Effectiveness and Safety of First‐Line Non‐Bismuth Quadruple Concomitant Therapy Versus Single‐Capsule Bismuth Quadruple Therapy

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Abstract
Background: The V Spanish Consensus Conference on Helicobacter pylori recommended either a 14‐day non‐bismuth quadruple concomitant therapy (CT: proton pump inhibitor [PPI], clarithromycin, amoxicillin, and metronidazole) or a 10‐day bismuth‐containing quadruple therapy (Sc‐BQT: PPI, bismuth, tetracycline, and metronidazole in a single capsule). The relative advantages of each remain uncertain.Aim: To compare the effectiveness and safety of first‐line empirical CT versus Sc‐BQT in Spain.Methods: We analysed data from treatment‐naïve patients enrolled in the European Registry on H. pylori Management (Hp‐EuReg; 2013–2024). Multivariate logistic regression with propensity score weighting and bootstrap analysis (10,000 replicas) estimated modified intention‐to‐treat effectiveness and safety.Results: We evaluated 13,787 treatments: 7234 (52%) with CT—10 and 14 days, and 6553 (48%) with Sc‐BQT—every 6 and 8 h. Sc‐BQT showed greater effectiveness than 14‐day CT (94% vs. 91%; p < 0.001). However, 14‐day CT with standard‐dose PPI (93%) outperformed Sc‐BQT every 6 h with low‐dose PPI (90%) (p = 0.043). Sc‐BQT every 8 h with high‐dose PPI achieved the highest eradication (98%) (p = 0.015). Adherence was similar with Sc‐BQT (94%) and 14‐day CT (93%), being highly associated with eradication success (p < 0.001). Sc‐BQT, particularly with low‐ or standard‐dose PPI, had a better safety profile (p < 0.001).Conclusion: Sc‐BQT is more effective, better tolerated, and more broadly applicable than 14‐day CT. Both regimens achieved ≥ 90% success, but Sc‐BQT's stewardship‐friendly profile further supports its use as first‐line therapy for H. pylori eradication.
Funding Information
  • H2020 Health (101095359)
  • UK Research and Innovation (10058099)

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