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.Machine Learning-Based Predictor for Treatment Outcomes of Patients With Salivary Gland Cancer After Operation
Min Cheol JEONG ; Yoon Woo KOH ; Eun Chang CHOI ; Jae-Yol LIM ; Se-Heon KIM ; Young Min PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2022;65(6):334-342
Background and Objectives:
The purpose of this study was to analyze the survival data of salivary gland cancer (SGCs) patients to construct machine learning and deep learning models that can predict survival and use them to stratify SGC patients according to risk estimate.Subjects and Method We retrospectively analyzed the clinicopathologic data from 460 patients with SGCs from 2006 to 2018.
Results:
In Cox proportional hazard (CPH) model, pM, stage, lymphovascular invasion, lymph node ratio, and age exhibited significant correlation with patient’s survival. In the CPH model, the c-index value for the training set was 0.85, and that for the test set was 0.81. In the Random Survival Forest model, the c-index value for the training set was 0.86, and that for the test set was 0.82. Stage and age exhibited high importance in both the Random Survival Forest and CPH models. In the deep learning-based model, the c-index value was 0.72 for the training set and 0.72 for the test set. Among the three models mentioned above, the Random Survival Forest model exhibited the highest performance in predicting the survival of SGC patients.
Conclusion
A survival prediction model using machine learning techniques showed acceptable performance in predicting the survival of SGC patients. Although large-scale clinical and multicenter studies should be conducted to establish more powerful predictive model, we expect that individualized treatment can be realized according to risk stratification made by the machine learning model.
3.Phenotypes of Severe Cutaneous Adverse Reactions Caused by Nonsteroidal Anti-inflammatory Drugs
Suh Young LEE ; Young Hee NAM ; Young Il KOH ; Sae Hoon KIM ; Sujeong KIM ; Hye Ryun KANG ; Min Hye KIM ; Jun Gyu LEE ; Jung Won PARK ; Hye Kyung PARK ; Hyen O LA ; Mi Yeong KIM ; Seong Ju PARK ; Yong Eun KWON ; Jae Woo JUNG ; Sang Hyon KIM ; Cheol Woo KIM ; Min Seok YANG ; Min Gyu KANG ; Jin Yong LEE ; Joo Hee KIM ; Sang Heon KIM ; Gyu Young HUR ; Young Koo JEE ; Hyun Jung JIN ; Chan Sun PARK ; Yi Yeong JEONG ; Young Min YE
Allergy, Asthma & Immunology Research 2019;11(2):212-221
PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are common cause of severe cutaneous adverse reactions (SCARs). The present study aimed to investigate the characteristics of SCARs induced by NSAIDs in the Korean SCAR registry. METHODS: A retrospective survey of NSAID-induced SCARs recorded between 2010 and 2015 at 27 university hospitals in Korea was conducted. Clinical phenotypes of SCARs were classified into Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), SJS-TEN overlap syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). Causative NSAIDs were classified into 7 groups according to their chemical properties: acetaminophen, and propionic, acetic, salicylic, fenamic and enolic acids. RESULTS: A total of 170 SCARs, consisting of 85 SJS, 32 TEN, 17 SJS-TEN overlap syndrome and 36 DRESS reactions, were induced by NSAIDs: propionic acids (n=68), acetaminophen (n=38), acetic acids (n=23), salicylic acids (n=16), coxibs (n=8), fenamic acids (n=7), enolic acids (n=5) and unclassified (n=5). Acetic acids (22%) and coxibs (14%) accounted for higher portions of DRESS than other SCARs. The phenotypes of SCARs induced by both propionic and salicylic acids were similar (SJS, TEN and DRESS, in order). Acetaminophen was primarily associated with SJS (27%) and was less involved in TEN (10%). DRESS occurred more readily among subjects experiencing coxib-induced SCARs than other NSAID-induced SCARs (62.5% vs. 19.7%, P = 0.013). The mean time to symptom onset was longer in DRESS than in SJS or TEN (19.1 ± 4.1 vs. 6.8 ±1.5 vs. 12.1 ± 3.8 days). SCARs caused by propionic salicylic acids showed longer latency, whereas acetaminophen- and acetic acid-induced SCARs appeared within shorter intervals. CONCLUSIONS: The present study indicates that the phenotypes of SCARs may differ according to the chemical classifications of NSAIDs. To establish the mechanisms and incidences of NSAID-induced SCARs, further prospective studies are needed.
