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Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis

Authors
 Kwang Jae Lee  ;  Byoung Kwan Son  ;  Gwang Ha Kim  ;  Hye‐Kyung Jung  ;  Hwoon‐Yong Jung  ;  Il‐Kwun Chung  ;  In‐Kyung Sung  ;  Jin Il Kim  ;  Jong Hyeok Kim  ;  Joon Seong Lee  ;  Joong Goo Kwon  ;  Jung Ho Park  ;  Kyu Chan Huh  ;  Kyung Sik Park  ;  Moo‐In Park  ;  Nayoung Kim  ;  Oh Young Lee  ;  Sam Ryong Jee  ;  Sang Kil Lee  ;  Sei Jin Youn  ;  Sung Kook Kim  ;  Soo Teik Lee  ;  Su Jin Hong  ;  Suck Chei Choi  ;  Tae Nyeun Kim  ;  Young Hoon Youn  ;  Hyo Ju Park  ;  Min Ja Kang  ;  Chi Hye Park  ;  Bong Tae Kim  ;  Sangjun Youn  ;  Geun Seog Song  ;  Poong‐Lyul Rhee 
Citation
 ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Vol.49(7) : 864-872, 2019 
Journal Title
 ALIMENTARY PHARMACOLOGY & THERAPEUTICS 
ISSN
 0269-2813 
Issue Date
2019
Abstract
BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. AIM: To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE). METHODS: In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed. RESULTS: The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated. CONCLUSION: Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.
Files in This Item:
T201902120.pdf Download
DOI
10.1111/apt.15185
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Youn, Young Hoon(윤영훈) ORCID logo https://orcid.org/0000-0002-0071-229X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/170337
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