1.Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Jun Sung MOON ; Il Rae PARK ; Hae Jin KIM ; Choon Hee CHUNG ; Kyu Chang WON ; Kyung Ah HAN ; Cheol-Young PARK ; Jong Chul WON ; Dong Jun KIM ; Gwan Pyo KOH ; Eun Sook KIM ; Jae Myung YU ; Eun-Gyoung HONG ; Chang Beom LEE ; Kun-Ho YOON
Diabetes & Metabolism Journal 2023;47(6):808-817
Background:
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods:
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results:
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
2.Risk Factors and Comorbidities Associated With the Allergic Rhinitis Phenotype in Children According to the ARIA Classification
Sungsu JUNG ; So Yeon LEE ; Jisun YOON ; Hyun Ju CHO ; Young Ho KIM ; Dong In SUH ; Song I YANG ; Ji won KWON ; Gwang Cheon JANG ; Yong Han SUN ; Sung Il WOO ; You Sook YOUN ; Kang Seo PARK ; Eun LEE ; Hwa Jin CHO ; Myung Hee KOOK ; Hye Ryoung YI ; Hai Lee CHUNG ; Ja Hyeong KIM ; Hyung Young KIM ; Jin A JUNG ; Hyang Ok WOO ; Jeom Kyu LEE ; Woo Sung CHANG ; Nam Hee DO ; Hyejoo CHO ; Soo Jong HONG
Allergy, Asthma & Immunology Research 2020;12(1):72-85
PURPOSE: Data are lacking on the association between the allergic rhinitis (AR) phenotype and sensitization to specific allergens or bronchial hyperresponsiveness (BHR) in children. We here investigated risk factors and comorbidities, including sensitization to specific allergens and BHR, for the AR phenotype by AR and its Impact on Asthma (ARIA) classification in a general population-based birth cohort study. METHODS: We enrolled 606 children aged 7 years from the Panel Study of Korean Children. The AR phenotype was assigned in accordance with the ARIA classification in children. Skin prick tests and Provocholine provocation test were performed. Risk factors and comorbidities for AR phenotypes were then analyzed. RESULTS: The prevalence of mild and moderate to severe AR in our study cohort was 37.2% and 8.8%, respectively. Recent use of analgesics or antipyretics and current cat ownership were associated with the risk of mild persistent AR. Sensitizations to Dermatophagoides Pteronyssinus (Der p), Japanese hop and cat were associated with moderate to severe persistent AR. Children with moderate to severe AR had a higher risk of current asthma and BHR compared to mild AR cases (adjusted odds ratio [aOR], 5.26; 95% confidence interval [CI], 1.77–15.62). Moderate to severe AR with allergic sensitization was associated with the highest risk of BHR (aOR, 11.77; 95% CI, 3.40–40.74). CONCLUSIONS: Moderate to severe-persistent AR is more closely related to respiratory comorbidities and sensitizations than mild AR. Stratifying the AR phenotype by ARIA classification may assist in disease management.
Allergens
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Analgesics
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Animals
;
Antipyretics
;
Asian Continental Ancestry Group
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Asthma
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Bronchial Hyperreactivity
;
Cats
;
Child
;
Classification
;
Cohort Studies
;
Comorbidity
;
Dermatophagoides pteronyssinus
;
Disease Management
;
Humans
;
Methacholine Chloride
;
Odds Ratio
;
Ownership
;
Parturition
;
Phenotype
;
Prevalence
;
Rhinitis, Allergic
;
Risk Factors
;
Skin
3.Custody Evaluation in High-conflict Situations Focused on Domestic Violence and Parental Alienation Syndrome
Duk Soo MOON ; Myung Hoon LEE ; Dong Sun CHUNG ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):66-73
In a divorced family, child-centered custody evaluation is essential to ensure the child’s best interests and healthy adaptation. A mental health professional’s role and involvement are required in gaining an in-depth understanding of various environments and dynamics surrounding the child and family. Domestic violence, including child abuse and intimate partner violence (IPV) or parental alienation syndrome (PAS), is often observed in cases of custody evaluation in high-conflict divorced families, sometimes accompanied by allegations.Such cases warrant an extremely careful approach by the evaluator, who needs to be competent in interpreting the familial dynamics based on a reasonable context understanding. Genuine professionalism is a must for a custody evaluator to best help the child and carry out a high-quality custody evaluation process, and evaluators need to be ready for this task through adequate preparation and empowerment. This article is devoted to examining custody evaluation in divorced families in cases of IPV, child abuse, and PAS.
