1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.The Association of Smoking Status with Diabetic Microvascular Complications in Korean Patients with Type 2 Diabetes
Yongin CHO ; Hye-Sun PARK ; Da Hea SEO ; Seong Hee AHN ; Seongbin HONG ; Young Ju SUH ; Suk CHON ; Jeong-Taek WOO ; Sei Hyun BAIK ; Kwan Woo LEE ; So Hun KIM
Yonsei Medical Journal 2024;65(8):427-433
Purpose:
Few studies have investigated the association between smoking and microvascular complications in the Asian population with type 2 diabetes mellitus (T2DM). We aimed to investigate the relationship between smoking status and microvascular complications in Korean patients with T2DM.
Materials and Methods:
From the Korean National Diabetes Program cohort, we included 2316 Korean male with T2DM who had baseline clinical information available, including their smoking status, and underwent diabetic complication studies.
Results:
Compared to non-smokers, current smokers had higher odds of any-microvascular complications [adjusted odds ratio (aOR) 1.45, 95% confidence interval (CI) 1.07–1.97, p=0.016]. The odds of neuropathy were significantly higher; however, the odds of retinopathy were significantly lower in current smokers than in nonsmokers (all p<0.05). Among those who underwent repeated complication tests after 3 years, the risk of newly developed retinopathy was significantly increased in ex-smokers [aOR 3.77 (95% CI 1.61–8.87), p=0.002]. Within ex-smokers, long smoking duration and smoking cessation within the recent 5 years were associated with an increased risk of newly developed retinopathy (all p<0.05).
Conclusion
Male smokers had higher odds of having overall diabetic microvascular complications, including neuropathy. However, the odds of having retinopathy were significantly lower among current smokers. More attention and research are needed regarding the increased risk of retinopathy development in ex-smokers who have recently stopped smoking after a long history of smoking.
3.The incidence and risk factors of extrapulmonary manifestations in Mycoplasma pneumoniae pneumonia
Yoo Kyung PARK ; You Na PARK ; Ji Eun MOON ; Hyo-Bin KIM ; Meeyong SHIN ; Eun LEE ; Chul-Hong KIM ; Ju Suk LEE ; Yong Ju LEE ; Bong-Seong KIM ; Hyung Young KIM ; Sungsu JUNG ; Yunsun KIM ; Sangyoung KIM ; Chorong PARK ; Ju-Hee SEO ; Jung Yeon SHIM ; In Suk SOL ; Myongsoon SUNG ; Dae Jin SONG ; Young Min AHN ; Hea Lin OH ; Jinho YU ; Kyung Suk LEE ; Gwang Cheon JANG ; Yoon-Young JANG ; Hai Lee CHUNG ; Eun Hee CHUNG ; Sung-Min CHOI ; Yun Jung CHOI ; Man Yong HAN ; Jin Tack KIM ; Chang-Keun KIM ; Hyeon-Jong YANG
Allergy, Asthma & Respiratory Disease 2022;10(4):207-214
Purpose:
Mycoplasma pneumoniae pneumonia (MP) is a major cause of community-acquired pneumonia (CAP) in children and is associated with extrapulmonary manifestations (EPM). The incidence and risk factors for EPM in children are unknown.
Methods:
This was a retrospective study involving 65,243 pediatric patients with CAP between 2010 and 2015 at 23 nationwide hospitals in South Korea. Medical records were reviewed to collect information regarding the clinical characteristics, radiological results, and laboratory findings. Logistic regression with multivariate analysis was performed to evaluate the risk factors associated with EPM in MP.
Results:
The incidence of EPM was 23.9%, including elevation of liver enzymes (18.1%), mucocutaneous manifestations (4.4%), proteinuria (4.1%), cardiovascular and neurological manifestations (0.4%), hematologic manifestations (0.2%), and arthritis (0.2%). Statistical analysis showed that mucocutaneous manifestations significantly increased with elevated alanine aminotransferase (adjusted odds ratio [aOR], 3.623; 95% confidence interval [CI], 1.933-6.790) and atopic sensitization (aOR, 2.973; 95% CI, 1.615–5.475) and decreased with respiratory virus coinfection (aOR, 0.273; 95% CI, 0.084–0.887). Elevated liver enzymes were significantly associated with elevated lactate dehydrogenase (aOR, 3.055; 95% CI, 2.257–4.137), presence of pleural effusion (aOR, 2.635; 95% CI, 1.767–3.930), and proteinuria with respiratory virus coinfection (aOR, 2.245; 95% CI, 1.113–4.527).
Conclusion
Approximately 24% of pediatric patients with MP had various EPM. As the risk factors associated with each EPM were different, it is necessary to evaluate the various clinical aspects and findings of MP to predict and prepare for the occurrence of EPM.