Acetaminophen
;
Acetates
;
Acetic Acid
;
Anti-Inflammatory Agents, Non-Steroidal
;
Cicatrix
;
Classification
;
Cyclooxygenase 2 Inhibitors
;
Diethylpropion
;
Drug Hypersensitivity
;
Drug Hypersensitivity Syndrome
;
Hospitals, University
;
Incidence
;
Korea
;
Phenotype
;
Propionates
;
Prospective Studies
;
Retrospective Studies
;
Salicylates
;
Salicylic Acid
;
Stevens-Johnson Syndrome
4.Rationale and Design of the High Platelet Inhibition with Ticagrelor to Improve Left Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction (HEALING-AMI) Trial
Yongwhi PARK ; Si Wan CHOI ; Ju Hyeon OH ; Eun Seok SHIN ; Sang Yeub LEE ; Jeongsu KIM ; Weon KIM ; Jeong Won SUH ; Dong Heon YANG ; Young Joon HONG ; Mark Y CHAN ; Jin Sin KOH ; Jin Yong HWANG ; Jae Hyeong PARK ; Young Hoon JEONG ;
Korean Circulation Journal 2019;49(7):586-599
BACKGROUND AND OBJECTIVES: Impaired recovery from left ventricular (LV) dysfunction is a major prognostic factor after myocardial infarction (MI). Because P2Y12 receptor blockade inhibits myocardial injury, ticagrelor with off-target properties may have myocardial protection over clopidogrel. In animal models, ticagrelor vs. clopidogrel protects myocardium against reperfusion injury and improves remodeling after MI. We aimed to investigate the effect of ticagrelor on sequential myocardial remodeling process after MI. METHODS: High platelet inhibition with ticagrelor to improve LV remodeling in patients with ST-segment elevation MI (HEALING-AMI) is an investigator-initiated, randomized, open-label, assessor-blinded, multi-center trial done at 10 sites in Korea. Patients will be enrolled if they have ST-segment elevation MI (STEMI) treated with primary percutaneous coronary intervention and a planned duration of dual antiplatelet treatment of at least 6 months. Screened patients will be randomly assigned (1:1) using an internet-based randomization with a computer-generated blocking with stratification across study sites to either ticagrelor or clopidogrel treatment. The co-primary primary endpoints are LV remodeling index with three-dimensional echocardiography and the level of N-terminal prohormone B-type natriuretic peptide (NT-proBNP) at 6 months representing post-MI remodeling processes. Changes of LV end-systolic/diastolic volume indices and LV ejection fraction between baseline and 6-month follow-up will be also evaluated. Analysis is per protocol. CONCLUSIONS: HEALING-AMI is testing the effect of ticagrelor in reducing adverse LV remodeling following STEMI. Our trial would show the benefit of ticagrelor vs. clopidogrel related to the recovery of post-MI LV dysfunction beyond potent platelet inhibition. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02224534
Blood Platelets
;
Echocardiography, Three-Dimensional
;
Follow-Up Studies
;
Humans
;
Korea
;
Models, Animal
;
Myocardial Infarction
;
Myocardium
;
Natriuretic Peptide, Brain
;
Percutaneous Coronary Intervention
;
Random Allocation
;
Reperfusion Injury
;
Ventricular Remodeling
5.Rationale and Design of the High Platelet Inhibition with Ticagrelor to Improve Left Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction (HEALING-AMI) Trial
Yongwhi PARK ; Si Wan CHOI ; Ju Hyeon OH ; Eun Seok SHIN ; Sang Yeub LEE ; Jeongsu KIM ; Weon KIM ; Jeong Won SUH ; Dong Heon YANG ; Young Joon HONG ; Mark Y CHAN ; Jin Sin KOH ; Jin Yong HWANG ; Jae Hyeong PARK ; Young Hoon JEONG ;
Korean Circulation Journal 2019;49(7):586-599
BACKGROUND AND OBJECTIVES:
Impaired recovery from left ventricular (LV) dysfunction is a major prognostic factor after myocardial infarction (MI). Because P2Y12 receptor blockade inhibits myocardial injury, ticagrelor with off-target properties may have myocardial protection over clopidogrel. In animal models, ticagrelor vs. clopidogrel protects myocardium against reperfusion injury and improves remodeling after MI. We aimed to investigate the effect of ticagrelor on sequential myocardial remodeling process after MI.
