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.Metachronous Development of Peritoneal Carcinomatosis in a Patient with Autoimmune Pancreatitis
Kyu Won LEE ; Jae Hyuck CHANG ; Jeana KIM ; Tae Ho KIM ; Chang Whan KIM ; Jae Kwang KIM ; Sok Won HAN
The Korean Journal of Gastroenterology 2020;75(6):356-361
Autoimmune pancreatitis (AIP) is a rare and unique type of chronic pancreatitis. The prognosis of AIP, particularly when associated with pancreatic cancer or a related malignancy, is not known. Only a few cases, where metachronous pancreas-related cancer developed during follow-up, have been reported. Most of these patients either underwent surgery or steroid therapy. This paper reports a case of a 66-year-old woman with untreated type I AIP who developed peritoneal carcinomatosis more than 2 years later. Initially, the patient had a markedly elevated serum IgG4 level and a diffuse, infiltrative mass-like lesion in the pancreatic head, in which the biopsy results were consistent with type I AIP. The patient was not treated with steroids because of a cerebellar infarction. Twenty-eight months after the diagnosis of AIP, peritoneal carcinomatosis developed without noticeable changes in the pancreas from the initial findings.
3.A Ruptured Cystic Artery Pseudoaneurysm with Concurrent Cholecystoduodenal Fistula: A Case Report and Literature Review
Dong Hwi KIM ; Tae Ho KIM ; Chang Whan KIM ; Jae Hyuck CHANG ; Sok Won HAN ; Jae Kwang KIM ; Seung Hwan LEE ; Jeana KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2018;18(2):135-141
Pseudoaneurysms of the cystic artery and cholecystoduodenal fistula formation are rare complications of cholecystitis and either may result from an inflammatory process in the abdomen. A 68-year-old man admitted with acute cholecystitis subsequently developed massive upper gastrointestinal (GI) bleeding. Abdominal computed tomography showed acute calculous cholecystitis and hemobilia secondary to bleeding from the cystic artery. Angiography suggested a ruptured pseudoaneurysm of the cystic artery. Upper GI endoscopy showed a deep active ulcer with an opening that was suspected to be that of a fistula at the duodenal bulb. The patient was managed successfully with multimodality treatment that included embolization followed by elective laparoscopic cholecystectomy. Presently, there is no clear consensus regarding the clinical management of this disease. We have been able to confirm various clinical features, diagnoses, and treatments of this disease through a literature review. A multidisciplinary approach through interagency/interdepartmental collaboration is necessary for better management of this disease.
Abdomen
;
Aged
;
Aneurysm, False
;
Angiography
;
Arteries
;
Cholecystectomy, Laparoscopic
;
Cholecystitis
;
Cholecystitis, Acute
;
Consensus
;
Cooperative Behavior
;
Diagnosis
;
Endoscopy
;
Fistula
;
Hemobilia
;
Hemorrhage
;
Humans
;
Intestinal Fistula
;
Ulcer
4.Endoscopic Resection of Xanthogranulomatous Gastritis Presenting as a Subepithelial Tumor: A Case Report
Tae Wan KIM ; Tae Ho KIM ; Chang Whan KIM ; Jae Hyuck CHANG ; Sok Won HAN ; Jae Kwang KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2018;18(3):198-203
Xanthogranulomatous gastritis (XGG) presenting as a subepithelial tumor (SET) is a very rare entity. We report a case of SET-like XGG diagnosed and treated with endoscopic resection. A 55-year-old female patient was initially referred with a 1.5-cm SET located at the anterior wall of the middle antrum. Endoscopic ultrasound examination revealed submucosal invasion without any perigastric lymph node enlargement. Endoscopic resection was performed for an accurate diagnosis and treatment, and the lesion was diagnosed histopathologically as XGG. At the 18-month follow-up after endoscopic resection, there was no evidence of XGG recurrence. SET-like XGG is very rare and the diagnosis is a preoperative challenge. However, inflammatory tumors should be considered in the differential diagnosis of SET
Diagnosis
;
Diagnosis, Differential
;
Female
;
Follow-Up Studies
;
Gastritis
;
Humans
;
Lymph Nodes
;
Middle Aged
;
Recurrence
;
Ultrasonography
5.A Case of Endoscopically Treated Gastric Lymphangioma.
Mo Eun JUNG ; Tae Ho KIM ; Sok Won HAN
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2016;16(4):235-237
No abstract available.
Lymphangioma*
6.Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery.
