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).
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.
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