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.Issues pertaining to Mg, Zn and Cu in the 2020 Dietary Reference Intakes for Koreans
Hae-Yun CHUNG ; Mi-Kyung LEE ; Wookyoung KIM ; Mi-Kyeong CHOI ; Se-Hong KIM ; Eunmee KIM ; Mi-Hyun KIM ; Jung-Heun HA ; Hongmie LEE ; Yun-Jung BAE ; In-Sook KWUN
Nutrition Research and Practice 2022;16(S1):s113-s125
In the current years, it has now become necessary to establish standards for micronutrient intake based on scientific evidence. This review discusses issues related to the development of the 2020 Dietary Reference Intakes for Koreans (KDRI) for magnesium (Mg), zinc (Zn), and copper (Cu), and future research directions. Following issues were encountered when establishing the KDRI for these minerals. First, characteristics of Korean subjects need to be applied to estimate nutrient requirements. When calculating the estimated average requirement (EAR), the KDRI used the results of balance studies for Mg absorption and factorial analysis for Zn, which is defined as the minimum amount to offset endogenous losses for Zn and Mg. For Cu, a combination of indicators, such as depletion/repletion studies, were applied, wherein all reference values were based on data obtained from other countries. Second, there was a limitation in that it was difficult to determine whether reference values of Mg, Zn, and Cu intakes in the 2020 KDRI were achievable. This might be due to the lack of representative previous studies on intakes of these nutrients, and an insufficient database for Mg, Zn, and Cu contents in foods. This lack of database for mineral content in food poses a problem when evaluating the appropriateness of intake. Third, data was insufficient to assess the adequacy of Mg, Zn, and Cu intakes from supplements when calculating reference values, considering the rise in both demand and intake of mineral supplements. Mg is more likely to be consumed as a multi-nutrient supplement in combination with other minerals than as a single supplement. Moreover, Zn-Cu interactions in the body need to be considered when determining the reference intake values of Zn and Cu. It is recommended to discuss these issues present in the 2020 KDRI development for Mg, Zn, and Cu intakes in a systematic way, and to find relevant solutions.
3.Nationwide “Pediatric Nutrition Day” survey on the nutritional status of hospitalized children in South Korea
Yoo Min LEE ; Eell RYOO ; Jeana HONG ; Ben KANG ; Byung-Ho CHOE ; Ji-Hyun SEO ; Ji Sook PARK ; Hyo-Jeong JANG ; Yoon LEE ; Eun Jae CHANG ; Ju Young CHANG ; Hae Jeong LEE ; Ju Young KIM ; Eun Hye LEE ; Hyun Jin KIM ; Ju-Young CHUNG ; You Jin CHOI ; So Yoon CHOI ; Soon Chul KIM ; Ki-Soo KANG ; Dae Yong YI ; Kyung Rye MOON ; Ji Hyuk LEE ; Yong Joo KIM ; Hye Ran YANG
Nutrition Research and Practice 2021;15(2):213-224
BACKGROUND/OBJECTIVES:
To evaluate the nutritional status and prevalence of malnutrition in hospitalized children at admission and during hospitalization in South Korea.
SUBJECTS/METHODS:
This first cross-sectional nationwide “Pediatric Nutrition Day (pNday)” survey was conducted among 872 hospitalized children (504 boys, 368 girls; 686 medical, 186 surgical) from 23 hospitals in South Korea. Malnutrition risk was screened using the Pediatric Yorkhill Malnutrition Score (PYMS) and the Screening Tool Risk on Nutritional status and Growth. Nutritional status was assessed by z-scores of weight-for-age for underweight, weight-for-height for wasting, and height-for-age for stunting as well as laboratory tests.
RESULTS:
At admission, of the 872 hospitalized children, 17.2% were underweight, and the prevalence of wasting and stunting was 20.2% and 17.3%, respectively. During hospitalization till pNday, 10.8% and 19.6% experienced weight loss and decreased oral intake, respectively.During the aforementioned period, fasting was more prevalent in surgical patients (7.5%) than in medical patients (1.6%) (P < 0.001). According to the PYMS, 34.3% and 30% of the children at admission and on pNday, respectively, had a high-risk of malnutrition, requiring consultation with the nutritional support team (NST). However, only 4% were actually referred to the NST during hospitalization.
