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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.
Drug Des Devel Ther. 2019; 13:1347-1356.DD

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).

Authors+Show Affiliations

Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung, Taiwan.Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.Division of Family Physicians, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31118571

Citation

Chiang, Hung-Hsien, et al. "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." Drug Design, Development and Therapy, vol. 13, 2019, pp. 1347-1356.
Chiang HH, Wu DC, Hsu PI, et al. 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. Drug Des Devel Ther. 2019;13:1347-1356.
Chiang, H. H., Wu, D. C., Hsu, P. I., Kuo, C. H., Tai, W. C., Yang, S. C., Wu, K. L., Yao, C. C., Tsai, C. E., Liang, C. M., Wang, Y. K., Wang, J. W., Huang, C. F., & Chuah, S. K. (2019). 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. Drug Design, Development and Therapy, 13, 1347-1356. https://doi.org/10.2147/DDDT.S193559
Chiang HH, et al. 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. Drug Des Devel Ther. 2019;13:1347-1356. PubMed PMID: 31118571.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chiang,Hung-Hsien, AU - Wu,Deng-Chyang, AU - Hsu,Pin-I, AU - Kuo,Chao-Hung, AU - Tai,Wei-Chen, AU - Yang,Shih-Cheng, AU - Wu,Keng-Liang, AU - Yao,Chih-Chien, AU - Tsai,Cheng-En, AU - Liang,Chih-Ming, AU - Wang,Yao-Kuang, AU - Wang,Jiunn-Wei, AU - Huang,Chih-Fang, AU - Chuah,Seng-Kee, AU - ,, Y1 - 2019/04/26/ PY - 2018/11/06/received PY - 2019/03/12/accepted PY - 2019/5/24/entrez PY - 2019/5/24/pubmed PY - 2020/2/28/medline KW - 24-week response KW - GERDQ score KW - dexlansoprazole KW - esomeprazole KW - gastroesophageal reflux disease KW - on-demand SP - 1347 EP - 1356 JF - Drug design, development and therapy JO - Drug Des Devel Ther VL - 13 N2 - 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). SN - 1177-8881 UR - https://www.unboundmedicine.com/medline/citation/31118571/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_ L2 - https://dx.doi.org/10.2147/DDDT.S193559 DB - PRIME DP - Unbound Medicine ER -