J Neurogastroenterol Motil.
2020 Jan;26(1):85-95. 10.5056/jnm19031.
Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole
- Affiliations
-
- 1Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong, China
- 2Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Taiwan
- 3Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan
- 4Division of Gastroenterology, Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, Korea
- 5Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea
- KMID: 2500653
- DOI: http://doi.org/10.5056/jnm19031
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 24- hour 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).
Conclusion
In Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.
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