Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis
Kang Nyeong Lee, Oh Young Lee, Hoon Jai Chun, Jin Il Kim, Sung Kook Kim, Sang Woo Lee, Kyung Sik Park, Kook Lae Lee, Suck Chei Choi, Jaeyoung Jang, Gwang Ha Kim, In‐Kyung Sung, Moo In Park, Joong Goo Kwon, Nayoung Kim, Jae Jun Kim, Soo Teik Lee, Hyun‐Soo Kim, Ki Bae Kim, Yong Chan Lee, Myung‐Gyu Choi, Joon Seong Lee, Hwoon‐Yong Jung, Kwang Jae Lee, Jie‐Hyun Kim, Hyunsoo Chung
Abstract
BACKGROUND: -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: 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.