Randomised clinical trial: a dose‐ranging study of vonoprazan, a novel potassium‐competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. Issue 6 (22nd July 2015)

• Record Type: Journal Article
• Authors: Ashida, K.; Sakurai, Y.; Nishimura, A.; Kudou, K.; Hiramatsu, N.; Umegaki, E.; Iwakiri, K.; Chiba, T.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 42:Issue 6(2015)
• Page Start: 685
• Page End: 695
• Publication Date: 2015-07-22
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.13331
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt13331-abs-0001"> <title>Summary</title> <sec id="apt13331-sec-0001" sec-type="section"> <title>Background</title> <p>The potassium‐competitive acid blocker vonoprazan (VPZ) has potent acid‐inhibitory effects and may offer clinical advantages over conventional therapy for acid‐related disorders.</p> </sec> <sec id="apt13331-sec-0002" sec-type="section"> <title>Aim</title> <p>To investigate the efficacy and safety of VPZ in patients with erosive oesophagitis (EO).</p> </sec> <sec id="apt13331-sec-0003" sec-type="section"> <title>Methods</title> <p>In this multicentre, randomised, double‐blind, parallel‐group, dose‐ranging study, patients ≥20 years with endoscopically confirmed EO [Los Angeles (LA) grades A−D] received VPZ 5, 10, 20 or 40 mg, or lansoprazole (LPZ) 30 mg once daily for 8 weeks. The primary endpoint was the proportion of healed EO subjects as shown by endoscopy at week 4.</p> </sec> <sec id="apt13331-sec-0004" sec-type="section"> <title>Results</title> <p>A total of 732 subjects received VPZ or LPZ. The proportion of healed EO subjects at week 4 was 92.3%, 92.5%, 94.4%, 97.0% and 93.2%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. All VPZ doses were non‐inferior to LPZ when adjusted for baseline LA grades A/B and C/D. Among those with LA grades C/D, the proportions of healed EO subjects were 87.3%, 86.4%, 100%, 96.0% and 87.0%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. The incidence of adverse events was similar across the groups.</p> </sec> <sec id="apt13331-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Vonoprazan was effective and non‐inferior to LPZ in healing EO. VPZ 20 mg or higher was highly efficacious for severe EO (LA grades C/D). VPZ was associated with no safety concern during this 8‐week study, while there was a dose‐dependent increase in serum gastrin. Once‐daily VPZ 20 mg is the recommended clinical dose for treating EO.</p> </sec> </abstract>