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.Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: Prospective Observational Study Based on Post-Marketing Surveillance Data.
Won Suk CHOI ; Seong Yeol RYU ; Jacob LEE ; Sang Bum HONG ; Joong Sik EOM ; Jonghwan SHIN ; Ki Ho PARK ; Taekgeun OHK ; Jin Won CHUNG ; Doo Ryeon CHUNG ; Dong Kee KIM ; Sang Rok LEE ; Pill Young KIM ; Shin Woo KIM ; Ji Yun NOH ; Joon Young SONG ; Hee Jin CHEONG ; Woo Joo KIM
Journal of Korean Medical Science 2018;33(32):e212-
BACKGROUND: The safety and clinical effectiveness data of peramivir in the real clinical field are limited. A prospective observational study was conducted based on the post-marketing surveillance data to evaluate the post-marketing safety and effectiveness of peramivir in Korean adults with seasonal influenza. METHODS: Among adults aged 20 years or older who were diagnosed with influenza A or B, patients who started peramivir within 48 hours from the initial symptoms of influenza were enrolled. All adverse events (AEs) that occurred within 7 days after administration of peramivir were checked. For the evaluation of effectiveness, changes in the severity of influenza symptoms and daily living performance were examined before and 7 days after the administration of peramivir. The date on which influenza related symptoms disappeared was checked. RESULTS: A total of 3,024 patients were enrolled for safety evaluation and 2,939 patients were for effectiveness evaluation. In the safety evaluation, 42 AEs were observed in 35 (1.16%) patients. The most common AE was fever. AEs were mostly rated as mild in severity. Serious AEs were observed in 10 patients and two of them died. However, both deaths were considered to be less relevant to peramivir. In the effectiveness evaluation, the severity of influenza symptoms decreased by 10.68 ± 4.01 points and daily living performance was improved 5.59 ± 2.16 points. Influenza related symptoms disappeared on average 3.02 ± 2.39 days after peramivir administration. CONCLUSION: Peramivir showed a tolerable safety profile and acceptable effectiveness in Korean adult patients with seasonal influenza.
Adult*
;
Fever
;
Humans
;
Influenza, Human*
;
Observational Study*
;
Prospective Studies*
;
Seasons
;
Treatment Outcome
3.Deficiency of Lipocalin-2 Promotes Proliferation and Differentiation of Osteoclast Precursors via Regulation of c-Fms Expression and Nuclear Factor-kappa B Activation.
Hyun Ju KIM ; Boram OHK ; Woo Youl KANG ; Sook Jin SEONG ; Kyoungho SUK ; Mi Sun LIM ; Shin Yoon KIM ; Young Ran YOON
Journal of Bone Metabolism 2016;23(1):8-15
BACKGROUND: Lipocalin-2 (LCN2), a small glycoprotein, has a pivotal role in diverse biological processes such as cellular proliferation and differentiation. We previously reported that LCN2 is implicated in osteoclast formation induced by receptor activator of nuclear factor-kappa B ligand (RANKL) and macrophage colony-stimulating factor (M-CSF). In the present study, we used a knockout mouse model to further investigate the role of LCN2 in osteoclast development. METHODS: Osteoclastogenesis was assessed using primary bone marrow-derived macrophages. RANKL and M-CSF signaling was determined by immunoblotting, cell proliferation by bromodeoxyuridine (BrdU) enzyme-linked immunosorbent assay (ELISA), and apoptosis by cell death detection ELISA. Bone morphometric parameters were determined using a micro-computed tomography system. RESULTS: Our results showed that LCN2 deficiency increases tartrate-resistant acid phosphatase (TRAP)-positive multinucleated osteoclast formation in vitro, a finding that reflects enhanced proliferation and differentiation of osteoclast lineage cells. LCN2 deficiency promotes M-CSF-induced proliferation of bone marrow macrophages (BMMs), osteoclast precursors, without altering their survival. The accelerated proliferation of LCN2-deficient precursors is associated with enhanced expression and activation of the M-CSF receptor, c-Fms. Furthermore, LCN2 deficiency stimulates the induction of c-Fos and nuclear factor of activated T cells c1 (NFATc1), key transcription factors for osteoclastogenesis, and promotes RANKL-induced inhibitor of kappa B (IkappaBalpha) phosphorylation. Interestingly, LCN2 deficiency does not affect basal osteoclast formation in vivo, suggesting that LCN2 might play a role in the enhanced osteoclast development that occurs under some pathological conditions. CONCLUSIONS: Our study establishes LCN2 as a negative modulator of osteoclast formation, results that are in accordance with our previous findings.
