The efficacy of Keverprazan based quadruple therapy for Helicobacter pylori eradication:a phase III, randomized, double-blind, multicenter trial

• Published in: International journal of antimicrobial agents p. 107320
• Main Authors: Tan, Niandi, Wu, Hao, Lan, Cheng, Liu, Chengxia, Liao, Aijun, Jiao, Zhiyong, Su, Dongxing, Zhang, Xiaomei, Zhang, Zhe, Xiao, Weiming, Li, Fangfang, Li, Xing, Xia, Min, Qiu, Rongyuan, Chen, Huixin, Liu, Youli, Su, Mei, Chen, Minhu, Xiao, Yinglian
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 16.09.2024
• Subjects: Esomeprazole; Helicobacter pylori eradication; Keverprazan; potassium-competitive acid blocker; potassium-competitive acid blocker; Keverprazan; Esomeprazole; Helicobacter pylori eradication
• ISSN: 0924-8579; 1872-7913; 1872-7913
• DOI: 10.1016/j.ijantimicag.2024.107320

•This was a randomized, positive drug-controlled study with non- inferior design•This study evaluated the efficacy of Keverprazan therapy in H. pylori treatment•Regimen of Keverprazan 20 mg twice daily proved to be effective against H. pylori.•Keverprazan therapy was superior to PPI on eradication rate in per protocol set Keverprazan is a novel potassium-competitive acid blocker, whose advantages as a potent acid suppressor in Helicobacter pylori (H. pylori) eradication has not yet been demonstrated. This study aimed to evaluate the efficacy of Keverprazan as a component of bismuth quadruple therapy in H. pylori treatment. Adult patients with H. pylori infection were enrolled and randomized to take Keverprazan (KEV group) or Esomeprazole (ESO group)-quadruple therapy (regimen contains Keverprazan 20 mg or Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, bismuth potassium citrate 240 mg) twice daily for 14 days. The primary endpoint was the H. pylori eradication rate at 4 weeks after treatment. Full analysis set showed the H. pylori eradication rates were 87.8% (252/287) and 82.52% (236/286) for KEV group and ESO group, respectively (difference: 5.29%; 95% CI: -0.55% to 11.18%). Superiority of Keverprazan over Esomeprazole in terms of eradication rate was observed in the per-protocol set (P=0.0382). The eradication rates for patients resistant or not resistant to clarithromycin were both numerically higher in KEV group than ESO group (83.45% vs. 76.98% for clarithromycin-resistance; 96.67 vs. 93.38% for clarithromycin-nonresistance). The incidence of adverse events was similar in KEV and ESO group (76.31% vs. 77.62%), with most adverse events (>90%) being mild in severity and leading to no deaths. Keverprazan 20 mg twice daily, used as a component of bismuth quadruple therapy provided effective H. pylori eradication and was non-inferior to Esomeprazole-based regimen. [Display omitted]