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 principles of presenting statistical results using figures
Jae Hong PARK ; Dong Kyu LEE ; Hyun KANG ; Jong Hae KIM ; Francis Sahngun NAHM ; EunJin AHN ; Junyong IN ; Sang Gyu KWAK ; Chi-Yeon LIM
Korean Journal of Anesthesiology 2022;75(2):139-150
Tables and figures are commonly adopted methods for presenting specific data or statistical analysis results. Figures can be used to display characteristics and distributions of data, allowing for intuitive understanding through visualization and thus making it easier to interpret the statistical results. To maximize the positive aspects of figure presentation and increase the accuracy of the content, in this article, the authors will describe how to choose an appropriate figure type and the necessary components to include. Additionally, this article includes examples of figures that are commonly used in research and their essential components using virtual data.
3.Clinical Features of Hepatitis C Virus-related Acute-on-chronic Liver Failure in a Korean Population
Jung Woo CHOI ; Ji Yoon KWAK ; Sang Soo LEE ; Hyun-gyu KIM ; Ho Jin SON ; Hankyu JEON ; Hee Jin KIM ; Ra Ri CHA ; Jae Min LEE ; Hyun Jin KIM
The Korean Journal of Gastroenterology 2022;80(4):169-176
Background/Aims:
Acute-on-chronic liver failure (ACLF) is a widely recognized concept in which acute decompensation (AD) in patients with cirrhosis results in organ failure and high short-term mortality. On the other hand, few studies reflecting the various etiologies of cirrhosis are available. This study examined the clinical features of patients with hepatitis C virus (HCV)-related ACLF.
Methods:
Between January 2005 and December 2018, 109 HCV-related cirrhosis patients hospitalized for AD (ascites, hepatic encephalopathy, gastrointestinal hemorrhage, and bacterial infection) were enrolled for ACLF defined by the European Association for the Study of the Liver (EASL).
Results:
ACLF developed in 35 patients (32.1%) on admission. Eight, eight, and 19 patients had ACLF grades 1, 2, and 3, respectively. The 28-day and 90-day mortality rates were very low (2.7% and 5.4%, respectively) in patients without ACLF and very high (60.0% and 74.3%, respectively) in those with ACLF. In patients with HCV-related ACLF, compared to previous studies on hepatitis B virus-related ACLF and alcohol-related ACLF, the prevalence of liver failure was very low (17.1%), whereas that of kidney failure was very high (71.4%). Compared with all other prognostic scores, the Chronic liver failure Consortium Organ Failure score predicted the 90-day mortality most accurately, with an area under the receiver operator characteristic of 0.921.
Conclusions
HCV-related ACLF has unique clinical characteristics distinct from hepatitis B virus-related and alcohol-related ACLF. ACLF defined by EASL can be useful for predicting the short-term mortality in HCV-related cirrhosis.
5.The principles of presenting statistical results: Table
Sang Gyu KWAK ; Hyun KANG ; Jong Hae KIM ; Tae Kyun KIM ; EunJin AHN ; Dong Kyu LEE ; Sangseok LEE ; Jae Hong PARK ; Francis Sahngun NAHM ; Junyong IN
Korean Journal of Anesthesiology 2021;74(2):115-119
General medical journals such as the Korean Journal of Anesthesiology (KJA) receive numerous manuscripts every year. However, reviewers have noticed that the tables presented in various manuscripts have great diversity in their appearance, resulting in difficulties in the review and publication process. It might be due to the lack of clear written instructions regarding reporting of statistical results for authors. Therefore, the present article aims to briefly outline reporting methods for several table types, which are commonly used to present statistical results. We hope this article will serve as a guideline for reviewers as well as for authors, who wish to submit a manuscript to the KJA.
