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.Lecanemab: Appropriate Use Recommendations by Korean Dementia Association
Kee Hyung PARK ; Geon Ha KIM ; Chi-Hun KIM ; Seong-Ho KOH ; So Young MOON ; Young Ho PARK ; Sang Won SEO ; Bora YOON ; Jae-Sung LIM ; Byeong C. KIM ; Hee-Jin KIM ; Hae Ri NA ; YongSoo SHIM ; YoungSoon YANG ; Chan-Nyoung LEE ; Hak Young RHEE ; San JUNG ; Jee Hyang JEONG ; Hojin CHOI ; Dong Won YANG ; Seong Hye CHOI
Dementia and Neurocognitive Disorders 2024;23(4):165-187
Lecanemab (product name Leqembi ® ) is an anti-amyloid monoclonal antibody treatment approved for use in Korea for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The Korean Dementia Association has created recommendations for the appropriate use of lecanemab to assist clinicians. These recommendations include selecting patients for administration, necessary pre-administration tests and preparations,administration methods, monitoring for amyloid related imaging abnormalities (ARIA), and communication with patients and caregivers. Lecanemab is recommended for patients with MCI or mild dementia who confirmed positive amyloid biomarkers, and should not be administered to patients with severe hypersensitivity to lecanemab or those unable to undergo magnetic resonance imaging (MRI) evaluation. To predict the risk of ARIA before administration, apolipoprotein E genotyping is conducted, and regular brain MRI evaluations are recommended to monitor for ARIA during treatment. The most common adverse reactions are infusion-related reactions, which require appropriate management upon occurrence. Additional caution is needed when co-administering with anticoagulants or tissue plasminogen activator due to the risk of macrohemorrhage. Clinicians should consider the efficacy and necessary conditions for administration, as well as the safety of lecanemab, to make a comprehensive decision regarding its use.
5.Establishing Integrated Treatment Centers to Improve Mental Health Services: International Examples and Strategies for South Korea
Han-Sung LEE ; Hyunju LEE ; Yu Jin LEE ; Soon-Beom HONG ; Se Hyun KIM ; Hye Yoon PARK ; Soo-Hee CHOI ; Jee Eun PARK ; Sang Jin RHEE ; Juwon LEE ; Sukkyung LEE ; Jee Hoon SOHN ; Yong Min AHN
Journal of Korean Neuropsychiatric Association 2024;63(4):207-217
The global burden of mental illness has increased significantly since the COVID-19 pandemic. In South Korea, despite this rising burden, the utilization of mental health services remains critically low compared to other countries. This study evaluated successful integrated treatment centers from various countries, including the United States, the United Kingdom, and Australia, to identify the best practices that can be applied to South Korean society. These international examples informed the development of Mind the SHIM (SNUH Health in Mind) center, an integrated treatment model designed to address the gaps in non-pharmacological mental health services in South Korea. Mind the SHIM center focuses on developing and validating programs tailored to local needs, emphasizing professional education, systematic program delivery, and community collaboration. The biopsychosocial approach of the center is expected to enhance the overall quality of life of the patients and increase the utilization of mental health services, reducing the broader economic and social burden of mental illness in South Korea.
6.Establishing Integrated Treatment Centers to Improve Mental Health Services: International Examples and Strategies for South Korea
Han-Sung LEE ; Hyunju LEE ; Yu Jin LEE ; Soon-Beom HONG ; Se Hyun KIM ; Hye Yoon PARK ; Soo-Hee CHOI ; Jee Eun PARK ; Sang Jin RHEE ; Juwon LEE ; Sukkyung LEE ; Jee Hoon SOHN ; Yong Min AHN
Journal of Korean Neuropsychiatric Association 2024;63(4):207-217
The global burden of mental illness has increased significantly since the COVID-19 pandemic. In South Korea, despite this rising burden, the utilization of mental health services remains critically low compared to other countries. This study evaluated successful integrated treatment centers from various countries, including the United States, the United Kingdom, and Australia, to identify the best practices that can be applied to South Korean society. These international examples informed the development of Mind the SHIM (SNUH Health in Mind) center, an integrated treatment model designed to address the gaps in non-pharmacological mental health services in South Korea. Mind the SHIM center focuses on developing and validating programs tailored to local needs, emphasizing professional education, systematic program delivery, and community collaboration. The biopsychosocial approach of the center is expected to enhance the overall quality of life of the patients and increase the utilization of mental health services, reducing the broader economic and social burden of mental illness in South Korea.
7.Lecanemab: Appropriate Use Recommendations by Korean Dementia Association
Kee Hyung PARK ; Geon Ha KIM ; Chi-Hun KIM ; Seong-Ho KOH ; So Young MOON ; Young Ho PARK ; Sang Won SEO ; Bora YOON ; Jae-Sung LIM ; Byeong C. KIM ; Hee-Jin KIM ; Hae Ri NA ; YongSoo SHIM ; YoungSoon YANG ; Chan-Nyoung LEE ; Hak Young RHEE ; San JUNG ; Jee Hyang JEONG ; Hojin CHOI ; Dong Won YANG ; Seong Hye CHOI
Dementia and Neurocognitive Disorders 2024;23(4):165-187
Lecanemab (product name Leqembi ® ) is an anti-amyloid monoclonal antibody treatment approved for use in Korea for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The Korean Dementia Association has created recommendations for the appropriate use of lecanemab to assist clinicians. These recommendations include selecting patients for administration, necessary pre-administration tests and preparations,administration methods, monitoring for amyloid related imaging abnormalities (ARIA), and communication with patients and caregivers. Lecanemab is recommended for patients with MCI or mild dementia who confirmed positive amyloid biomarkers, and should not be administered to patients with severe hypersensitivity to lecanemab or those unable to undergo magnetic resonance imaging (MRI) evaluation. To predict the risk of ARIA before administration, apolipoprotein E genotyping is conducted, and regular brain MRI evaluations are recommended to monitor for ARIA during treatment. The most common adverse reactions are infusion-related reactions, which require appropriate management upon occurrence. Additional caution is needed when co-administering with anticoagulants or tissue plasminogen activator due to the risk of macrohemorrhage. Clinicians should consider the efficacy and necessary conditions for administration, as well as the safety of lecanemab, to make a comprehensive decision regarding its use.
