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.Comparison of Fentanyl versus Meperidine in Combination with Midazolam for Sedative Colonoscopy in Korea
Gwan Woo HONG ; Jun Kyu LEE ; Jung Hyeon LEE ; Ji Hun BONG ; Sung Hun CHOI ; Hyeki CHO ; Ji Hyung NAM ; Dong Kee JANG ; Hyoun Woo KANG ; Jae Hak KIM ; Yun Jeong LIM ; Moon Soo KOH ; Jin Ho LEE
Clinical Endoscopy 2020;53(5):562-567
Background/Aims:
Combination of midazolam and opioids is used widely for endoscopic sedation. Compared with meperidine, fentanyl is reportedly associated with rapid recovery, turnover rate of endoscopy room, and quality of endoscopy. We compared fentanyl with meperidine when combined with midazolam for sedative colonoscopy.
Methods:
A retrospective, cross-sectional, 1:2 matching study was conducted. Induction and recovery time were compared as the primary outcomes. Moreover, cecal intubation time, withdrawal time, total procedure time of colonoscopy, paradoxical reaction, adenoma detection rate, and adverse effect of midazolam or opioids were assessed as the secondary outcomes.
Results:
A total of 129 subjects (43 fentanyl vs. 86 meperidine) were included in the analysis. The fentanyl group showed significantly more rapid induction time (4.5±2.7 min vs. 7.5±4.7 min, p<0.001), but longer recovery time (59.5±25.6 min vs. 50.3±10.9 min, p=0.030) than the meperidine group. In multivariate analysis, the induction time of the fentanyl group was 3.40 min faster (p<0.001), but the recovery time was 6.38 min longer (p=0.046) than that of the meperidine group. There was no difference in withdrawal time and adenoma detection rate between the two groups.
Conclusions
The fentanyl group had more rapid sedation induction time but longer recovery time than the meperidine group.
3.Vegetarianism as a protective factor for asymptomatic colonic diverticulosis in Asians: a retrospective cross-sectional and case-control study
Jihun BONG ; Hyoun Woo KANG ; Hyeki CHO ; Ji Hyung NAM ; Dong Kee JANG ; Jae Hak KIM ; Jun Kyu LEE ; Yun Jeong LIM ; Moon-Soo KOH ; Jin Ho LEE
Intestinal Research 2020;18(1):121-129
Background/Aims:
Dietary fiber intake is considered a protective factor for diverticular disease such as diverticulitis. However, evidence for an inverse connection between dietary fiber consumption and asymptomatic colonic diverticulosis is lacking. Specifically, few studies have investigated this subject in Asians with different presentations of diverticulosis. Therefore, we assessed the protective effects of a vegetarian diet for asymptomatic colonic diverticulosis in Buddhist monks who are obligatory vegetarians for spiritual reasons compared with the general population.
Methods:
A retrospective, cross-sectional, case-control study was conducted in age- and sex-matched Buddhist monks and the general population who underwent colonoscopy for screening at a Korean health promotion center from August 2005 to June 2018. We compared the prevalence of asymptomatic diverticulosis between the 2 groups using a self-administered questionnaire.
Results:
In this study, a total of 1,316 individuals were included (Buddhist monks of 658 and general population of 658) with a mean age of 52.6±9.5 years. The prevalence of asymptomatic diverticulosis in Buddhist monks was lower compared with the general population (6.7% [44/658] vs. 10.8% [71/658], P=0.008). Buddhist monks had a higher rate of high body mass index (BMI) and metabolic syndrome. By a multivariate regression analysis model, a nonvegetarian diet (odds ratio [OR], 1.82; 95% confidence interval [CI], 1.21–2.72, P=0.004), old age (OR, 4.53; 95% CI, 1.36–15.12; P=0.014), male sex (OR, 1.91; 95% CI, 1.28–2.85; P=0.002), and a high BMI (OR, 1.50; 95% CI, 1.01–2.23; P=0.047) were independent predictors of asymptomatic diverticulosis. Moreover, a nonvegetarian diet was associated with both right-sided and left-sided diverticulosis.
