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.Korean Medication Algorithm Project for Bipolar Disorder 2022:Rapid Cycling
Jong-Hyun JEONG ; Won-Myong BAHK ; Young Sup WOO ; Bo-Hyun YOON ; Jeong Seok SEO ; IL Han CHOO ; Chan-Mo YANG ; Won KIM ; Jung Goo LEE ; Se-Hoon SHIM ; Sung-Yong PARK ; InKi SOHN ; Moon-Doo KIM ; Myung Hun JUNG ; Duk-In JON
Journal of Korean Neuropsychiatric Association 2022;61(3):204-213
Objectives:
This study revised the Korean Medication Algorithm Project for Bipolar Disorder 2018 for rapid cycling.
Methods:
Questionnaires to survey the expert opinion of medication for rapid cycling were completed by a review committee consisting of 87 Korean expert psychiatrists. The experts’ opinions were classified into three categories based on the lowest category in which the confidence interval fell (6.5≤ for first-line, 3.5≤ for second-line, and 3.5> for third-line treatment).
Results:
The first-line treatments were a combination of mood stabilizers and atypical antipsychotics, atypical antipsychotics monotherapy, or mood stabilizer monotherapy. Furthermore, a mood stabilizer with lamotrigine therapy and an atypical antipsychotic with lamotrigine combinations was the first-line treatment for a depressive episode. The first-line medications in all episodes were valproate, lithium, quetiapine, olanzapine, and aripiprazole. Risperidone was the first-line medication in manic episodes and mixed states, and lamotrigine was the first-line medication for treating depressive episodes.
Conclusion
Compared to the surveys in 2018, the preference for atypical antipsychotics and lamotrigine has increased, and the modalities as a second-line treatment are more diversified.
9.Korean Medication Algorithm Project for Bipolar Disorder 2022: Children and Adolescents
Chan-Mo YANG ; Won-Myong BAHK ; Young Sup WOO ; Jong-Hyun JEONG ; Jeong Seok SEO ; IL Han CHOO ; Won KIM ; Jung Goo LEE ; Myung Hun JUNG ; Duk-In JON ; Sung-Yong PARK ; InKi SOHN ; Moon-Doo KIM ; Bo-Hyun YOON ; Se-Hoon SHIM
Journal of Korean Neuropsychiatric Association 2022;61(3):224-236
Objectives:
The objective of this study was to revise the Korean Medication Algorithm Project for Bipolar Disorder (KMAP-BP) 2022: children and adolescents.
Methods:
We performed a survey, using a questionnaire comprising 23 questions according to various situations facing children and adolescents with bipolar disorders. A total of 40 of the 60 experts in child and adolescent psychiatry responded to the survey.
Results:
The first-line pharmacotherapeutic strategies for manic and depressive episodes in children with bipolar disorders were a combination of mood stabilizer (MS) and atypical antipsychotics (AAP). The first-line medications selected for these children were aripiprazole (treatment of choice, TOC) and risperidone. The first-line pharmacotherapeutic strategies for manic episodes in adolescents were a combination of MS and an AAP (TOC), monotherapy with MS, and monotherapy with an AAP. Lithium, valproate, aripiprazole, risperidone, and quetiapine were selected as first-line medications for these adolescents. First-line pharmacotherapeutic strategies for depressive episodes in adolescents were a combination of MS and an AAP, monotherapy with MS, and monotherapy with an AAP. The first-line pharmacotherapeutic strategies for the depressive episodes in adolescents at high risk for bipolar disorder were a combination of MS and AAP and monotherapy with an AAP. Lithium, valproate, aripiprazole (TOC), quetiapine, and risperidone were selected as first-line medications for the treatment of depressive episodes in adolescents with bipolar disorder.
Conclusion
It is expected that the present KMAP-BP 2022: children and adolescents will give the direction and be usefully applied by clinicians to treat children and adolescents with bipolar disorders.
10.Korean Medication Algorithm Project for Bipolar Disorder 2022: Maintenance Therapy
Jung Goo LEE ; Won-Myong BAHK ; Young Sup WOO ; Jong-Hyun JEONG ; Jeong Seok SEO ; IL Han CHOO ; Chan-Mo YANG ; Won KIM ; Se-Hoon SHIM ; Myung Hun JUNG ; Duk-In JON ; Sung-Yong PARK ; InKi SOHN ; Moon-Doo KIM ; Bo-Hyun YOON
Journal of Korean Neuropsychiatric Association 2022;61(3):214-223
Objectives:
In this study, we investigated and organized the maintenance-treatment strategies for Bipolar I and II disorders outlined in The Korean Medication Algorithm Project for Bipolar disorder 2022 (KMAP-BP 2022).
Methods:
The questionnaire sought to survey expert opinion on medication for bipolar disorders and was completed by a review committee consisting of 87 experienced Korean psychiatrists. It comprised 56 questions, and each question included various sub-items. The questionnaire for the maintenance treatments covered overall treatment strategies after acute mood episodes in bipolar I and II disorders, the choice of mood stabilizers and atypical antipsychotics and antidepressants, duration of medication, and treatment strategies for breakthrough symptoms.
Results:
In the case of bipolar I disorder, mood stabilizer monotherapy, atypical antipsychotics monotherapy, and a combination of mood stabilizers and atypical antipsychotics were selected as the first-line treatments. In maintenance management of bipolar II disorder, mood stabilizer monotherapy, atypical antipsychotics monotherapy, and combinations of mood stabilizers were selected as the preferred first-line treatments.
Conclusion
There has been a growing body of evidence that atypical antipsychotics have a greater preference than observed in the previous KMAP-BP of 2018. Also, monotherapy of mood stabilizers or atypical antipsychotics was more frequently selected in KMAP-BP 2022 than in the KMAP-BP 2018.

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