METHODS:
High platelet inhibition with ticagrelor to improve LV remodeling in patients with ST-segment elevation MI (HEALING-AMI) is an investigator-initiated, randomized, open-label, assessor-blinded, multi-center trial done at 10 sites in Korea. Patients will be enrolled if they have ST-segment elevation MI (STEMI) treated with primary percutaneous coronary intervention and a planned duration of dual antiplatelet treatment of at least 6 months. Screened patients will be randomly assigned (1:1) using an internet-based randomization with a computer-generated blocking with stratification across study sites to either ticagrelor or clopidogrel treatment. The co-primary primary endpoints are LV remodeling index with three-dimensional echocardiography and the level of N-terminal prohormone B-type natriuretic peptide (NT-proBNP) at 6 months representing post-MI remodeling processes. Changes of LV end-systolic/diastolic volume indices and LV ejection fraction between baseline and 6-month follow-up will be also evaluated. Analysis is per protocol.
CONCLUSIONS
HEALING-AMI is testing the effect of ticagrelor in reducing adverse LV remodeling following STEMI. Our trial would show the benefit of ticagrelor vs. clopidogrel related to the recovery of post-MI LV dysfunction beyond potent platelet inhibition.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02224534
6.Anterolateral Thigh Thickness Measurement in Positron Emission Tomography-Computed Tomography for the Prediction of Free Flap Reconstruction Outcomes in Head and Neck Cancer.
Myung Jin BAN ; Jae Hong PARK ; Hyung Kwon BYEON ; Jae Won CHANG ; Jeong Hyun AHN ; Ji Hoon KIM ; Won Shik KIM ; Yoon Woo KOH ; Se Heon KIM ; Eun Chang CHOI
Korean Journal of Otolaryngology - Head and Neck Surgery 2016;59(11):780-786
BACKGROUND AND OBJECTIVES: Anterolateral thigh (ALT) flaps are commonly used for head and neck surgery reconstruction. However, a thick ALT often leads to long operation times. Therefore, ALT thickness on a preoperative non contrast image of positron emission tomography-computed tomography (PET-CT) scan was measured to predict surgical outcome. SUBJECTS AND METHOD: The correlation between ALT thickness and total reconstruction time was analyzed in 106 patients. The differences in ALT thickness between the successful and compromised-flap groups were analyzed retrospectively. RESULTS: Median ALT thickness was 4.49 mm, and total reconstruction time was 190 min. Total reconstruction time was significantly correlated with ALT thickness (p=0.019). ALT thickness, body mass index (BMI), total reconstruction time and ischemia time were significantly greater in the compromised-flap group than in the successful group. In the multivariate analysis, only BMI and ischemia time were predictors for the compromised flap. CONCLUSION: ALT thickness measured on a non-contrast image of PET-CT scan is useful as a surgical outcome predictor with respect to total reconstruction time. A further study may suggest the risk of a thick ALT in a compromised flap in head and neck reconstruction using an ALT free flap.
Body Mass Index
;
Electrons*
;
Free Tissue Flaps*
;
Head and Neck Neoplasms*
;
Head*
;
Humans
;
Ischemia
;
Methods
;
Multivariate Analysis
;
Neck
;
Positron-Emission Tomography
;
Retrospective Studies
;
Thigh*
7.Nontuberculous Mycobacterial Lung Disease Caused by Mycobacterium simiae: The First Reported Case in South Korea.
Suk Hyeon JEONG ; Su Young KIM ; Hyun LEE ; Jun Soo HAM ; Keum Bit HWANG ; Subin HWANG ; Sun Hye SHIN ; Myung Jin CHUNG ; Seung Heon LEE ; Sung Jae SHIN ; Won Jung KOH
Tuberculosis and Respiratory Diseases 2015;78(4):432-435
This is a report of the first South Korean case of a lung disease caused by Mycobacterium simiae. The patient was a previously healthy 52-year-old female. All serial isolates were identified as M. simiae by multi-locus sequencing analysis, based on hsp65, rpoB, 16S-23S rRNA internal transcribed spacer, and 16S rRNA fragments. A chest radiography revealed deterioration, and the follow-up sputum cultures were persistently positive, despite combination antibiotic treatment, including azithromycin, ethambutol, and rifampin. To the best of our knowledge, this is the first confirmed case of a lung disease caused by M. simiae in South Korea.
Azithromycin
;
Bronchiectasis
;
Ethambutol
;
Female
;
Follow-Up Studies
;
Humans
;
Korea*
;
Lung Diseases*
;
Lung*
;
Middle Aged
;
Mycobacterium*
;
Nontuberculous Mycobacteria
;
Radiography
;
Rifampin
;
Sputum
;
Thorax
8.Current Status of Intensive Care Units Registered as Critical Care Subspecialty Training Hospitals in Korea.
