Aspirin is by far the largest used drug all over the world, assumed in billions of doses every year. That’s why any news regarding the safety of aspirin must be given great attention, as it can have a significant global impact.

“The efficacy of aspirin in the prevention of cardiovascular disease needs to be balanced against the associated increased risk of bleeding, especially of gastrointestinal origin, which is the most common source. There is an urgent need to reduce bleeding events both in primary cardiovascular disease prevention, where the risk-benefit relationship is being questioned, and in secondary cardiovascular disease prevention, where the benefits exceed the bleeding risk, but aspirin is often used in combination with other antiplatelet drugs, which increases the risk.”

Several strategies have been proposed to minimize the risk of gastrointestinal bleeding in people taking aspirin, including aspirin dose reduction and long-term combination therapy with antisecretory drugs. Helicobacter pylori is considered a risk factor for peptic ulcer bleeding in people taking aspirin. A strategy to reduce this risk is to eradicate the infection in people taking aspirin, which is an attractive option because it is a short-term treatment with a long-term preventive effect, but the available studies have reported discordant results.

Results of the Helicobacter Eradication Aspirin Trial (HEAT), a randomized, double-blind, placebo-controlled trial conducted in UK primary care in 30 166 patients aged 60 years or older who had been prescribed aspirin at a dose of 325 mg or less per day and had urea breath testing for H pylori, is now available. 5353 patients had a positive breath-test result and were randomized to receive active H pylori eradication treatment or placebo for 7 days. The primary outcome was time to hospitalization and was not met: the primary outcome was subsequently analyzed in two periods of 2·5 years each, which showed a significant reduction in the incidence of the primary outcome in the active eradication group compared with the placebo group within the first 2·5 years but not thereafter or in the overall period.

“The trial results showed a progressive loss of aspirin-induced ulcer bleeding protection after H pylori eradication and are difficult to interpret. However, the trial adds valuable information because the maximum follow-up of patients in the few small previously available clinical trials was only 12 months, and these trials were aimed at the secondary prevention of ulcer bleeding. The effect of H pylori eradication was not as strong as expected, and should not change the current clinical practice guidelines, which recommend H pylori eradication only in patients taking aspirin who are at high risk of bleeding. Furthermore, we still require studies designed to evaluate the effects of H pylori eradication in patients who have not used aspirin previously, for whom, based on findings of the HEAT trial, the benefits might be greater.”1

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References

  1. Lanas, A., & Santilli, F. (2022). Aspirin and Helicobacter pylori interaction. The Lancet, 400(10363), 1560–1561. https://doi.org/10.1016/s0140-6736(22)02000-1

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