Seven‐Day Versus 14‐Day Tegoprazan and Tetracycline‐Containing Quadruple Therapy for First‐Line Eradication of Helicobacter pylori Infection: A Randomized, Open‐Label, Noninferiority Trial

• DOI: 10.1111/hel.70036
• Publication Date: 2025-04-24T11:36:16Z
• Authors: Xue‐Ping Nan; Hong‐Yu Zhao; Lei‐Na Guo; Rui‐Qi Zheng; Xi‐Lan Wang; Yong‐Fen Wang; Yan‐Hua Su; Wen‐Rong Geng; Xiu‐Lan Liu; Hai‐Miao Xu; Ke‐Lun Zhou; Yu‐Ting Guo; Jian‐Hua Cao; Zhong‐Xue Han; Qing‐Zhou Kong; Xiu‐Li Zuo; Yan‐Qing Li; Yue‐Yue Li
• Keywords: Regimen; Intention-to-treat analysis

ABSTRACT Background and Aims Tegoprazan, a new class of drugs, is potassium‐competitive acid blocker (P‐CAB) that inhibits gastric H+/K+‐ATPase through different mechanism than proton pump inhibitor. Tetracycline also has anti‐ Helicobacter pylori properties. However, only few randomized controlled trials (RCTs) have investigated the efficacy tegoprazan tetracycline‐containing quadruple therapy (TTQT) for treating H. infections, which this RCT explored. Methods This multicenter included treatment‐naïve adults with infection who received 7 or 14 days TTQT (50‐mg tegoprazan, 220‐mg bismuth potassium citrate, 1000‐mg amoxicillin twice daily 500‐mg tetracycline four times daily). The primary outcome was eradication rate; secondary endpoints incidence adverse events, treatment compliance, regimen costs. Results study 258 patients. rates in 7‐ 14‐day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) 91.47% (118/129, CI: 84.90%–95.45%), respectively, intention‐to‐treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority p < 0.001); 92.86% (117/126, 86.50%–96.48%) 93.65% (118/126, 87.47%–97.02%), modified 0.79%; −6.36%–7.99%; 94.35% (117/124, 88.29%–97.50%) 95.12% (117/123, 89.24%–98.00%), per‐protocol −0.77%; −5.91%–7.48%; 0.001). Significantly fewer events occurred 7‐day group (22.48% vs. 35.67%, = 0.020). Treatment compliance did not differ between two groups. Conclusions efficacies first‐line comparable, effects group. trial been registered at Clinical Trials.gov (NCT05997433).