1.Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial
Jie-Eun LEE ; Seung Hee YU ; Sung Rae KIM ; Kyu Jeung AHN ; Kee-Ho SONG ; In-Kyu LEE ; Ho-Sang SHON ; In Joo KIM ; Soo LIM ; Doo-Man KIM ; Choon Hee CHUNG ; Won-Young LEE ; Soon Hee LEE ; Dong Joon KIM ; Sung-Rae CHO ; Chang Hee JUNG ; Hyun Jeong JEON ; Seung-Hwan LEE ; Keun-Young PARK ; Sang Youl RHEE ; Sin Gon KIM ; Seok O PARK ; Dae Jung KIM ; Byung Joon KIM ; Sang Ah LEE ; Yong-Hyun KIM ; Kyung-Soo KIM ; Ji A SEO ; Il Seong NAM-GOONG ; Chang Won LEE ; Duk Kyu KIM ; Sang Wook KIM ; Chung Gu CHO ; Jung Han KIM ; Yeo-Joo KIM ; Jae-Myung YOO ; Kyung Wan MIN ; Moon-Kyu LEE
Diabetes & Metabolism Journal 2024;48(4):730-739
Background:
It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia.
Methods:
This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment.
Results:
After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events.
Conclusion
The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.
2.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.
3.Eosinophil-mediated lung inflammation associated with elevated natural killer T cell response in COVID-19 patients
Dong-Min KIM ; Jun-Won SEO ; Yuri KIM ; Uni PARK ; Na-Young HA ; Hyoree PARK ; Na Ra YUN ; Da Young KIM ; Sung Ho YOON ; Yong Sub NA ; Do Sik MOON ; Sung-Chul LIM ; Choon-Mee KIM ; Yeon-Sook KIM ; Nam-Hyuk CHO
The Korean Journal of Internal Medicine 2022;37(1):201-209
Background/Aims:
Coronavirus disease 2019 (COVID-19) is associated with acute respiratory syndrome. The mechanisms underlying the different degrees of pneumonia severity in patients with COVID-19 remain elusive. This study provides evidence that COVID-19 is associated with eosinophil-mediated inflammation.
Methods:
We performed a retrospective case series of three patients with laboratory and radiologically confirmed COVID-19 pneumonia admitted to Chosun University Hospital. Demographic and clinical data on inflammatory cell lung infiltration and cytokine levels in patients with COVID-19 were collected.
Results:
Cytological analysis of sputum, tracheal aspirates, and bronchoalveolar lavage fluid (BALF) samples from all three patients revealed massive infiltration of polymorphonuclear cells (PMNs), such as eosinophils and neutrophils. All sputum and BALF specimens contained high levels of eosinophil cationic proteins. The infiltration of PMNs into the lungs, together with elevated levels of natural killer T (NKT) cells in BALF and peripheral blood samples from patients with severe pneumonia in the acute phase was confirmed by flow cytometry.
Conclusions
These results suggest that the lungs of COVID-19 patients can exhibit eosinophil-mediated inflammation, together with an elevated NKT cell response, which is associated with COVID-19 pneumonia.
4.Guidelines for the Surgical Management of Oral Cancer: Korean Society of Thyroid-Head and Neck Surgery
Young hoon JOO ; Jae keun CHO ; Bon seok KOO ; Minsu KWON ; Seong keun KWON ; Soon young KWON ; Min su KIM ; Jeong kyu KIM ; Heejin KIM ; Innchul NAM ; Jong lyel ROH ; Young min PARK ; Il seok PARK ; Jung je PARK ; Sung chan SHIN ; Soon hyun AHN ; Seongjun WON ; Chang hwan RYU ; Tae mi YOON ; Giljoon LEE ; Doh young LEE ; Myung chul LEE ; Joon kyoo LEE ; Jin choon LEE ; Jae yol LIM ; Jae won CHANG ; Jeon yeob JANG ; Man ki CHUNG ; Yuh seok JUNG ; Jae gu CHO ; Yoon seok CHOI ; Jeong seok CHOI ; Guk haeng LEE ; Phil sang CHUNG
Clinical and Experimental Otorhinolaryngology 2019;12(2):107-144
Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to provide guidance on the implementation of a surgical treatment of oral cancer. MEDLINE databases were searched for articles on subjects related to “surgical management of oral cancer” published in English. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. The quality of evidence was rated with use RoBANS (Risk of Bias Assessment Tool for Nonrandomized Studies) and AMSTAR (A Measurement Tool to Assess the Methodological Quality of Systematic Reviews). Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. Additional directives are provided as expert opinions and Delphi questionnaire when insufficient evidence existed. The Committee developed 68 evidence-based recommendations in 34 categories intended to assist clinicians and patients and counselors, and health policy-makers. Proper surgical treatment selection for oral cancer, which is directed by patient- and subsite-specific factors, remains the greatest predictor of successful treatment outcomes. These guidelines are intended for use in conjunction with the individual patient's treatment goals.
