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.
4.Risk Assessment of Metachronous Gastric Neoplasm after Endoscopic Resection for Early Gastric Cancer According to Age at Helicobacter pylori Eradication
Seunghan LEE ; Soo-Jeong CHO ; Hyunsoo CHUNG ; Bokyung KIM ; Mi Jin OH ; Yun Suk NA ; Jun Hee LEE ; Jiyoon KIM ; Sang Gyun KIM
Gut and Liver 2024;18(6):992-1001
Background/Aims:
Helicobacter pylori eradication can reduce the incidence of metachronous gastric neoplasm (MGN) after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). This study evaluated the risk of developing MGN after ESD for EGC based on age at H.pylori eradication.
Methods:
Data of patients who underwent curative ESD for EGC with H. pylori infection between 2005 and 2018 were retrospectively analyzed. The patients were allocated to four groups according to age at H. pylori eradication: group 1 (<50 years), group 2 (50–59 years), group 3 (60–69years), and group 4 (≥70 years).
Results:
All patients were followed up for at least 5 years after ESD. The 5-year cumulative incidence of MGN was 2.1%, 7.0%, 8.7%, and 16.7% in groups 1, 2, 3, and 4, respectively (p<0.001), and groups 3 and 4 showed a significant increase in the risk of MGN (hazard ratio [HR], 4.66; 95% confidence interval [CI], 1.09 to 19.92 and HR, 10.75; 95% CI, 2.45 to 47.12).After adjustments for moderate to severe intestinal metaplasia based on the updated Sydney system, groups 3 and 4 remained significantly associated with MGN (HR, 4.40; 95% CI, 1.03 to 18.84 and HR, 10.14; 95% CI, 2.31 to 44.57).
Conclusions
The incidence of MGN after ESD for EGC increased with age at H. pylori eradication. Age at H. pylori eradication ≥60 years was an independent risk factor for MGN, even after adjusting for the presence of advanced intestinal metaplasia.
5.Risk Assessment of Metachronous Gastric Neoplasm after Endoscopic Resection for Early Gastric Cancer According to Age at Helicobacter pylori Eradication
Seunghan LEE ; Soo-Jeong CHO ; Hyunsoo CHUNG ; Bokyung KIM ; Mi Jin OH ; Yun Suk NA ; Jun Hee LEE ; Jiyoon KIM ; Sang Gyun KIM
Gut and Liver 2024;18(6):992-1001
Background/Aims:
Helicobacter pylori eradication can reduce the incidence of metachronous gastric neoplasm (MGN) after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). This study evaluated the risk of developing MGN after ESD for EGC based on age at H.pylori eradication.
Methods:
Data of patients who underwent curative ESD for EGC with H. pylori infection between 2005 and 2018 were retrospectively analyzed. The patients were allocated to four groups according to age at H. pylori eradication: group 1 (<50 years), group 2 (50–59 years), group 3 (60–69years), and group 4 (≥70 years).
Results:
All patients were followed up for at least 5 years after ESD. The 5-year cumulative incidence of MGN was 2.1%, 7.0%, 8.7%, and 16.7% in groups 1, 2, 3, and 4, respectively (p<0.001), and groups 3 and 4 showed a significant increase in the risk of MGN (hazard ratio [HR], 4.66; 95% confidence interval [CI], 1.09 to 19.92 and HR, 10.75; 95% CI, 2.45 to 47.12).After adjustments for moderate to severe intestinal metaplasia based on the updated Sydney system, groups 3 and 4 remained significantly associated with MGN (HR, 4.40; 95% CI, 1.03 to 18.84 and HR, 10.14; 95% CI, 2.31 to 44.57).
Conclusions
The incidence of MGN after ESD for EGC increased with age at H. pylori eradication. Age at H. pylori eradication ≥60 years was an independent risk factor for MGN, even after adjusting for the presence of advanced intestinal metaplasia.
6.Risk Assessment of Metachronous Gastric Neoplasm after Endoscopic Resection for Early Gastric Cancer According to Age at Helicobacter pylori Eradication
Seunghan LEE ; Soo-Jeong CHO ; Hyunsoo CHUNG ; Bokyung KIM ; Mi Jin OH ; Yun Suk NA ; Jun Hee LEE ; Jiyoon KIM ; Sang Gyun KIM
Gut and Liver 2024;18(6):992-1001
Background/Aims:
Helicobacter pylori eradication can reduce the incidence of metachronous gastric neoplasm (MGN) after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). This study evaluated the risk of developing MGN after ESD for EGC based on age at H.pylori eradication.
Methods:
Data of patients who underwent curative ESD for EGC with H. pylori infection between 2005 and 2018 were retrospectively analyzed. The patients were allocated to four groups according to age at H. pylori eradication: group 1 (<50 years), group 2 (50–59 years), group 3 (60–69years), and group 4 (≥70 years).