Hyung Min JI ; Jun HAN ; Dong San JIN ; Hyunseok SUH ; Yoon Sok CHUNG ; Ye Yeon WON
Clinics in Orthopedic Surgery 2016;8(2):194-202
BACKGROUND: The purpose of this retrospective study was to determine the prevalence of sarcopenia and sarcopenic obesity among patients who underwent orthopedic surgery (OS). METHODS: A total of 222 patients were reviewed immediately after or prior to OS. In the control group, 364 patients from outpatient departments (OPDs) who did not have any OS were enrolled. Whole-body dual-energy X-ray absorptiometry was used to analyze body composition. Skeletal muscle mass was adjusted for height squared, total body weight, and height and fat mass (residuals). Obesity was defined as body mass index (BMI) > 25.0 kg/m2. RESULTS: The prevalence of sarcopenia in the OS group was 25.7%, 44.1%, and 26.6%, respectively, according to the 3 different criteria. The prevalence was significantly lower in the OPD group (6.0%, 33.1%, and 14.8%, respectively). The highest rates of sarcopenia with height-adjusted definition were seen in patients with a femoral neck fracture. In the multivariate analysis, factors associated with sarcopenia were male gender, older age, and lower BMI (odds ratio [OR]: 28.38, 1.03, and 1.83, respectively) when muscle mass was adjusted for height, whereas male gender, older age, and higher BMI were associated with sarcopenia (OR: 1.04, 2.57, and 1.83, respectively) when adjusted for weight. When residuals were used as a cutoff, decreased BMI and total hip bone mineral density (0.1 g/cm2) were independent risk factors associated with sarcopenia (OR: 1.09 and 1.05). The prevalence of sarcopenic obesity ranged from 1.8% to 21.2%. CONCLUSIONS: Our study demonstrated a high prevalence of sarcopenia among OS patients.
Absorptiometry, Photon
;
Body Composition
;
Body Mass Index
;
Body Weight
;
Bone Density
;
Femoral Neck Fractures
;
Hip
;
Humans
;
Male
;
Multivariate Analysis
;
Muscle, Skeletal
;
Obesity*
;
Orthopedics*
;
Outpatients
;
Prevalence
;
Retrospective Studies
;
Risk Factors
;
Sarcopenia*
7.Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery.
Hyung Min JI ; Jun HAN ; Dong San JIN ; Hyunseok SUH ; Yoon Sok CHUNG ; Ye Yeon WON
Clinics in Orthopedic Surgery 2016;8(2):194-202
BACKGROUND: The purpose of this retrospective study was to determine the prevalence of sarcopenia and sarcopenic obesity among patients who underwent orthopedic surgery (OS). METHODS: A total of 222 patients were reviewed immediately after or prior to OS. In the control group, 364 patients from outpatient departments (OPDs) who did not have any OS were enrolled. Whole-body dual-energy X-ray absorptiometry was used to analyze body composition. Skeletal muscle mass was adjusted for height squared, total body weight, and height and fat mass (residuals). Obesity was defined as body mass index (BMI) > 25.0 kg/m2. RESULTS: The prevalence of sarcopenia in the OS group was 25.7%, 44.1%, and 26.6%, respectively, according to the 3 different criteria. The prevalence was significantly lower in the OPD group (6.0%, 33.1%, and 14.8%, respectively). The highest rates of sarcopenia with height-adjusted definition were seen in patients with a femoral neck fracture. In the multivariate analysis, factors associated with sarcopenia were male gender, older age, and lower BMI (odds ratio [OR]: 28.38, 1.03, and 1.83, respectively) when muscle mass was adjusted for height, whereas male gender, older age, and higher BMI were associated with sarcopenia (OR: 1.04, 2.57, and 1.83, respectively) when adjusted for weight. When residuals were used as a cutoff, decreased BMI and total hip bone mineral density (0.1 g/cm2) were independent risk factors associated with sarcopenia (OR: 1.09 and 1.05). The prevalence of sarcopenic obesity ranged from 1.8% to 21.2%. CONCLUSIONS: Our study demonstrated a high prevalence of sarcopenia among OS patients.
Absorptiometry, Photon
;
Body Composition
;
Body Mass Index
;
Body Weight
;
Bone Density
;
Femoral Neck Fractures
;
Hip
;
Humans
;
Male
;
Multivariate Analysis
;
Muscle, Skeletal
;
Obesity*
;
Orthopedics*
;
Outpatients
;
Prevalence
;
Retrospective Studies
;
Risk Factors
;
Sarcopenia*
8.Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.
Beom Jin KIM ; Hyun Soo KIM ; Hyun Joo SONG ; Il Kwun CHUNG ; Gwang Ha KIM ; Byung Wook KIM ; Ki Nam SHIM ; Seong Woo JEON ; Yun Jin JUNG ; Chang Hun YANG ; Ji Hyun KIM ; Tae Ho KIM ; Sang Gyun KIM ; Woon Geon SHIN ; Sun Moon KIM ; Sok Won HAN ; Jun Haeng LEE ; Kyung Ho KIM ; Sue K PARK ; Byung Joo PARK ; Joongyub LEE ; Jae G KIM
Journal of Korean Medical Science 2016;31(8):1246-1253
Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.
