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

• Published in: Gut Vol. 65; no. 9; pp. 1439 - 1446
• Main Authors: Murakami, Kazunari, Sakurai, Yuuichi, Shiino, Madoka, Funao, Nobuo, Nishimura, Akira, Asaka, Masahiro
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.09.2016; BMJ Publishing Group
• Series: Original article
• Subjects: Acids; Adult; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Breath Tests - methods; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Clinical medicine; Competition; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Drug dosages; Drug Monitoring - methods; Drug Therapy, Combination - methods; Electrocardiography; Enzymes; Female; Gastric cancer; Helicobacter Infections - complications; Helicobacter Infections - diagnosis; Helicobacter Infections - drug therapy; Helicobacter Pylori; Helicobacter pylori - drug effects; Helicobacter pylori - isolation & purification; Humans; Lansoprazole - administration & dosage; Lansoprazole - adverse effects; Lymphoma; Male; Medical laboratories; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; Peptic Ulcer - diagnosis; Peptic Ulcer - drug therapy; Peptic Ulcer - etiology; Potassium; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - adverse effects; Protons; Pyrroles - administration & dosage; Pyrroles - adverse effects; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Treatment Outcome; Ulcers; Japan; HELICOBACTER PYLORI - TREATMENT; CLINICAL TRIALS; ANTIBIOTIC THERAPY; HELICOBACTER PYLORI INFECTION
• ISSN: 0017-5749; 1468-3288
• DOI: 10.1136/gutjnl-2015-311304

ObjectiveThe 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.DesignA 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.ResultsOf 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.ConclusionVonoprazan 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.Trial registration numberNCT01505127.