, 1.51]) but not in ESTHER (HR 1.33 [95% CI: 0.54, 3.29]).
When restricting the exposure to only new users, low-dose aspirin use was associated with a significant 1.8-fold increased risk of gastric ulcer incidence in the UK Biobank (HR 1.82 [95% CI: 1.58, 2.11]) and a 2.8-fold increased risk in ESTHER (HR 2.83 [95% CI: 1.4, 5.71]) in multivariable models.
As for duodenal ulcers in new users, low-dose aspirin use was associated with a 1.7-fold increased risk in the UK Biobank (HR 1.66 [95% CI: 1.36, 2.04]) and with a 3.9-fold increased risk in ESTHER (HR 3.89 [95% CI: 1.46, 10.42]).
The findings from these 2 large cohort studies show that low-dose aspirin use is a "strong and independent" risk factor for both gastric and duodenal ulcers among new users of low-dose aspirin but not among prevalent users.
Persons taking low-dose aspirin for years who do not experience GI symptoms may tolerate the drug well, the authors pointed out.
"Important" Study"This is an important study," Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School in Boston, told Medscape Medical News.
"Much of the literature on aspirin (or [nonsteroidal anti-inflammatory drugs (NSAIDs)]) and gastric/duodenal ulcer risks are from full-dose aspirin or its equivalent," he explained. "Less is known about the safety or risks of low-dose aspirin.
"This study, using two complementary data sources, showed that low-dose aspirin was associated with an increase in risk among new users," said Ananthakrishnan, who was not involved in the analysis. "However, while there is an increase in risk, any potential increase must be balanced against the benefit of low-dose aspirin for its other health effects, including cardioprotection.
"In addition, that there was no association among prevalent users suggests that in those who have been on low-dose aspirin for many years without any gastric or duodenal ulcers, continued use is likely safe, provided there continues to be benefit from it for other indications," he added.
The study had no commercial funding. Schöttker and Ananthakrishnan have disclosed no relevant disclosures financial relationships.
Aliment Pharmacol Ther. 2022;56:251-262.