4.Analgesic effect of structured anal skin care for perianal dermatitis after low anterior resection in the rectal cancer patients: prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial
Gyung Mo SON ; In Young LEE ; Mi Sook YUN ; Jung-Hea YOUN ; Hong Min AN ; Kyung Hee KIM ; Seung Mi YEO ; Bokyung KU ; Myeong Suk KWON ; Kun Hyung KIM
Annals of Surgical Treatment and Research 2022;103(6):360-371
Purpose:
This prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial aimed to assess the alleviation of anal pain by applying structured anal skin care including skin protectants in rectal cancer patients with low anterior resection syndrome (LARS) combined with anal pain.
Methods:
From December 2017 to May 2020, 42 patients with LARS (scores of ≥21) and anal pain (visual analogue scale [VAS] score of ≥3) were randomly assigned and observed for 4 weeks. The conventional treatment consisted of dietary management, sitz baths, prohibition of anal scrubbing, loperamide, and dioctahedral smectite. In the anal care group, cleanser, barrier cream, and barrier spray were applied to the anal skin after defecation following the conventional treatment. The primary outcome was analgesic effect on anal pain after 2 weeks of structured treatment (anal care group) or conventional (control group). The cutoff for analgesic effect was a decrease in the anal pain score (VAS score of ≥2 or ≥30% reduction).
Results:
As a primary outcome, the analgesic effect was significantly higher in the anal care group (P = 0.034). The incontinence-associated dermatitis skin condition score was significantly improved in the anal care group than control group after 4 weeks (P = 0.023). There were no significant differences in LARS scores and quality of life scores between 2 groups.
Conclusion
Structured anal skin care has a significant analgesic effect in reducing anal pain and improving anal skin conditions in patients with LARS after rectal cancer surgery.
5.Seasonal patterns and etiologies of croup in children during the period 2010–2015: A multicenter retrospective study
Yong Ju LEE ; Hyo Bin KIM ; Bong Seong KIM ; Chang Keun KIM ; Cheol Hong KIM ; Hyung Young KIM ; Sangyoung KIM ; Yunsun KIM ; Chorong PARK ; Ju Hee SEO ; In Suk SOL ; Myongsoon SUNG ; Min Seob SONG ; Dae Jin SONG ; Young Min AHN ; Hea Lin OH ; Jinho YU ; Kyung Suk LEE ; Eun LEE ; Ju Suk LEE ; Gwang Cheon JANG ; Yoon Young JANG ; Eun Hee CHUNG ; Hai Lee CHUNG ; Sung Min CHOI ; Yun Jung CHOI ; Man Yong HAN ; Hyeon Jong YANG ; Jung Yeon SHIM ; Jin Tack KIM ;
Allergy, Asthma & Respiratory Disease 2019;7(2):78-85
PURPOSE: Croup is known to have epidemics in seasonal and biennial trends, and to be strongly associated with epidemics of parainfluenza virus. However, seasonal and annual epidemics of croup have not been clearly reported in Korea. This study aimed to examine the seasonal/annual patterns and etiologies of childhood croup in Korea during a consecutive 6-year period. METHODS: Pediatric croup data were collected from 23 centers in Korea from 1 January 2010 to 31 December 2015. Electronic medical records, including multiplex reverse transcription polymerase chain reaction (RT-PCR) results, demographics and clinical information were cross-sectionally reviewed and analyzed. RESULTS: Overall, 2,598 childhood croup patients requiring hospitalization were identified during the study period. Among them, a total of 927 who underwent RT-PCR were included in the analysis. Males (61.5%) predominated, and most (63.0%) of them were younger than 2 years of age (median, 19 months; interquartile range, 11–31 months). Peak hospitalization occurred in 2010 and 2012 in even-numbered years, and parainfluenza virus (PIV, 39.7%) was the most common cause of childhood croup requiring hospitalization, followed by respiratory syncytial virus (14.9%), human rhinovirus (12.5%), Mycoplasma pneumonaie (10.6%), and human coronavirus (7.3%). CONCLUSION: It is concluded that croup hospitalization has a biennial pattern in even-numbered years. PIV may be the most common cause of childhood croup; however, croup epidemics could be attributed to other viruses.
Child
;
Coronavirus
;
Croup
;
Demography
;
Electronic Health Records
;
Hospitalization
;
Humans
;
Korea
;
Male
;
Mycoplasma
;
Paramyxoviridae Infections
;
Polymerase Chain Reaction
;
Respiratory Syncytial Viruses
;
Retrospective Studies
;
Reverse Transcription
;
Rhinovirus
;
Seasons
6.The factors associated with Vitamin D deficiency in community dwelling elderly in Korea.
