Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 21, 2016; 22(23): 5430-5435
Published online Jun 21, 2016. doi: 10.3748/wjg.v22.i23.5430
Randomized study of lafutidine vs lansoprazole in patients with mild gastroesophageal reflux disease
Ryuta Takenaka, Hiroyuki Okada, Seiji Kawano, Yoshinori Komazawa, Fumiya Yoshinaga, Shinji Nagata, Masafumi Inoue, Hirohisa Komatsu, Seiji Onogawa, Yoshinori Kushiyama, Shinichi Mukai, Hiroko Todo, Hideharu Okanobu, Noriaki Manabe, Shinji Tanaka, Ken Haruma, Yoshikazu Kinoshita
Ryuta Takenaka, Department of Gastroenterology, Tsuyama Chuo Hospital, Tsuyama 708-0841, Japan
Hiroyuki Okada, Seiji Kawano, Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama 708-0841, Japan
Yoshinori Komazawa, Division of Internal Medicine, Izumo City General Medical Center, Izumo 691-0003, Japan
Fumiya Yoshinaga, Department of Gastroenterology, Mihara Red Cross Hospital, Mihara 723-0011, Japan
Shinji Nagata, Department of Endoscopy, Hiroshima City Asa Citizens Hospital, Hiroshima 731-0293, Japan
Masafumi Inoue, Department of Gastroenterology, Okayama Red Cross Hospital, Okayama 700-0941, Japan
Hirohisa Komatsu, Department of Gastroenterology, Hiroshima General Hospital, Hiroshima 734-8551, Japan
Seiji Onogawa, Department of Gastroenterology, Onomichi General Hospital, Onomichi 722-8508, Japan
Yoshinori Kushiyama, Department of Gastroenterology, Matsue Red Cross Hospital, Matsue 690-8506, Japan
Shinichi Mukai, Department of Gastroenterology, Miyoshi Central Hospital, Miyoshi 728-0023, Japan
Hiroko Todo, Department of Gastroenterology, Hiroshima-Nishi Medical Center, Hiroshima 739-0651, Japan
Hideharu Okanobu, Department of Gastroenterology, Chugoku Rosai Hospital, Kure 737-0134, Japan
Noriaki Manabe, Department of Gastroenterology, Kawasaki Medical School Hospital, Kurashiki 701-0192, Japan
Shinji Tanaka, Department of Endoscopy, Hiroshima University Hospital, Hiroshima 734-8551, Japan
Ken Haruma, Department of General Internal Medicine 2, Kawasaki Hospital, Kawasaki Medical School, Okayama 708-0841, Japan
Yoshikazu Kinoshita, Department of Gastroenterology and Hepatology, Shimane University Hospital, Izumo 693-0021, Japan
Author contributions: Okada H, Tanaka S, Haruma K and Kinoshita Y designed this study; Takenaka R, Okada H, Kawano S, Komazawa Y, Yoshinaga F, Nagata S, Inoue M, Komatsu H, Onogawa S, Kushiyama Y, Mukai S, Todo H, Okanobu H, Manabe N and Kinoshita Y performed the research; Takenaka R and Kinoshita Y analyzed the data; Takenaka R, Okada H and Kinoshita Y wrote the paper and all co-authors approved the final version of the paper.
Supported by Taiho pharmaceutical co. Ltd.
Institutional review board statement: The study was reviewed and approved by the ethics committee of all participating institutions.
Clinical trial registration statement: This study is registered at UMIN Clinical Trial Registry. The registration identification number is UMIN000006162.
Informed consent statement: All study participants, or their legal guardian, provided informed written prior to study enrollment.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.
Data sharing statement: No additional data are available.
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: Ryuta Takenaka, MD, PhD, Department of Gastroenterology, Tsuyama Chuo Hospital, 1756 Kawasaki, Tsuyama 708-0841, Japan. rtakenak@tch.or.jp
Telephone: +81-868-218111 Fax: +81-868-218201
Received: February 14, 2016
Peer-review started: February 15, 2016
First decision: March 21, 2016
Revised: April 17, 2016
Accepted: May 21, 2016
Article in press: May 23, 2016
Published online: June 21, 2016
Processing time: 119 Days and 15 Hours
Abstract

AIM: To compare the clinical efficacy of the second-generation H2RA lafutidine with that of lansoprazole in Japanese patients with mild gastroesophageal reflux disease (GERD).

METHODS: Patients with symptoms of GERD and a diagnosis of grade A reflux esophagitis (according to the Los Angeles classification) were randomized to receive lafutidine (10 mg, twice daily) or lansoprazole (30 mg, once daily) for an initial 8 wk, followed by maintenance treatment comprising half-doses of the assigned drug for 24 wk. The primary endpoint was the frequency and severity of heartburn during initial and maintenance treatment. The secondary endpoints were the sum score of questions 2 and 3 in the Gastrointestinal Symptom Rating Scale (GSRS), and the satisfaction score.

RESULTS: Between April 2012 and March 2013, a total of 53 patients were enrolled, of whom 24 and 29 received lafutidine and lansoprazole, respectively. After 8 wk, the frequency and severity of heartburn was significantly reduced in both groups. However, lafutidine was significantly inferior to lansoprazole with regard to the severity of heartburn during initial and maintenance treatment (P = 0.016). The sum score of questions 2 and 3 in the GSRS, and satisfaction scores were also significantly worse in the lafutidine group than the lansoprazole group (P = 0.0068 and P = 0.0048, respectively).

CONCLUSION: The clinical efficacy of lafutidine was inferior to that of lansoprazole, even in Japanese patients with mild GERD.

Keywords: Gastroesophageal reflux disease; Proton pump inhibitors; Histamine receptor-2 antagonists; Los Angeles classification

Core tip: The clinical efficacy of the second-generation H2RA lafutidine was inferior to that of lansoprazole, particularly during maintenance therapy, even in Japanese patients with mild gastroesophageal reflux disease.