Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis

Yu Kyung Cho, Jae Hak Kim, Hyun Soo Kim, Tae Oh Kim, Jung Hwan Oh, Suck Chei Choi, Jeong Seop Moon, Sang Kil Lee, Sung Woo Jung, Sung Soo Kim, Hye Kyung Jung, Sang Pyo Lee, Gab Jin Cheon, Moo In Park, Hwoon Yong Jung, Kwang Hyun Ko, In Kyung Sung, Si Hyung Lee, Ju Yup Lee, Soo Teik LeePoong Lyul Rhee, Nayoung Kim, Su Jin Hong, Hyun Jin Kim, Gwang Ha Kim, Kwang Jae Lee, Sung Kook Kim, Woon Geon Shin, Oh Young Lee

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Background: Tegoprazan is a novel potassium-competitive acid blocker used to treat acid-related disorders. Aim: To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in healed erosive oesophagitis (EE). Methods: In this phase 3, double-blind, multi-centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels. Results: We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan-treated than lansoprazole-treated patients. Conclusions: Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.

Original languageEnglish
Pages (from-to)72-80
Number of pages9
JournalAlimentary Pharmacology and Therapeutics
Volume57
Issue number1
DOIs
StatePublished - Jan 2023

Bibliographical note

Funding Information:
Declaration of personal interests: The authors thank all the investigators who contributed to this study. Statistical analysis was supported by Heechan Lee, Heehyun Kim, Jihyeon Kim, Min Ja Kang and Bong Tae Kim who are employees of HK inno.N Corp., Seoul, Korea.

Publisher Copyright:
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

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