Randomized Controlled Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 14, 2018; 24(14): 1550-1561
Published online Apr 14, 2018. doi: 10.3748/wjg.v24.i14.1550
Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole
Kiyoshi Ashida, Katsuhiko Iwakiri, Naoki Hiramatsu, Yuuichi Sakurai, Tetsuharu Hori, Kentarou Kudou, Akira Nishimura, Eiji Umegaki
Kiyoshi Ashida, Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto 607-8062, Japan
Katsuhiko Iwakiri, Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo 113-8603, Japan
Naoki Hiramatsu, Department of Gastroenterology and Hepatology, Osaka Rosai Hospital, Sakai, Osaka 591-8025, Japan
Yuuichi Sakurai, Tetsuharu Hori, Kentarou Kudou, Akira Nishimura, Takeda Pharmaceutical Company Limited, Osaka 540-8645, Japan
Eiji Umegaki, Department of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Hyogo 650-0017, Japan
Author contributions: Ashida K, Sakurai Y, Hori T and Nishimura A were involved in study conception and design; Hiramatsu N served as Medical Expert; Umegaki E, Iwakiri K and Ashida K served as the Central Adjudication Committee; Kudou K conducted statistical analyses; all authors were involved in the drafting and critical revision of the manuscript, and approved the final version, including the authorship list.
Institutional review board statement: The study was reviewed and approved by the institutional review board of each participating site.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT01459367.
Informed consent statement: All study participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: Kiyoshi Ashida has received fees and honoraria from Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Company Limited; Katsuhiko Iwakiri has received grants, fees, and honoraria from Takeda Pharmaceutical Company Limited, and fees from Otsuka Pharmaceutical Company Limited; Yuuichi Sakurai, Tetsuharu Hori, Kentarou Kudou, and Akira Nishimura are full-time employees of Takeda Pharmaceutical Company Limited; Naoki Hiramatsu and Eiji Umegaki have no conflicts of interest to declare.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Kiyoshi Ashida, MD, PhD, Department of Gastroenterology, Rakuwakai Otowa Hospital, 2 Otowachinji-cho, Yamashina-ku, Kyoto 607-8062, Japan. rakuwadr1185@rakuwadr.com
Telephone: +81-75-5934111 Fax: +81-75-5934160
Received: November 30, 2017
Peer-review started: December 1, 2017
First decision: December 13, 2017
Revised: February 6, 2018
Accepted: March 7, 2018
Article in press: March 6, 2018
Published online: April 14, 2018
Processing time: 131 Days and 12.8 Hours
Core Tip

Core tip: Proton pump inhibitors (PPIs), including lansoprazole, are widely used to maintain healing of erosive esophagitis (EE) in patients with gastroesophageal reflux disease; however, symptoms of reflux persist in significant numbers of patients treated with PPIs. We compared two doses of the novel potassium-competitive acid blocker vonoprazan (10 and 20 mg once daily) with lansoprazole at its approved dose of 15 mg once daily as maintenance therapy for healed EE in 607 Japanese patients. Vonoprazan was shown to be non-inferior to lansoprazole 15 mg at both investigated doses, while demonstrating a similar safety profile.