Adult
;
Age Factors
;
Aged
;
Anti-Bacterial Agents/*therapeutic use
;
Databases, Factual
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/*drug therapy/microbiology
;
Helicobacter pylori/isolation & purification
;
Humans
;
Internet
;
Logistic Models
;
Male
;
Middle Aged
;
Prospective Studies
;
Proton Pump Inhibitors/*therapeutic use
;
Registries
;
Republic of Korea
;
Treatment Outcome
9.Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.
Beom Jin KIM ; Hyun Soo KIM ; Hyun Joo SONG ; Il Kwun CHUNG ; Gwang Ha KIM ; Byung Wook KIM ; Ki Nam SHIM ; Seong Woo JEON ; Yun Jin JUNG ; Chang Hun YANG ; Ji Hyun KIM ; Tae Ho KIM ; Sang Gyun KIM ; Woon Geon SHIN ; Sun Moon KIM ; Sok Won HAN ; Jun Haeng LEE ; Kyung Ho KIM ; Sue K PARK ; Byung Joo PARK ; Joongyub LEE ; Jae G KIM
Journal of Korean Medical Science 2016;31(8):1246-1253
Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.
Adult
;
Age Factors
;
Aged
;
Anti-Bacterial Agents/*therapeutic use
;
Databases, Factual
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/*drug therapy/microbiology
;
Helicobacter pylori/isolation & purification
;
Humans
;
Internet
;
Logistic Models
;
Male
;
Middle Aged
;
Prospective Studies
;
Proton Pump Inhibitors/*therapeutic use
;
Registries
;
Republic of Korea
;
Treatment Outcome
10.Efficacy of a Once-Monthly Pill Containing Ibandronate and Cholecalciferol on the Levels of 25-Hydroxyvitamin D and Bone Markers in Postmenopausal Women with Osteoporosis.
In Jin CHO ; Ho Yeon CHUNG ; Sung Woon KIM ; Jae Won LEE ; Tae Won LEE ; Hye Soon KIM ; Sin Gon KIM ; Han Seok CHOI ; Sung Hee CHOI ; Chan Soo SHIN ; Ki Won OH ; Yong Ki MIN ; Jung Min KOH ; Yumie RHEE ; Dong Won BYUN ; Yoon Sok CHUNG ; Jeong Hyun PARK ; Dong Jin CHUNG ; Minho SHONG ; Eun Gyoung HONG ; Chang Beom LEE ; Ki Hyun BAEK ; Moo Il KANG
Endocrinology and Metabolism 2015;30(3):272-279
BACKGROUND: The present study evaluated the efficacy of a combination of ibandronate and cholecalciferol on the restoration of the levels of 25-hydroxyvitamin D (25[OH]D) and various bone markers in postmenopausal women with osteoporosis. METHODS: This was a randomized, double-blind, active-controlled, prospective 16-week clinical trial conducted in 20 different hospitals. A total of 201 postmenopausal women with osteoporosis were assigned randomly to one of two groups: the IBN group, which received a once-monthly pill containing 150 mg ibandronate (n=99), or the IBN+ group, which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol (n=102). Serum levels of 25(OH)D, parathyroid hormone (PTH), and various bone markers were assessed at baseline and at the end of a 16-week treatment period. RESULTS: After 16 weeks of treatment, the mean serum levels of 25(OH)D significantly increased from 21.0 to 25.3 ng/mL in the IBN+ group but significantly decreased from 20.6 to 17.4 ng/mL in the IBN group. Additionally, both groups exhibited significant increases in mean serum levels of PTH but significant decreases in serum levels of bone-specific alkaline phosphatase and C-telopeptide of type 1 collagen (CTX) at 16 weeks; no significant differences were observed between the groups. However, in subjects with a vitamin D deficiency, IBN+ treatment resulted in a significant decrease in serum CTX levels compared with IBN treatment. CONCLUSION: The present findings demonstrate that a once-monthly pill containing ibandronate and cholecalciferol may be useful for the amelioration of vitamin D deficiency in patients with postmenopausal osteoporosis. Moreover, this treatment combination effectively decreased serum levels of resorption markers, especially in subjects with a vitamin D deficiency, over the 16-week treatment period.
Alkaline Phosphatase
;
Cholecalciferol*
;
Collagen Type I
;
Female
;
Humans
;
Osteoporosis*
;
Osteoporosis, Postmenopausal
;
Parathyroid Hormone
;
Prospective Studies
;
Vitamin D Deficiency

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