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.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
5.Current Management of Type 2 Diabetes Mellitus in Primary Care Clinics in Korea
Da Hea SEO ; Shinae KANG ; Yong ho LEE ; Jung Yoon HA ; Jong Suk PARK ; Byoung Wan LEE ; Eun Seok KANG ; Chul Woo AHN ; Bong Soo CHA
Endocrinology and Metabolism 2019;34(3):282-290
BACKGROUND: This study investigated the overall status of diabetes control and screening for diabetic microvascular complications in patients with type 2 diabetes mellitus attending primary care clinics in Korea. METHODS: In this cross-sectional observational study, 191 primary care clinics were randomly selected across Korea from 2015 to 2016. In total, 3,227 subjects were enrolled in the study. RESULTS: The patients followed at the primary care clinics were relatively young, with a mean age of 61.4±11.7 years, and had a relatively short duration of diabetes (mean duration, 7.6±6.5 years). Approximately 14% of subjects had diabetic microvascular complications. However, the patients treated at the primary care clinics had suboptimal control of hemoglobin A1c levels, blood pressure, and serum lipid levels, along with a metabolic target achievement rate of 5.9% according to the Korean Diabetes Association guidelines. The screening rates for diabetic nephropathy, retinopathy, and neuropathy within the past 12 months were 28.4%, 23.3%, and 13.3%, respectively. CONCLUSION: The overall status of diabetes management, including the frequency of screening for microvascular complications, was suboptimal in the primary care clinics. More efforts should be made and more resources need to be allocated for primary care physicians to promote adequate healthcare delivery, which would result in stricter diabetes control and improved management of diabetic complications.
Blood Pressure
;
Delivery of Health Care
;
Diabetes Complications
;
Diabetes Mellitus, Type 2
;
Diabetic Nephropathies
;
Humans
;
Korea
;
Mass Screening
;
Observational Study
;
Physicians, Primary Care
;
Primary Health Care
;
Tertiary Care Centers
6.Effect of College Students' Perceived Stress, Cognitive Response to Stress, and Somatization on Heart Rate Variability
Journal of Korean Biological Nursing Science 2019;21(3):178-187
PURPOSE: The purpose of this study was to investigate how college students' perceived stress, cognitive stress, and somatization affect their heart rate variability (HRV). METHODS: This study is a cross-sectional survey research on 191 university students, registered at the G University. The perceived stress scale (PSS) and cognitive stress response scale, were used to assess level of stress. The somatization symptom scale of the Symptom Check List 90 (SCL-90), was used to assess level of somatization caused by stress. To assess heart rate variability (HRV), we conducted a five-minute test using a pulse wave analyzer, to analyze short-term HRV. RESULTS: The SCL-90 somatization score had relatively high positive correlation (p<.001) with cognitive stress, but low positive correlation (p<.001) with perceived stress. Cognitive stress response had low negative correlation (p<.001) with 1nSDNN and 1nRMSSD among HRV parameters. Perceived stress was not correlated with HRV. Multiple regression analysis showed that variables of perceived stress, cognitive stress, and somatization symptoms, could not explain HRV. By contrast, one of the HRV indicators, 1nSDNN, was affected by age, gender, and aggressive-hostile thought, the latter being a subscale of the cognitive stress response scale. CONCLUSION: This study suggests that stress evaluation for people in early adulthood will be more effective, if the evaluation examines cognitive stress and heart rate variability.
Cross-Sectional Studies
;
Heart Rate
;
Heart
;
Humans
;
Mental Fatigue
;
Somatoform Disorders
7.Recurrent Acute Pericarditis Induced by 5-aminosalicylates in a Patient with Inflammatory Bowel Disease.
A Ra CHOI ; Mi Na KIM ; Ji Hoon LEE ; Yong Kang LEE ; Yoon Hea PARK ; Hye Sun SHIN ; Tak Geun OH ; Hee Jin PARK ; Min Suk PARK ; Seungtaek LIM ; Soo Jung PARK ; Sung Pil HONG ; Tae Il KIM ; Won Ho KIM ; Jae Hee CHEON
Intestinal Research 2012;10(3):289-294
Inflammatory bowel disease (IBD) is an idiopathic chronic inflammation of the intestines. IBD treatment may require anti-inflammatory agents such as sulfasalazine or 5-aminosalicylate (5-ASA) and immunomodulators to control the symptoms. However, these agents have a variety of common adverse effects such as nausea, vomiting, skin rash, leukopenia, thrombocytopenia, and infections. Moreover, rare side effects such as nephrotic syndrome, pneumonitis, and pericarditis can occur. A 21-year-old male was admitted to the hospital due to acute chest pain, fever, and sweating. The patient had a history of Crohn's disease and had been taking mesalazine for 3 weeks. Chest x-ray, echocardiography, and clinical manifestations revealed that the patient had acute pericarditis. However, we did not recognize the relationship between these findings and 5-ASA at that time. Two years later, the patient took 5-ASA again, and similar symptoms occurred, which led us to confirm that he suffered from pericarditis induced by this drug. We report a case of acute recurrent pericarditis that developed after taking 5-ASA for IBD treatment with a review of the literature.
Anti-Inflammatory Agents
;
Chest Pain
;
Colitis, Ulcerative
;
Crohn Disease
;
Echocardiography
;
Exanthema
;
Fever
;
Humans
;
Immunologic Factors
;
Inflammation
;
Inflammatory Bowel Diseases
;
Intestines
;
Leukopenia
;
Male
;
Mesalamine
;
Nausea
;
Nephrotic Syndrome
;
Pericarditis
;
Pneumonia
;
Sulfasalazine
;
Sweat
;
Sweating
;
Thorax
;
Thrombocytopenia
;
Vomiting
;
Young Adult
8.Annual Report on External Quality Assessment in Immunoassay in Korea (2009).