4.Custody Evaluation Process and Report Writing
Dong Sun CHUNG ; Duk Soo MOON ; Myung Hoon LEE ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):58-65
As in western countries, divorce rates in South Korea have recently been rising, and family disruption has become one of serious social problems. Parents are able to express their opinions and wishes confidently, but the thoughts and wishes of children, especially infants and young children, tend to be ignored. Children can also experience several emotional and behavioral problems during the process of and after their parents’ divorce. When South Korean family courts determine custody arrangements, they typically do not have a systematic strategy and process based on custody evaluation to help children and their parents overcome conflicts and build healthy parent-child relationships after divorce. Furthermore, under the current court system, it is difficult for mental health specialists and child psychiatrists to intervene in familial conflicts as mediators or therapists during the course of divorce proceedings. Acknowledging these limitations, the South Korean family court system implemented a formal program for custody evaluations by child psychiatrists and psychologists in 2017. However, they have faced challenges such as a shortage of experienced specialist and lack of a training system or instruments for evaluation. In this paper, the authors aim to share professional knowledge of and experiences with aspects of the custody evaluation process, such as indications, procedures, methods, psychological tests, resources, and final report writing, to better serve children and their parents undergoing a painful divorce process.
5.The Concept and Historical Background of Custody Evaluation
Myung Hoon LEE ; Dong Sun CHUNG ; Duk Soo MOON ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):53-57
This article reviews a wide range of literature on the standards and process of child custody evaluation in the US, and proposes custody evaluation standards appropriate to Korea. Custody evaluation refers to the process of making psychiatric and psychological evaluations of each parent and the child during a custody dispute and presenting to the family court a report of custody evaluation with the aim of safeguarding the best interests of the child. In the past, it was thought that children arethe fathers’ possessions or that younger children should be raised by the mother; however, currently, custody rights are evaluated in accordance with the principle of the best interests of the child. The principle is all-encompassing and vague and hence, the court makes increasingly more requests to mental health professionals for custody evaluation. Since the Seoul Family Court introduced the expert consultation system in 2017, the involvement of mental health professionals in child custody decisions has increased in Korea. Custody evaluators should try to be neutral and find the objective facts, keeping in mind that their role is to aid the court in making a custody decision.
6.Custody Evaluation in High-conflict Situations Focused on Domestic Violence and Parental Alienation Syndrome
Duk Soo MOON ; Myung Hoon LEE ; Dong Sun CHUNG ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):66-73
In a divorced family, child-centered custody evaluation is essential to ensure the child’s best interests and healthy adaptation. A mental health professional’s role and involvement are required in gaining an in-depth understanding of various environments and dynamics surrounding the child and family. Domestic violence, including child abuse and intimate partner violence (IPV) or parental alienation syndrome (PAS), is often observed in cases of custody evaluation in high-conflict divorced families, sometimes accompanied by allegations.Such cases warrant an extremely careful approach by the evaluator, who needs to be competent in interpreting the familial dynamics based on a reasonable context understanding. Genuine professionalism is a must for a custody evaluator to best help the child and carry out a high-quality custody evaluation process, and evaluators need to be ready for this task through adequate preparation and empowerment. This article is devoted to examining custody evaluation in divorced families in cases of IPV, child abuse, and PAS.
7.Custody Evaluation Process and Report Writing
Dong Sun CHUNG ; Duk Soo MOON ; Myung Hoon LEE ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):58-65
As in western countries, divorce rates in South Korea have recently been rising, and family disruption has become one of serious social problems. Parents are able to express their opinions and wishes confidently, but the thoughts and wishes of children, especially infants and young children, tend to be ignored. Children can also experience several emotional and behavioral problems during the process of and after their parents’ divorce. When South Korean family courts determine custody arrangements, they typically do not have a systematic strategy and process based on custody evaluation to help children and their parents overcome conflicts and build healthy parent-child relationships after divorce. Furthermore, under the current court system, it is difficult for mental health specialists and child psychiatrists to intervene in familial conflicts as mediators or therapists during the course of divorce proceedings. Acknowledging these limitations, the South Korean family court system implemented a formal program for custody evaluations by child psychiatrists and psychologists in 2017. However, they have faced challenges such as a shortage of experienced specialist and lack of a training system or instruments for evaluation. In this paper, the authors aim to share professional knowledge of and experiences with aspects of the custody evaluation process, such as indications, procedures, methods, psychological tests, resources, and final report writing, to better serve children and their parents undergoing a painful divorce process.
