Efficacy and Tolerability of 14-Day Tegoprazan- versus Rabeprazole-Based Triple Therapy for Eradication of Helicobacter pylori: A Real-World Evidence Study

Abstract

Background/Aims: Tegoprazan, a new, fast, and strong potassium-competitive acid blocker, has been approved for the treatment of gastric acid-related diseases in Korea. However, realworld clinical data regarding this drug are scarce. We aimed to compare the Helicobacter pylori eradication rates of tegoprazan-and rabeprazole-based triple therapy. Methods:We retrospectively reviewed data from patients who received first-line treatment for H. pylori infection using tegoprazan-or rabeprazole-based triple therapy for 2 weeks (50 mg tegoprazan or 20 mg rabeprazole+1,000 mg amoxicillin+500 mg clarithromycin twice daily). The primary endpoint was the eradication rate as determined by intention-to-treat analysis.Results: Of the 677 patients included in our study, 344 and 333 received tegoprazan-based and rabeprazole-based triple therapy, respectively. The eradication rate from intention-to-treat analysis was 76.7% (95% confidence interval [CI], 72.1% to 81.0%) for tegoprazan-based triple therapy and 75.4% (95% CI, 70.5% to 79.8%) for rabeprazole-based triple therapy. There was no significant difference in the eradication rates between the two groups (p>0.999). Per-protocol analysis also revealed no significant difference between the eradication rates of the two groups (tegoprazan 83.4% [95% CI, 79.0% to 87.2%] vs rabeprazole 83.5% [79.0% to 87.4%], p>0.999). Furthermore, there was no significant difference in adverse event rates between the two groups (tegoprazan, 27.6%; rabeprazole, 25.8%; p=0.604). Conclusions:The eradication rate of tegoprazan-based triple therapy was similar to that of rabeprazole-based triple therapy. Further studies on the dose-escalation effect of tegoprazan for H. pylori eradication and the efficacy of tegoprazan in regimens other than conventional triple therapy are needed.

Comparative efficacy of tegoprazan versus esomeprazole/sodium bicarbonate for the treatment of Helicobacter pylori infection

“…Although this study did not include an esomeprazole-based triplet regimen, we could infer the impact of sodium bicarbonate on H. pylori eradication therapy by reviewing the results of previous studies. In an earlier multicenter randomized controlled trial and our real-world study, tegoprazan-based triple therapy showed an eradication rate similar to that of PPI-based triple therapy ( 9 , 10 ). Although P-CAB typically exerts a rapid and potent acid-inhibitory effect, the dosage of P-CAB may be critical for achieving a high eradication rate.…”

“…However, diarrhea was more common in patients receiving tegoprazan-based quadruple therapy than in those receiving rabeprazole-based quadruple therapy. Considering the high risk of diarrhea with bismuth-containing quadruple therapy ( 10 ), the incidence of diarrhea with second-line rabeprazole-based quadruple therapy in this study (4.2%) was relatively low. Although the underlying cause for this inconsistency remains unclear, it could be explained by the relatively high proportion of patients who received first-line esomeprazole/sodium bicarbonate–based triple therapy in the second-line rabeprazole-based quadruple therapy group.…”

“…Although 50 mg of tegoprazan rapidly increases the intragastric pH > 4, its ability to maintain the intragastric pH > 6 may be weaker than that of vonoprazan (20 mg) ( 15 ). Compared with 20 mg of vonoprazan, 50 mg of tegoprazan, which is currently available in South Korea, may be insufficient to ensure a high eradication rate that exceeds PPI therapy ( 10 ). Consistently, available evidence indicates that both 50 mg of tegoprazan and the standard dose of PPI similarly affect H. pylori eradication.…”

“…Recently, a multicenter trial conducted in the United States and Europe confirmed that vonoprazan-based triple therapy exerted superior efficacy to that of PPI-based triple therapy ( 8 ). In South Korea, tegoprazan, a new P-CAB, was approved in 2021 for treating H. pylori infection ( 9 , 10 ).…”

Treatment of Helicobacter pylori with potassium competitive acid blockers: A systematic review and meta-analysis

“…Eradicating H. pylori is of utmost significance, serving as the primary treatment for low-grade G-MALT, mitigating the recurrence of peptic ulcers, and lowering the risk of gastric adenocarcinoma in high-risk populations[ 10 - 12 ]. This critical therapeutic intervention not only addresses immediate health concerns but also plays a pivotal role in preventing more severe and potentially life-threatening conditions associated with H. pylori infection.…”