Dataset Information

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

ABSTRACT:

Background

Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K⁺/H⁺-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner.

Aim

To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE).

Methods

Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups.

Results

Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups.

Conclusion

Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.

SUBMITTER: Lee KN

PROVIDER: S-EPMC9730436 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

Lee Kang Nyeong KN Lee Oh Young OY Chun Hoon Jai HJ Kim Jin Il JI Kim Sung Kook SK Lee Sang Woo SW Park Kyung Sik KS Lee Kook Lae KL Choi Suck Chei SC Jang Jae-Young JY Kim Gwang Ha GH Sung In-Kyung IK Park Moo In MI Kwon Joong Goo JG Kim Nayoung N Kim Jae Jun JJ Lee Soo Teik ST Kim Hyun Soo HS Kim Ki Bae KB Lee Yong Chan YC Choi Myung-Gyu MG Lee Joon Seong JS Jung Hwoon-Yong HY Lee Kwang Jae KJ Kim Jie-Hyun JH Chung Hyunsoo H

World journal of gastroenterology 20221101 44

<h4>Background</h4>Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K<sup>+</sup>/H<sup>+</sup>-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner.<h4>Aim</h4>To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE).<h4>Methods</h4>Korean adult patients with endoscopically confirm ...[more]

PMID: 36504556

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Dataset Information

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

Background

Aim

Methods

Results

Conclusion

Publications

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

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