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%),…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 258 participants or records.
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