Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter pylori Eradication: A Real-World Evidence Study
Abstract
OBJECTIVES
This study aimed to evaluate the efficacy and safety of various bismuth-containing quadruple therapies (BQTs) with potassium-competitive acid blockers (P-CABs) for Helicobacter pylori eradication.
METHODS
This multicenter retrospective cohort study evaluated 1730 treatment-naïve patients receiving P-CABs-based BQTs (P-BcQT). The regimens consisted of one P-CAB (vonoprazan or tegoprazan), bismuth, and two antibiotics including amoxicillin, clarithromycin, levofloxacin, tetracycline and cefuroxime, with a treatment duration of 10 to 14 days. We comprehensively assessed eradication rates, adverse events, and risk factors predictive of positive results. Receiver operating characteristic curve analysis identified optimal cut-off values for predicting outcomes, while multivariate regression determined independent predictors of treatment failure and adverse events.
RESULTS
The overall eradication rate was 92.3% and 92.9% by modified intention-to-treat and per-protocol analysis, respectively. Multivariate analysis revealed three independent predictors of failure: high body surface area (BSA ≥1.76 m²) (OR: 1.545, 95% CI: 1.010-2.362, P = 0.045), low compliance (OR: 3.442, 95% CI: 1.891-6.266, P < 0.001), and suboptimal antibiotic combinations. Especially, amoxicillin/clarithromycin (P = 0.005) and cefuroxime/levofloxacin regimens (P < 0.001) demonstrated significantly higher failure trend compared to amoxicillin/tetracycline combinations. The adverse event rate was 26.9%,…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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