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      Drug Design, Development and Therapy (submit here)

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      Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial

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          Abstract

          Purpose: Research comparing the clinical efficacy of dexlansoprazole and esomeprazole has been limited. This study aims to compare the clinical efficacy of single doses of dexlansoprazole (modified-release 60 mg) and esomeprazole (40 mg) after 24-week follow-up in patients with mild erosive esophagitis.

          Methods: We enrolled 86 adult GERD subjects, randomized in a 1:1 ratio to two sequence groups defining the order in which they received single doses of dexlansoprazole (n=43) and esomeprazole (n=43) for 8 weeks as initial treatment. Patients displaying complete symptom resolution (CSR) by the end of initial treatment (8 weeks) were switched to on-demand therapy until the end of 24 weeks. Follow-up endoscopy was performed either at the end of 24 weeks or when severe reflux symptoms occurred. Five patients were lost to follow-up, leaving 81 patients (dexlansoprazole, n=41; esomeprazole, n=40) in the per-protocol analysis.

          Results: The GERDQ scores at 4-, 8-, 12-, 16-, 20-, and 24-week posttreatment were less than the baseline score. The CSR, rate of symptom relapse, days to symptom resolution, sustained healing rate of erosive esophagitis, treatment failure rate, and the number of tablets taken in 24 weeks were similar in both groups. The esomeprazole group had more days with reflux symptoms than the dexlansoprazole group (37.3±37.8 vs 53.9±54.2; P=0.008). In the dexlansoprazole group, patients exhibited persistent improvement in the GERDQ score during the on-demand period (week 8 vs week 24; P<0.001) but not in the esomeprazole group (week 8 vs week 24; P=0.846).

          Conclusions: This study suggests that the symptom relief effect for GERD after 24 weeks was similar for dexlansoprazole and esomeprazole. Dexlansoprazole exhibited fewer days with reflux symptoms in the 24-week study period, with better persistent improvement in the GERDQ score in the on-demand period.

          (ClinicalTrials. gov number: NCT03128736)

          Most cited references36

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          Gastro-oesophageal reflux disease.

          Paul Moayyedi, Nicholas J. Talley (2006)
          Gastro-oesophageal reflux disease refers to reflux of gastric contents into the oesophagus leading to oesophagitis, reflux symptoms sufficient to impair quality of life, or long-term complications. Transient relaxation of the lower oesophageal sphincter is believed to be the primary mechanism of the disease although the underlying cause remains uncertain. Obesity and smoking are weakly associated with the disease and genetic factors might be important. A negative association with Helicobacter pylori exists, but eradication of H pylori does not seem to cause reflux disease. Diagnosis is imprecise as there is no gold standard. Reflux symptoms are helpful in diagnosis but they lack sensitivity. Ambulatory oesophageal pH monitoring also seems to be insensitive despite high specificity. Empirical acid suppression with a proton-pump inhibitor (PPI) has reasonable sensitivity but poor specificity. Some evidence suggests that once patients develop the disease, severity is determined early and patients seem to continue with that phenotype long term. Unfortunately, most patients do not respond to life-style advice and require further therapy. H2 receptor antagonists and PPIs are better than placebo in oesophagitis, with a number needed to treat of five and two, respectively. In non-erosive reflux disease, acid suppression is better than placebo but the response rate is lower. Most patients need long-term treatment because the disease usually relapses. The role of endoscopic therapy is uncertain. Anti-reflux surgery is probably as effective as PPI therapy although there is a low operative mortality and morbidity.
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            Prevalence, clinical spectrum and health care utilization of gastro-oesophageal reflux disease in a Chinese population: a population-based study.