Results:
All patients were followed up for at least 5 years after ESD. The 5-year cumulative incidence of MGN was 2.1%, 7.0%, 8.7%, and 16.7% in groups 1, 2, 3, and 4, respectively (p<0.001), and groups 3 and 4 showed a significant increase in the risk of MGN (hazard ratio [HR], 4.66; 95% confidence interval [CI], 1.09 to 19.92 and HR, 10.75; 95% CI, 2.45 to 47.12).After adjustments for moderate to severe intestinal metaplasia based on the updated Sydney system, groups 3 and 4 remained significantly associated with MGN (HR, 4.40; 95% CI, 1.03 to 18.84 and HR, 10.14; 95% CI, 2.31 to 44.57).
Conclusions
The incidence of MGN after ESD for EGC increased with age at H. pylori eradication. Age at H. pylori eradication ≥60 years was an independent risk factor for MGN, even after adjusting for the presence of advanced intestinal metaplasia.
7.Effect of Ropivacaine Local Injection According to Depth in Clavicular Surgery
Tae Gyun KIM ; Dae Yeung KIM ; Woo Jin SHIN ; Byung Hak OH ; Jin Woong YI
The Journal of the Korean Orthopaedic Association 2024;59(5):342-350
Purpose:
Osteosynthesis of a clavicular fracture can obtain good clinical results even with conservative treatment. The development of surgical techniques and improvements in internal fixation have led to the use of metal plates and screws. Although there are intramedullary nails or minimally invasive plate osteosynthesis that can reduce soft tissue damage, these techniques are not used often because most require a skin incision about the length of the metal plate to be inserted. This study compared the postoperative pain to determine the appropriate injection depth.
Materials and Methods:
A prospective, single-institute, single-blind, randomized study was designed. The patients in the study had clavicular fractures and who underwent the removal of implant. The patients judged to have difficulty indicating pain were excluded.Ropivacaine was injected between plate fixation and muscle suturing. The visual analog scale (VAS) pain score, patient-controlled analgesia (PCA) use, and additional pain medication usage were measured after surgery and every 4 hours.
Results:
Thirty-four clavicle shaft fracture patients were classified into 16 patients in the subcutaneous injection group and 18 in the muscle injection group. Seventeen implant removal patients were divided into eight patients in the subcutaneous injection group and another nine in the muscle injection group. In the fracture group, the mean VAS for the subcutaneous injection group was 4.20±2.68 immediately after surgery, 4.47±1.85 at 4 hours, 1.93±1.44 at 24 hours, and 1.60±1.35 at 48 hours. The mean VAS for the muscle injection group was 4.23±1.59 immediately after surgery, 3.00±1.47 at 4 hours, 1.69±1.03 at 24 hours, and 1.31±1.11 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.332). In the implant removal group, the mean VAS for the subcutaneous injection group was 4.75±1.58 immediately after surgery, 3.75±1.04 at 4 hours, 1.75±0.89 at 24 hours, and 1.75±0.89 at 48 hours. The mean VAS for the muscle injection group was 3.78±1.20 immediately after surgery, 3.22±0.83 at 4 hours, 1.89±1.17 at 24 hours, and 1.11±1.01 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.181).
Conclusion
The postoperative VAS pain score and PCA usage were not statistically significant regardless of the ropivacaine injection site in clavicular surgery, but each group had significantly different VAS pain scores and PCA usage according to time after surgery. In addition, the muscle injection group tended to have a lower average VAS than the subcutaneous injection group in the implant removal patient group.
8.Effect of Ropivacaine Local Injection According to Depth in Clavicular Surgery
Tae Gyun KIM ; Dae Yeung KIM ; Woo Jin SHIN ; Byung Hak OH ; Jin Woong YI
The Journal of the Korean Orthopaedic Association 2024;59(5):342-350
Purpose:
Osteosynthesis of a clavicular fracture can obtain good clinical results even with conservative treatment. The development of surgical techniques and improvements in internal fixation have led to the use of metal plates and screws. Although there are intramedullary nails or minimally invasive plate osteosynthesis that can reduce soft tissue damage, these techniques are not used often because most require a skin incision about the length of the metal plate to be inserted. This study compared the postoperative pain to determine the appropriate injection depth.
Materials and Methods:
A prospective, single-institute, single-blind, randomized study was designed. The patients in the study had clavicular fractures and who underwent the removal of implant. The patients judged to have difficulty indicating pain were excluded.Ropivacaine was injected between plate fixation and muscle suturing. The visual analog scale (VAS) pain score, patient-controlled analgesia (PCA) use, and additional pain medication usage were measured after surgery and every 4 hours.
Results:
Thirty-four clavicle shaft fracture patients were classified into 16 patients in the subcutaneous injection group and 18 in the muscle injection group. Seventeen implant removal patients were divided into eight patients in the subcutaneous injection group and another nine in the muscle injection group. In the fracture group, the mean VAS for the subcutaneous injection group was 4.20±2.68 immediately after surgery, 4.47±1.85 at 4 hours, 1.93±1.44 at 24 hours, and 1.60±1.35 at 48 hours. The mean VAS for the muscle injection group was 4.23±1.59 immediately after surgery, 3.00±1.47 at 4 hours, 1.69±1.03 at 24 hours, and 1.31±1.11 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.332). In the implant removal group, the mean VAS for the subcutaneous injection group was 4.75±1.58 immediately after surgery, 3.75±1.04 at 4 hours, 1.75±0.89 at 24 hours, and 1.75±0.89 at 48 hours. The mean VAS for the muscle injection group was 3.78±1.20 immediately after surgery, 3.22±0.83 at 4 hours, 1.89±1.17 at 24 hours, and 1.11±1.01 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.181).