Conclusions
A nonvegetarian diet may increase a risk of asymptomatic colonic diverticulosis in Asians.
4.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resolute™ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES: Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD. METHODS: From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months. RESULTS: Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE. CONCLUSIONS: Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
Coronary Artery Disease
;
Coronary Vessels
;
Death
;
Drug-Eluting Stents
;
Follow-Up Studies
;
Heart Failure
;
Humans
;
Hypertension
;
Incidence
;
Korea
;
Male
;
Myocardial Infarction
;
Percutaneous Coronary Intervention
;
Prospective Studies
;
Stents
;
Thrombosis
;
Treatment Outcome
5.The Effect of Daily Low Dose Tadalafil on Cerebral Perfusion and Cognition in Patients with Erectile Dysfunction and Mild Cognitive Impairment
Jin Bong CHOI ; Kang Jun CHO ; Joon Chul KIM ; Chung Ho KIM ; Yong An CHUNG ; Hyeonseok S JEONG ; Yong Soo SHIM ; Jun Sung KOH
Clinical Psychopharmacology and Neuroscience 2019;17(3):432-437
OBJECTIVE: The aims of this study were to investigate the effects of daily low-dose tadalafil on cognitive function and to examine whether there was a change in cerebral blood flow (CBF) in patients with erectile dysfunction (ED) and mild cognitive impairment. METHODS: Male patients aged 50 to 75 years with at least three months of ED (International Index of Erectile Function [IIEF]-5 score ≤ 21) and mild cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≤ 22) were included in the study. The subjects were prescribed a low-dose PDE5 inhibitor (tadalafil 5 mg) to be taken once daily for eight weeks. Changes in MoCA score and single-photon emission computed tomography (SPECT) study between the two time-points were assessed by paired t tests. RESULTS: Overall, 30 male patients were assigned to the treatment group in this study and 25 patients completed the eight-week treatment course. Five patients were withdrawn due to adverse events such as myalgia and dizziness. Mean baseline IIEF and MoCA scores were 7.52 ± 4.84 and 18.92 ± 1.78. After the eight-week treatment, mean IIEF and MoCA scores were increased to 12.92 ± 7.27 (p < 0.05) and 21.8 ± 1.71 (p < 0.05), respectively. Patients showed increased relative regional CBF in the postcentral gyrus, precuneus, and brainstem after tadalafil administration versus at baseline (p < 0.001). CONCLUSION: The results of this prospective clinical study suggest that daily use of tadalafil 5 mg increases some regional CBF and improves cognitive function in patients with ED and mild cognitive impairment.
Brain Stem
;
Cerebrovascular Circulation
;
Clinical Study
;
Cognition
;
Dizziness
;
Erectile Dysfunction
;
Humans
;
Male
;
Methylenebis(chloroaniline)
;
Mild Cognitive Impairment
;
Myalgia
;
Parietal Lobe
;
Perfusion
;
Phosphodiesterase Inhibitors
;
Prospective Studies
;
Somatosensory Cortex
;
Tadalafil
;
Tomography, Emission-Computed
6.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resoluteâ„¢ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES:
Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resoluteâ„¢ zotarolimus-eluting stent (R-ZES; Resoluteâ„¢ Integrity) for patients with DLCAD.
METHODS:
From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months.
RESULTS:
Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE.
