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 Outcome after Everolimus-Eluting Stent Implantation for Small Vessel Coronary Artery Disease: XIENCE Asia Small Vessel Study
Doo Sun SIM ; Dae Young HYUN ; Young Joon HONG ; Ju Han KIM ; Youngkeun AHN ; Myung Ho JEONG ; Sang Rok LEE ; Jei Keon CHAE ; Keun Ho PARK ; Young Youp KOH ; Kyeong Ho YUN ; Seok Kyu OH ; Seung Jae JOO ; Sun Ho HWANG ; Jong Pil PARK ; Jay Young RHEW ; Su Hyun KIM ; Jang Hyun CHO ; Seung Uk LEE ; Dong Goo KANG
Chonnam Medical Journal 2024;60(1):78-86
There are limited data on outcomes after implantation of everolimus-eluting stents (EES) in East Asian patients with small vessel coronary lesions. A total of 1,600 patients treated with XIENCE EES (Abbott Vascular, CA, USA) were divided into the small vessel group treated with one ≤2.5 mm stent (n=119) and the non-small vessel group treated with one ≥2.75 mm stent (n=933). The primary end point was a patient-oriented composite outcome (POCO), a composite of all-cause death, myocardial infarction (MI), and any repeat revascularization at 12 months. The key secondary end point was a device-oriented composite outcome (DOCO), a composite of cardiovascular death, target-vessel MI, and target lesion revascularization at 12 months. The small vessel group was more often female, hypertensive, less likely to present with ST-elevation MI, and more often treated for the left circumflex artery, whereas the non-small vessel group more often had type B2/C lesions, underwent intravascular ultrasound, and received unfractionated heparin. In the propensity matched cohort, the mean stent diameter was 2.5±0.0 mm and 3.1±0.4 mm in the small and non-small vessel groups, respectively. Propensity-adjusted POCO at 12 months was 6.0% in the small vessel group and 4.3% in the non-small vessel group (p=0.558). There was no significant difference in DOCO at 12 months (small vessel group: 4.3% and non-small vessel group: 1.7%, p=0.270).Outcomes of XIENCE EES for small vessel disease were comparable to those for non-small vessel disease at 12-month clinical follow-up in real-world Korean patients.
5.Psychometric Properties of the Korean Version of Functioning Assessment Short Test in Bipolar Disorder
Hangoeunbi KANG ; Bo-Hyun YOON ; Won-Myong BAHK ; Young Sup WOO ; Won KIM ; Jonghun LEE ; InKi SOHN ; Sung-Yong PARK ; Duk-In JON ; Myung Hun JUNG ; Moon-Doo KIM ; Young-Eun JUNG ; Hyung-Mo SUNG ; Young-Min PARK ; Jung Goo LEE ; Sang-Yeol LEE ; Seung-Ho JANG ; Eun-Sung LIM ; In Hee SHIM ; Kwanghun LEE ; Sae-Heon JANG
Clinical Psychopharmacology and Neuroscience 2023;21(1):188-196
Objective:
The Functioning Assessment Short Test (FAST) is a relatively specific test for bipolar disorders designed to assess the main functioning problems experienced by patients. This brief instrument includes 24 items assessing impairment or disability in 6 domains of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. It has already been translated into standardized versions in several languages. The aim of this study is to measure the validity and reliability of the Korean version of FAST (K-FAST).
Methods:
A total of 209 bipolar disorder patients were recruited from 14 centers in Korea. K-FAST, Young Mania Rating Scale (YMRS), Bipolar Depression Rating Scale (BDRS), Global Assessment of Functioning (GAF) and the World Health Organization Quality of Life Assessment Instrument Brief Form (WHOQOL-BREF) were administered, and psychometric analysis of the K-FAST was conducted.
Results:
The internal consistency (Cronbach’s alpha) of the K-FAST was 0.95. Test-retest reliability analysis showed a strong correlation between the two measures assessed at a 1-week interval (ICC = 0.97; p < 0.001). The K-FAST exhibited significant correlations with GAF (r = −0.771), WHOQOL-BREF (r = −0.326), YMRS (r = 0.509) and BDRS (r = 0.598). A strong negative correlation with GAF pointed to a reasonable degree of concurrent validity. Although the exploratory factor analysis showed four factors, the confirmatory factor analysis of questionnaires had a good fit for a six factors model (CFI = 0.925; TLI = 0.912; RMSEA = 0.078).
Conclusion
The K-FAST has good psychometric properties, good internal consistency, and can be applicable and acceptable to the Korean context.
