Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis
- Authors
- Lee, Kwang Jae; Son, Byoung Kwan; Kim, Gwang Ha; Jung, Hye-Kyung; Jung, Hwoon-Yong; Chung, Il-Kwun; Sung, In-Kyung; Kim, Jin Il; Kim, Jong Hyeok; Lee, Joon Seong; Kwon, Joong Goo; Park, Jung Ho; Huh, Kyu Chan; Park, Kyung Sik; Park, Moo-In; Kim, Nayoung; Lee, Oh Young; Jee, Sam Ryong; Lee, Sang Kil; Youn, Sei Jin; Kim, Sung Kook; Lee, Soo Teik; Hong, Su Jin; Choi, Suck Chei; Kim, Tae Nyeun; Youn, Young Hoon; Park, Hyo Ju; Kang, Min Ja; Park, Chi Hye; Kim, Bong Tae; Youn, Sangjun; Song, Geun Seog; Rhee, Poong-Lyul
- Issue Date
- Apr-2019
- Publisher
- Blackwell Publishing Inc.
- Keywords
- Randomised Phase 3 Trial: Tegoprazan; a Novel Potassium-Competitive Acid Blocker; vs. Esomeprazole in Patients With Erosive Oesophagitis
- Citation
- Alimentary Pharmacology and Therapeutics, v.49, no.7, pp 864 - 872
- Pages
- 9
- Journal Title
- Alimentary Pharmacology and Therapeutics
- Volume
- 49
- Number
- 7
- Start Page
- 864
- End Page
- 872
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/4631
- DOI
- 10.1111/apt.15185
- ISSN
- 0269-2813
1365-2036
- 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.
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