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.
© 2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd.
Randomised Clinical Trial: Vonoprazan, a Novel Potassium-Competitive Acid Blocker, vs. Lansoprazole for the Healing of Erosive OesophagitisK Ashida et al. Aliment Pharmacol Ther 43 (2), 240-51. PMID 26559637. - Randomized Controlled TrialThe non-inferiority of vonoprazan to lansoprazole in EE was verified in the comparison study, and vonoprazan was well-tolerated and effective during the long-term mainten …
Randomised Clinical Trial: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of Tegoprazan (CJ-12420), a Novel Potassium-Competitive Acid Blocker, in Healthy Male SubjectsS Han et al. Aliment Pharmacol Ther 50 (7), 751-759. PMID 31437865.Tegoprazan was well tolerated and showed rapid and potent gastric acid suppression. This supports the further development of tegoprazan as a treatment for acid-related di …
Efficacy of Esomeprazole 40 Mg vs. Lansoprazole 30 Mg for Healing Moderate to Severe Erosive OesophagitisMB Fennerty et al. Aliment Pharmacol Ther 21 (4), 455-63. PMID 15709997. - Clinical TrialWith 8 weeks' treatment, esomeprazole 40 mg once daily heals moderate to severe EE faster and in more patients, and resolves heartburn in more patients after 4 weeks of t …
Esomeprazole: A Review of Its Use in the Management of Acid-Related DisordersLJ Scott et al. Drugs 62 (10), 1503-38. PMID 12093317. - ReviewEsomeprazole is an effective, well tolerated treatment for managing GORD and for eradicating H. pylori infection in patients with duodenal ulcer disease. In 8-week double …
Review of Esomeprazole in the Treatment of Acid DisordersDA Johnson. Expert Opin Pharmacother 4 (2), 253-64. PMID 12562316. - ReviewEsomeprazole (Nexium, AstraZeneca) is the (S)-isomer of omeprazole and the first proton pump inhibitor to be developed as an optical isomer. Esomeprazole has an improved …
Cited by 1 PubMed Central articles
Randomised Phase 3 Trial: Tegoprazan, a Novel Potassium-Competitive Acid Blocker, vs. Esomeprazole in Patients With Erosive OesophagitisKJ Lee et al. Aliment Pharmacol Ther 49 (7), 864-872. PMID 30843245.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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