Fourteen‐Day Tegoprazan–Amoxicillin Dual Therapy as the First‐Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial

• DOI: 10.1111/hel.13098
• Publication Date: 2024-06-10T05:10:45Z
• Authors: Qingzhou Kong; Iqtida Ahmed Mirza; Xiaoqian Zhang; Xiaohui Song; Xiaowei Li; Qiumei Zhang; Lidong Xu; Yuting Guo; Yanan Yu; Xiuli Zuo; Yanqing Li; Yueyue Li
• Keywords: Male; Adult; Sulfonamides; Helicobacter pylori; Amoxicillin; Proton Pump Inhibitors; Esomeprazole; Middle Aged; Helicobacter Infections; Anti-Bacterial Agents; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Breath Tests; Humans; Female; Drug Therapy, Combination; Pyrroles; Aged

ABSTRACT Background Potassium‐competitive acid blockers have demonstrated enormous potential in the eradication treatment of Helicobacter pylori infection, with tegoprazan being one representatives. The available data on safety and efficacy dual therapy are limited. Materials Methods multicenter, noninferiority, randomized‐controlled trial was conducted from May 2023 to March 2024. Treatment‐naive subjects were randomly assigned (1:1) enter either tegoprazan–amoxicillin (TA) group (tegoprazan 50 mg twice daily amoxicillin 750 four times daily) or esomeprazole–amoxicillin (EA) (esomeprazole 20 all daily), a duration for 14 days. primary outcome rate as determined by 13 C‐urea breath test, including per‐protocol (PP) analysis intention‐to‐treat (ITT) analysis. Secondary outcomes adverse events compliance. Results A total 368 individuals included randomization. rates EA TA 84.2% 85.8%, respectively, according an ITT ( p = 0.77), 88.5% 88.2%, PP 1.00). not inferior those both 0.0023) analyses 0.0009). There no significant statistical differences incidence compliance between two groups. multivariate logistic regression revealed that poor increased risk failure < 0.001). Conclusions Dual containing is safe effective be considered clinical first‐line option, but further optimization involving antimicrobial susceptibility testing adjustments dosage frequency warranted. Trial Registration ClinicalTrials.gov ID: NCT05870683.