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

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

Journal: Alimentary pharmacology & therapeutics 2022;57(1):72-80

PMID: 36314172

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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.

Address: Catholic Photomedicine Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.; Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, South Korea.; Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju, South Korea.; Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, South Korea.; Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.; Department of Internal Medicine, Wonkwang University Hospital, Iksan, South Korea.; Department of Internal Medicine, Inje University, Seoul Paik Hospital, Seoul, South Korea.; Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.; Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.; Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, South Korea.; Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, South Korea.; Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea.; Department of Internal Medicine, GangNeung Asan Hospital, College of Medicine, Ulsan University, Gangneung, South Korea.; Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.; Department of Gastroenterology, Asan Medical Center, University of Ulsan, Seoul, South Korea.; Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.; Department of Internal Medicine, Konkuk University Medical Center, Seoul, South Korea.; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.; Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea.; Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, South Korea.; Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.; Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam and Seoul National University College of Medicine, Seoul, South Korea.; Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, South Korea.; Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Changwon, South Korea.; Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.; Department of Gastroenterology, Ajou University Hospital, Ajou University School of Medicine, Suwon, South Korea.; Department of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea.; Department of Internal Medicine, Hallym University College of Medicine/Institute for Liver and Digestive Diseases, Chuncheon, South Korea.; Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.

DOI: 10.1111/apt.17255

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MeSH Terms: Humans, Lansoprazole, Gastrins