Sang Hyun KWAK ; Cheol Won JEONG ; Seong Heon LEE ; Hyun Jeong LEE ; Younsuck KOH
Journal of Korean Medical Science 2014;29(3):431-437
There is a lack of information on critical care in Korea. The aim of this study was to determine the current status of Korean intensive care units (ICUs), focusing on the organization, characteristics of admitted patients, and nurse and physician staffing. Critical care specialists in charge of all 105 critical care specialty training hospitals nationwide completed a questionnaire survey. Among the ICUs, 56.4% were located in or near the capital city. Only 38 ICUs (17.3%) had intensive care specialists with a 5-day work week. The average daytime nurse-to-patient ratio was 1:2.7. Elderly people > or = 65 yr of age comprised 53% of the adult patients. The most common reasons for admission to adult ICUs were respiratory insufficiency and postoperative management. Nurse and physician staffing was insufficient for the appropriate critical care in many ICUs. Staffing was worse in areas outside the capital city. Much effort, including enhanced reimbursement of critical care costs, must be made to improve the quality of critical care at the national level.
Adult
;
Aged
;
Aged, 80 and over
;
Critical Care/*organization & administration
;
Hospitals
;
Humans
;
Intensive Care Units
;
Middle Aged
;
Nursing Staff, Hospital/*statistics & numerical data
;
Outcome Assessment (Health Care)
;
Physicians/*statistics & numerical data
;
Questionnaires
;
Republic of Korea
9.A Case of Painful Hashimoto Thyroiditis that Mimicked Subacute Thyroiditis
Hye Mi SEO ; Miyeon KIM ; Jaeseok BAE ; Jo Heon KIM ; Jeong Won LEE ; Sang Ah LEE ; Gwanpyo KOH ; Dae Ho LEE
Chonnam Medical Journal 2012;48(1):69-72
Hashimoto thyroiditis (HT) is an autoimmune thyroid disorder that usually presents as a diffuse, nontender goiter, whereas subacute thyroiditis (SAT) is an uncommon disease that is characterized by tender thyroid enlargement, transient thyrotoxicosis, and an elevated erythrocyte sedimentation rate (ESR). Very rarely, patients with HT can present with painful, tender goiter or fever, a mimic of SAT. We report a case of painful HT in a 68-year-old woman who presented with pain and tenderness in a chronic goiter. Her ESR was definitely elevated and her thyroid laboratory tests suggested subclinical hypothyroidism of autoimmune origin. (99m)Tc pertechnetate uptake was markedly decreased. Fine needle aspiration biopsy revealed reactive and polymorphous lymphoid cells and occasional epithelial cells with Hurthle cell changes. Her clinical symptoms showed a dramatic response to glucocorticoid treatment. She became hypothyroid finally and is now on levothyroxine therapy.
Aged
;
Biopsy
;
Biopsy, Fine-Needle
;
Blood Sedimentation
;
Epithelial Cells
;
Female
;
Fever
;
Goiter
;
Hashimoto Disease
;
Humans
;
Hydrazines
;
Hypothyroidism
;
Lymphocytes
;
Sodium Pertechnetate Tc 99m
;
Thyroid Gland
;
Thyroiditis, Subacute
;
Thyrotoxicosis
;
Thyroxine
10.A Case of Hemangiopericytoma Occurring in the Infratemporal Fossa.
Tae Kyung KOH ; Jong Chul HONG ; Jin Sook JEONG ; Heon Soo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2010;53(8):511-514
Hemangiopericytoma is an uncommon vascular tumor in the head and neck region that originates from Zimmerman's pericytes, the small, spindle-shaped pericapillary cells. Clinical diagnosis of such a lesion is an extremely challenging task because there are very few detailed reports of such lesions and one would hardly think of a diagnosis such as hemangiopericytoma while examining a lesion. Only 15% of hemangiopericytomas are localized in the cervicofacial region, with occurrence in the infratemporal fossa is particularly exceptional. In this article, we report an unusual case of hemangiopericytoma originating from the right infratemporal area and extending into the pterygomaxillary fissure, the buccal fat pad, and the hard palate. We present a case of infratemporal fossa hemangiopericytoma that was treated by resection of the transantral approach.
Adipose Tissue
;
Head
;
Hemangiopericytoma
;
Neck
;
Palate, Hard
;
Pericytes

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