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.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.
5.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.
6.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.
7.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.
8.Practice guidelines for managing extrahepatic biliary tract cancers
Hyung Sun KIM ; Mee Joo KANG ; Jingu KANG ; Kyubo KIM ; Bohyun KIM ; Seong-Hun KIM ; Soo Jin KIM ; Yong-Il KIM ; Joo Young KIM ; Jin Sil KIM ; Haeryoung KIM ; Hyo Jung KIM ; Ji Hae NAHM ; Won Suk PARK ; Eunkyu PARK ; Joo Kyung PARK ; Jin Myung PARK ; Byeong Jun SONG ; Yong Chan SHIN ; Keun Soo AHN ; Sang Myung WOO ; Jeong Il YU ; Changhoon YOO ; Kyoungbun LEE ; Dong Ho LEE ; Myung Ah LEE ; Seung Eun LEE ; Ik Jae LEE ; Huisong LEE ; Jung Ho IM ; Kee-Taek JANG ; Hye Young JANG ; Sun-Young JUN ; Hong Jae CHON ; Min Kyu JUNG ; Yong Eun CHUNG ; Jae Uk CHONG ; Eunae CHO ; Eui Kyu CHIE ; Sae Byeol CHOI ; Seo-Yeon CHOI ; Seong Ji CHOI ; Joon Young CHOI ; Hye-Jeong CHOI ; Seung-Mo HONG ; Ji Hyung HONG ; Tae Ho HONG ; Shin Hye HWANG ; In Gyu HWANG ; Joon Seong PARK
Annals of Hepato-Biliary-Pancreatic Surgery 2024;28(2):161-202
Background:
s/Aims: Reported incidence of extrahepatic bile duct cancer is higher in Asians than in Western populations. Korea, in particular, is one of the countries with the highest incidence rates of extrahepatic bile duct cancer in the world. Although research and innovative therapeutic modalities for extrahepatic bile duct cancer are emerging, clinical guidelines are currently unavailable in Korea. The Korean Society of Hepato-Biliary-Pancreatic Surgery in collaboration with related societies (Korean Pancreatic and Biliary Surgery Society, Korean Society of Abdominal Radiology, Korean Society of Medical Oncology, Korean Society of Radiation Oncology, Korean Society of Pathologists, and Korean Society of Nuclear Medicine) decided to establish clinical guideline for extrahepatic bile duct cancer in June 2021.
Methods:
Contents of the guidelines were developed through subgroup meetings for each key question and a preliminary draft was finalized through a Clinical Guidelines Committee workshop.
Results:
In November 2021, the finalized draft was presented for public scrutiny during a formal hearing.
Conclusions
The extrahepatic guideline committee believed that this guideline could be helpful in the treatment of patients.
9.2023 Clinical Practice Guidelines for Diabetes Management in Korea: Full Version Recommendation of the Korean Diabetes Association
Jun Sung MOON ; Shinae KANG ; Jong Han CHOI ; Kyung Ae LEE ; Joon Ho MOON ; Suk CHON ; Dae Jung KIM ; Hyun Jin KIM ; Ji A SEO ; Mee Kyoung KIM ; Jeong Hyun LIM ; Yoon Ju SONG ; Ye Seul YANG ; Jae Hyeon KIM ; You-Bin LEE ; Junghyun NOH ; Kyu Yeon HUR ; Jong Suk PARK ; Sang Youl RHEE ; Hae Jin KIM ; Hyun Min KIM ; Jung Hae KO ; Nam Hoon KIM ; Chong Hwa KIM ; Jeeyun AHN ; Tae Jung OH ; Soo-Kyung KIM ; Jaehyun KIM ; Eugene HAN ; Sang-Man JIN ; Jaehyun BAE ; Eonju JEON ; Ji Min KIM ; Seon Mee KANG ; Jung Hwan PARK ; Jae-Seung YUN ; Bong-Soo CHA ; Min Kyong MOON ; Byung-Wan LEE
Diabetes & Metabolism Journal 2024;48(4):546-708
10.Real-World Treatment Patterns according to Clinical Practice Guidelines in Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease in Korea: Multicenter, Retrospective, Observational Study
Ye Seul YANG ; Nam Hoon KIM ; Jong Ha BAEK ; Seung-Hyun KO ; Jang Won SON ; Seung-Hwan LEE ; Sang Youl RHEE ; Soo-Kyung KIM ; Tae Seo SOHN ; Ji Eun JUN ; In-Kyung JEONG ; Chong Hwa KIM ; Keeho SONG ; Eun-Jung RHEE ; Junghyun NOH ; Kyu Yeon HUR ;
Diabetes & Metabolism Journal 2024;48(2):279-289
Background:
Recent diabetes management guidelines recommend that sodium-glucose cotransporter 2 inhibitors (SGLT2is) or glucagon-like peptide 1 receptor agonists (GLP-1RAs) with proven cardiovascular benefits should be prioritized for combination therapy in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD). This study was aimed at evaluating SGLT2i or GLP-1RA usage rates and various related factors in patients with T2DM and established CVD.
Methods:
We enrolled adults with T2DM aged ≥30 years who were hospitalized due to established CVD from January 2019 to May 2020 at 13 secondary and tertiary hospitals in Korea in this retrospective observational study.
Results:
Overall, 2,050 patients were eligible for analysis among 2,107 enrolled patients. The mean patient age, diabetes duration, and glycosylated hemoglobin level were 70.0 years, 12.0 years, and 7.5%, respectively. During the mean follow-up duration of 9.7 months, 25.7% of the patients were prescribed SGLT2is after CVD events. However, only 1.8% were prescribed GLP-1RAs. Compared with SGLT2i non-users, SGLT2i users were more frequently male and obese. Furthermore, they had a shorter diabetes duration but showed worse glycemic control and better renal function at the time of the event. GLP-1RA users had a longer duration of diabetes and worse glycemic control at the time of the event than GLP-1RA non-users.
Conclusion
The SGLT2i or GLP-1RA prescription rates were suboptimal in patients with T2DM and established CVD. Sex, body mass index, diabetes duration, glycemic control, and renal function were associated with the use of these agents.

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