Conclusion
The postoperative VAS pain score and PCA usage were not statistically significant regardless of the ropivacaine injection site in clavicular surgery, but each group had significantly different VAS pain scores and PCA usage according to time after surgery. In addition, the muscle injection group tended to have a lower average VAS than the subcutaneous injection group in the implant removal patient group.
9.Risk Assessment of Metachronous Gastric Neoplasm after Endoscopic Resection for Early Gastric Cancer According to Age at Helicobacter pylori Eradication
Seunghan LEE ; Soo-Jeong CHO ; Hyunsoo CHUNG ; Bokyung KIM ; Mi Jin OH ; Yun Suk NA ; Jun Hee LEE ; Jiyoon KIM ; Sang Gyun KIM
Gut and Liver 2024;18(6):992-1001
Background/Aims:
Helicobacter pylori eradication can reduce the incidence of metachronous gastric neoplasm (MGN) after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). This study evaluated the risk of developing MGN after ESD for EGC based on age at H.pylori eradication.
Methods:
Data of patients who underwent curative ESD for EGC with H. pylori infection between 2005 and 2018 were retrospectively analyzed. The patients were allocated to four groups according to age at H. pylori eradication: group 1 (<50 years), group 2 (50–59 years), group 3 (60–69years), and group 4 (≥70 years).
Results:
All patients were followed up for at least 5 years after ESD. The 5-year cumulative incidence of MGN was 2.1%, 7.0%, 8.7%, and 16.7% in groups 1, 2, 3, and 4, respectively (p<0.001), and groups 3 and 4 showed a significant increase in the risk of MGN (hazard ratio [HR], 4.66; 95% confidence interval [CI], 1.09 to 19.92 and HR, 10.75; 95% CI, 2.45 to 47.12).After adjustments for moderate to severe intestinal metaplasia based on the updated Sydney system, groups 3 and 4 remained significantly associated with MGN (HR, 4.40; 95% CI, 1.03 to 18.84 and HR, 10.14; 95% CI, 2.31 to 44.57).
Conclusions
The incidence of MGN after ESD for EGC increased with age at H. pylori eradication. Age at H. pylori eradication ≥60 years was an independent risk factor for MGN, even after adjusting for the presence of advanced intestinal metaplasia.
10.Effect of Ropivacaine Local Injection According to Depth in Clavicular Surgery
Tae Gyun KIM ; Dae Yeung KIM ; Woo Jin SHIN ; Byung Hak OH ; Jin Woong YI
The Journal of the Korean Orthopaedic Association 2024;59(5):342-350
Purpose:
Osteosynthesis of a clavicular fracture can obtain good clinical results even with conservative treatment. The development of surgical techniques and improvements in internal fixation have led to the use of metal plates and screws. Although there are intramedullary nails or minimally invasive plate osteosynthesis that can reduce soft tissue damage, these techniques are not used often because most require a skin incision about the length of the metal plate to be inserted. This study compared the postoperative pain to determine the appropriate injection depth.
Materials and Methods:
A prospective, single-institute, single-blind, randomized study was designed. The patients in the study had clavicular fractures and who underwent the removal of implant. The patients judged to have difficulty indicating pain were excluded.Ropivacaine was injected between plate fixation and muscle suturing. The visual analog scale (VAS) pain score, patient-controlled analgesia (PCA) use, and additional pain medication usage were measured after surgery and every 4 hours.
Results:
Thirty-four clavicle shaft fracture patients were classified into 16 patients in the subcutaneous injection group and 18 in the muscle injection group. Seventeen implant removal patients were divided into eight patients in the subcutaneous injection group and another nine in the muscle injection group. In the fracture group, the mean VAS for the subcutaneous injection group was 4.20±2.68 immediately after surgery, 4.47±1.85 at 4 hours, 1.93±1.44 at 24 hours, and 1.60±1.35 at 48 hours. The mean VAS for the muscle injection group was 4.23±1.59 immediately after surgery, 3.00±1.47 at 4 hours, 1.69±1.03 at 24 hours, and 1.31±1.11 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.332). In the implant removal group, the mean VAS for the subcutaneous injection group was 4.75±1.58 immediately after surgery, 3.75±1.04 at 4 hours, 1.75±0.89 at 24 hours, and 1.75±0.89 at 48 hours. The mean VAS for the muscle injection group was 3.78±1.20 immediately after surgery, 3.22±0.83 at 4 hours, 1.89±1.17 at 24 hours, and 1.11±1.01 at 48 hours; the mean VAS score was not statistically significant in the two groups (p=0.181).
Conclusion
The postoperative VAS pain score and PCA usage were not statistically significant regardless of the ropivacaine injection site in clavicular surgery, but each group had significantly different VAS pain scores and PCA usage according to time after surgery. In addition, the muscle injection group tended to have a lower average VAS than the subcutaneous injection group in the implant removal patient group.

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