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.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e72-
Treatment should be initiated for all suspected, clinical, or confirmed cases of scabies. Patients affected should be adequately isolated, and high-risk groups with close contact histories should be treated regardless of their symptoms. Optimal treatment strategies can be selected based on age, clinical subtype, and the patient's health status. In Korea, commercially available preparations for scabies treatment include topical 5% permethrin, topical 10% crotamiton, and oral ivermectin. Topical 5% permethrin is the first-line selective treatment for both classic and crusted scabies. Alternative treatments include topical 10% crotamiton and oral ivermectin. After completing treatment, followup visits at 2 and 4 weeks are recommended to monitor the therapeutic response. Treatment is considered to have failed if scabies mites or burrows are detected, new clinical characteristics develop, or there is an aggravation of pruritus. Scabies itch should be adequately managed with emollients, oral antihistamines, and topical corticosteroids. Preventive measures, including personal hygiene, patient education, and environmental control, should be implemented to reduce the transmission of scabies.
5.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 1. Epidemiology, clinical manifestations, and diagnosis — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e73-
Scabies is a skin disease caused by the parasite Sarcoptes scabiei var. hominis, which is primarily transmitted via direct skin or sexual contact or, less commonly, via contact with infested fomites. In Korea, the incidence of scabies has decreased from approximately 50,000 cases per year in 2010 to about 30,000 cases per year in 2021. However, outbreaks are consistently observed in residential facilities, such as nursing homes, especially among older adults. The clinical manifestations of scabies vary based on the patient’s age, health status, the number of mites, and the route of transmission.Typical symptoms of classic scabies include intense nocturnal itching and characteristic skin rashes (burrows and erythematous papules), with a predilection for the interdigital web spaces, inner wrists, periumbilical areas, axillae, and genital areas. In contrast, older adults with immunodeficiency or neurological disorders may exhibit hyperkeratotic scaly lesions or an atypical distribution with mild to no itching (crusted scabies). The diagnosis of scabies is based on clinical symptoms and the results of diagnostic tests aimed at identifying the presence of the parasite. While a history of close contact and characteristic clinical findings suggest scabies, confirmation of the diagnosis requires detecting scabies mites, eggs, or scybala. This can be achieved through light microscopy of skin samples, noninvasive dermoscopy, and other high-resolution in vivo imaging techniques.
6.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e72-
Treatment should be initiated for all suspected, clinical, or confirmed cases of scabies. Patients affected should be adequately isolated, and high-risk groups with close contact histories should be treated regardless of their symptoms. Optimal treatment strategies can be selected based on age, clinical subtype, and the patient's health status. In Korea, commercially available preparations for scabies treatment include topical 5% permethrin, topical 10% crotamiton, and oral ivermectin. Topical 5% permethrin is the first-line selective treatment for both classic and crusted scabies. Alternative treatments include topical 10% crotamiton and oral ivermectin. After completing treatment, followup visits at 2 and 4 weeks are recommended to monitor the therapeutic response. Treatment is considered to have failed if scabies mites or burrows are detected, new clinical characteristics develop, or there is an aggravation of pruritus. Scabies itch should be adequately managed with emollients, oral antihistamines, and topical corticosteroids. Preventive measures, including personal hygiene, patient education, and environmental control, should be implemented to reduce the transmission of scabies.
7.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 1. Epidemiology, clinical manifestations, and diagnosis — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e73-
Scabies is a skin disease caused by the parasite Sarcoptes scabiei var. hominis, which is primarily transmitted via direct skin or sexual contact or, less commonly, via contact with infested fomites. In Korea, the incidence of scabies has decreased from approximately 50,000 cases per year in 2010 to about 30,000 cases per year in 2021. However, outbreaks are consistently observed in residential facilities, such as nursing homes, especially among older adults. The clinical manifestations of scabies vary based on the patient’s age, health status, the number of mites, and the route of transmission.Typical symptoms of classic scabies include intense nocturnal itching and characteristic skin rashes (burrows and erythematous papules), with a predilection for the interdigital web spaces, inner wrists, periumbilical areas, axillae, and genital areas. In contrast, older adults with immunodeficiency or neurological disorders may exhibit hyperkeratotic scaly lesions or an atypical distribution with mild to no itching (crusted scabies). The diagnosis of scabies is based on clinical symptoms and the results of diagnostic tests aimed at identifying the presence of the parasite. While a history of close contact and characteristic clinical findings suggest scabies, confirmation of the diagnosis requires detecting scabies mites, eggs, or scybala. This can be achieved through light microscopy of skin samples, noninvasive dermoscopy, and other high-resolution in vivo imaging techniques.