6.The principles of presenting statistical results: Table
Sang Gyu KWAK ; Hyun KANG ; Jong Hae KIM ; Tae Kyun KIM ; EunJin AHN ; Dong Kyu LEE ; Sangseok LEE ; Jae Hong PARK ; Francis Sahngun NAHM ; Junyong IN
Korean Journal of Anesthesiology 2021;74(2):115-119
General medical journals such as the Korean Journal of Anesthesiology (KJA) receive numerous manuscripts every year. However, reviewers have noticed that the tables presented in various manuscripts have great diversity in their appearance, resulting in difficulties in the review and publication process. It might be due to the lack of clear written instructions regarding reporting of statistical results for authors. Therefore, the present article aims to briefly outline reporting methods for several table types, which are commonly used to present statistical results. We hope this article will serve as a guideline for reviewers as well as for authors, who wish to submit a manuscript to the KJA.
7.Comparison of three risk stratification models for non-clear cell renal cell carcinoma patients treated with temsirolimus as first-line therapy
In Hee LEE ; Byung Woog KANG ; Jong Gwang KIM ; Woo Kyun BAE ; Myung Seo KI ; Inkeun PARK ; Jae-Cheol JO ; Jin Young KIM ; Sung Ae KOH ; Kyung Hee LEE ; Yoon Young CHO ; Hun Mo RYOO ; Sang Gyu KWAK ; Jung Lim LEE ; Sun Ah LEE
The Korean Journal of Internal Medicine 2020;35(1):185-193
Background/Aims:
For metastatic renal cell carcinoma (RCC), various prognostic scoring systems have been developed. However, owing to the low prevalence of nonclear cell RCC, the three most commonly used tools were mainly developed based on patients with clear cell histology. Accordingly, this study applied three prognostic models to Korean non-clear cell RCC patients treated with first-line temsirolimus.
Methods:
This study analyzed data for 74 patients with non-clear cell RCC who were treated with temsirolimus as the first-line therapy at eight medical centers between 2011 and 2016. The receiver-operating characteristic (ROC) curves for the different prognostic models were analyzed.
Results:
Twenty-seven (36.5%), 24 (32.4%), and 44 patients (59.5%) were assigned to the poor prognosis groups of the Memorial Sloan-Kettering Cancer Center (MSKCC), International Metastatic RCC Database Consortium (IMDC), and Advanced Renal Cell Carcinoma (ARCC) risk stratification models, respectively. All three prognostic models reliably discriminated the risk groups to predict progression-free survival and overall survival (p < 0.001). The area under the ROC curve (AUC) for progression and survival was highest for the ARCC model (0.777; 0.734), followed by the IMDC (0.756; 0.724) and the MSKCC (0.742; 0.712) models. Furthermore, the sensitivity and specificity for predicting progression were highest with the ARCC model (sensitivity 63.6%, specificity 85.7%), followed by the MSKCC (sensitivity 58.2%, specificity 86.5%) and the IMDC models (sensitivity 56.4%, specificity 85.7%).
Conclusions
All three prognostic models accurately predicted the survival of the non-clear cell RCC patients treated with temsirolimus as the first-line therapy. Furthermore, the ARCC risk model performed better than the other risk models in predicting survival.
8.Changes in Neck Angle, Neck Length, Maximum Diameter, Maximum Area and Thrombus after Endovascular Aneurysm Repair
Jae Hoon LEE ; Ki Hyuk PARK ; Sang Gyu KWAK
Vascular Specialist International 2020;36(2):82-88
Purpose:
The correlation of initial anatomy of the aneurysm, aneurysmal remodeling and endoleaks is controversial. We performed a retrospective study to measure aneurysmal remodeling with time, and to assess the structural changes in the aneurysm neck after endovascular aneurysm repair (EVAR).
Materials and Methods:
From January 2013 to February 2018, 108 patients with abdominal aortic aneurysms (AAA) underwent EVAR. Follow-up computed tomography images were available for 90 patients. Anatomic variables, including the neck angle, neck length, maximal diameter, maximal area, and thrombus volume were measured. Temporal changes were measured preoperatively, immediate postoperatively (within 1 week after EVAR), and at 6 months, 1 year, and 2 years post-EVAR. Correlation between the variables according to the temporal changes and presence of type Ia endoleaks (T1aE) was analyzed.
