Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis

K Ashida, Y Sakurai, T Hori, K Kudou, A Nishimura, N Hiramatsu, E Umegaki, K Iwakiri, K Ashida, Y Sakurai, T Hori, K Kudou, A Nishimura, N Hiramatsu, E Umegaki, K Iwakiri

Abstract

Background: Vonoprazan is a novel potassium-competitive acid blocker which may provide clinical benefit in acid-related disorders.

Aim: To verify the non-inferiority of vonoprazan vs. lansoprazole in patients with erosive oesophagitis (EE), and to establish its long-term safety and efficacy as maintenance therapy.

Methods: In this multicentre, randomised, double-blind, parallel-group comparison study, patients with endoscopically confirmed EE (LA Classification Grades A-D) were randomly allocated to receive vonoprazan 20 mg or lansoprazole 30 mg once daily after breakfast. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 8. In addition, subjects who achieved healed EE in the comparison study were re-randomised into a long-term study to investigate the safety and efficacy of vonoprazan 10 or 20 mg as maintenance therapy for 52 weeks.

Results: Of the 409 eligible subjects randomised, 401 completed the comparison study, and 305 entered the long-term maintenance study. The proportion of patients with healed EE up to week 8 was 99.0% for vonoprazan (203/205) and 95.5% for lansoprazole (190/199), thus verifying the non-inferiority of vonoprazan (P < 0.0001). Vonoprazan was also effective in patients with more severe EE (LA Classification Grades C/D) and CYP2C19 extensive metabolisers. In the long-term maintenance study, there were few recurrences (<10%) of EE in patients treated with vonoprazan 10 or 20 mg. Overall, vonoprazan was well-tolerated.

Conclusions: The non-inferiority of vonoprazan to lansoprazole in EE was verified in the comparison study, and vonoprazan was well-tolerated and effective during the long-term maintenance study.

© 2015 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Patient disposition during a short‐term (8‐week) double‐blind comparison of vonoprazan (VPZ) and lansoprazole (LPZ) and long‐term (52‐week) single‐blind maintenance study with VPZ 10 or 20 mg in patients with erosive oesophagitis (EE)
Figure 2
Figure 2
Arithmetic mean serum gastrin, pepsinogen I and pepsinogen II levels at baseline and after 2, 4 and 8 weeks' treatment with vonoprazan (VPZ) 20 mg or lansoprazole (LPZ) 30 mg once daily in patients with erosive oesophagitis (EE). Each bar shows the standard deviation. Difference between vonoprazan and lansoprazole groups: ***P < 0.0001; *P < 0.05.

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