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Randomized Controlled Trial
. 2023 Nov 15;17(6):884-893.
doi: 10.5009/gnl220457. Epub 2023 Feb 15.

Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis

Gwang Ha Kim  1 , Myung-Gyu Choi  2 , Jin Il Kim  3 , Soo Teik Lee  4 , Hoon Jai Chun  5 , Kook Lae Lee  6 , Suk Chei Choi  7 , Jae-Young Jang  8 , Yong Chan Lee  9 , Jae Gyu Kim  10 , Ki Bae Kim  11 , Ki-Nam Shim  12 , Chong Il Sohn  13 , Sung Kook Kim  14 , Sang Gyun Kim  15 , Jin Seok Jang  16 , Nayoung Kim  17 , Hwoon-Yong Jung  18 , Hyojin Park  19 , Kyu Chan Huh  20 , Kwang Jae Lee  21 , Su Jin Hong  22 , Song Baek  23 , Jin Joo Han  23 , Oh Young Lee  24
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis

Gwang Ha Kim et al. Gut Liver. .

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).

Keywords: Fexuprazan; Gastritis; Phase III clinical trial; Potassium-competitive acid blocker.

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Conflict of interest statement

CONFLICTS OF INTEREST

O.Y.L. was a member of outside directors at the Daewoong Co., Ltd. from March 24, 2018, to November 2, 2021. G.H.K. and Y.C.L. are editorial board members of the Journal but were not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1
Flowchart of patient progression through the study.
Fig. 2
Fig. 2
Erosion improvement rate according to the full participant analysis set.
See this image and copyright information in PMC

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