Acid Phosphatase
;
Animals
;
Apoptosis
;
Biological Processes
;
Bone Marrow
;
Bromodeoxyuridine
;
Cell Death
;
Cell Proliferation
;
Enzyme-Linked Immunosorbent Assay
;
Glycoproteins
;
Immunoblotting
;
Macrophage Colony-Stimulating Factor
;
Macrophages
;
Mice
;
Mice, Knockout
;
NF-kappa B
;
Osteoclasts*
;
Phosphorylation
;
RANK Ligand
;
T-Lymphocytes
;
Transcription Factors
4.Identification and partial purification of antibacterial compounds against Streptococcus mutans from Galla Rhois.
Ae Ri SHIN ; Seung Ho OHK ; Choong Ho CHOI ; Suk Jin HONG
Journal of Korean Academy of Oral Health 2016;40(1):3-8
OBJECTIVES: This study aims to identify and partially purify antibacterial compounds against Streptococcus mutans from Galla Rhois extract. METHODS: Galla Rhois was extracted with n-hexane or ethanol and concentrated in a rotary evaporator. The antibacterial effect of the Galla Rhois extract against S. mutans was determined by the paper discdiffusion method with n-hexane, ethanol, methanol, ethyl acetate, dimethyl sulfoxide (DMSO), acetone, and distilled water as the solvents. The active compounds were purified by partition chromatography, thin-layer chromatography (TLC), and high-performance liquid chromatography (HPLC). RESULTS: The antibacterial effect of the n-hexane extract was more effective against S. mutans than the ethanol extract (P<0.05). The antibacterial component of Galla Rhois was partially purified using partition chromatography and HPLC, and the antibacterial activity was confirmed. CONCLUSIONS: The partially purified component of Galla Rhois showed strong antibacterial effect against S. mutans. These results confirm that the antibacterial compounds of Galla Rhois can be used for the prevention of dental caries.
Acetone
;
Chromatography
;
Chromatography, High Pressure Liquid
;
Chromatography, Liquid
;
Chromatography, Thin Layer
;
Dental Caries
;
Dimethyl Sulfoxide
;
Ethanol
;
Methanol
;
Solvents
;
Streptococcus mutans*
;
Streptococcus*
;
Water
5.Growth inhibition effect of Rubus coreanus Miquel on Candida albicans.
Ae Ri SHIN ; Seung Ho OHK ; Choong Ho CHOI ; Suk Jin HONG
Journal of Korean Academy of Oral Health 2015;39(3):168-173
OBJECTIVES: In this study, the growth inhibition effect of Rubus coreanus Miquel on Candida albicans (C. albicans) was observed. METHODS: The Rubus coreanus Miquel was extracted with 70% methanol and concentrated with a rotary evaporator. Antifungal effect of Rubus coreanus Miquel extract on C. albicans was determined by paper disc diffusion method and standard plate count method. Seven different concentrations (2, 4, 8, 15, 30, 60, 120 mg/ml) of the extract were tested by paper disc diffusion method. Two kinds of concentration (8, 60 mg/ml) of the extract were tested using standard plate count method on C. albicans with different incubating time (for 6, 12, 24 hours immediately after the cultivation). Morphological changes of C. albicans cells after exposure to the extract were observed with scanning electron microscopy (SEM) images. RESULTS: The Rubus coreanus Miquel extract showed an antifungal effect on C. albicans in 8, 15, 30, 60, 120 mg/ml of concentrations (P<0.05). The extract with 8 mg/ml of concentration showed about 30% of growth inhibition at 6 h and with 60 mg/ml it showed about 90% of growth inhibition at 24 h. SEM analysis showed damaged surfaces of C. albicans cells when treated with Rubus coreanus Miquel extract. CONCLUSIONS: The Rubus coreanus Miquel might have the potential as a nobel growth inhibitory agent against C. albicans that causes oral infection.
