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.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.
3.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.
5.A Hybrid Online and Offline International Conference of the Korean Pancreatobiliary Association in Post-COVID-19 Era
Jae Min LEE ; Hee Seung LEE ; Suk Pyo SHIN ; Yun Nah LEE ; Hyung Ku CHON ; Sung Ill JANG ; Jun Kyu LEE ; The Public Affair Board of Korean Pancreatobiliary Association
Korean Journal of Pancreas and Biliary Tract 2021;26(1):49-57
Background:
/Aim: The COVID-19 pandemic has changed the way of traditional conference and meeting. Since social distancing rule was important issue, many conferences across the world were cancelled or postponed indefinitely. In 2020, International Conference of the Korean Pancreatobiliary Association (IC-KPBA) was held as a hybrid online and offline conference. Here, we report the result of a national survey about online and offline medical conference in Korea.
Methods:
The survey was performed for both online and offline participants after IC-KPBA. The contents of survey included their way to access the hybrid online-offline conference and satisfaction with the conference format.
Results:
Total of 78 participants answered the survey and there was no technical problem. Most offline participants were satisfied the prevention measures at conference hall as follows; very satisfied-56%; satisfied-34%. The quality of video and audio were generally satisfactory in both conference hall and virtual conference. ‘Live online lectures’ is the most preferred method of lecture delivery and personal computer with LAN network is preferred to access online conference. Eighty seven percent of offline participants and 91% of online participants answered satisfied and very satisfied, respectively.
Conclusions
Participants of IC-KPBA 2020 with hybrid online-offline conference showed a high level of satisfaction.
7.Impact of health-related quality of life on survival after dialysis initiation: a prospective cohort study in Korea
Jeonghwan LEE ; Yong Chul KIM ; Kim KWON ; Lilin LI ; Sohee OH ; Do Hyoung KIM ; Jung Nam AN ; Jang-Hee CHO ; Dong Ki KIM ; Yong-Lim KIM ; Yun Kyu OH ; Chun Soo LIM ; Yon Su KIM ; Jung Pyo LEE
Kidney Research and Clinical Practice 2020;39(4):426-440
Background:
The effect of each health-related quality of life (HRQOL) component on hemodialysis prognosis has not been well studied. We aimed to investigate the clinical factors associated with HRQOL and the effect of HRQOL after dialysis initiation on long-term survival in an Asian population.
Methods:
A total of 568 hemodialysis patients were included from a nationwide prospective cohort study. HRQOL was evaluated using the Kidney Disease Quality of Life (KDQOL) Short FormTM 1.3 at 3 months after dialysis initiation. The effect of each KDQOL item score on mortality was analyzed. Multivariable Cox analysis was performed after adjusting for age, sex, modified Charlson comorbidity index, and causes of primary kidney disease.
Results:
Old age, diabetes mellitus, high comorbidities, and low serum albumin levels were associated with poor physical health status. Decreased urine output was associated with both poor physical and mental health status.The scores of 3 indices in the kidney disease domain (effect of kidney disease, social support, and dialysis staff encouragement) showed significant associations with mortality, as did the 3 indices (physical function, physical role limitation, and body pain) in the physical health domain. Neither the 4 indices in the mental health domain nor the mental composite score showed a significant association with mortality. However, a high physical composite score was associated with decreased overall patient mortality (P = 0.003). The effect of physical composite score on survival was prominent among young or middle-aged groups.
Conclusion
Poor physical health status 3 months after hemodialysis start correlates significantly with overall mortality.
8.Impact of health-related quality of life on survival after dialysis initiation: a prospective cohort study in Korea
Jeonghwan LEE ; Yong Chul KIM ; Kim KWON ; Lilin LI ; Sohee OH ; Do Hyoung KIM ; Jung Nam AN ; Jang-Hee CHO ; Dong Ki KIM ; Yong-Lim KIM ; Yun Kyu OH ; Chun Soo LIM ; Yon Su KIM ; Jung Pyo LEE
Kidney Research and Clinical Practice 2020;39(4):426-440
Background:
The effect of each health-related quality of life (HRQOL) component on hemodialysis prognosis has not been well studied. We aimed to investigate the clinical factors associated with HRQOL and the effect of HRQOL after dialysis initiation on long-term survival in an Asian population.
Methods:
A total of 568 hemodialysis patients were included from a nationwide prospective cohort study. HRQOL was evaluated using the Kidney Disease Quality of Life (KDQOL) Short FormTM 1.3 at 3 months after dialysis initiation. The effect of each KDQOL item score on mortality was analyzed. Multivariable Cox analysis was performed after adjusting for age, sex, modified Charlson comorbidity index, and causes of primary kidney disease.
