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.Does anti-thymocyte globulin have a place in busulfan/fludarabine conditioning for matched related donor hematopoietic stem cell transplantation?.
Young Sok JI ; Min Sung LEE ; Chang Wook MIN ; Seong Kyu PARK ; Se Hyung KIM ; Jina YUN ; Hyun Jung KIM ; Kyoung Ha KIM ; Chan Kyu KIM ; Kyu Taek LEE ; Jong Ho WON ; Dae Sik HONG
The Korean Journal of Internal Medicine 2016;31(4):750-761
BACKGROUND/AIMS: There is controversy about the prophylactic effect of anti-thymocyte globulin (ATG) on graft versus host disease (GVHD) in the setting of matched related-donor hematopoietic stem cell transplantation (HSCT). This study assessed the inf luences of ATG on the incidences of acute and chronic GVHD and other clinical outcomes in matched related-donor HSCT. METHODS: Sixty-one patients received allogeneic HSCT from human leukocyte antigen-matched, related donors. Patients received busulfan/fludarabine conditioning regimens and standard GVHD prophylaxis with or without additional ATG. RESULTS: There was no significant difference in the cumulative incidences of overall acute GVHD, grade II to IV acute GVHD at day 100, and chronic GVHD during the follow-up period between the ATG and non-ATG groups. Three-year overall survival rates were very similar, but three year disease-free survival of the non-ATG group was higher than that of the ATG group (56.2% for ATG vs. 63.1% for non-ATG, p = 0.597). Relapse rate at 3 years in the ATG group was slightly higher than that of the non-ATG group (37.5% vs. 20%, p = 0.29). Non-relapse mortality rate at 3 years was lower in the ATG group (6.25% vs. 15.6%, p = 0.668). CONCLUSIONS: Although the addition of ATG doesn't guarantee a reduction in the incidences of acute and chronic GVHD, pre-transplantation ATG may result in lower non-relapse mortality in the context of matched related-donor HSCT with a busulfan/fludarabine conditioning regimen. However, caution is needed when using ATG because of a possibility to increase relapse rate.
Antilymphocyte Serum*
;
Disease-Free Survival
;
Follow-Up Studies
;
Graft vs Host Disease
;
Hematopoietic Stem Cell Transplantation*
;
Hematopoietic Stem Cells*
;
Humans
;
Incidence
;
Leukocytes
;
Mortality
;
Recurrence
;
Survival Rate
;
Tissue Donors*
6.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
7.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
8.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
9.A Case of Acute Phlegmonous Gastritis Diagnosed with Endoscopic Submucosal Biopsy and Bacterial Culture and Improved by Antibiotics Treatment.
Mi Ae SONG ; Jae Hyuck CHANG ; Mo Eun JUNG ; Sang Won SON ; Tae Ho KIM ; Chang Whan KIM ; Sok Won HAN
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2013;13(3):202-206
Phlegmonous gastritis is a rare disease of acute suppurative inflammation in the stomach wall. It is rapidly progressive and potentially fatal. Its mortality rate remains very high because the clinical diagnosis is often delayed. Many patients with phlegmonous gastritis undergo surgery. We present the case of 63-year-old woman with epigastric pain, fever, nausea and vomiting. The presumed diagnosis of acute phlegmonous gastritis was made by esophagogastroduodenoscopy, abdominal computed tomography, endoscopic ultrasonography and deep submucosal biopsy assisted with hook knife. Acinetobacter baumannii was cultured in the aspiration from the stomach. We treated the patient with antibiotics alone. Early recognition of phlegmonous gastritis by endoscopic biopsies and bacteriological study may improve the prognosis of these patient.
Acinetobacter baumannii
;
Anti-Bacterial Agents
;
Biopsy
;
Biopsy, Needle
;
Cellulitis
;
Endoscopy, Digestive System
;
Endosonography
;
Female
;
Fever
;
Gastritis
;
Humans
;
Inflammation
;
Middle Aged
;
Nausea
;
Prognosis
;
Rare Diseases
;
Stomach
;
Vomiting
10.Noninvasive predictors of nonalcoholic steatohepatitis in Korean patients with histologically proven nonalcoholic fatty liver disease.
Young Seok KIM ; Eun Sun JUNG ; Wonhee HUR ; Si Hyun BAE ; Jong Young CHOI ; Myeong Jun SONG ; Chang Wook KIM ; Se Hyun JO ; Chang Don LEE ; Young Sok LEE ; Sang Wook CHOI ; Jin Mo YANG ; Jeong Won JANG ; Sang Gyune KIM ; Seung Won JUNG ; Hee Kyung KIM ; Hee Bok CHAE ; Seung Kew YOON
Clinical and Molecular Hepatology 2013;19(2):120-130
BACKGROUND/AIMS: The aims of this study were (1) to identify the useful clinical parameters of noninvasive approach for distinguishing nonalcoholic steatohepatitis (NASH) from nonalcoholic fatty liver disease (NAFLD), and (2) to determine whether the levels of the identified parameters are correlated with the severity of liver injury in patients with NASH. METHODS: One hundred and eight consecutive patients with biopsy-proven NAFLD (age, 39.8+/-13.5 years, mean+/-SD; males, 67.6%) were prospectively enrolled from 10 participating centers across Korea. RESULTS: According to the original criteria for NAFLD subtypes, 67 patients (62.0%) had NASH (defined as steatosis with hepatocellular ballooning and/or Mallory-Denk bodies or fibrosis > or =2). Among those with NAFLD subtype 3 or 4, none had an NAFLD histologic activity score (NAS) below 3 points, 40.3% had a score of 3 or 4 points, and 59.7% had a score >4 points. Fragmented cytokeratin-18 (CK-18) levels were positively correlated with NAS (r=0.401), as well as NAS components such as lobular inflammation (r=0.387) and ballooning (r=0.231). Fragmented CK-18 was also correlated with aspartate aminotransferase (r=0.609), alanine aminotransferase (r=0.588), serum ferritin (r=0.432), and the fibrosis stage (r=0.314). A fragmented CK-18 cutoff level of 235.5 U/L yielded sensitivity, specificity, and positive and negative predictive values of 69.0%, 64.9%, 75.5% (95% CI 62.4-85.1), and 57.1% (95% CI 42.2-70.9), respectively, for the diagnosis of NASH. CONCLUSIONS: Serum fragmented CK-18 levels can be used to distinguish between NASH and NAFL. Further evaluation is required to determine whether the combined measurement of serum CK-18 and ferritin levels improves the diagnostic performance of this distinction.
Adult
;
Aged
;
Aged, 80 and over
;
Alanine Transaminase/blood
;
Asian Continental Ancestry Group
;
Aspartate Aminotransferases/blood
;
Biological Markers/blood
;
Fatty Liver/classification/metabolism/*pathology
;
Female
;
Ferritins/blood
;
Fibrosis/complications
;
Humans
;
Keratin-18/analysis
;
Male
;
Middle Aged
;
Predictive Value of Tests
;
Prospective Studies
;
Republic of Korea
;
Severity of Illness Index
;
Young Adult

Result Analysis
Print
Save
E-mail