Candida albicans*
;
Candida*
;
Diffusion
;
Methanol
;
Microscopy, Electron, Scanning
6.A Case of Sheehan's Syndrome Presenting Central Diabetes Insipidus.
Dong Jin KIM ; Nan Hee KIM ; Ju Ri PARK ; Sae Jeong YANG ; Hye Suk KIM ; Hye Jin YOO ; Soo Yeon PARK ; Ohk Hyun RYU ; Kye Won LEE ; Hee Young KIM ; Ji A SEO ; Sin Gon KIM ; Kyung Mook CHOI ; Sei Hyun BAIK ; Dong Seop CHOI
Journal of Korean Society of Endocrinology 2006;21(4):333-337
Sheehan's syndrome occurs as a result of ischemic pituitary necrosis due to severe postpartum hemorrhage. The manifestations of this clinical syndrome are most often caused by a deficiency in the hormones produced by the anterior pituitary gland, whereas the neurohypophysis is usually preserved but can be involved in severe cases that manifest as diabetes insipidus. This is a report of Sheehan's syndrome that manifested with diabetes insipidus as presenting symptom 2 month's after delivery. The patient suffered massive bleeding, so received a blood transfusion. A combined pituitary stimulation and water deprivation test revealed deficiencies of not only anterior pituitary hormones, such as growth hormone and prolactin, but also of anti-diuretic hormone. We report this case, with a review of the literature.
Blood Transfusion
;
Diabetes Insipidus
;
Diabetes Insipidus, Neurogenic*
;
Growth Hormone
;
Hemorrhage
;
Humans
;
Hypopituitarism*
;
Necrosis
;
Pituitary Gland, Anterior
;
Pituitary Gland, Posterior
;
Pituitary Hormones, Anterior
;
Postpartum Hemorrhage
;
Prolactin
;
Water Deprivation
7.A Case of Sheehan's Syndrome Presenting Central Diabetes Insipidus.
Dong Jin KIM ; Nan Hee KIM ; Ju Ri PARK ; Sae Jeong YANG ; Hye Suk KIM ; Hye Jin YOO ; Soo Yeon PARK ; Ohk Hyun RYU ; Kye Won LEE ; Hee Young KIM ; Ji A SEO ; Sin Gon KIM ; Kyung Mook CHOI ; Sei Hyun BAIK ; Dong Seop CHOI
Journal of Korean Society of Endocrinology 2006;21(4):333-337
Sheehan's syndrome occurs as a result of ischemic pituitary necrosis due to severe postpartum hemorrhage. The manifestations of this clinical syndrome are most often caused by a deficiency in the hormones produced by the anterior pituitary gland, whereas the neurohypophysis is usually preserved but can be involved in severe cases that manifest as diabetes insipidus. This is a report of Sheehan's syndrome that manifested with diabetes insipidus as presenting symptom 2 month's after delivery. The patient suffered massive bleeding, so received a blood transfusion. A combined pituitary stimulation and water deprivation test revealed deficiencies of not only anterior pituitary hormones, such as growth hormone and prolactin, but also of anti-diuretic hormone. We report this case, with a review of the literature.
Blood Transfusion
;
Diabetes Insipidus
;
Diabetes Insipidus, Neurogenic*
;
Growth Hormone
;
Hemorrhage
;
Humans
;
Hypopituitarism*
;
Necrosis
;
Pituitary Gland, Anterior
;
Pituitary Gland, Posterior
;
Pituitary Hormones, Anterior
;
Postpartum Hemorrhage
;
Prolactin
;
Water Deprivation
8.Clinicopathologic Features of Early Hepatocellular Carcinoma.