CONCLUSIONS
Malnutrition was prevalent at admission and during hospitalization in pediatric patients, with many children experiencing weight loss and poor oral intake. To improve the nutritional status of hospitalized children, it is important to screen and identify all children at risk of malnutrition and refer malnourished patients to the multidisciplinary NST for proper nutritional interventions.
4.Nationwide “Pediatric Nutrition Day” survey on the nutritional status of hospitalized children in South Korea
Yoo Min LEE ; Eell RYOO ; Jeana HONG ; Ben KANG ; Byung-Ho CHOE ; Ji-Hyun SEO ; Ji Sook PARK ; Hyo-Jeong JANG ; Yoon LEE ; Eun Jae CHANG ; Ju Young CHANG ; Hae Jeong LEE ; Ju Young KIM ; Eun Hye LEE ; Hyun Jin KIM ; Ju-Young CHUNG ; You Jin CHOI ; So Yoon CHOI ; Soon Chul KIM ; Ki-Soo KANG ; Dae Yong YI ; Kyung Rye MOON ; Ji Hyuk LEE ; Yong Joo KIM ; Hye Ran YANG
Nutrition Research and Practice 2021;15(2):213-224
BACKGROUND/OBJECTIVES:
To evaluate the nutritional status and prevalence of malnutrition in hospitalized children at admission and during hospitalization in South Korea.
SUBJECTS/METHODS:
This first cross-sectional nationwide “Pediatric Nutrition Day (pNday)” survey was conducted among 872 hospitalized children (504 boys, 368 girls; 686 medical, 186 surgical) from 23 hospitals in South Korea. Malnutrition risk was screened using the Pediatric Yorkhill Malnutrition Score (PYMS) and the Screening Tool Risk on Nutritional status and Growth. Nutritional status was assessed by z-scores of weight-for-age for underweight, weight-for-height for wasting, and height-for-age for stunting as well as laboratory tests.
RESULTS:
At admission, of the 872 hospitalized children, 17.2% were underweight, and the prevalence of wasting and stunting was 20.2% and 17.3%, respectively. During hospitalization till pNday, 10.8% and 19.6% experienced weight loss and decreased oral intake, respectively.During the aforementioned period, fasting was more prevalent in surgical patients (7.5%) than in medical patients (1.6%) (P < 0.001). According to the PYMS, 34.3% and 30% of the children at admission and on pNday, respectively, had a high-risk of malnutrition, requiring consultation with the nutritional support team (NST). However, only 4% were actually referred to the NST during hospitalization.
CONCLUSIONS
Malnutrition was prevalent at admission and during hospitalization in pediatric patients, with many children experiencing weight loss and poor oral intake. To improve the nutritional status of hospitalized children, it is important to screen and identify all children at risk of malnutrition and refer malnourished patients to the multidisciplinary NST for proper nutritional interventions.
5.Application of Six Sigma Metrics to Improve Quality Control for Point-of-care Glucose Testing
Sholhui PARK ; Wookeun LEE ; Tae-Dong JEONG ; Hae-Sun CHUNG ; Ki-Sook HONG
The Ewha Medical Journal 2020;43(3):43-48
Objectives:
Six sigma is a quality management system for the assessment of precisionand accuracy. We aim to apply the six sigma rule to quality control (QC) of point-of-care(POC) glucose meters in a tertiary hospital.
Methods:
Thirty POC glucose meters installed at Ewha Womans University MokdongHospital were monitored between January 2013 and March 2014. The QC data fromthe POC glucose meters at low and high levels were collected. The monthly mean, standarddeviation, bias, coefficient of variation, and mean sigma metrics were calculated.The correlation between accuracy and precision was assessed based on the percentagebias and coefficient of variation. Comprehensive instructions on the QC and maintenanceof the devices were provided in the departments with poor sigma scores. Afollow-up assessment was performed after the intervention.