Results:
Old age, diabetes mellitus, high comorbidities, and low serum albumin levels were associated with poor physical health status. Decreased urine output was associated with both poor physical and mental health status.The scores of 3 indices in the kidney disease domain (effect of kidney disease, social support, and dialysis staff encouragement) showed significant associations with mortality, as did the 3 indices (physical function, physical role limitation, and body pain) in the physical health domain. Neither the 4 indices in the mental health domain nor the mental composite score showed a significant association with mortality. However, a high physical composite score was associated with decreased overall patient mortality (P = 0.003). The effect of physical composite score on survival was prominent among young or middle-aged groups.
Conclusion
Poor physical health status 3 months after hemodialysis start correlates significantly with overall mortality.
9.Choroidal Thickness Analysis in Patients with Erectile Dysfunction.
Yong Kyu KIM ; Jang Hoon LEE ; Sung Pyo PARK ; Dae Yul YANG
The World Journal of Men's Health 2019;37(1):85-92
PURPOSE: To investigate the morphological features of choroidal vasculature in patients with erectile dysfunction (ED) by analyzing choroidal thickness using optical coherence tomography. MATERIALS AND METHODS: We enrolled 39 patients with ED and 19 controls. ED was defined as an erectile function domain score < 26 on the International Index of Erectile Function (IIEF) questionnaire. Small-choroidal-vessel-layer (SCVL) thickness was calculated by subtracting large-choroidal-vessel-layer (which corresponded to Haller's layer) thickness from total choroidal thickness. Choroidal thickness was compared between the ED and control groups. RESULTS: SCVL thickness was lesser in the ED group than in the control group (control, 69.8±24.3 µm vs. ED, 55.1±19.9 µm; p=0.017). Among patients without diabetes, the ED group showed significantly lesser SCVL thickness than did the control group (control, 77.1±22.7 µm vs. ED, 56.5±20.9 µm; p=0.021). However, among patients with diabetes, choroidal thickness showed no significant intergroup difference. Multiple linear regression analysis revealed that spherical equivalent (standardized coefficient β=0.294; p=0.019) and the IIEF erectile function score (standardized coefficient β=0.315; p=0.012) were significantly associated with SCVL thickness. CONCLUSIONS: SCVL thickness, including the choriocapillaris layer and medium-sized choroidal vascular layer, decreased in proportion to ED severity, suggesting that microvascular changes in choroidal vessels may occur before specific ocular diseases in patients with ED.
Choroid*
;
Erectile Dysfunction*
;
Humans
;
Linear Models
;
Male
;
Tomography, Optical Coherence
10.The Effect of Mycophenolate Mofetil versus Cyclosporine as Combination Therapy with Low Dose Corticosteroids in High-risk Patients with Idiopathic Membranous Nephropathy: a Multicenter Randomized Trial
Ji Young CHOI ; Dong Ki KIM ; Yang Wook KIM ; Tae Hyun YOO ; Jung Pyo LEE ; Hyun Chul CHUNG ; Kyu Hyang CHO ; Won Suk AN ; Duk Hyun LEE ; Hee Yeon JUNG ; Jang Hee CHO ; Chan Duck KIM ; Yong Lim KIM ; Sun Hee PARK
Journal of Korean Medical Science 2018;33(9):e74-
BACKGROUND: Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy (MN) remains controversial. The effect of mycophenolate mofetil (MMF) versus cyclosporine (CsA) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center randomized trial (www.ClinicalTrials.gov NCT01282073). METHODS: A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were randomly assigned to receive MMF combined with low-dose corticosteroids (MMF group) versus CsA combined with low-dose corticosteroids (CsA group), respectively, and followed up for 48 weeks. Complete or partial remission rate of proteinuria and estimated glomerular filtration rate (eGFR) at 48 weeks were compared. RESULTS: The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day, respectively, in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day, respectively, in the CsA group. In total, 76.1% of the MMF group and 66.7% of the CsA group achieved remission at 48 weeks (95% confidence interval, −0.18 to 0.38). There was no difference in eGFR between the two groups. Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group (P = 0.001), but were unchanged in the no-response group. There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks. CONCLUSION: In combination with low-dose corticosteroids, the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN, with similar adverse effects including gastrointestinal symptoms. Trial registry at ClinicalTrials.gov (www.ClinicalTrials.gov NCT01282073).
Adrenal Cortex Hormones
;
Cyclosporine
;
Glomerular Filtration Rate
;
Glomerulonephritis, Membranous
;
Humans
;
Proteinuria
;
Quality of Life

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