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.
Bibliographical noteFunding Information:
Dr. Poong‐Lyul Rhee, Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea. Email: email@example.com Funding Information This study was funded in full by CJ Healthcare Corp, Seoul, Korea.
Declaration of personal interests: The authors would like to thank all the investigators who contributed to this study. Statistical analysis was supported by Jae Hoon Kwon. Hyo Ju Park, Min Ja Kang, Chi Hye Park, Bong Tae Kim, Sangjun Youn and Geun Seog Song are employees of CJ Healthcare Corp., Seoul, Korea.
© 2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd.
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)