Gut Liver.
2023 Nov;17(6):884-893. 10.5009/gnl220457.
Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
- Kim GH
1 - Choi MG2
- Kim JI3
- Lee ST4
- Chun HJ5
- Lee KL6
- Choi SC7
- Jang JY8
- Lee YC9
- Kim JG10
- Kim KB11
- Shim KN12
- Sohn CI13
- Kim SK14
- Kim SG15
- Jang JS16
- Kim N17
- Jung HY18
- Park H19
- Huh KC20
- Lee KJ21
- Hong SJ22
- Baek S23
- Han JJ23
- Lee OY24
- Affiliations
-
- 1Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
- 2Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 3Department of Internal Medicine, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 4Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea
- 5Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
- 6Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University of College of Medicine, Seoul, Korea
- 7Department of Internal Medicine, Wonkwang University Hospital, Wonkwang University College of Medicine, Iksan, Korea
- 8Department of Gastroenterology and Hepatology, College of Medicine, Kyung Hee University, Seoul, Korea
- 9Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
- 10Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
- 11Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
- 12Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
- 13Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
- 14Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
- 15Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
- 16Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
- 17Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
- 18Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 19Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 20Division of Gastroenterology, Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea
- 21Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
- 22Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
- 23Daewoong Pharmaceutical Co., Ltd., Seoul, Korea
- 24Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
- KMID: 2548447
- DOI: http://doi.org/10.5009/gnl220457
Abstract
- Background/Aims
Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis.
Methods
In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events.
Results
Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups. No significant difference was noted in the incidence of adverse drug reactions.
Conclusions
Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
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