Results:
The mean sigma values for the low and high controls were 3.29 and 3.71, respectively.At the low and high controls, 36.6% and 10% of the glucose meters showeda sigma value <3. The causes of low sigma values included the use of expired controlmaterials, prolonged air exposure of the sample strip, lack of user training, and errors indevice maintenance. On follow-up monitoring for 3 months following QC intervention,23.3% (low control) and 6.6% (high control) of the glucose meters scored a sigma value<3, indicating improved QC.
Conclusion
Sigma metrics-based QC can successfully improve accuracy and precisionof POC glucose meters in an objective and quantitative manner and can be usedfor follow up after QC intervention.
6.Socioeconomic burden of sugar-sweetened beverages consumption in Korea
Jee Seon SHIM ; Nam Hoon KANG ; Jung Sug LEE ; Ki Nam KIM ; Hae Kyung CHUNG ; Hae Rang CHUNG ; Hung Ju KIM ; Yoon Sook AHN ; Moon Jeong CHANG
Nutrition Research and Practice 2019;13(2):134-140
BACKGROUND/OBJECTIVES: Excessive sugar consumption may increase the risk for development of several diseases. Although average dietary sugar intake of Koreans is within the recommended level, an increasing trend has been found in all age groups. This study aimed to evaluate the population attributable fractions (PAF) to dietary sugar for disease and death in Korea, and to estimate the socioeconomic effects of a reduction in dietary sugar. MATERIALS/METHODS: The prevalence of sugar-sweetened beverages (SSB) overconsumption (≥ 20 g of sugar from beverages) was analyzed using the Korean National Health and Nutrition Examination Survey 2015. Disease-specific relative risks of excessive SSB consumption were obtained through reviewing previous studies. Using the prevalence of SSB overconsumption and each relative risk, PAFs for morbidity and mortality were calculated. Socioeconomic costs of diseases and death attributable to SSB overconsumption were estimated by using representative data on national medical expenditures, health insurance statistics, employment information, and previous reports. RESULTS: Disease-specific PAF to SSB consumption ranged from 3.11% for stroke to 9.05% for obesity and dental caries, respectively. Costs from disease caused by SSB overconsumption was estimated at 594 billion won in 2015. About 39 billion won was estimated to be from SSB consumption-related deaths, and a total of 633 billion won was predicted to have been saved through preventing SSB overconsumption. CONCLUSIONS: Sugars overconsumption causes considerable public burdens, although the cost estimates do not include any informal expenditure. Information on these socioeconomic effects helps both health professionals and policy makers to create and to implement programs for reducing sugar consumption.
Administrative Personnel
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Beverages
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Carbohydrates
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Dental Caries
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Dietary Sucrose
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Employment
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Health Expenditures
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Health Occupations
;
Humans
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Insurance
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Korea
;
Mortality
;
Nutrition Surveys
;
Obesity
;
Prevalence
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Public Health
;
Stroke
7.Serotype Distribution and Antimicrobial Resistance of Invasive and Noninvasive Streptococcus pneumoniae Isolates in Korea between 2014 and 2016
Dong Chul PARK ; Si Hyun KIM ; Dongeun YONG ; In Bum SUH ; Young Ree KIM ; Jongyoun YI ; Wonkeun SONG ; Sae Am SONG ; Hee Won MOON ; Hae Kyung LEE ; Kyoung Un PARK ; Sunjoo KIM ; Seok Hoon JEONG ; Jaehyeon LEE ; Joseph JEONG ; Yu Kyung KIM ; Miae LEE ; Jihyun CHO ; Jong Wan KIM ; Kyeong Seob SHIN ; Sang Hyun HWANG ; Jae Woo CHUNG ; Hye In WOO ; Chae Hoon LEE ; Namhee RYOO ; Chulhun L CHANG ; Hyun Soo KIM ; Jayoung KIM ; Jong Hee SHIN ; Soo Hyun KIM ; Mi Kyung LEE ; Seong Gyu LEE ; Sook Jin JANG ; Kyutaeg LEE ; HunSuk SUH ; Yong Hak SOHN ; Min Jung KWON ; Hee Joo LEE ; Ki Ho HONG ; Kwang Sook WOO ; Chul Min PARK ; Jeong Hwan SHIN
Annals of Laboratory Medicine 2019;39(6):537-544