Hyon Suk KIM ; Young Lan KIM ; Jungyong PARK ; Oh Hun KWON ; Deog An KIM ; Jin Q KIM ; Young Kyu SUN ; Seob SHIN ; Hwan Sub LIM ; Hea Sun CHUN ; Young Soon JUNG
Journal of Laboratory Medicine and Quality Assurance 2010;32(1):103-114
Two trials with 15 test items of external quality assessment survey were performed in 2009. The test items were constituted three immunoassay categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items commonly used in clinical laboratories and performed by immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 494 institutions in the first trial survey and 519 institutions in the second survey. All of the fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used for the two trials in 2009 survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 494 and 519 laboratories and the response rate were 97.6% and 98.3% in 2009. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Stability tests of home-made control materials were performed and confirmed the CV values were in acceptable ranges. 4. Workshops titled "National health examination for tumors" and "Standardization and harmonization of laboratory tests" were held on September 4, 2009 and December 16, 2009 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control, and Immunoserology Subcommittee, respectively. The quality of the participating laboratories seems to be continuously improved. And, this year, new sixty eight laboratories were participated to our Immunoassay Subcommittee.
Congresses as Topic
;
Immunoassay
;
Immunoglobulin A
;
Immunoglobulin M
;
Immunoproteins
;
Korea
;
Quality Control
;
Thyroid Hormones
;
Biomarkers, Tumor
9.Cytogenetic Analysis of Amniotic Fluid, CVS, and Abortus in a University Hospital for Ten Years.
Sook Hyang CHOI ; Jeong Yeal AHN ; Kyung Hee KIM ; Hye Ryun YANG ; Yang Hee LEE ; Myoung Suk YOO ; Han Ik SUH ; Pil Whan PARK ; Yiel Hea SEO
Journal of Laboratory Medicine and Quality Assurance 2009;31(2):293-299
BACKGROUND: This study was conducted to analyze, compare, and assess the indications, incidences, and types of chromosomal abnormalities in the amniotic fluid, chorionic villus sampling (CVS), and abortus and to compare these with those previously reported. METHODS: The study subjects included 1,995 cases of amniocentesis and 169 cases of abortus, 20 cases of CVS, 21 cases of cord blood, and 2 cases of cardiac-puncture fluid in the last ten years (June 1999 to May 2009). RESULTS: Among the indications, the maternal serum and triple/quad markers testing positive emerged the highest (57.5%). Other factors those were found were an advanced maternal age (over35) (19.5%) and abnormal ultrasonography findings (8.2%). The frequency of chromosomal abnormality in the amniotic fluid was 4.5%, wherein the numerical abnormality was 3.1% and the structural abnormality was 1.4%. Among the numerical abnormalities, trisomy of chromosome 21 emerged the highest (1.4%). The frequency of the chromosomal abnormality of CVS and abortus was 39.1%, the numerical abnormality was 23.7%, and the order of frequency for trisomy was obtained chromosomes 16, 22, and 21. In the sex ratio of the normal chromosomes, it was 1.1%, but it resulted in 0.5% in CVS. CONCLUSIONS: The results of this chromosomal study on amniotic fluid, CVS, and abortus could serve as useful data regarding the prenatal genetic abnormalities of fetuses and for genetic consultation.
Amniocentesis
;
Amniotic Fluid
;
Chorionic Villi Sampling
;
Chromosome Aberrations
;
Chromosomes, Human, Pair 21
;
Cytogenetic Analysis
;
Cytogenetics
;
Female
;
Fetal Blood
;
Fetus
;
Incidence
;
Maternal Age
;
Pregnancy
;
Sex Ratio
;
Trisomy
10.Ultrasound-guided local injection of potassium chloride (KCl) and methotrexate (MTX) in the treatment of cornual pregnancy.
Hea Ree PARK ; Myoung Jin MOON ; Seung Joo SHIN ; Sung Woon JANG ; Eun Hee AHN ; Sang Hee JUNG ; Sung Shin SHIM ; Suk Ho KANG ; Hyun Chul KIM ; Youn Yeung HWANG ; Min Jung BAEK
Korean Journal of Obstetrics and Gynecology 2009;52(1):68-74
OBJECTIVE: To evaluate efficacy and safety of local injection of potassium chloride (KCl) and methotrexate (MTX) in the treatment of cornual pregnancy. METHODS: We retrospectively reviewed all cases of cornual pregnancy treated conservatively from 2005 through August 2007. Eight cases were identified and two cases were heterotopic interstitial pregnancy. All cases were managed with local injection of KCl or methotrexate under ultrasound guidance and 2 cases were treated with intra-muscular injection of MTX in combination. After the procedure all cases with cardiac activity was confirmed to be aborted by ultrasound. Also serial follow-up sonographic examination and serum beta-hCG measurement were performed. RESULTS: The mean initial beta-hCG level was 53,331.6 mIU/mL and ranged from 14,332 mIU/mL to 125,721 mIU/mL. Mean gestational age was 48.3 days from 40 to 65 days. All cases were aborted successfully and follow up beta-hCG were declined abruptly. Two cases of heterotopic pregnancy resulted in successful deliveries at full term. CONCLUSION: Cornual resection or hysterectomy should no longer be the first line of treatment for hemodynamically stable patients with cornual pregnancy. They can be successfully treated through local injection of MTX or KCl by ultrasound guidance.
Follow-Up Studies
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Gestational Age
;
Humans
;
Hysterectomy
;
Methotrexate
;
Potassium
;
Potassium Chloride
;
Pregnancy
;
Pregnancy, Heterotopic
;
Retrospective Studies

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