Eradication of Helicobacter pylori protects against peptic ulcer bleeding in older adults over the first couple of years, a study shows, but the effect appears to be lost at later time points. “The loss of ulcer protection with time appears to be a real phenomenon that cannot be attributed to increasing use of gastroprotective drugs, which would have an opposite effect,” the authors conclude. They attribute these findings to possible enhanced acid secretion or reduced release of protective prostaglandins after H. pylori eradication.
The randomized, double-blinded, placebo-controlled Helicobacter Eradication Aspirin Trial (HEAT) was conducted at 1,208 U.K. primary care centers. Participants were 60 years of age or older receiving aspirin at a daily dose of 325 mg or less and with a positive C13 urea breath test for H. pylori at screening. Interventions were a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication; n = 2,677), or oral placebo (control, n = 2,675), twice daily for 1 week. The primary outcome was time to hospitalization or death due to definite or probable peptic ulcer bleeding.
“Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (P = 0.0068), requiring analysis over separate time periods,” the authors report based on findings over a median of 5.0 years. “There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2.5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0.92 [95% CI 0.41–2.04] per 1000 person-years vs 17 episodes, rate 2.61 [1.62–4.19] per 1000 person-years; hazard ratio [HR] 0.35 [95% CI 0.14–0.89]; P = 0.028). This advantage remained significant after adjusting for the competing risk of death (P = 0.028) but was lost with longer follow-up (HR 1.31 [95% CI 0.55–3.11] in the period after the first 2.5 years; P = 0.54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients).”