title: Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study.
abstract: The objective of this study was to assess the efficacy, safety and tolerability of vonoprazan, a novel potassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.
  
  
  
  A randomised, double-blind, multicentre, parallel-group study was conducted to verify the non-inferiority of vonoprazan 20 mg to lansoprazole 30 mg as part of first-line triple therapy (with amoxicillin 750 mg and clarithromycin 200 or 400 mg) in H pylori-positive patients with gastric or duodenal ulcer history. The first 50 patients failing first-line therapy with good compliance also received second-line vonoprazan-based triple therapy (with amoxicillin 750 mg and metronidazole 250 mg) as an open-label treatment.
  
  
  
  Of the 650 subjects randomly allocated to either first-line triple therapy, 641 subjects completed first-line therapy and 50 subjects completed second-line therapy. The first-line eradication rate (primary end point) was 92.6% (95% CI 89.2% to 95.2%) with vonoprazan versus 75.9% (95% CI 70.9% to 80.5%) with lansoprazole, with the difference being 16.7% (95% CI 11.2% to 22.1%) in favour of vonoprazan, thus confirming the non-inferiority of vonoprazan (p<0.0001). The second-line eradication rate (secondary end point) was also high (98.0%; 95% CI 89.4% to 99.9%) in those who received second-line therapy (n=50). Both first-line triple therapies were well tolerated with no notable differences. Second-line triple therapy was also well tolerated.
  
  
  
  Vonoprazan is effective as part of first-line triple therapy and as part of second-line triple therapy in H pylori-positive patients with a history of gastric or duodenal ulcer.
  
  
  
  NCT01505127.
authors.affiliation: Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan.
authors.forename: Kazunari
authors.initials: K
authors.lastname: Murakami
authors.affiliation: Takeda Pharmaceutical Company Ltd., Osaka, Japan.
authors.forename: Yuuichi
authors.initials: Y
authors.lastname: Sakurai
authors.affiliation: Takeda Pharmaceutical Company Ltd., Osaka, Japan.
authors.forename: Madoka
authors.initials: M
authors.lastname: Shiino
authors.affiliation: Takeda Pharmaceutical Company Ltd., Osaka, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Funao
authors.affiliation: Takeda Pharmaceutical Company Ltd., Osaka, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Nishimura
authors.affiliation: Health Sciences University of Hokkaido, Hokkaido, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Asaka
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D001944:Breath Tests / Q000379:methods; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D064747:Lansoprazole / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D010437:Peptic Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: C552956:1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D011758:Pyrroles; D013449:Sulfonamides; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin
keywords: ANTIBIOTIC THERAPY; CLINICAL TRIALS; HELICOBACTER PYLORI - TREATMENT; HELICOBACTER PYLORI INFECTION