8.The Concept and Historical Background of Custody Evaluation
Myung Hoon LEE ; Dong Sun CHUNG ; Duk Soo MOON ; Young Sook KWACK
Journal of the Korean Academy of Child and Adolescent Psychiatry 2020;31(2):53-57
This article reviews a wide range of literature on the standards and process of child custody evaluation in the US, and proposes custody evaluation standards appropriate to Korea. Custody evaluation refers to the process of making psychiatric and psychological evaluations of each parent and the child during a custody dispute and presenting to the family court a report of custody evaluation with the aim of safeguarding the best interests of the child. In the past, it was thought that children arethe fathers’ possessions or that younger children should be raised by the mother; however, currently, custody rights are evaluated in accordance with the principle of the best interests of the child. The principle is all-encompassing and vague and hence, the court makes increasingly more requests to mental health professionals for custody evaluation. Since the Seoul Family Court introduced the expert consultation system in 2017, the involvement of mental health professionals in child custody decisions has increased in Korea. Custody evaluators should try to be neutral and find the objective facts, keeping in mind that their role is to aid the court in making a custody decision.
9.Long-Term Expansion of Functional Human Pluripotent Stem Cell-Derived Hepatic Organoids
Seon Ju MUN ; Yeon-Hwa HONG ; Hyo-Suk AHN ; Jae-Sung RYU ; Kyung-Sook CHUNG ; Myung Jin SON
International Journal of Stem Cells 2020;13(2):279-286
A human cell-based liver model capable of long-term expansion and mature hepatic function is a fundamental requirement for pre-clinical drug development. We previously established self-renewing and functionally mature human pluripotent stem cell-derived liver organoids as an alternate to primary human hepatocytes. In this study, we tested long-term prolonged culture of organoids to increase their maturity. Organoid growing at the edge of Matrigel started to deteriorate two weeks after culturing, and the expression levels of the functional mature hepatocyte marker ALB were decreased at four weeks of culture. Replating the organoids weekly at a 1:2 ratio in fresh Matrigel, resulted in healthier morphology with a thicker layer compared to organoids maintained on the same Matrigel and significantly increased ALB expression until three weeks, although, it decreased sharply at four weeks. The levels of the fetal hepatocyte marker AFP were considerably increased in long-term cultures of organoids. Therefore, we performed serial passaging of organoids, whereby they were mechanically split weekly at a 1:3∼1:5 ratio in fresh Matrigel. The organoids expanded so far over passage 55, or 1 year, without growth retardation and maintained a normal karyotype after long-term cryopreservation. Differentiation potentials were maintained or increased after long-term passaging, while AFP expression considerably decreased after passaging. Therefore, these data demonstrate that organoids can be exponentially expanded by serial passaging, while maintaining long-term functional maturation potential. Thus, hepatic organoids can be a practical and renewable cell source for human cell-based and personalized 3D liver models.
10.Effects of the Integrated Stress Management Program on Stress and Depression in Psychiatric Inpatients
Ji Eun KIM ; Myung Sill CHUNG ; Mi Sook KWON ; Sunah KANG ; Jain KO ; Hyeon A KANG ; Mi Hui SEO ; Young Ok SONG ; Yoonyoung NAM
Journal of Korean Academy of Psychiatric and Mental Health Nursing 2019;28(3):226-235
PURPOSE: The purpose of this study was to test the effects on stress and depression by developing and implementing an integrated stress management program for inpatients in the psychiatric closed ward. METHODS: The study was a one-group pretest-posttest design. A total of 36 patients in the closed ward participated in this study. Data were collected through self-report questionnaires to measure hospital stress and depression. Data were analyzed by using t-tests and one-way ANOVA with SPSS/WIN 21.0. RESULTS: Integrated stress management program was designed based on Lazarus and Folkman stress-appraisal-coping model. Total of eight 1-hour sessions were delivered for four weeks in the group. There were significant differences in the inpatient stress scores before and after the intervention. However, the integrated stress management program showed some reduction in depression but did not show signifiant differences statistically. CONCLUSION: Our study findings confirm that the use of the integrated stress management program can reduce stress of the patients, that enable them to stabilize their minds at hospitalization. However, further study is needed to confirm the effects on depression. Thus, it would be beneficial to provide psychiatric nursing intervention tailored to psychiatric patients' symptoms, especially for reducing inpatient stress.
Depression
;
Hospitalization
;
Humans
;
Inpatients
;
Managed Care Programs
;
Psychiatric Nursing
;
Stress, Psychological

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