Randomized Controlled Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 28, 2022; 28(44): 6294-6309
Published online Nov 28, 2022. doi: 10.3748/wjg.v28.i44.6294
Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis
Kang Nyeong Lee, Oh Young Lee, Hoon Jai Chun, Jin Il Kim, Sung Kook Kim, Sang Woo Lee, Kyung Sik Park, Kook Lae Lee, Suck Chei Choi, Jae-Young Jang, Gwang Ha Kim, In-kyung Sung, Moo In Park, Joong Goo Kwon, Nayoung Kim, Jae Jun Kim, Soo Teik Lee, Hyun Soo Kim, Ki Bae Kim, Yong Chan Lee, Myung-Gyu Choi, Joon Seong Lee, Hwoon-Yong Jung, Kwang Jae Lee, Jie-Hyun Kim, Hyunsoo Chung
Kang Nyeong Lee, Oh Young Lee, Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea
Hoon Jai Chun, Department of Internal Medicine, Korea University Anam Hospital, Seoul 02841, South Korea
Jin Il Kim, Department of Internal Medicine, The Catholic University of Korea, Yeouido ST. Mary’s Hospital, Seoul 07260, South Korea
Sung Kook Kim, Department of Internal Medicine, Kyungpook National University Hospital, Daegu 41944, South Korea
Sang Woo Lee, Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si 15355, South Korea
Kyung Sik Park, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu 42601, South Korea
Kook Lae Lee, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul 07061, South Korea
Suck Chei Choi, Department of Internal Medicine, Wonkwang University Hospital, Iksan 54538, South Korea
Jae-Young Jang, Department of Internal Medicine, KyungHee University Medical Center, Seoul 02447, South Korea
Gwang Ha Kim, Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan 47241, South Korea
In-kyung Sung, Department of Internal Medicine, KKonkuk University Medical Center, Seoul 05030, South Korea
Moo In Park, Department of Internal Medicine, Kosin University Gaspel Hospital, Busan 49267, South Korea
Joong Goo Kwon, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu 42471, South Korea
Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si 13620, Gyeonggi-do, South Korea
Jae Jun Kim, Department of Internal Medicine, Samsung Medical Center, Seoul 06351, South Korea
Soo Teik Lee, Department of Internal Medicine, Chonbuk National University Hospital, Jeonju-si 54907, South Korea
Hyun Soo Kim, Department of Internal Medicine, Chonnam National University Hospital, Gwangju 61469, South Korea
Ki Bae Kim, Department of Internal medicine, Chungbuk National University School of Medicine, Cheong Ju 28644, South Korea
Yong Chan Lee, Department of Internal Medicine, Severance Hospital, Seoul 03722, South Korea
Myung-Gyu Choi, Department of Internal Medicine, The Catholic University of Korea, Seoul ST. Mary’s Hospital, Seoul 06591, South Korea
Joon Seong Lee, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul 04401, South Korea
Hwoon-Yong Jung, Department of Internal Medicine, Asan Medical Center, Seoul 05505, South Korea
Kwang Jae Lee, Department of Gastroenterology, Ajou University School of Medicine, Suwon 16499, South Korea
Jie-Hyun Kim, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, South Korea
Hyunsoo Chung, Department of Internal Medicine, Seoul National University Hospital, Seoul 03080, South Korea
Author contributions: Lee OY contributed to study design, acquisition and interpretation of data, and critically reviewed and edited the manuscript; Lee KN contributed to the data interpretation, and drafting and editing the manuscript; All authors contributed to enrolment of patients, agreed to be responsible for every aspect of this work, reviewed and finally approved the manuscript.
Institutional review board statement: This study was approved by the institutional review boards (IRBs) of each institution, conducted in compliance with the relevant ethics guidelines. All the study medications and procedures performed were in accordance with the 1964 Declaration of Helsinki and its later amendments, or comparable ethical standards.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT03736369.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The corresponding author, Lee OY, had been a member of outside directors at the Daewoong Pharmaceutical Co., Ltd, form the period March 24 2018 to Nov 2 2021. All other authors declare no conflict of interests regarding this study.
Data sharing statement: Data are available upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Checklist, and the manuscript was prepared and revised according to the CONSORT 2010 Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Oh Young Lee, MD, PhD, Professor, Department of Internal Medicine, Hanyang University College of Medicine, 222, Wangsimni-ro, Seongdong-gu, Soeul 04763, South Korea. leeoy@hanyang.ac.kr
Received: September 4, 2022
Peer-review started: September 4, 2022
First decision: October 4, 2022
Revised: October 17, 2022
Accepted: November 9, 2022
Article in press: November 9, 2022
Published online: November 28, 2022
Processing time: 81 Days and 14.1 Hours
Core Tip

Core Tip: A mainstay therapy of erosive esophagitis (EE) is acid suppression using proton pump inhibitors (PPIs), which have shortcomings such as their slow absorption and variability in metabolism. Acid suppression can be competitively and reversibly achieved by a novel potassium-competitive acid blocker, fexuprazan. We compared the efficacy and safety of fexuprazan and esomeprazole (each 40 mg once daily) in patients with EE for 8 wk. We conclude that fexuprazan is a new alternative to PPIs, by showing that fexuprazan is not inferior to esomeprazole in endoscopic healing rate of EE at week 8 and in safety profiles.