CONCLUSIONS
Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
7.Clinical Applicability of Newly Developed Image-based Cell Counter for Counting CD34+ Cells: Comparison with Flow Cytometric Analysis
Wee Jin RAH ; Eun Kyung SHIN ; Hani KOH ; Jin Young SUH ; Misoo CHANG ; Eunwoo NAM ; Jong Hyun OH ; Yumi JUNG ; Ji Yeon LEE ; Sung Rok BONG ; Sung Hun HONG ; Jee Young KIM ; Sunmi HAN ; Jeoung Ku HWANG ; Chanil CHUNG ; Young Ho LEE
Clinical Pediatric Hematology-Oncology 2016;23(2):125-132
BACKGROUND: Flow cytometric analysis is the standard method for enumerating CD34+ stem cells in hematopoietic stem cell transplantation. However, it has some limitations such as expensive instrumentation, high reagent costs, and discrepancies between technicians and laboratories. We compared counts of total nucleated cells (TNCs) and CD34+ cells counts obtained from a flow cytometer with a newly-developed image-based microscopic cell counter (ADAM II) to evaluate the possibility of clinical application of the ADAM II.METHODS: We used 18 samples of circulating peripheral blood (PB) and waste tube fractions of peripheral blood stem cells (PBSCs) harvested by apheresis after G-CSF mobilization from adult volunteer donors. We assessed the reproducibility and linearity of the new procedure and compared the numbers of TNCs and viable CD34+ cells determined with the ADAM II and two different flow cytometers (FACSCalibur, FACSCanto II).RESULTS: Numbers of viable CD34+ cells determined with the ADAM II were accurate over the expected range; the intra-assay coefficient of variation was ≤19.8%. Linearity was also satisfactory (R²=0.99). TNC counts obtained with the ADAM II were highly correlated with those obtained with the FACSCalibur (R²>0.9841, P<0.0001) and FACSCanto II (R²>0.9620, P<0.0001), as were the numbers of viable CD34+ cells obtained with the ADAM II and the FACSCalibur and FACSCanto II (R²>0.9911, P<0.0001 and R²>0.9791, P<0.0001), respectively.CONCLUSION: The newly developed image-based microscopic cell counter (ADAM II) appears to be suitable for enumerating TNCs and viable CD34+ cells.
Adult
;
Blood Component Removal
;
Cell Count
;
Granulocyte Colony-Stimulating Factor
;
Hematopoietic Stem Cell Transplantation
;
Humans
;
Methods
;
Stem Cells
;
Tissue Donors
;
Volunteers
8.Phenotype and endotype in pediatric asthma.
Hyeon Jong YANG ; Bong Seong KIM ; Woo Kyung KIM ; Jakyoung KIM ; Jin Tack KIM ; Dong In SUH ; Young Yull KOH ; Youn Ho SHIN ; So Yeon LEE ; Dae Hyun LIM ; Ji Tae CHOUNG ; Hyo Bin KIM
Allergy, Asthma & Respiratory Disease 2014;2(2):85-90
Asthma is not a homogeneous disease presenting variable clinical features, but a complex disorder consisting of many different disease entities characterized by variable air-flow limitation. To date, there are little effective preventive-strategies for the development of asthma, and it has been emphasized that early identification and intervention are the best ways to reduce the associated morbidities, quality of life, and socioeconomic burden. Predicting the natural course of asthma is still difficult, although various phenotypic approaches and predictive scores are developed and widely used. The present phenotypes and predictive scores may be reliable in the population, but those appear to be unreliable in each individual in real practice. Either undertreatment or overtreatment in childhood asthma is an important issue, because they are associated with poor compliance, increments of socioeconomic burdens, and poor quality of life. There is no doubt about the clinical efficacy of inhaled corticosteroid (ICS) in childhood asthma, but the negative effect of long-term use of ICS on the height is emerging. Therefore general physicians should consider an individualized management using specific phenotypes and endotypes, and regularly re-evaluate the drug-response, level of control, and adherence/compliance to avoid inadequate treatment.
Asthma*
;
Child
;
Compliance
;
Humans
;
Phenotype*
;
Quality of Life
9.The Relationship between Hospital Departments and Risk of Developing Tuberculosis among Nurses Working at a University Hospitalin Korea: Retrospective Cohort Study.