BACKGROUND: Several factors contribute to differences in Streptococcus pneumoniae serotype distribution. We investigated the serotype distribution and antimicrobial resistance of S. pneumoniae isolated between 2014 and 2016 in Korea. METHODS: We collected a total of 1,855 S. pneumoniae isolates from 44 hospitals between May 2014 and May 2016, and analyzed the serotypes by sequential multiplex PCR. We investigated the distribution of each serotype by patient age, source of the clinical specimen, and antimicrobial resistance pattern. RESULTS: The most common serotypes were 11A (10.1%), followed by 19A (8.8%), 3 (8.5%), 34 (8.1%), 23A (7.3%), and 35B (6.2%). The major invasive serotypes were 3 (12.6%), 19A (7.8%), 34 (7.8%), 10A (6.8%), and 11A (6.8%). Serotypes 10A, 15B, 19A, and 12F were more common in patients ≤5 years old, while serotype 3 was more common in patients ≥65 years old compared with the other age groups. The coverage rates of pneumococcal conjugate vaccine (PCV)7, PCV10, PCV13, and pneumococcal polysaccharide vaccine 23 were 11.8%, 12.12%, 33.3%, and 53.6%, respectively. Of the 1,855 isolates, 857 (46.2%) were multi-drug resistant (MDR), with serotypes 11A and 19A predominant among the MDR strains. The resistance rates against penicillin, cefotaxime, and levofloxacin were 22.8%, 12.5%, and 9.4%, respectively. CONCLUSIONS: There were significant changes in the major S. pneumoniae serotypes in the community. Non-PCV13 serotypes increased in patients ≤5 years old following the introduction of national immunization programs with the 10- and 13-polyvalent vaccines.
Cefotaxime
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Humans
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Immunization Programs
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Korea
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Levofloxacin
;
Multiplex Polymerase Chain Reaction
;
Penicillins
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Pneumococcal Vaccines
;
Pneumonia
;
Serogroup
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Streptococcus pneumoniae
;
Streptococcus
;
Vaccines
8.Landscape of Actionable Genetic Alterations Profiled from 1,071 Tumor Samples in Korean Cancer Patients.
Se Hoon LEE ; Boram LEE ; Joon Ho SHIM ; Kwang Woo LEE ; Jae Won YUN ; Sook Young KIM ; Tae You KIM ; Yeul Hong KIM ; Young Hyeh KO ; Hyun Cheol CHUNG ; Chang Sik YU ; Jeeyun LEE ; Sun Young RHA ; Tae Won KIM ; Kyung Hae JUNG ; Seock Ah IM ; Hyeong Gon MOON ; Sukki CHO ; Jin Hyoung KANG ; Jihun KIM ; Sang Kyum KIM ; Han Suk RYU ; Sang Yun HA ; Jong Il KIM ; Yeun Jun CHUNG ; Cheolmin KIM ; Hyung Lae KIM ; Woong Yang PARK ; Dong Young NOH ; Keunchil PARK
Cancer Research and Treatment 2019;51(1):211-222
PURPOSE: With the emergence of next-generation sequencing (NGS) technology, profiling a wide range of genomic alterations has become a possibility resulting in improved implementation of targeted cancer therapy. In Asian populations, the prevalence and spectrum of clinically actionable genetic alterations has not yet been determined because of a lack of studies examining high-throughput cancer genomic data. MATERIALS AND METHODS: To address this issue, 1,071 tumor samples were collected from five major cancer institutes in Korea and analyzed using targeted NGS at a centralized laboratory. Samples were either fresh frozen or formalin-fixed, paraffin embedded (FFPE) and the quality and yield of extracted genomic DNA was assessed. In order to estimate the effect of sample condition on the quality of sequencing results, tissue preparation method, specimen type (resected or biopsied) and tissue storage time were compared. RESULTS: We detected 7,360 non-synonymous point mutations, 1,164 small insertions and deletions, 3,173 copy number alterations, and 462 structural variants. Fifty-four percent of tumors had one or more clinically relevant genetic mutation. The distribution of actionable variants was variable among different genes. Fresh frozen tissues, surgically resected specimens, and recently obtained specimens generated superior sequencing results over FFPE tissues, biopsied specimens, and tissues with long storage duration. CONCLUSION: In order to overcome, challenges involved in bringing NGS testing into routine clinical use, a centralized laboratory model was designed that could improve the NGS workflows, provide appropriate turnaround times and control costs with goal of enabling precision medicine.