Sun Hea KIM ; Jung Eun OH ; Dong Won SONG ; Choo Yon CHO ; Sung Ho HONG ; Yong Jin CHO ; Byung Wook YOO ; Kyung Suk SHIN ; Hyun JOE ; Hwang Sik SHIN ; Doo Yong SON
Nutrition Research and Practice 2018;12(5):387-395
BACKGROUND/OBJECTIVES: Recent studies showed vitamin D deficiency is linked to chronic diseases in addition to skeletal metabolism which could threaten the elderly. We analyzed health conditions and socio-demographic factors associated with vitamin D deficiency in community dwelling people aged 65 years and older. SUBJECTS/METHOD: Data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2010 to 2012 were obtained. A total of 2,687 subjects aged 65 years and older were participated. The cutoff value of the Vitamin D deficiency was considered as serum 25-hydroxyvitamin D [25(OH)D] ≤ 20 ng/mL (50 nmol/L). RESULTS: The overall prevalence rate of vitamin D deficiency in the elderly was 62.1%. The factors such as female, obesity, metabolic syndrome, current smoker, and skipping breakfast were positively associated with vitamin D deficiency, but high intensity of physical activity and more than 9 hours of sleep duration were negatively associated with vitamin D deficiency (all P < 0.05). CONCLUSIONS: It is important that health professions know that the factors proved in this study are connected to vitamin D deficiency thus provide information and intervention strategies of vitamin D deficiency to old aged people.
Aged*
;
Aging
;
Breakfast
;
Chronic Disease
;
Female
;
Health Occupations
;
Humans
;
Independent Living*
;
Korea*
;
Metabolism
;
Motor Activity
;
Nutrition Surveys
;
Obesity
;
Prevalence
;
Risk Factors
;
Vitamin D Deficiency*
;
Vitamin D*
;
Vitamins*
7.Analysis of risk factor and clinical characteristics of angiodysplasia presenting as upper gastrointestinal bleeding.
Dae Bum KIM ; Woo Chul CHUNG ; Seok Jong LEE ; Hea Jung SUNG ; Seokyung WOO ; Hyo Suk KIM ; Yeon Oh JEONG ; Hyewon LEE ; Yeon Ji KIM
The Korean Journal of Internal Medicine 2016;31(4):669-677
BACKGROUND/AIMS: Angiodysplasia is important in the differential diagnosis of upper gastrointestinal bleeding (UGIB), but the clinical features and outcomes associated with UGIB from angiodysplasia have not been characterized. We aimed to analyze the clinical characteristics and outcomes of angiodysplasia presented as UGIB. METHODS: Between January 2004 and December 2013, a consecutive series of patients admitted with UGIB were retrospectively analyzed. Thirty-five patients with bleeding from angiodysplasia were enrolled. We compared them with an asymptomatic control group (incidental finding of angiodysplasia in health screening, n = 58) and bleeding control group (simultaneous finding of angiodysplasia and peptic ulcer bleeding, n = 28). RESULTS: When patients with UGIB from angiodysplasia were compared with the asymptomatic control group, more frequent rates of nonantral location and large sized lesion (≥ 1 cm) were evident in multivariate analysis. When these patients were compared with the bleeding control group, they were older (mean age: 67.94 ± 9.16 years vs.55.07 ± 13.29 years, p = 0.03) and received less transfusions (p = 0.03). They also had more frequent rate of recurrence (40.0% vs. 20.7%, p = 0.02). CONCLUSIONS: Non-antral location and large lesions (≥ 1 cm) could be risk factors of UGIB of angiodysplasia. UGIB due to angiodysplasia was more common in older patients. Transfusion requirement would be less and a tendency of clinical recurrence might be apparent.
Angiodysplasia*
;
Diagnosis, Differential
;
Endoscopy
;
Hemorrhage*
;
Humans
;
Mass Screening
;
Multivariate Analysis
;
Peptic Ulcer
;
Recurrence
;
Retrospective Studies
;
Risk Factors*
8.Effects of the Combination Herbal Extract on Working Memory and White Matter Integrity in Healthy Individuals with Subjective Memory Complaints : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Oran KWON ; Sunho LEE ; Soonhyun BAN ; Jooyeon J IM ; Doo Suk LEE ; Eun Hee LEE ; Joohee KIM ; Soo Mee LIM ; Sang Gon LEE ; Ilhyang KANG ; Kyung Hee KIM ; Sujung YOON ; Sun Hea LEE
Journal of the Korean Society of Biological Psychiatry 2015;22(2):63-77
OBJECTIVES: The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. METHODS: Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. RESULTS: The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. CONCLUSIONS: Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.
Animals
;
Anisotropy
;
Diffusion Tensor Imaging
;
Gastrodia
;
Humans
;
Memory*
;
Memory, Short-Term*
;
Mice
;
Salvia miltiorrhiza
9.Clinical Characteristics of Asthma Combined with COPD Feature.
