1.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
2.Impact of Metabolic Health and Its Changes on Erosive Esophagitis Remission: A Cohort Study
Nam Hee KIM ; Yoosoo CHANG ; Seungho RYU ; Chong Il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):54-62
Background/Aims:
We aim to compare the remission of erosive esophagitis (EE) among individuals with different phenotypes based on their metabolic health and obesity status and investigate the impact of changes in metabolic health on the EE remission.
Methods:
Asymptomatic adults (n = 16 845) with EE at baseline, who underwent follow-up esophagogastroduodenoscopy (EGD) were categorized into 4 groups as follows: metabolically healthy (MH) nonobese, metabolically unhealthy (MU) nonobese, MH obese, and MU obese. EE was defined as grade A or higher mucosal breaks observed using esophagogastroduodenoscopy.
Results:
During a median follow-up of 2.2 years, the remission rates of EE were 286.4/10 3 , 260.1/10 3 , 201.5/10 3 , and 219.9/10 3 person-years in MH nonobese, MU nonobese, MH obese, and MU obese groups, respectively. Multivariate-adjusted hazard ratios (95% CI) for EE remission among the MH nonobese, MU nonobese, and MH obese groups versus that of the MU obese group were 1.30 (1.23-1.37), 1.17 (1.12-1.23), and 0.98 (0.90-1.06), respectively, whereas those of the persistent MH, progression of MH to MU, and remission of MU to MH compared with the persistent MU group were 1.37 (1.23-1.52), 1.15 (1.01-1.30), and 1.28 (1.12-1.46), respectively.Increased EE remission in the persistent MH group was consistently observed in individuals with and without obesity (or abdominal obesity).
Conclusions
Metabolic health and nonobesity independently and favorably impact EE remission. Maintaining normal weight and healthy metabolic status may contribute to EE remission.
3.Stratifying Risk of Lymph Node Metastasis After Non-Curative Endoscopic Submucosal Dissection of Early Gastric Cancer: Comparison of the eCura System and Elderly Criteria
Tae-woo KIM ; Hyo-Joon YANG ; Giho LEE ; Soo-Kyung PARK ; Yoon Suk JUNG ; Jung Ho PARK ; Dong Il PARK ; Chong Il SOHN
Journal of Gastric Cancer 2025;25(2):370-381
Purpose:
The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system.
Materials and Methods:
A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared.
Results:
In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM.
Conclusions
Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.
4.Stratifying Risk of Lymph Node Metastasis After Non-Curative Endoscopic Submucosal Dissection of Early Gastric Cancer: Comparison of the eCura System and Elderly Criteria
Tae-woo KIM ; Hyo-Joon YANG ; Giho LEE ; Soo-Kyung PARK ; Yoon Suk JUNG ; Jung Ho PARK ; Dong Il PARK ; Chong Il SOHN
Journal of Gastric Cancer 2025;25(2):370-381
Purpose:
The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system.
Materials and Methods:
A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared.
Results:
In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM.
Conclusions
Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.
5.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
6.Impact of Metabolic Health and Its Changes on Erosive Esophagitis Remission: A Cohort Study
Nam Hee KIM ; Yoosoo CHANG ; Seungho RYU ; Chong Il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):54-62
Background/Aims:
We aim to compare the remission of erosive esophagitis (EE) among individuals with different phenotypes based on their metabolic health and obesity status and investigate the impact of changes in metabolic health on the EE remission.
Methods:
Asymptomatic adults (n = 16 845) with EE at baseline, who underwent follow-up esophagogastroduodenoscopy (EGD) were categorized into 4 groups as follows: metabolically healthy (MH) nonobese, metabolically unhealthy (MU) nonobese, MH obese, and MU obese. EE was defined as grade A or higher mucosal breaks observed using esophagogastroduodenoscopy.
Results:
During a median follow-up of 2.2 years, the remission rates of EE were 286.4/10 3 , 260.1/10 3 , 201.5/10 3 , and 219.9/10 3 person-years in MH nonobese, MU nonobese, MH obese, and MU obese groups, respectively. Multivariate-adjusted hazard ratios (95% CI) for EE remission among the MH nonobese, MU nonobese, and MH obese groups versus that of the MU obese group were 1.30 (1.23-1.37), 1.17 (1.12-1.23), and 0.98 (0.90-1.06), respectively, whereas those of the persistent MH, progression of MH to MU, and remission of MU to MH compared with the persistent MU group were 1.37 (1.23-1.52), 1.15 (1.01-1.30), and 1.28 (1.12-1.46), respectively.Increased EE remission in the persistent MH group was consistently observed in individuals with and without obesity (or abdominal obesity).