Academies and Institutes
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Asian Continental Ancestry Group
;
DNA
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Humans
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Korea
;
Methods
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Paraffin
;
Point Mutation
;
Precision Medicine
;
Prevalence
9.Knowledge, Confidence, and Learning Needs Regarding Advance Directives among Hospital Nurses
Nan Soon JANG ; Hae Sook PARK ; Mi Ra KIM ; Joo Yeon LEE ; Yeo Won CHO ; Kyoung Mi KIM ; Youn Jung SON
Journal of Korean Critical Care Nursing 2018;11(1):35-45
PURPOSE: Nurses' knowledge regarding advance directives may affect their administration of and confidence towards end of life care. This study aimed to describe the relationships of knowledge, confidence, and learning needs with advance directives among hospital nurses.METHOD: This cross-sectional study was performed at a tertiary university hospital in Seoul between September 25 and October 14, 2017. Convenience sampling was used to recruit nurses who provided bedside care and had at least 1 year of clinical experience. We used a validated self-report questionnaire.RESULTS: The mean score of knowledge, confidence and learning needs were 5.00±1.73, 29.81±7.52, and 64.54±8.48 respectively. Hospital nurses' knowledge, confidence and learning needs were significantly different according to age, job position, educational level and perceived advance directives. Knowledge regarding advance directives was significantly associated with confidence (r = .27, p < .001) and learning needs (r = .16, p = .005).CONCLUSION: Knowledge regarding advance directives was relatively low compared to the findings of previous studies. Therefore, nurses should be knowledgeable and encouraged to initiate advance directives. It is necessary to develop a standardized educational program regarding advance directives based on Korean cultures.
Advance Directives
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Cross-Sectional Studies
;
Learning
;
Methods
;
Seoul
;
Terminal Care
10.Psychological Distress and Drawing Tests among Women with Breast Cancer.
Jiyeon KIM ; Soyoung YOUN ; Byeongil CHOI ; Kyung Hae JUNG ; Seung Do AHN ; Sook Yeon HWANG ; Seockhoon CHUNG ; Jaedam LEE
Journal of Korean Medical Science 2018;33(17):e140-
BACKGROUND: The aim of this study was to evaluate the use of the Diagnostic Drawing Series (DDS) as a screening tool for the breast cancer patients with psychological distress. METHODS: All of 64 patients with breast cancer participated in this study. Patients' depressive and anxiety symptoms were assessed using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) when the DDS was applied to the partipicants. RESULTS: Depressed patients used more enclosure in the Feeling drawings (P = 0.002) and tilt in Free drawings (P = 0.048). Patients with anxiety drew a picture over 67% of the paper (P = 0.015) in Tree drawing and more medium pressure (P = 0.049) in Feeling drawings. Thirty four subjects (77.3%) of unstable emotion group used over 67% of the space (P = 0.002). More Landscapes were observed in the Feeling drawings of unstable patients (P = 0.042). CONCLUSION: These results suggested that DDS could be used as a supplemental screening tool for psychological distress in breast cancer patients.
Anxiety
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Breast Neoplasms*
;
Breast*
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Depression
;
Female
;
Humans
;
Mass Screening
;
Trees

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