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Summary   Background  The potassium‐competitive acid blocker vonoprazan ( VPZ ) has potent acid‐inhibitory effects and may offer clinical advantages over conventional therapy for acid‐related disorders.    Aim  To investigate the efficacy and safety of  VPZ  in patients with erosive oesophagitis ( EO ).    Methods  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.    Results  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.    Conclusions  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 .

alimentary pharmacology and therapeutics

Randomised clinical trial: a dose‐ranging study of vonoprazan, a novel potassium‐competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis