1.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
2.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
3.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
4.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
5.Occupation classification model based on DistilKoBERT: using the 5th and 6th Korean Working Condition Surveys
Tae-Yeon KIM ; Seong-Uk BAEK ; Myeong-Hun LIM ; Byungyoon YUN ; Domyung PAEK ; Kyung Ehi ZOH ; Kanwoo YOUN ; Yun Keun LEE ; Yangho KIM ; Jungwon KIM ; Eunsuk CHOI ; Mo-Yeol KANG ; YoonHo CHO ; Kyung-Eun LEE ; Juho SIM ; Juyeon OH ; Heejoo PARK ; Jian LEE ; Jong-Uk WON ; Yu-Min LEE ; Jin-Ha YOON
Annals of Occupational and Environmental Medicine 2024;36(1):e19-
Accurate occupation classification is essential in various fields, including policy development and epidemiological studies. This study aims to develop an occupation classification model based on DistilKoBERT. This study used data from the 5th and 6th Korean Working Conditions Surveys conducted in 2017 and 2020, respectively. A total of 99,665 survey participants, who were nationally representative of Korean workers, were included. We used natural language responses regarding their job responsibilities and occupational codes based on the Korean Standard Classification of Occupations (7th version, 3-digit codes). The dataset was randomly split into training and test datasets in a ratio of 7:3. The occupation classification model based on DistilKoBERT was fine-tuned using the training dataset, and the model was evaluated using the test dataset. The accuracy, precision, recall, and F1 score were calculated as evaluation metrics. The final model, which classified 28,996 survey participants in the test dataset into 142 occupational codes, exhibited an accuracy of 84.44%. For the evaluation metrics, the precision, recall, and F1 score of the model, calculated by weighting based on the sample size, were 0.83, 0.84, and 0.83, respectively. The model demonstrated high precision in the classification of service and sales workers yet exhibited low precision in the classification of managers. In addition, it displayed high precision in classifying occupations prominently represented in the training dataset. This study developed an occupation classification system based on DistilKoBERT, which demonstrated reasonable performance. Despite further efforts to enhance the classification accuracy, this automated occupation classification model holds promise for advancing epidemiological studies in the fields of occupational safety and health.
6.Occupation classification model based on DistilKoBERT: using the 5th and 6th Korean Working Condition Surveys
Tae-Yeon KIM ; Seong-Uk BAEK ; Myeong-Hun LIM ; Byungyoon YUN ; Domyung PAEK ; Kyung Ehi ZOH ; Kanwoo YOUN ; Yun Keun LEE ; Yangho KIM ; Jungwon KIM ; Eunsuk CHOI ; Mo-Yeol KANG ; YoonHo CHO ; Kyung-Eun LEE ; Juho SIM ; Juyeon OH ; Heejoo PARK ; Jian LEE ; Jong-Uk WON ; Yu-Min LEE ; Jin-Ha YOON
Annals of Occupational and Environmental Medicine 2024;36(1):e19-
Accurate occupation classification is essential in various fields, including policy development and epidemiological studies. This study aims to develop an occupation classification model based on DistilKoBERT. This study used data from the 5th and 6th Korean Working Conditions Surveys conducted in 2017 and 2020, respectively. A total of 99,665 survey participants, who were nationally representative of Korean workers, were included. We used natural language responses regarding their job responsibilities and occupational codes based on the Korean Standard Classification of Occupations (7th version, 3-digit codes). The dataset was randomly split into training and test datasets in a ratio of 7:3. The occupation classification model based on DistilKoBERT was fine-tuned using the training dataset, and the model was evaluated using the test dataset. The accuracy, precision, recall, and F1 score were calculated as evaluation metrics. The final model, which classified 28,996 survey participants in the test dataset into 142 occupational codes, exhibited an accuracy of 84.44%. For the evaluation metrics, the precision, recall, and F1 score of the model, calculated by weighting based on the sample size, were 0.83, 0.84, and 0.83, respectively. The model demonstrated high precision in the classification of service and sales workers yet exhibited low precision in the classification of managers. In addition, it displayed high precision in classifying occupations prominently represented in the training dataset. This study developed an occupation classification system based on DistilKoBERT, which demonstrated reasonable performance. Despite further efforts to enhance the classification accuracy, this automated occupation classification model holds promise for advancing epidemiological studies in the fields of occupational safety and health.
7.Occupation classification model based on DistilKoBERT: using the 5th and 6th Korean Working Condition Surveys
Tae-Yeon KIM ; Seong-Uk BAEK ; Myeong-Hun LIM ; Byungyoon YUN ; Domyung PAEK ; Kyung Ehi ZOH ; Kanwoo YOUN ; Yun Keun LEE ; Yangho KIM ; Jungwon KIM ; Eunsuk CHOI ; Mo-Yeol KANG ; YoonHo CHO ; Kyung-Eun LEE ; Juho SIM ; Juyeon OH ; Heejoo PARK ; Jian LEE ; Jong-Uk WON ; Yu-Min LEE ; Jin-Ha YOON
Annals of Occupational and Environmental Medicine 2024;36(1):e19-
Accurate occupation classification is essential in various fields, including policy development and epidemiological studies. This study aims to develop an occupation classification model based on DistilKoBERT. This study used data from the 5th and 6th Korean Working Conditions Surveys conducted in 2017 and 2020, respectively. A total of 99,665 survey participants, who were nationally representative of Korean workers, were included. We used natural language responses regarding their job responsibilities and occupational codes based on the Korean Standard Classification of Occupations (7th version, 3-digit codes). The dataset was randomly split into training and test datasets in a ratio of 7:3. The occupation classification model based on DistilKoBERT was fine-tuned using the training dataset, and the model was evaluated using the test dataset. The accuracy, precision, recall, and F1 score were calculated as evaluation metrics. The final model, which classified 28,996 survey participants in the test dataset into 142 occupational codes, exhibited an accuracy of 84.44%. For the evaluation metrics, the precision, recall, and F1 score of the model, calculated by weighting based on the sample size, were 0.83, 0.84, and 0.83, respectively. The model demonstrated high precision in the classification of service and sales workers yet exhibited low precision in the classification of managers. In addition, it displayed high precision in classifying occupations prominently represented in the training dataset. This study developed an occupation classification system based on DistilKoBERT, which demonstrated reasonable performance. Despite further efforts to enhance the classification accuracy, this automated occupation classification model holds promise for advancing epidemiological studies in the fields of occupational safety and health.