Advisory Committees
;
Bias (Epidemiology)
;
Carcinoma, Squamous Cell
;
Counseling
;
Expert Testimony
;
Humans
;
Mouth Neoplasms
;
Neck
;
Republic of Korea
5.Treatments of Infra-Orbital Dark Circles by Various Etiologies.
Kui Young PARK ; Hyun Jung KWON ; Choon Shik YOUN ; Seong Jun SEO ; Myeong Nam KIM
Annals of Dermatology 2018;30(5):522-528
Dark circles refer to visible darkness of the infra-orbital areas. Dark circles are a cosmetic concern for many individuals, although not a medical concern. Moreover, clear definitions and possible causes of dark circles have not been elucidated. This study reviews the possible causes and treatment options for dark circles based on a review of the medical literature and the authors' clinical experience. Potential factors that contribute to dark circles include excessive pigmentation, shadowing due to tear troughs and infra-orbital fat herniation, shadowing due to infraorbital laxity and wrinkles, and thin, translucent skin overlying the orbicularis oculi muscle. Given the different possible causes for dark circles, therapeutic modalities must be individualized for each patient. Because various factors cause dark circles, it is useful to identify the underlying causes in order to select the appropriate treatment.
Darkness
;
Humans
;
Pigmentation
;
Shadowing (Histology)
;
Skin
;
Tears
6.Amebic liver abscesses resulting in diagnosis of human immunodeficiency virus infection.
Seok Weon KIM ; Hyeok Choon KWON ; Seung Woo NAM ; Jong Kyung CHOI ; Joo Won CHUNG ; Dong Won JANG ; Soo Yoen PARK
Yeungnam University Journal of Medicine 2017;34(1):96-100
Amebic liver abscess (ALA) is the most common extraintestinal manifestation of amebiasis. Amebiasis, a parasitic infection caused by Entamoeba histolytica, used to be a prevalent protozoan disease in Korea, however, with an improving sanitary system, it has been among very uncommon etiology of liver abscess. A recent report suggested that ALA is an emerging parasitic infection in human immunodeficiency virus (HIV)-infected patients even in areas where the disease is not endemic and recommended HIV screening in patients in areas where ALA is not endemic, particularly those without history of travel to a disease-endemic area. We report on two patients who were admitted for treatment of ALA and then diagnosed as HIV infection. We also reviewed the etiology and characteristics of ALA in our hospital during the last 5 years.
Amebiasis
;
Diagnosis*
;
Entamoeba histolytica
;
HIV Infections
;
HIV*
;
Humans*
;
Korea
;
Liver Abscess
;
Liver Abscess, Amebic*
;
Mass Screening
7.Amebic liver abscesses resulting in diagnosis of human immunodeficiency virus infection
Seok Weon KIM ; Hyeok Choon KWON ; Seung Woo NAM ; Jong Kyung CHOI ; Joo Won CHUNG ; Dong Won JANG ; Soo Yoen PARK
Yeungnam University Journal of Medicine 2017;34(1):96-100
Amebic liver abscess (ALA) is the most common extraintestinal manifestation of amebiasis. Amebiasis, a parasitic infection caused by Entamoeba histolytica, used to be a prevalent protozoan disease in Korea, however, with an improving sanitary system, it has been among very uncommon etiology of liver abscess. A recent report suggested that ALA is an emerging parasitic infection in human immunodeficiency virus (HIV)-infected patients even in areas where the disease is not endemic and recommended HIV screening in patients in areas where ALA is not endemic, particularly those without history of travel to a disease-endemic area. We report on two patients who were admitted for treatment of ALA and then diagnosed as HIV infection. We also reviewed the etiology and characteristics of ALA in our hospital during the last 5 years.
Amebiasis
;
Diagnosis
;
Entamoeba histolytica
;
HIV Infections
;
HIV
;
Humans
;
Korea
;
Liver Abscess
;
Liver Abscess, Amebic
;
Mass Screening
8.Projections of Demand for Cardiovascular Surgery and Supply of Surgeons.
Jung Jeung LEE ; Nam Hee PARK ; Kun Sei LEE ; Hyun Keun CHEE ; Sung Bo SIM ; Myo Jeong KIM ; Ji Suk CHOI ; Myunghwa KIM ; Choon Seon PARK
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S37-S43
BACKGROUND: While demand for cardiovascular surgery is expected to increase gradually along with the rapid increase in cardiovascular diseases with respect to the aging population, the supply of thoracic and cardiovascular surgeons has been continuously decreasing over the past 10 years. Consequently, this study aims to achieve guidance in establishing health care policy by analyzing the supply and demand for cardiovascular surgeries in the medical service area of Korea. METHODS: After investigating the actual number of cardiovascular surgeries performed using the National Health Insurance claim data of the Health Insurance Review and Assessment Service, as well as drawing from national statistics concerning the elderly population aged 65 and over, this study estimated the number of future cardiovascular surgeries by using a cell-based model. To be able to analyze the supply and demand of surgeons, the recent status of new surgeons specializing in thoracic and cardiovascular surgeries and the ratio of their subspecialties in cardiovascular surgeries were investigated. Then, while taking three different scenarios into account, the number of cardiovascular surgeons expected be working in 5-year periods was projected. RESULTS: The number of cardiovascular surgeries, which was recorded at 10,581 cases in 2014, is predicted to increase consistently to reach a demand of 15,501 cases in 2040—an increase of 46.5%. There was a total of 245 cardiovascular surgeons at work in 2014. Looking at 5 year spans in the future, the number of surgeons expected to be supplied in 2040 is 184, to retire is 249, and expected to be working is 309—an increase of −24.9%, 1.6%, and 26.1%, respectively compared to those in 2014. This forecasts a demand-supply imbalance in every scenario. CONCLUSION: Cardiovascular surgeons are the most central resource in the medical service of highly specialized cardiovascular surgeries, and fostering the surgeons requires much time, effort, and resources; therefore, by analyzing the various factors affecting the supply of cardiovascular surgeons, an active intervention of policies can be prescribed for the areas that have failed to meet the appropriate market distributions.
