H pylori Eradication Protects Against Aspirin-Related Peptic Ulcer Bleeding

The establishment of H pylori eradication as an alternative or addition to antisecretory protection adds to the protective strategies available for safe aspirin prescribing.

Eradication of Helicobacter pylori (H pylori)infection effectively protects against aspirin-associated peptic ulcer bleeding in patients aged 60 years and older, according to study findings published in Lancet.

Researchers conducted a randomized, double-blind, placebo-controlled trial between September 14, 2012, and November 22, 2017, at 1208 primary care centers across the United Kingdom. They sought to assess whether H pylori eradication would effectively prevent aspirin-associated peptic ulcer bleeding in patients aged 60 years or older receiving daily aspirin doses of 325 mg or fewer.

A total of 5351 patients with C13 urea breath tests that were positive for H pylori infection were randomly assigned to either the active eradication group (n=2677) or to the placebo group (n=2675). The eradication group received a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg twice daily for 1 week, while the placebo group received an oral placebo dose twice daily for 1 week. Follow-up lasted a median of 5 years.

Overall, 657 patients died during follow-up (eradications group, n=306; placebo group, n=351). Peptic ulceration caused only 2 deaths and only 1 of these ulcers caused active bleeding. 

Patients who received the combination H pylori eradication treatment demonstrated significantly reduced incidence of hospitalization or death due to peptic ulcer bleeds during the first 2.5 years of follow-up compared with the placebo group (6 vs. 17 episodes, respectively; rates, 0.92 vs. 2.61 per 1000 person-years; hazard ratio [HR], 0.35; 95% CI, 0.14-0.89; P =.028).

H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term.

This clear advantage diminished over time during the follow-ups after the first 2.5 years (HR, 1.31; 95% CI, 0.55-3.11; P =.54).

The most common adverse event reported in the eradication group was taste disturbance among 787 patients. Only 3 patients experienced serious adverse events related to treatment, including extreme stomach pain (n=2) and arrhythmia with hypertension (n=1).

Study limitations included potential confounding factors including use of other drugs including over-the-counter medications, simplicity of the trial, and low rate of outcome events leading to termination of the study prior to reaching the planned number of events, and possible population selection-bias.

H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term,” the study authors conclude. “Our findings should provoke a re-evaluation of strategies for the safe prescribing of aspirin and of the balance of risks and benefits of its use in cardiovascular disease and cancer prevention.”Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

References:

Hawkey C, Avery A, Coupland CAC, et al. Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial. Lancet. 2022;400(10363):1597-1606. doi:10.1016/S0140-6736(22)01843-8