8.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e72-
Treatment should be initiated for all suspected, clinical, or confirmed cases of scabies. Patients affected should be adequately isolated, and high-risk groups with close contact histories should be treated regardless of their symptoms. Optimal treatment strategies can be selected based on age, clinical subtype, and the patient's health status. In Korea, commercially available preparations for scabies treatment include topical 5% permethrin, topical 10% crotamiton, and oral ivermectin. Topical 5% permethrin is the first-line selective treatment for both classic and crusted scabies. Alternative treatments include topical 10% crotamiton and oral ivermectin. After completing treatment, followup visits at 2 and 4 weeks are recommended to monitor the therapeutic response. Treatment is considered to have failed if scabies mites or burrows are detected, new clinical characteristics develop, or there is an aggravation of pruritus. Scabies itch should be adequately managed with emollients, oral antihistamines, and topical corticosteroids. Preventive measures, including personal hygiene, patient education, and environmental control, should be implemented to reduce the transmission of scabies.
9.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 1. Epidemiology, clinical manifestations, and diagnosis — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e73-
Scabies is a skin disease caused by the parasite Sarcoptes scabiei var. hominis, which is primarily transmitted via direct skin or sexual contact or, less commonly, via contact with infested fomites. In Korea, the incidence of scabies has decreased from approximately 50,000 cases per year in 2010 to about 30,000 cases per year in 2021. However, outbreaks are consistently observed in residential facilities, such as nursing homes, especially among older adults. The clinical manifestations of scabies vary based on the patient’s age, health status, the number of mites, and the route of transmission.Typical symptoms of classic scabies include intense nocturnal itching and characteristic skin rashes (burrows and erythematous papules), with a predilection for the interdigital web spaces, inner wrists, periumbilical areas, axillae, and genital areas. In contrast, older adults with immunodeficiency or neurological disorders may exhibit hyperkeratotic scaly lesions or an atypical distribution with mild to no itching (crusted scabies). The diagnosis of scabies is based on clinical symptoms and the results of diagnostic tests aimed at identifying the presence of the parasite. While a history of close contact and characteristic clinical findings suggest scabies, confirmation of the diagnosis requires detecting scabies mites, eggs, or scybala. This can be achieved through light microscopy of skin samples, noninvasive dermoscopy, and other high-resolution in vivo imaging techniques.
10.Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention — a secondary publication
Jin PARK ; Soon-Hyo KWON ; Young Bok LEE ; Hei Sung KIM ; Jie Hyun JEON ; Gwang Seong CHOI ;
The Ewha Medical Journal 2024;47(4):e72-
Treatment should be initiated for all suspected, clinical, or confirmed cases of scabies. Patients affected should be adequately isolated, and high-risk groups with close contact histories should be treated regardless of their symptoms. Optimal treatment strategies can be selected based on age, clinical subtype, and the patient's health status. In Korea, commercially available preparations for scabies treatment include topical 5% permethrin, topical 10% crotamiton, and oral ivermectin. Topical 5% permethrin is the first-line selective treatment for both classic and crusted scabies. Alternative treatments include topical 10% crotamiton and oral ivermectin. After completing treatment, followup visits at 2 and 4 weeks are recommended to monitor the therapeutic response. Treatment is considered to have failed if scabies mites or burrows are detected, new clinical characteristics develop, or there is an aggravation of pruritus. Scabies itch should be adequately managed with emollients, oral antihistamines, and topical corticosteroids. Preventive measures, including personal hygiene, patient education, and environmental control, should be implemented to reduce the transmission of scabies.

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