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

Joong Goo Kwon, Hyunsoo Chung, Jie-Hyun Kim, Kwang Jae Lee, Hwoon-Yong Jung, Joon Seong Lee, Myung-Gyu Choi, Yong Chan Lee, Ki Bae Kim, Hyun Soo Kim, Soo Teik Lee, Jae Jun Kim, Nayoung Kim, Kang Nyeong Lee, Moo In Park, In-Kyung Sung, Gwang Ha Kim, Jae-Young Jang, Suck Chei Choi, Kook Lae Lee, Kyung Sik Park, Sang Woo Lee, Sung Kook Kim, Jin Il Kim, Hoon Jai Chun, Oh Young Lee

Journal: World journal of gastroenterology 2022;28(44):6294-6309

PMID: 36504556

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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, = 107; esomeprazole 40 mg, = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) 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.

Address: Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea.; Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea. [email protected].; Department of Internal Medicine, Korea University Anam Hospital, Seoul 02841, South Korea.; Department of Internal Medicine, The Catholic University of Korea, Yeouido ST. Mary's Hospital, Seoul 07260, South Korea.; Department of Internal Medicine, Kyungpook National University Hospital, Daegu 41944, South Korea.; Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si 15355, South Korea.; Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu 42601, South Korea.; Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul 07061, South Korea.; Department of Internal Medicine, Wonkwang University Hospital, Iksan 54538, South Korea.; Department of Internal Medicine, KyungHee University Medical Center, Seoul 02447, South Korea.; Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan 47241, South Korea.; Department of Internal Medicine, KKonkuk University Medical Center, Seoul 05030, South Korea.; Department of Internal Medicine, Kosin University Gaspel Hospital, Busan 49267, South Korea.; Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu 42471, South Korea.; Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si 13620, Gyeonggi-do, South Korea.; Department of Internal Medicine, Samsung Medical Center, Seoul 06351, South Korea.; Department of Internal Medicine, Chonbuk National University Hospital, Jeonju-si 54907, South Korea.; Department of Internal Medicine, Chonnam National University Hospital, Gwangju 61469, South Korea.; Department of Internal medicine, Chungbuk National University School of Medicine, Cheong Ju 28644, South Korea.; Department of Internal Medicine, Severance Hospital, Seoul 03722, South Korea.; Department of Internal Medicine, The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul 06591, South Korea.; Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul 04401, South Korea.; Department of Internal Medicine, Asan Medical Center, Seoul 05505, South Korea.; Department of Gastroenterology, Ajou University School of Medicine, Suwon 16499, South Korea.; Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, South Korea.; Department of Internal Medicine, Seoul National University Hospital, Seoul 03080, South Korea.

DOI: 10.3748/wjg.v28.i44.6294

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MeSH Terms: Adult, Humans, Esomeprazole, Gastrins, Quality of Life, Esophagitis, Peptic Ulcer, H(+)-K(+)-Exchanging ATPase, Drug-Related Side Effects and Adverse Reactions