Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis
- Lee, Kang Nyeong; Lee, Oh Young; Chun, Hoon Jai; Kim, Jin Il; Kim, Sung Kook; Lee, Sang Woo; Park, Kyung Sik; Lee, Kook Lae; Choi, Suck Chei; Jang, Jae-Young; Kim, Gwang Ha; Sung, In-kyung; Park, Moo In; Kwon, Joong Goo; Kim, Nayoung; Kim, Jae Jun; Lee, Soo Teik; Kim, Hyun Soo; Kim, Ki Bae; Lee, Yong Chan; Choi, Myung-Gyu; Lee, Joon Seong; Jung, Hwoon-Yong; Lee, Kwang Jae; Kim, Jie-Hyun; Chung, Hyunsoo
- Issue Date
- Baishideng Publishing Group
- Gastroesophageal reflux; Esophagitis; Proton pump inhibitors; Heartburn; Quality of life
- World Journal of Gastroenterology, v.28, no.44, pp.6294 - 6309
- Journal Title
- World Journal of Gastroenterology
- Start Page
- End Page
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.
To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE).
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.
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.
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.
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- 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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