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


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.

SUBMITTER: Lee KJ 

PROVIDER: S-EPMC6594096 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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

Lee Kwang Jae KJ   Son Byoung Kwan BK   Kim Gwang Ha GH   Jung Hye-Kyung HK   Jung Hwoon-Yong HY   Chung Il-Kwun IK   Sung In-Kyung IK   Kim Jin Il JI   Kim Jong Hyeok JH   Lee Joon Seong JS   Kwon Joong Goo JG   Park Jung Ho JH   Huh Kyu Chan KC   Park Kyung Sik KS   Park Moo-In MI   Kim Nayoung N   Lee Oh Young OY   Jee Sam Ryong SR   Lee Sang Kil SK   Youn Sei Jin SJ   Kim Sung Kook SK   Lee Soo Teik ST   Hong Su Jin SJ   Choi Suck Chei SC   Kim Tae Nyeun TN   Youn Young Hoon YH   Park Hyo Ju HJ   Kang Min Ja MJ   Park Chi Hye CH   Kim Bong Tae BT   Youn Sangjun S   Song Geun Seog GS   Rhee Poong-Lyul PL  

Alimentary pharmacology & therapeutics 20190306 7


<h4>Background</h4>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.<h4>Aim</h4>To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE).<h4>Methods</h4>In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Cl  ...[more]

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