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©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis
Jing Sun, Yao-Zong Yuan, Xiao-Hua Hou, Duo-Wu Zou, Bin Lu, Min-Hu Chen, Fei Liu, Kai-Chun Wu, Xiao-Ping Zou, Yan-Qing Li, Li-Ya Zhou
Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
Xiao-Hua Hou, Department of Gastroenterology, Union Hospital Medical College, Huazhong University of Science and Technology, Wuhan 430074, Hubei Province, China
Duo-Wu Zou, Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai 200433, China
Bin Lu, Department of Gastroenterology, Zhejiang Traditional Chinese Medicine Hospital, Hangzhou 310006, Zhejiang Province, China
Min-Hu Chen, Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, Guangdong Province, China
Fei Liu, Department of Gastroenterology, Shanghai East Hospital, Shanghai 200120, China
Kai-Chun Wu, Department of Gastroenterology, Xijing Hospital, the Fourth Military Medical College, Xi’an 710032, Shaanxi Province, China
Xiao-Ping Zou, Department of Gastroenterology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing 210093, Jiangsu Province, China
Yan-Qing Li, Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, China
Li-Ya Zhou, Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
Author contributions: Yuan YZ is the guarantor of the article, who took responsibility for the integrity of the work as a whole, from inception to published article; Sun J, Zou XP, Hou XH and Li YQ helped to perform the research; Zou D and Lu B collected and analyzed the data; Chen MH and Liu F designed the research; Wu KC and Zhou LY contributed to the paper review and the design of the study; all authors approved the final version of the article, including the authorship list.
Supported by Grant from AstraZeneca.
Ethics approval: The study was reviewed and approved by the Ethics Committee of Ruijin Hospital Affiliated with Shanghai Jiaotong University School of Medicine.
Clinical trial registration: This study is registered at https://clinicaltrials.gov/. The registration identification number is D9612L00127.
Informed consent: All study participants provided informed written consent prior to study enrolment.
Conflict-of-interest: The authors have no personal conflicting interests to declare. This study was funded in full by AstraZeneca. Initial data analyses were undertaken by Yonggang Wu, who was the bio-statistician of Jiaxing Tigermed Data Co., and were funded by AstraZeneca. Writing support was provided by the medical writing group of Jiaxing Tigermed Data Co. and was funded by AstraZeneca. Medical writing and editorial support were provided by Catherine Hill of PharmaGenesis™ London and Richard Claes of Oxford PharmaGenesis™ Ltd and were funded by AstraZeneca.
Data sharing: 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: Yao-Zong Yuan, MD, PhD, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Rui Jin Er Road, Shanghai 200025, China. yyz28@medmail.com.cn
Telephone: +86-21-64150773 Fax: +86-21-64333548
Received: October 28, 2014
Peer-review started: October 28, 2014
First decision: December 26, 2014
Revised: January 19, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: June 14, 2015
AIM: To compare symptom control with esomeprazole regimens for non-erosive reflux disease and chronic gastritis in patients with a negative endoscopy.
METHODS: This randomized, open-label study was designed in line with clinical practice in China. Patients with typical reflux symptoms for ≥ 3 mo and a negative endoscopy who had a Gastroesophageal Reflux Disease Questionnaire score ≥ 8 were randomized to initial treatment with esomeprazole 20 mg once daily either for 8 wk or for 2 wk. Patients with symptom relief could enter another 24 wk of maintenance/on-demand treatment, where further courses of esomeprazole 20 mg once daily were given if symptoms recurred. The primary endpoint was the symptom control rate at week 24 of the maintenance/on-demand treatment period. Secondary endpoints were symptom relief rate, success rate (defined as patients who had symptom relief after initial treatment and after 24 wk of maintenance treatment), time-to-first-relapse and satisfaction rate.
RESULTS: Based on the data collected in the modified intention-to-treat population (MITT; patients in the ITT population with symptom relief after initial esomeprazole treatment, n = 262), the symptom control rate showed a small but statistically significant difference in favor of the 8-wk regimen (94.9% vs 87.3%, P = 0.0473). Among the secondary endpoints, based on the data collected in the ITT population (n = 305), the 8-wk group presented marginally better results in symptom relief after initial esomeprazole treatment (88.3% vs 83.4%, P = 0.2513) and success rate over the whole study (83.8% vs 72.8%, P = 0.0258). The 8-wk regimen was found to provide a 46% reduction in risk of relapse vs the 2-wk regimen (HR = 0.543; 95%CI: 0.388-0.761). In addition, fewer unscheduled visits and higher patient satisfaction supported the therapeutic benefits of the 8-wk regimen over the 2-wk regimen. Safety was comparable between the two groups, with both regimens being well tolerated.
CONCLUSION: Chinese patients diagnosed with chronic gastritis achieved marginally better control of reflux symptoms with an 8-wk vs a 2-wk esomeprazole regimen, with a similar safety profile.
Core tip: In China, physicians tend to perform endoscopies on patients presenting with typical symptoms of gastro-esophageal reflux disease, such as reflux or heartburn. If endoscopy findings are negative, patients are usually diagnosed with chronic gastritis rather than non-erosive reflux disease (NERD) and treated with a 2-wk course of proton pump inhibitors (PPIs). We compared symptom control rates when patients were treated with a 2-wk course of PPIs vs an 8-wk course, as recommended for patients with NERD. In this multicenter, randomized, open-label study, the 8-wk PPI regimen provided marginally better symptom control and relief rates than the 2-wk regimen, with a similar safety profile.
