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

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