8.Lecanemab: Appropriate Use Recommendations by Korean Dementia Association
Kee Hyung PARK ; Geon Ha KIM ; Chi-Hun KIM ; Seong-Ho KOH ; So Young MOON ; Young Ho PARK ; Sang Won SEO ; Bora YOON ; Jae-Sung LIM ; Byeong C. KIM ; Hee-Jin KIM ; Hae Ri NA ; YongSoo SHIM ; YoungSoon YANG ; Chan-Nyoung LEE ; Hak Young RHEE ; San JUNG ; Jee Hyang JEONG ; Hojin CHOI ; Dong Won YANG ; Seong Hye CHOI
Dementia and Neurocognitive Disorders 2024;23(4):165-187
Lecanemab (product name Leqembi ® ) is an anti-amyloid monoclonal antibody treatment approved for use in Korea for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The Korean Dementia Association has created recommendations for the appropriate use of lecanemab to assist clinicians. These recommendations include selecting patients for administration, necessary pre-administration tests and preparations,administration methods, monitoring for amyloid related imaging abnormalities (ARIA), and communication with patients and caregivers. Lecanemab is recommended for patients with MCI or mild dementia who confirmed positive amyloid biomarkers, and should not be administered to patients with severe hypersensitivity to lecanemab or those unable to undergo magnetic resonance imaging (MRI) evaluation. To predict the risk of ARIA before administration, apolipoprotein E genotyping is conducted, and regular brain MRI evaluations are recommended to monitor for ARIA during treatment. The most common adverse reactions are infusion-related reactions, which require appropriate management upon occurrence. Additional caution is needed when co-administering with anticoagulants or tissue plasminogen activator due to the risk of macrohemorrhage. Clinicians should consider the efficacy and necessary conditions for administration, as well as the safety of lecanemab, to make a comprehensive decision regarding its use.
9.Establishing Integrated Treatment Centers to Improve Mental Health Services: International Examples and Strategies for South Korea
Han-Sung LEE ; Hyunju LEE ; Yu Jin LEE ; Soon-Beom HONG ; Se Hyun KIM ; Hye Yoon PARK ; Soo-Hee CHOI ; Jee Eun PARK ; Sang Jin RHEE ; Juwon LEE ; Sukkyung LEE ; Jee Hoon SOHN ; Yong Min AHN
Journal of Korean Neuropsychiatric Association 2024;63(4):207-217
The global burden of mental illness has increased significantly since the COVID-19 pandemic. In South Korea, despite this rising burden, the utilization of mental health services remains critically low compared to other countries. This study evaluated successful integrated treatment centers from various countries, including the United States, the United Kingdom, and Australia, to identify the best practices that can be applied to South Korean society. These international examples informed the development of Mind the SHIM (SNUH Health in Mind) center, an integrated treatment model designed to address the gaps in non-pharmacological mental health services in South Korea. Mind the SHIM center focuses on developing and validating programs tailored to local needs, emphasizing professional education, systematic program delivery, and community collaboration. The biopsychosocial approach of the center is expected to enhance the overall quality of life of the patients and increase the utilization of mental health services, reducing the broader economic and social burden of mental illness in South Korea.
10.Lecanemab: Appropriate Use Recommendations by Korean Dementia Association
Kee Hyung PARK ; Geon Ha KIM ; Chi-Hun KIM ; Seong-Ho KOH ; So Young MOON ; Young Ho PARK ; Sang Won SEO ; Bora YOON ; Jae-Sung LIM ; Byeong C. KIM ; Hee-Jin KIM ; Hae Ri NA ; YongSoo SHIM ; YoungSoon YANG ; Chan-Nyoung LEE ; Hak Young RHEE ; San JUNG ; Jee Hyang JEONG ; Hojin CHOI ; Dong Won YANG ; Seong Hye CHOI
Dementia and Neurocognitive Disorders 2024;23(4):165-187
Lecanemab (product name Leqembi ® ) is an anti-amyloid monoclonal antibody treatment approved for use in Korea for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The Korean Dementia Association has created recommendations for the appropriate use of lecanemab to assist clinicians. These recommendations include selecting patients for administration, necessary pre-administration tests and preparations,administration methods, monitoring for amyloid related imaging abnormalities (ARIA), and communication with patients and caregivers. Lecanemab is recommended for patients with MCI or mild dementia who confirmed positive amyloid biomarkers, and should not be administered to patients with severe hypersensitivity to lecanemab or those unable to undergo magnetic resonance imaging (MRI) evaluation. To predict the risk of ARIA before administration, apolipoprotein E genotyping is conducted, and regular brain MRI evaluations are recommended to monitor for ARIA during treatment. The most common adverse reactions are infusion-related reactions, which require appropriate management upon occurrence. Additional caution is needed when co-administering with anticoagulants or tissue plasminogen activator due to the risk of macrohemorrhage. Clinicians should consider the efficacy and necessary conditions for administration, as well as the safety of lecanemab, to make a comprehensive decision regarding its use.

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