Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter pylori Eradication: A Real-World Evidence Study.

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%, with lower body mass index (BMI <28.38 kg/m²) (P = 0.011) and long treatment duration (P = 0.007) emerging as independent risk factors. Overall compliance was excellent (95.6%).

CONCLUSIONS

P-BcQT demonstrated promising efficacy as a first-line H. pylori treatment regimen. However, regimens containing clarithromycin or levofloxacin appear less effective. Future optimization may focus on shorter treatment durations, personalized dosing adjustments and regional resistance patterns.