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

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 YounSung 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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)864-872
Number of pages9
JournalAlimentary Pharmacology and Therapeutics
Volume49
Issue number7
DOIs
Publication statusPublished - 2019 Apr

    Fingerprint

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

Cite this

Lee, K. J., Son, B. K., Kim, G. H., Jung, H. K., Jung, H. Y., Chung, I. K., Sung, I. K., Kim, J. I., Kim, J. H., Lee, J. S., Kwon, J. G., Park, J. H., Huh, K. C., Park, K. S., Park, M. I., Kim, N., Lee, O. Y., Jee, S. R., Lee, S. K., ... Rhee, P. L. (2019). Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis. Alimentary Pharmacology and Therapeutics, 49(7), 864-872. https://doi.org/10.1111/apt.15185