10 20

Cited 0 times in

Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole

Authors
 Justin C Y Wu  ;  Bor-Shyang Sheu  ;  Ming-Shiang Wu  ;  Yong Chan Lee  ;  Myung-Gyu Choi 
Citation
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, Vol.26(1) : 85-95, 2020-01 
Journal Title
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY 
ISSN
 2093-0879 
Issue Date
2020-01
Keywords
Asia ; Dexlansoprazole ; Esophagitis ; Gastroesophageal reflux ; Heartburn
Abstract
Background/aims: Since the use of dexlansoprazole in Asian subjects with gastroesophageal reflux disease (GERD) has not been adequately characterized, this study was conducted to evaluate the efficacy and safety of dexlansoprazole modified-release in Asian subjects with non-erosive reflux disease (NERD) and erosive esophagitis (EE). Methods: In this phase 4, open-label, non-randomized, uncontrolled, multicenter, multi-country study sponsored by Takeda, subjects aged ≥ 20 years with persistent typical GERD symptoms for at least 6 months underwent endoscopy. Based on endoscopic findings, they were assigned to either dexlansoprazole modified-release 30 mg once-daily for 4 weeks (NERD group) or dexlansoprazole modified-release 60 mg once-daily for 8 weeks (EE group). The primary endpoint was the percentage of days that subjects did not experience any 24hour heartburn or acid regurgitation. Results: Of the 445 subjects screened from Hong Kong, South Korea, and Taiwan, 208 were enrolled in the NERD group (mean age: 53.6 years, male: 34.6%) and 88 in the EE group (mean age: 51.7 years, male: 55.7%). Over the treatment period, the median percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation was 26.9% and 65.5% in the NERD and EE groups, respectively; for nighttime heartburn or acid regurgitation the proportions were 59.3% and 83.3%, respectively. The treatment was well tolerated with low incidence of treatment-related adverse events in NERD and EE groups (6.7% and 5.7%, respectively). Conclusions: In Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.
Files in This Item:
T202004800.pdf Download
DOI
10.5056/jnm19031
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Yong Chan(이용찬) ORCID logo https://orcid.org/0000-0001-8800-6906
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/180473
사서에게 알리기
  feedback

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse

Links