Tegoprazan-based therapy found superior for Helicobacter pylori eradication in China
Nationwide trial finds tegoprazan regimen non-inferior to esomeprazole, with higher success rates and similar safety
image: *Safety set: all participants who received treatment at least once after randomization. †Full analysis set: all randomized participants who received at least one dose of the study drug and completed a post-baseline efficacy assessment. ‡Per-protocol set: a subset of the full analysis set with no significant protocol deviations impacting efficacy evaluation. §Detailed reasons for major protocol deviations affecting efficacy assessment were provided in the Supplementary Table 3,https://links.lww.com/CM9/C616.
Credit: Dr. Liya Zhou, Peking University Third Hospital, China Image source link: http://doi.org/10.1097/CM9.0000000000003780
A nationwide, multicenter trial in China compares tegoprazan-based (TACB) and esomeprazole-based (EACB) triple therapy plus bismuth for Helicobacter pylori. TACB has 93.5% eradication in the full analysis set, superior to EACB’s 86.4%, with comparable safety and high compliance.
Helicobacter pylori infection, linked to gastritis and gastric cancer, demands effective first-line treatments—especially in China, where prevalence and gastric cancer rates are high. A new phase III randomized controlled trial, published online in Chinese Medical Journal, on August 22, 2025, offers key insights into a promising alternative to standard therapy.
Conducted across 41 Chinese centers from October 2022 to September 2023, the double-blind, double-dummy study enrolled 561 treatment-naïve patients. Participants were randomized 1:1 to TACB (tegoprazan 50 mg, amoxicillin 1,000 mg, clarithromycin 500 mg, and bismuth 220 mg) or EACB (esomeprazole 20 mg, same antibiotics/bismuth), both twice daily for 14 days. Eradication was assessed via 13C-urea breath test 4–8 weeks post-treatment.
In the full analysis set, TACB achieved a 93.5% eradication rate (95% confidence interval (CI): 89.9–96.1%), significantly higher than EACB’s 86.4% (95% CI: 81.9–90.2%)—a 7.0% difference (95% CI: 2.1–12.0%). Superiority testing confirmed TACB’s advantage (P = 0.045 in amoxicillin-susceptible subgroups). Per-protocol set results mirrored this, with TACB at 93.9% and EACB at 87.1%.
Safety profiles were comparable: 75.5% of TACB patients and 73.4% of EACB patients reported treatment-emergent adverse events, mostly mild and transient. Compliance was high (98.4% vs. 98.8%, P = 0.362). Notably, TACB had more elevated serum gastrin, attributed to its stronger acid suppression, but levels normalized over time.
This trial supports tegoprazan—a potassium-competitive acid blocker (P-CAB)—as a viable first-line option. Unlike proton pump inhibitors (e.g., esomeprazole), P-CABs offer faster, more stable acid inhibition, enhancing antibiotic efficacy for acid-sensitive drugs like amoxicillin.
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Reference
DOI: 10.1097/CM9.0000000000003780