6.Korean Medication Algorithm Project for Bipolar Disorder 2022:Comparisons with Other Treatment Guidelines
Jong-Hyun JEONG ; Won-Myong BAHK ; Young Sup WOO ; Bo-Hyun YOON ; Jung Goo LEE ; Won KIM ; InKi SOHN ; Sung-Yong PARK ; Se-Hoon SHIM ; Jeong Seok SEO ; IL Han CHOO ; Chan-Mo YANG ; Myung Hun JUNG ; Duk-In JON ; Moon-Doo KIM
Clinical Psychopharmacology and Neuroscience 2023;21(1):32-48
The objective of this study was to compare recommendations of the Korean Medication Algorithm Project for Bipolar Disorder 2022 (KMAP-BP 2022) with other recently published guidelines for treating bipolar disorder. We reviewed a total of six recently published global treatment guidelines and compared treatment recommendation of the KMAP-BP 2022 with those of other guidelines. For initial treatment of mania, there were no significant differences across treatment guidelines. All guidelines recommended mood stabilizer (MS) or atypical antipsychotic (AAP) monotherapy or a combination of an MS with an AAP as a first-line treatment strategy in a same degree for mania. However, the KMAP-BP 2022 recommended MS + AAP combination therapy for psychotic mania, mixed mania and psychotic depression as treatment of choice. Aripiprazole, quetiapine and olanzapine were the first-line AAPs for nearly all phases of bipolar disorder across guidelines. Some guideline suggested olanzapine is a second-line options during maintenance treatment, related to concern about long-term tolerability. Most guidelines advocated newer AAPs (asenapine, cariprazine, long-acting injectable risperidone, and aripiprazole once monthly) as first-line treatment options for all phases while lamotrigine was recommended for depressive and maintenance phases. Lithium and valproic acid were commonly used as MSs in all phases of bipolar disorder. KMAP-BP 2022 guidelines were similar to other guidelines, reflecting current changes in prescription patterns for bipolar disorder based on accumulated research data. Strong preference for combination therapy was characteristic of KMAP-BP 2022, predominantly in the treatment of psychotic mania, mixed mania and psychotic depression.
7.Association Between Air Pollution and Viral Infection in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Juwhan CHOI ; Jae Jeong SHIM ; Myung Goo LEE ; Chin Kook RHEE ; Hyonsoo JOO ; Jin Hwa LEE ; Hye Yun PARK ; Woo Jin KIM ; Soo-Jung UM ; Deog Kyeom KIM ; Kyung Hoon MIN
Journal of Korean Medical Science 2023;38(9):e68-
Background:
Respiratory pathogen infections and air pollution are main causes of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Air pollution has a direct effect on the airway epithelial barrier and the immune system, which can have an influence on infection. However, studies on the relationship between respiratory infections and air pollutants in severe AECOPD are limited. Thus, the objective of this study was to investigate the correlation between air pollution and respiratory pathogen in severe AECOPD.
Methods:
This multicenter observational study was conducted by reviewing electronic medical records of patients with AECOPD at 28 hospitals in South Korea. Patients were divided into four groups according to the comprehensive air-quality index (CAI) used in Korea. Identification rates of bacteria and viruses of each group were analyzed.
Results:
Viral pathogens were identified in 270 (36.7%) of 735 patients. Viral identification rate was different (P = 0.012) according to air pollution. Specifically, the virus detection rate was 55.9% in the group of CAI ‘D’ with the highest air pollution. It was 24.4% in the group of CAI ‘A’ with the lowest air pollution. This pattern was clearly seen for influenza virus A (P = 0.042). When further analysis was performed with particulate matter (PM), the higher/lower the PM level, the higher/lower the virus detection rate. However, no significant difference was found in the analysis related to bacteria.
Conclusion
Air pollution may make COPD patients more susceptible to respiratory viral infections, especially influenza virus A. Thus, on days with poor air quality, COPD patients need to be more careful about respiratory infections.
8.The Korean Medication Algorithm Project for Depressive Disorder 2021: Comparisons with Other Treatment Guidelines
Young Sup WOO ; Won-Myong BAHK ; Jeong Seok SEO ; Young-Min PARK ; Won KIM ; Jong-Hyun JEONG ; Se-Hoon SHIM ; Jung Goo LEE ; Seung-Ho JANG ; Chan-Mo YANG ; Sheng-Min WANG ; Myung Hun JUNG ; Hyung Mo SUNG ; Il Han CHOO ; Bo-Hyun YOON ; Sang-Yeol LEE ; Duk-In JON ; Kyung Joon MIN
Clinical Psychopharmacology and Neuroscience 2022;20(1):37-50
The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) first was published in 2002, and has been revised four times, in 2006, 2012, 2017, and 2021. In this review, we compared recommendations from the recently revised KMAP-DD 2021 to four global clinical practice guidelines (CPGs) for depression published after 2010. The recommendations from the KMAP-DD 2021 were similar to those from other CPGs, although there were some differences. The KMAP-DD 2021 reflected social culture and the healthcare system in Korea and recent evidence about pharmacotherapy for depression, as did other recently published evidence-based guidelines. Despite some intrinsic limitations as an expert consensus-based guideline, the KMAP-DD 2021 can be helpful for Korean psychiatrists making decisions in clinical settings by complementing previously published evidence-based guidelines, especially for some clinical situations lacking evidence from rigorously designed clinical trials.