            Valerie Hu, Carolyn S. P. Lam, X. H. Xia … (2003)
            Population-based data on gastro-oesophageal reflux disease in Chinese are lacking. The prevalence, clinical spectrum and health care-seeking behaviour of subjects with gastro-oesophageal reflux disease were studied. Ethnic Chinese (3605) were invited to participate in a telephone survey using a validated gastro-oesophageal reflux disease questionnaire and the Hospital Anxiety and Depression Scale. A total of 2209 subjects (58% female; mean age, 40.3 years) completed the interview. The annual, monthly and weekly prevalence rates of gastro-oesophageal reflux disease were 29.8%, 8.9% and 2.5%, respectively. Gastro-oesophageal reflux disease symptoms were associated with non-cardiac chest pain [odds ratio (OR), 2.3; 95% confidence interval (95% CI), 1.7-3.1], dyspepsia (OR, 1.9; 95% CI, 1.4-2.5), globus (OR, 1.8; 95% CI, 1.2-2.7), acid feeling in the stomach (OR, 5.8; 95% CI, 4.5-7.5) and the use of non-steroidal anti-inflammatory drugs (OR, 2.3; 95% CI, 1.5-3.6), but not with dysphagia, bronchitis, asthma, hoarseness and pneumonia. Patients with gastro-oesophageal reflux disease had a significantly higher anxiety and depression score and required more days off work when compared with subjects without. The frequency of heartburn (P = 0.032), female gender (P < 0.001), degree of depression (P = 0.004) and social morbidity (P < 0.001) were independent factors associated with health care-seeking behaviour. The prevalence of gastro-oesophageal reflux disease was lower than that in Western populations, but carried a significant socio-economic burden in the studied Chinese population. The frequency of heartburn, female gender and psychosocial factors were associated with health care utilization in gastro-oesophageal reflux disease.
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              Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors.

              D Ahnen, E Solcia, C McClain … (2000)
              This review examines the evidence for the development of adverse effects due to prolonged gastric acid suppression with proton pump inhibitors. Potential areas of concern regarding long-term proton pump inhibitor use have included: carcinoid formation; development of gastric adenocarcinoma (especially in patients with Helicobacter pylori infection); bacterial overgrowth; enteric infections; and malabsorption of fat, minerals, and vitamins. Prolonged proton pump inhibitor use may lead to enterochromaffin-like cell hyperplasia, but has not been demonstrated to increase the risk of carcinoid formation. Long-term proton pump inhibitor treatment has not been documented to hasten the development or the progression of atrophic gastritis to intestinal metaplasia and gastric cancer, although long-term studies are required to allow definitive conclusions. At present, we do not recommend that patients be tested routinely for H. pylori infection when using proton pump inhibitors for prolonged periods. Gastric bacterial overgrowth does increase with acid suppression, but important clinical sequelae, such a higher rate of gastric adenocarcinoma, have not been seen. The risk of enteric infection may increase with acid suppression, although this does not seem to be a common clinical problem with prolonged proton pump inhibitor use. The absorption of fats and minerals does not appear to be significantly impaired with chronic acid suppression. However, vitamin B12 concentration may be decreased when gastric acid is markedly suppressed for prolonged periods (e.g. Zolllinger-Ellison syndrome), and vitamin B12 levels should probably be assessed in patients taking high-dose proton pump inhibitors for many years. Thus, current evidence suggests that prolonged gastric acid suppression with proton pump inhibitors rarely, if ever, produces adverse events. Nevertheless, continued follow-up of patients taking proton pump inhibitors for extended periods will provide greater experience regarding the potential gastrointestinal adverse effects of long-term acid suppression.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Drug Des Devel Ther
                Journal ID (iso-abbrev): Drug Des Devel Ther
                Journal ID (publisher-id): DDDT
                Journal ID (pmc): dddt
                Title: Drug Design, Development and Therapy
                Publisher: Dove
                ISSN (Electronic): 1177-8881
                Publication date (Electronic): 26 April 2019
                Publication date Collection: 2019
                Volume: 13
                Pages: 1347-1356
                Affiliations
                [1 ]Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine , Kaohsiung, Taiwan
                [2 ]Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University , Kaohsiung, Taiwan
                [3 ]Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University , Kaohsiung, Taiwan
                [4 ]Division of Family Physicians, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine , Kaohsiung, Taiwan
                Author notes
                Correspondence: Chih-Ming LiangDivision 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, Kaohsiung833, TaiwanTel +88 677 317 123 2360Fax +8 867 732 2402Email gimy54861439@ 123456gmail.com
                Article
                Publisher ID: 193559
                DOI: 10.2147/DDDT.S193559
                PMC ID: 6499145
                SO-VID: e497af6f-79ce-4960-b030-490f7ed2f440
                Copyright © © 2019 Chiang et al.
                License:

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                Date received : 06 November 2018
                Date accepted : 12 March 2019
                Page count
                Figures: 1, Tables: 3, References: 43, Pages: 10
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: dexlansoprazole,esomeprazole,24-week response,gastroesophageal reflux disease,on-demand,gerdq score
                Data availability:
                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: dexlansoprazole, esomeprazole, 24-week response, gastroesophageal reflux disease, on-demand, gerdq score

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