Hea Yon LEE ; Ji Young KANG ; Hyoung Kyu YOON ; Sook Young LEE ; Soon Suk KWON ; Young Kyoon KIM ; Chin Kook RHEE
Yonsei Medical Journal 2014;55(4):980-986
PURPOSE: In clinical practice, some patients with asthma show incompletely reversible airflow obstruction, resembling chronic obstructive pulmonary disease (COPD). The aim of this study was to analyze this overlap phenotype of asthma with COPD feature. MATERIALS AND METHODS: A total of 256 patients, over the age of 40 years or more with a diagnosis of asthma, based on either 1) positive response to bronchodilator: >200 mL forced expiratory volume in 1 s (FEV1) and >12% baseline or 2) positive methacholine or mannitol provocation test, were enrolled. Among the asthma patients, we defined the overlap group with incompletely reversible airflow obstruction [postbronchodilator FEV1/forced vital capacity (FVC) <70] at the initial time of admission and continuing airflow obstruction after at least 3 months follow up. We evaluated clinical features, serum eosinophil counts, serum total immunoglobulin (Ig) E with allergy skin prick test, spirometry, methacholine or mannitol provocation challenges and bronchodilator responses, based on their retrospective medical record data. All of the tests mentioned above were performed within one week. RESULTS: The study population was divided into two groups: asthma only (62%, n=159, postbronchodilator FEV1/FVC > or =70) and overlap group (38%, n=97, postbronchodilator FEV1/FVC <70). The overlap group was older, and contained more males and a higher percentage of current or ex-smokers than the asthma only group. Significantly lower FEV1 and higher total lung capacity, functional residual capacity, and residual volume were observed in the overlap group. Finally, significantly lower serum eosinophil count and higher IgE were seen in the overlap group. CONCLUSION: Our results showed that the overlap phenotype was older, male asthmatic patients who have a higher lifetime smoking intensity, more atopy and generally worse lung function.
Adult
;
Age Factors
;
Aged
;
Asthma/epidemiology/*physiopathology
;
Female
;
Forced Expiratory Volume/physiology
;
Humans
;
Male
;
Middle Aged
;
Pulmonary Disease, Chronic Obstructive/epidemiology/*physiopathology
;
Retrospective Studies
;
Sex Factors
10.The Related Factors Influencing on Self-rated Health Level of Middle-aged Women.
Hyejin LEE ; Kyung Hea LEE ; Eunkyung KIM ; Mi Jung KIM ; Suk Man HWANG
Korean Journal of Community Nutrition 2012;17(3):290-301
This survey of 836 midlife women (51.0 +/- 4.0 yrs) was undertaken by exclusively a face to face interview by well-trained interviewers guarantying data collection of higher quality. This survey data was analyzed using the SPSS program. The main purpose of this study was to describe the factors affecting self-rated health status, including dietary habits and physical . mental . social factors. In the self-rated health status of a 'good' group, age was lower (p < 0.05), monthly income was higher (p < 0.01), dietary habits score (p < 0.001) and appetite (p < 0.001) and the degree of movement (p < 0.001) and life satisfaction (p < 0.001), marital intimacy (p < 0.001) and relationship satisfaction with their children (p < 0.001) were significantly higher than the 'bad' group. The level of depression (p < 0.001) and severe feeling of menopausal symptoms (p < 0.001) were significantly higher in the 'poor' group. The results of correlation analysis demonstrated that educational level (r = 0.069, p < 0.05),income (r = 0.157, p < 0.001), eating habits (r = 0.235, p < 0.001), appetite (r = 0.263, p < 0.001), life satisfaction (r = 0.197, p < 0.001), marital intimacy (r = 0.167, p < 0.001), child relationship satisfaction (r = 0.149, p < 0.001), positive attitude toward menopause (r = 0.070, p < 0.05) showed a positive correlation, but depression (r = -0.122, p < 0.001) and menopausal symptoms (r = -0.292, p < 0.001) showed a negative association with self-rated health status. The predictable factors affecting the self-rated health status of middle-aged women were examined by multiple regression analysis. The 'menopausal symptoms - physical discomfort' was the most important variables followed by the 'appetite', 'eating habits', 'menopause symptoms - sensory problems', 'BMI', 'positive attitude toward menopause' and 'high marital intimacy'. These results showed that the 'appetite' and 'eating habits' are important factors affecting the self-rated health status. Therefore, a program of dietary education must be considered for the effective health education and counseling of middle-aged women.
Appetite
;
Child
;
Counseling
;
Surveys and Questionnaires
;
Depression
;
Eating
;
Female
;
Food Habits
;
Health Education
;
Health Status
;
Humans
;
Menopause
;
Women's Health

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