Conclusions
Metabolic health and nonobesity independently and favorably impact EE remission. Maintaining normal weight and healthy metabolic status may contribute to EE remission.
7.Stratifying Risk of Lymph Node Metastasis After Non-Curative Endoscopic Submucosal Dissection of Early Gastric Cancer: Comparison of the eCura System and Elderly Criteria
Tae-woo KIM ; Hyo-Joon YANG ; Giho LEE ; Soo-Kyung PARK ; Yoon Suk JUNG ; Jung Ho PARK ; Dong Il PARK ; Chong Il SOHN
Journal of Gastric Cancer 2025;25(2):370-381
Purpose:
The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system.
Materials and Methods:
A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared.
Results:
In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM.
Conclusions
Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.
8.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
9.Impact of Metabolic Health and Its Changes on Erosive Esophagitis Remission: A Cohort Study
Nam Hee KIM ; Yoosoo CHANG ; Seungho RYU ; Chong Il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):54-62
Background/Aims:
We aim to compare the remission of erosive esophagitis (EE) among individuals with different phenotypes based on their metabolic health and obesity status and investigate the impact of changes in metabolic health on the EE remission.
Methods:
Asymptomatic adults (n = 16 845) with EE at baseline, who underwent follow-up esophagogastroduodenoscopy (EGD) were categorized into 4 groups as follows: metabolically healthy (MH) nonobese, metabolically unhealthy (MU) nonobese, MH obese, and MU obese. EE was defined as grade A or higher mucosal breaks observed using esophagogastroduodenoscopy.
Results:
During a median follow-up of 2.2 years, the remission rates of EE were 286.4/10 3 , 260.1/10 3 , 201.5/10 3 , and 219.9/10 3 person-years in MH nonobese, MU nonobese, MH obese, and MU obese groups, respectively. Multivariate-adjusted hazard ratios (95% CI) for EE remission among the MH nonobese, MU nonobese, and MH obese groups versus that of the MU obese group were 1.30 (1.23-1.37), 1.17 (1.12-1.23), and 0.98 (0.90-1.06), respectively, whereas those of the persistent MH, progression of MH to MU, and remission of MU to MH compared with the persistent MU group were 1.37 (1.23-1.52), 1.15 (1.01-1.30), and 1.28 (1.12-1.46), respectively.Increased EE remission in the persistent MH group was consistently observed in individuals with and without obesity (or abdominal obesity).
Conclusions
Metabolic health and nonobesity independently and favorably impact EE remission. Maintaining normal weight and healthy metabolic status may contribute to EE remission.
10.Gastrointestinal Symptoms in Diabetes Occur Long before Diabetic Complications
Hwanseok JUNG ; Eun-Jung RHEE ; Mi Yeon LEE ; Jung Ho PARK ; Dong Il PARK ; Woo Kyu JEON ; Chong Il SOHN
Korean Journal of Medicine 2024;99(4):210-218
Background/Aims:
Gastrointestinal (GI) manifestations are common in patients with diabetes complications, such as autonomic neuropathy. However, the prevalence of GI symptoms before the development of diabetes complications is unclear.
Methods:
We conducted an interview survey of functional GI disorders among patients with diabetes visiting the endocrinology clinic of a general hospital using the Rome III criteria. The survey consisted of questions regarding functional dyspepsia, irritable bowel syndrome, and functional constipation, including functional defecation disorder.
Results:
In total, 509 patients were included in the analysis. The patients were divided into three groups: prediabetes (n = 115), diabetes without neuropathy (n = 275), and diabetes with neuropathy (n = 119). With regard to GI symptoms, the prevalences of functional dyspepsia in the prediabetes, diabetes without neuropathy, and diabetes with neuropathy groups were 16.52%, 27.27%, and 23.53%, respectively; those of irritable bowel syndrome were 8.70%, 11.68%, and 16.81%, respectively, and those of functional constipation were 8.85%, 11.85%, and 15.25%, respectively. In the subgroup analysis, symptoms of postprandial distress syndrome (e.g., postprandial fullness and early satiety) were more prevalent than symptoms of epigastric pain. In the constipation group, symptoms of pelvic outlet obstruction (such as the sensation of anorectal obstruction or blockage and the need for manual maneuvers to facilitate defecation) were more prevalent than symptoms of slow-transit constipation.
Conclusions
The prevalence of functional GI disorders increases with diabetes severity. Diabetes-related GI symptoms appear long before the onset of diabetes complications.

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