Empirical second-line therapy in 5,000 patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

Abstract

BACKGROUND & AIMS After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of current study was to assess the effectiveness and safety of second-line empirical treatment in Europe. METHODS This international, multicenter, prospective non-interventional Registry aimed to evaluate the decisions and outcomes of H. pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered at AEG-REDCap up to February 2021. Patients allergic to penicillin and those having received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. RESULTS Overall, 5,055 patients received empirical second-line treatment. Triple-therapy with amoxicillin and levofloxacin was most commonly prescribed (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple-therapy or levofloxacin-containing quadruple-therapy (with bismuth). In patients receiving triple-therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple-treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, three-in-one single capsule or levofloxacin-bismuth quadruple-therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization.