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KMID : 1188320230170060884
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Gut and Liver
2023 Volume.17 No. 6 p.884 ~ p.893
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Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
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Kim Gwang-Ha
Choi Myung-Gyu
Kim Jin-Il
Lee Soo-Teik
Chun Hoon-Jai
Lee Kook-Lae
Choi Suk-Chei
Jang Jae-Young
Lee Yong-Chan
Kim Jae-Gyu
Kim Ki-Bae
Shim Ki-Nam
Sohn Chong-Il
Kim Sung-Kook
Kim Sang-Gyun
Jang Jin-Seok
Kim Na-Young
Jung Hwoon-Yong
Park Hyo-Jin
Huh Kyu-Chan
Lee Kwang-Jae
Hong Su-Jin
Baek Song
Han Jin-Joo
Lee Oh-Young
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Abstract
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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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KEYWORD
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Fexuprazan, Gastritis, Phase III clinical trial, Potassium-competitive acid blocker
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