Clinical Trials Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 21, 2017; 23(47): 8395-8404
Published online Dec 21, 2017. doi: 10.3748/wjg.v23.i47.8395
First-week clinical responses to dexlansoprazole 60 mg and esomeprazole 40 mg for the treatment of grades A and B gastroesophageal reflux disease
Chih-Ming Liang, Ming-Te Kuo, Pin-I Hsu, Chao-Hung Kuo, Wei-Chen Tai, Shih-Cheng Yang, Keng-Liang Wu, Hsing-Ming Wang, Chih-Chien Yao, Cheng-En Tsai, Yao-Kuang Wang, Jiunn-Wei Wang, Chih-Fang Huang, Deng-Chyang Wu, Seng-Kee Chuah, Taiwan Acid-Related Disease Study Group
Chih-Ming Liang, Ming-Te Kuo, Wei-Chen Tai, Shih-Cheng Yang, Keng-Liang Wu, Hsing-Ming Wang, Chih-Chien Yao, Cheng-En Tsai, Seng-Kee Chuah, Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan
Pin-I Hsu, Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung 833, Taiwan
Chao-Hung Kuo, Yao-Kuang Wang, Jiunn-Wei Wang, Deng-Chyang Wu, Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung 833, Taiwan
Chih-Fang Huang, Division of Family Physicians, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan
Author contributions: Liang CM and Kuo MT contributed equally to this work; Chuah SK contributed to the research design and critical revision of the manuscript for important intellectual content; Hsu PI, Kuo CH, Tai WC, Yang SC, Wu KL, Wang HM, Yao CC, Tsai CE, Wang YK, Wang JW, Huang CF, Wu DC and Chuah SK performed the research; Liang CM and Kuo MT analyzed the data and wrote the manuscript; all authors approved the final version of the manuscript.
Supported by Research Foundation of Chang Gung Memorial Hospital, No. CMRPG8D1441.
Institutional review board statement: The study was reviewed and approved by the Chang Gung Memorial Hospital institutional review board.
Clinical trial registration statement: ClinicalTrials.gov number: NCT03128736.
Informed consent statement: The data collection in this study is based on reviewing computerized medical charts. Informed consent was obtained from all patients in the study.
Conflict-of-interest statement: None of the authors have a conflict of interest related to the manuscript.
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: Seng-Kee Chuah, MD, Chief Doctor, Professor, Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Ta Pei Road, Niao-Sung District, Kaohsiung 833, Taiwan. chuahsk@cgmh.org.tw
Telephone: +886-7-7317123-2360 Fax: +886-7-7322402
Received: July 28, 2017
Peer-review started: July 28, 2017
First decision: August 30, 2017
Revised: September 19, 2017
Accepted: September 26, 2017
Article in press: September 26, 2017
Published online: December 21, 2017
Processing time: 145 Days and 22.7 Hours
Core Tip

Core tip: No existing report has investigated the short-term clinical effects of dexlansoprazole 60 mg vs esomeprazole 40 mg. This study compared the one-week clinical effects of a single dose of the two drugs for grades A and B erosive esophagitis. We enrolled 175 adult patients with gastroesophageal reflux disease (GERD) and randomized them in a 1:1 ratio into a dexlansoprazole (n = 88) or esomeprazole group (n = 87) for an intention-to-treat analysis (ITT). The primary end-points were the complete symptom resolution (CSR) rates at days 1, 3, and 7. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3 (38.3% vs 18.4%, P = 0.046). In the esomeprazole group, female sex was a negative predictive factor for CSR at post-dose day 1 [OR = -1.249 ± 0.543; 95%CI: 0.287 (0.099-0.832), P = 0.022] and day 3 [OR = -1.254 ± 0.519; 95%CI: 0.285 (0.103-0.789), P = 0.016]. This pilot study suggested that the overall CSR rates for GERD patients were similar at days 1 through 7 for both the dexlansoprazole and esomeprazole groups, although a higher CSR was observed at day 3 in female patients who received a single dose of dexlansoprazole.