8.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.
9.Ruptured triple hormone-secreting adrenal cortical carcinoma with hyperaldosteronism, hypercortisolism, and elevated normetanephrine: a case report
Sin Yung WOO ; Seongji PARK ; Kun Young KWON ; Dong-Mee LIM ; Keun-Young PARK ; Jong-Dai KIM
Journal of Yeungnam Medical Science 2024;41(4):306-311
We report a case of a ruptured triple hormone-secreting adrenal mass with hyperaldosteronism, hypercortisolism, and elevated normetanephrine levels, diagnosed as adrenal cortical carcinoma (ACC) by histology. A 53-year-old male patient who initially presented with abdominal pain was referred to our hospital for angiocoagulation of an adrenal mass rupture. Abdominal computed tomography revealed a heterogeneous 19×11×15 cm right adrenal mass with invasion into the right lobe of the liver, inferior vena cava, retrocaval lymph nodes, and aortocaval lymph nodes. Angiocoagulation was performed. Laboratory evaluation revealed excess cortisol via a positive 1-mg overnight dexamethasone suppression test, primary hyperaldosteronism via a positive saline infusion test, and plasma normetanephrine levels three times higher than normal. An adrenal mass biopsy was performed for pathological confirmation to commence palliative chemotherapy because surgical management was not deemed appropriate considering the extent of the tumor. Pathological examination revealed stage T4N1M1 ACC. The patient started the first cycle of adjuvant mitotane therapy along with adjuvant treatment with doxorubicin, cisplatin, and etoposide, and was discharged. Clinical cases of dual cortisol- and aldosterone-secreting ACCs or ACCs presenting as pheochromocytomas have occasionally been reported; however, both are rare. Moreover, to the best of our knowledge, a triple hormone-secreting ACC has not yet been reported. Here, we report a rare case and its management. This case report underscores the necessity of performing comprehensive clinical and biochemical hormone evaluations in patients with adrenal masses because ACC can present with multiple hormone elevations.
10.Clinical Practice Guidelines for Oropharyngeal Dysphagia
Seoyon YANG ; Jin-Woo PARK ; Kyunghoon MIN ; Yoon Se LEE ; Young-Jin SONG ; Seong Hee CHOI ; Doo Young KIM ; Seung Hak LEE ; Hee Seung YANG ; Wonjae CHA ; Ji Won KIM ; Byung-Mo OH ; Han Gil SEO ; Min-Wook KIM ; Hee-Soon WOO ; Sung-Jong PARK ; Sungju JEE ; Ju Sun OH ; Ki Deok PARK ; Young Ju JIN ; Sungjun HAN ; DooHan YOO ; Bo Hae KIM ; Hyun Haeng LEE ; Yeo Hyung KIM ; Min-Gu KANG ; Eun-Jae CHUNG ; Bo Ryun KIM ; Tae-Woo KIM ; Eun Jae KO ; Young Min PARK ; Hanaro PARK ; Min-Su KIM ; Jungirl SEOK ; Sun IM ; Sung-Hwa KO ; Seong Hoon LIM ; Kee Wook JUNG ; Tae Hee LEE ; Bo Young HONG ; Woojeong KIM ; Weon-Sun SHIN ; Young Chan LEE ; Sung Joon PARK ; Jeonghyun LIM ; Youngkook KIM ; Jung Hwan LEE ; Kang-Min AHN ; Jun-Young PAENG ; JeongYun PARK ; Young Ae SONG ; Kyung Cheon SEO ; Chang Hwan RYU ; Jae-Keun CHO ; Jee-Ho LEE ; Kyoung Hyo CHOI
Journal of the Korean Dysphagia Society 2023;13(2):77-106
Objective:
Dysphagia is a common clinical condition characterized by difficulty in swallowing. It is sub-classified into oropharyngeal dysphagia, which refers to problems in the mouth and pharynx, and esophageal dysphagia, which refers to problems in the esophageal body and esophagogastric junction. Dysphagia can have a significant negative impact one’s physical health and quality of life as its severity increases. Therefore, proper assessment and management of dysphagia are critical for improving swallowing function and preventing complications. Thus a guideline was developed to provide evidence-based recommendations for assessment and management in patients with dysphagia.
Methods:
Nineteen key questions on dysphagia were developed. These questions dealt with various aspects of problems related to dysphagia, including assessment, management, and complications. A literature search for relevant articles was conducted using Pubmed, Embase, the Cochrane Library, and one domestic database of KoreaMed, until April 2021. The level of evidence and recommendation grade were established according to the Grading of Recommendation Assessment, Development and Evaluation methodology.
Results:
Early screening and assessment of videofluoroscopic swallowing were recommended for assessing the presence of dysphagia. Therapeutic methods, such as tongue and pharyngeal muscle strengthening exercises and neuromuscular electrical stimulation with swallowing therapy, were effective in improving swallowing function and quality of life in patients with dysphagia. Nutritional intervention and an oral care program were also recommended.
Conclusion
This guideline presents recommendations for the assessment and management of patients with oropharyngeal dysphagia, including rehabilitative strategies.

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