Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-LineHelicobacter PyloriEradication Therapy Administered with Bismuth

Abstract

Purpose To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth. Materials and Methods Eradication-naive H. pylori -infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the 13 C-urea breath test. Results Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis ( p =0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group ( p =0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6–141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6–189.1) were independent risk factors for eradication failure. Conclusion In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days.

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

“…To date, two studies have compared the effects of tegoprazan and PPIs in H. pylori eradication. 30,31 One retrospective study by Kim et al, 30 published in 2021, assessed the comparative efficacy of bismuth-containing quadruple regimens consisting of 50 mg tegoprazan, 30 mg lansoprazole, 1,000 mg amoxicillin, 500 mg clarithromycin, and 300 mg bismuth potassium citrate administered twice daily for 7 days. Consistent with our findings, this study did not demonstrate superior efficacy of tegoprazan-based therapy compared with PPI-based therapy.…”

7‐day versus 14‐day tegoprazan‐based triple therapy to treat Helicobacter pylori infection: Real‐world evidence

“…A recent study on tegoprazan-based therapy for 7 days in Korea showed an unsatisfactory eradication rate (79% and 88% in ITT and PP analyses, respectively) even though the regimen contained bismuth to increase the eradication rate. 12 Therefore, 14-day treatment should be considered when triple therapy is selected empirically in regions with high clarithromycin resistance.…”

“…Even though P‐CAB has a fast onset of action and strong acid‐inhibitory potency, P‐CAB‐based triple therapy for 7 days may be insufficient in regions with high clarithromycin resistance. A recent study on tegoprazan‐based therapy for 7 days in Korea showed an unsatisfactory eradication rate (79% and 88% in ITT and PP analyses, respectively) even though the regimen contained bismuth to increase the eradication rate 12 . Therefore, 14‐day treatment should be considered when triple therapy is selected empirically in regions with high clarithromycin resistance.…”

“…Drug adherence was defined as the administration of ≥ 70% of the prescribed medications. The severity of adverse events was classified as mild (transient symptoms that improved spontaneously), moderate (symptoms that required management), and severe (symptoms that led to an emergency visit) 12 …”

A randomized controlled trial to compare Helicobacter pylori eradication rates between the empirical concomitant therapy and tailored therapy based on 23S rRNA point mutations

“…Tegoprazan 50 mg combined with amoxicillin and clarithromycin did not achieve an acceptable eradication rate. [ 36 ] Authors explained that tegoprazan 50 mg (twice the dose used for gastroesophageal reflux disease) appears insufficient in suppressing the gastric acid and in achieving an acceptable eradication rate. In triple therapy with vonoprazan, the 20 mg dose is 4 times the dose used for gastroesophageal reflux disease.…”