Chang Ohk SUNG ; Suk Jin CHOI ; Cheol Keun PARK
Korean Journal of Pathology 2004;38(3):138-144
BACKGROUND: Early hepatocellular carcinoma (HCC) is an early stage HCC, and it is sometimes difficult to identify the margins of the cancer nodules in the resected specimens. METHODS: We studied 22 cases of early HCC to investigate the clinicopathologic features of early stage HCC. RESULTS: Seven of 22 cases were single HCC, and 15 were multicentric HCC. The average tumor size was 1.34 cm (0.4-2.7 cm). Early HCCs didn't destroy the basic architecture of the liver lobules or pseudolobules and the lesions had an indistinct margin. Most tumors were uniformly composed of well-differentiated cancer tissue that was characterized by an increased cell density and an irregular thin-trabecular pattern. The tumor retained a varying number of portal tracts. There was a replacing growth pattern at the tumor-nontumor boundary without tumor capsule. Three of 22 cases had a "nodule-in-nodule" lesion, and the inner nodules consisted of moderately differentiated HCC without portal tracts. All 22 cases showed no vascular invasion. All 7 patients with single early HCC have survived for the past 11-54 months without any local recurrence. But in one patient with single early HCC, multicentric HCC developed 20 months after surgery. CONCLUSION: The clinicopathologic features of early HCCs are quite different from those of advanced HCCs. The increased recognition of early HCC during routine clinical practice will contribute to improved patient survival.
Carcinoma, Hepatocellular*
;
Cell Count
;
Humans
;
Liver
;
Recurrence
9.Use of 2-Octylcyanoacrylate(Dermabond(R)) for Repair of Pediatric Facial Lacerations.
Kyung Suk KOH ; Sang Yup YOON ; Jae Jin OHK
Journal of the Korean Cleft Palate-Craniofacial Association 2002;3(2):137-140
This study is to compare a tissue adhesive, 2-octylcyanoacrylate(Dermabond(R)), with conventional wound closure techniques for pediatric facial lacerations. Twenty children presenting to Asan Medical Center Emergency Department with facial lacerations in July 2001 were enrolled into this prospective clinical trial study. These patients were randomly assigned to treatment with either 2-octylcyanoacrylate or 6-0 monofilament sutures. The two groups were similar in both clinical and demographic characteristics. Photography taken at three months after treatment were rated by two plastic surgeons blinded to the method of closure. There was no difference between the two groups for appearance scores based on a visual analog scale(60.4mm for 2-octylcyanoacrylate versus 62.9mm for 6-0 monofilament sutures). The length of time for laceration repair was decreased in the 2-octylcyanoacrylate group(3.1 minutes for 2-octylcyanoacrylate versus 9.3 minutes for 6-0 monofilament sutures, p<0.001). The parents' assessment of the pain felt by their children in the 2-octylcyanoacrylate group was less. Moreover, the use of 2-octylcyanoacrylate obviates the need for suture removal. In conclusion, the use of 2-octylcyanoacrylate for pediatric facial laceration repair in Korean is an acceptable alternative which includes many advantages to conventional suturing with a comparable cosmetic outcome.
Child
;
Chungcheongnam-do
;
Emergency Service, Hospital
;
Humans
;
Lacerations*
;
Photography
;
Prospective Studies
;
Sutures
;
Tissue Adhesives
;
Wound Closure Techniques
10.A Case of Ehlers-Danlos Syndrome Accompanied by Mitral Valvular Prolapse and Atrial Septal Defect.
Jin Woo KIM ; In Suk JUNG ; Kyung Soo LIM ; Yung Mi CHOI ; Jae Cheol CHOI ; Jong Han OHK ; Dong Ryong SHU
Korean Circulation Journal 1990;20(2):265-270
Ehlers-Danlos Syndrome(EDS) is an inherited disorder of the connective tissue disease that is usually transmitted as autosomal dominant trait. The defect in the biogenesis of collagen results in varying degree of skin hyperextensibility, joint hypermobility, skin fragility and bruising. There have been several reports of cardiac or great vessel abnormalities in patients with the EDS. A 45-year-old Woman was admitted to Maryknoll hospital because of orthopnea, palpitation and epigastric discomfort. Physical examination reveals multiple variable sized bruises and increased hyperelasticity on skin, and hypermobile joint in knee and proximal interphalanges of both hands. Mitral valvular prolapse and atrial septal defect were detected by echocardiography. We report a case of EDS accompanied by mitral valvular prolapse and ostium secundum atral septal defect with brief review of literature.
Organelle Biogenesis
;
Collagen
;
Connective Tissue Diseases
;
Contusions
;
Echocardiography
;
Ehlers-Danlos Syndrome*
;
Female
;
Hand
;
Heart Septal Defects, Atrial*
;
Humans
;
Joint Instability
;
Joints
;
Knee
;
Middle Aged
;
Physical Examination
;
Prolapse*
;
Skin

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