Aged
;
Aging
;
Cardiovascular Diseases
;
Delivery of Health Care
;
Economics, Medical
;
Foster Home Care
;
Health Policy
;
Health Services Needs and Demand
;
Humans
;
Insurance, Health
;
Korea
;
National Health Programs
;
Surgeons*
;
Thoracic Surgery
9.Development of Models for Regional Cardiac Surgery Centers.
Choon Seon PARK ; Nam Hee PARK ; Sung Bo SIM ; Sang Cheol YUN ; Hye Mi AHN ; Myunghwa KIM ; Ji Suk CHOI ; Myo Jeong KIM ; Hyunsu KIM ; Hyun Keun CHEE ; Sanggi OH ; Shinkwang KANG ; Sok Goo LEE ; Jun Ho SHIN ; Keonyeop KIM ; Kun Sei LEE
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S28-S36
BACKGROUND: This study aimed to develop the models for regional cardiac surgery centers, which take regional characteristics into consideration, as a policy measure that could alleviate the concentration of cardiac surgery in the metropolitan area and enhance the accessibility for patients who reside in the regions. METHODS: To develop the models and set standards for the necessary personnel and facilities for the initial management plan, we held workshops, debates, and conference meetings with various experts. RESULTS: After partitioning the plan into two parts (the operational autonomy and the functional comprehensiveness), three models were developed: the ‘independent regional cardiac surgery center’ model, the ‘satellite cardiac surgery center within hospitals’ model, and the ‘extended cardiac surgery department within hospitals’ model. Proposals on personnel and facility management for each of the models were also presented. A regional cardiac surgery center model that could be applied to each treatment area was proposed, which was developed based on the anticipated demand for cardiac surgery. The independent model or the satellite model was proposed for Chungcheong, Jeolla, North Gyeongsang, and South Gyeongsang area, where more than 500 cardiac surgeries are performed annually. The extended model was proposed as most effective for the Gangwon and Jeju area, where more than 200 cardiac surgeries are performed annually. CONCLUSION: The operation of regional cardiac surgery centers with high caliber professionals and quality resources such as optimal equipment and facility size, should enhance regional healthcare accessibility and the quality of cardiac surgery in South Korea.
Delivery of Health Care
;
Education
;
Gangwon-do
;
Health Facilities
;
Health Services Accessibility
;
Humans
;
Korea
;
Quality of Health Care
;
Thoracic Surgery*
10.The Association Between Treatment Frequency and Treatment Outcome for Cardiovascular Surgeries.
Ji Suk CHOI ; Choon Seon PARK ; Myunghwa KIM ; Myo Jeong KIM ; Kun Sei LEE ; Sung Bo SIM ; Hyun Keun CHEE ; Nam Hee PARK ; Sung Min PARK
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S20-S27
BACKGROUND: This study analyzed the association between the volume of heart surgeries and treatment outcomes for hospitals in the last five years. METHODS: Hospitals that perform heart surgeries were chosen throughout Korea as subjects using from the Health Insurance Review and Assessment Service. The treatment outcome of the heart surgeries was defined as the mortality within 30 postoperative days, while the annual volume of the surgeries was categorized. Logistic regression was used as the statistical analysis method, and the impacts of the variables on the heart surgery treatment outcomes were then analyzed. RESULTS: The chance of death of patients who received surgery in a hospital that performed 50 or more surgeries annually was noticeably lower than patients receiving operations from hospitals that performed fewer than 50 surgeries annually, indicating that the chance of death decreases as the annual volume of heart surgeries in the hospital increases. In particular, the mortality rate in hospitals that performed more than 200 surgeries annually was less than half of that in hospitals that performed 49 or fewer surgeries annually. CONCLUSION: These results indicate that accumulation of a certain level of heart surgery experience is critical in improving or maintaining the quality of heart surgeries. In order to improve the treatment outcomes of small hospitals, a support policy must be implemented that allows for cooperation with experienced professionals.
Heart
;
Humans
;
Insurance, Health
;
Korea
;
Logistic Models
;
Methods
;
Mortality
;
Quality of Health Care
;
Thoracic Surgery
;
Treatment Outcome*

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