9.Korean Medication Algorithm Project for Bipolar Disorder 2022:Mixed Features
Won KIM ; Won-Myong BAHK ; Young Sup WOO ; Jong-Hyun JEONG ; Jeong Seok SEO ; IL Han CHOO ; Chan-Mo YANG ; Jung Goo LEE ; Se-Hoon SHIM ; Bo-Hyun YOON ; Sung-Yong PARK ; InKi SOHN ; Moon-Doo KIM ; Myung Hun JUNG ; Duk-In JON
Journal of Korean Neuropsychiatric Association 2022;61(2):133-142
Objectives:
Treatment guidelines or an algorithm can help clinicians implement better practices and clinical decisions. Therefore, the Korean Medication Algorithm Project for Bipolar Disorder 2022 (KMAP-BP 2022) was revised again through a consensus of expert opinion. The diagnosis and treatment of mixed features are not simple, and there are many things to discuss. We describe the preferences and recommendations from KMAP-BP 2022 for the treatment of mood episodes with mixed features.
Methods:
We revised the KMAP-BP 2018 questionnaire and conducted the survey with expert clinicians. Out of ninety-three members of the review committee, eighty-seven completed the survey. We analyzed the answers, discussed the data, and held a clinician hearing.
Results:
In first-step strategies for mixed features with more manic symptoms, a combination of a mood stabilizer and an atypical antipsychotic is the treatment of choice. Mood stabilizer monotherapy and atypical antipsychotic monotherapy are preferred strategies. For mixed features with more depressive symptoms, a combination of mood stabilizer and atypical antipsychotic, a combination of atypical antipsychotic and lamotrigine (LMT), atypical antipsychotic monotherapy, a combination of mood stabilizer and LMT, and mood stabilizer monotherapy are preferred. For mixed features with similar manic symptoms and depressive symptoms, a combination of mood stabilizer and atypical antipsychotic, atypical antipsychotic monotherapy, and mood stabilizer monotherapy are preferred.
Conclusion
For mixed features, a combination of mood stabilizer and atypical antipsychotic is generally preferred, and LMT is preferred for depressive symptoms. Compared with KMAP-BP 2018, more diverse strategies and drugs are being attempted for the treatment of mixed features.
10.Korean Medication Algorithm Project for Bipolar Disorder 2022:Depressive Episode
Jeong Seok SEO ; Young Sup WOO ; Won-Myong BAHK ; Jong-Hyun JEONG ; Bo-Hyun YOON ; IL Han CHOO ; Chan-Mo YANG ; Won KIM ; Jung Goo LEE ; Se-Hoon SHIM ; Myung Hun JUNG ; Duk-In JON ; Sung-Yong PARK ; InKi SOHN ; Moon-Doo KIM
Journal of Korean Neuropsychiatric Association 2022;61(2):123-132
Objectives:
After the Korean Medication Algorithm Project for Bipolar Disorder (KMAP-BP) was developed in 2002, its fifth revision was completed in 2022 to reflect the recent rapid developments and research into bipolar disorder and its psychopharmacology.
Methods:
According to the methodology for previous versions, the depressive episode section of KMAP-BP 2022 was revised based on a survey consisting of 11 questions. Among ninetythree experts, eighty-seven members of the review committee (93.5%) completed the survey.The executive committee analyzed the results and discussed the final production of an algorithm by considering the scientific evidence.
Results:
Overall, the results from this study showed little change in comparison with previous versions of KMAP-BP. However, there have been significant changes in recommendations over the span of about 20 years. The preferences for lamotrigine and atypical antipsychotics, especially aripiprazole, quetiapine, and olanzapine, have shown a tendency to continuously increase, but the preferences for risperidone and ziprasidone have not increased, but have decreased. Moreover, the preference for typical antipsychotics has significantly decreased. Additionally, concerns over the use of antidepressants in bipolar depression have been raised, and their use is not recommended in KMAP-BP 2022 as a first-line treatment.
Conclusion
Pharmacotherapy for acute depressive episodes with various clinical progressions and various subtypes still shows diversity, compared to pharmacotherapy for mania. We look forward to the development of bipolar depressive, episode-specific therapeutic drugs in the future, and hope the fifth update of KMAP-BP will be a complementary option for clinicians and their patients with bipolar disorder.

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