Jin Ha YOON ; Sung Soo OH ; Ki Hyun LEE ; Sung Kyung KIM ; Je Ho OH ; Chung Se WON ; Sei Jin CHANG ; Bong Suk CHA ; Ae Yong EOM ; Sang Baek KOH
Korean Journal of Occupational and Environmental Medicine 2011;23(1):64-70
OBJECTIVES: To investigate the occurring characteristics of pulmonary tuberculosis (TB) among nurses working at a university hospital in Korea. METHODS: A retrospective cohort study was conducted using medical records from a university hospital. A total of 351 nurses without any pulmonary disease were enrolled during 2000~2007, and were followed up until October 2010. To compare with the incidence of TB between occupational subgroups, workplaces were divided into high and low TB-exposure risk departments. For statistical analysis, the relative risks for TB incidences between departments were estimated using Cox proportional hazards models and mean incidences were estimated with person-time years. RESULTS: Seven cases of TB were observed during 2001 person-years. Five and two cases were observed in the high and low TB-exposure risk departments, respectively. The relative risk of TB infection in the high TB-exposure risk departments were 6.52 (95% CI, 1.26~33.60) compared to that in the low TB-exposure risk department. The mean incidence of TB in the total nurses was 0.350% per person-year. CONCLUSIONS: According to the concept of occupational and environmental medicine, high TB-exposure risk departments were more likely to be at increased risk of tuberculosis.
Cohort Studies
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Environmental Medicine
;
Hospital Departments
;
Incidence
;
Lung Diseases
;
Medical Records
;
Proportional Hazards Models
;
Retrospective Studies
;
Tuberculosis
;
Tuberculosis, Pulmonary
10.Suicide Trend of Standardized Mortality Ratio and Age Standardized Proportion Mortality Ratio According to Occupational Groups in Korea: 1993-2007.
Jin Ha YOON ; Ki Hyun LEE ; Kyu Yeon HAHN ; Sei Jin CHANG ; Bong Suk CHA ; Seong Ho MIN ; Kyung Suk LEE ; Hye Seon CHAE ; Aeyong EOM ; Sang Baek KOH
Korean Journal of Occupational and Environmental Medicine 2011;23(2):173-182
OBJECTIVES: A number of studies on the trends of socioeconomic differences in suicide mortality have indicated that these inequality gaps have widened over time and highlight that certain occupations have more suicide risk than others. However suicide rates according to occupation based socioeconomic position have not been frequently studied in Korea. The purpose of this study is to report trends and inequality of suicide according to occupation based social class during 1993-2007 in Korea and to identify occupations with significantly high standardized mortality ratios (SMRs) and proportional mortality ratios (PMRs) for both men and women. METHODS: Korean census records for the years 1995, 2000, and 2005 were linked with the cause of death records from Korean National Statistical Office (KNSO) for the periods 1993-1997, 1998-2003, and 2004-2007 respectively. This data was used to calculate age adjusted proportional mortality ratios (PMRs) and standardized mortality ratios (SMRs) for both men and women aged 25~54 years according to five occupation based socioeconomic positions. RESULTS: Among men, the agricultural-fishery-forestry group had the greatest suicide rate (SMR: 341) with a high PMR (113) and the manual labor group showed the highest PMR (118), while the managers-professional occupation group showed the lowest sPMR (78) and SMR (21). Among women, the agricultural-fishery group had the highest score in SMR (316) and PMR (130), and the technical-artificer group showed the lowest sPMR (71) and SMR (27). The inequality gaps in the suicide mortality rate according to occupation had widened during 1998-2002, but showed a recovery trend plot after 2003. CONCLUSIONS: Although the occupation based socioeconomic inequalities show a recovery trend after 2003, the excess inequality from suicide remains as high as it was prior to the 2002 year in some occupational groups. The results of the current study indicate that the manual and agricultural-fishery-forestry groups were high risk groups of suicide.
Aged
;
Cause of Death
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Censuses
;
Female
;
Humans
;
Korea
;
Male
;
Occupational Groups
;
Occupations
;
Social Class
;
Socioeconomic Factors
;
Suicide

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