Results:
The mean follow-up period was 10.63±20.34 months. Significant decreases in neck angle and length occurred immediately postoperative (P<0.001 and 0.036). Maximum diameter decreased at 6 months post-EVAR (P=0.003), but no significant changes in the maximal area occurred over time (P=0.142). Thrombus volume in the aneurysm sac increased immediately post-EVAR (P=0.008). There was no significant relationship between T1aE and neck changes in the group and time comparison (P=0.815 and 0.970).
Conclusion
Changes in neck angle, length and thrombus volume occurred immediately after EVAR, whereas a change in the maximum diameter of the AAA was noted 6 months after EVAR. Preoperative anatomic variables related with T1aE were not found.
9.Long-term benefits of chest compression-only cardiopulmonary resuscitation training using real-time visual feedback manikins: a randomized simulation study
Tae Chang JANG ; Hyun Wook RYOO ; Sungbae MOON ; Jae Yun AHN ; Dong Eun LEE ; Won Kee LEE ; Sang Gyu KWAK ; Jung Ho KIM
Clinical and Experimental Emergency Medicine 2020;7(3):206-212
Objective:
Cardiopulmonary resuscitation (CPR) education with a feedback device is known to result in better CPR skills compared to one without the feedback device. However, its long-term benefits have not been established. The purpose of this study was to evaluate the long-term CPR skill retention after training using real-time visual manikins in comparison to that of non-feedback manikins.
Methods:
We recruited 120 general university students who were randomly divided into the real-time feedback group (RTFG) and the non-feedback group. Of them, 95 (RTFG, 48; non-feedback group, 47) attended basic life support and automated external defibrillation training for 1 hour. For comparison of retention of CPR skills, the two groups were evaluated based on 2-minute chest compression performed immediately after training and at 3, 6, and 9 months. The CPR parameters between the two groups were also compared using a generalized linear model.
Results:
At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001). This significant difference was maintained until 6 months after training, but there was no difference at 9 months after training. However, there was no significant difference in the chest compression rate and the correct hand position at any time point.
Conclusion
CPR training with a real-time visual feedback manikin improved skill acquisition in chest compression depth, but only until 6 months after the training. It could be a more effective educational method for basic life support training in laypersons.
10.Fasting Plasma Glucose Level Independently Predicts the Mortality of Patients with Coronavirus Disease 2019 Infection: A Multicenter, Retrospective Cohort Study
Min Cheol CHANG ; Jong-Moon HWANG ; Jae-Han JEON ; Sang Gyu KWAK ; Donghwi PARK ; Jun Sung MOON
Endocrinology and Metabolism 2020;35(3):595-601
Background:
Coronavirus disease 2019 (COVID-19) has become a global pandemic, which prompts a consensus for the necessity to seek risk factors for this critical disease. Risk factors affecting mortality of the disease remain elusive. Diabetes and hyperglycemia are known to negatively affect a host’s antiviral immunity. We evaluated the relationship between a history of diabetes, fasting plasma glucose (FPG) levels and mortality among severely ill patients with COVID-19.
Methods:
This was a retrospective cohort study that assessed 106 adult inpatients (aged ≥18 years) from two tertiary hospitals in Daegu, South Korea. The participants were transferred to tertiary hospitals because their medical condition required immediate intensive care. The demographic and laboratory data were compared between COVID-19 patients who survived and those who did not.
Results:
Compared with the survivor group, age, and the proportions of diabetes, chronic lung disease and FPG were significantly higher in the deceased group. In the Cox proportional hazards regression model for survival analysis, FPG level and age were identified as significant predictors of mortality (P<0.05). The threshold values for predicting high mortality were age >68 years and FPG of 168 mg/dL, respectively. Among those without diabetes, high FPG remained a significant predictor of mortality (P<0.04).
Conclusion
High FPG levels significantly predicted mortality in COVID-19, regardless of a known history of diabetes. These results suggest intensive monitoring should be provided to COVID-19 patients who have a high FPG level.

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