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.Consideration for Coronavirus Disease 2019 Drug Treatment in Patients with Epilepsy on Antiepileptic Drugs
Jung-Ick BYUN ; Jun-Sang SUNWOO ; Kyung Wook KANG ; Keun Tae KIM ; Daeyoung KIM ; Dong Wook KIM ; Saeyoon KIM ; Se Hee KIM ; Woojun KIM ; Hye-Jin MOON ; Hea Ree PARK ; Jong-Geun SEO ; Min Kyung CHU ; Kyoung Jin HWANG ; Dae-Won SEO ;
Journal of the Korean Neurological Association 2022;40(2):121-126
Several medications are approved to treat coronavirus disease 2019 (COVID-19) in Korea including nirmatrelvir/ritonavir, remdesivir, and regdanvimab. There is potential drug-drug interaction between antiepileptic drugs (AEDs) and the medications used to treat COVID-19. Several AEDs such as phenytoin, carbamazepine, phenobarbital, and primidone are strong cytochrome P450 inducers and can inhibit the drugs used for COVID-19. Particularly, these drugs are contraindicated with nirmatrelvir/ritonavir (Paxlovid®). There is a weaker drug-drug interaction between the AEDs and remdesivir. No significant interaction has been reported between the AEDs and molnupiravir. Pharmacokinetic interactions of the AEDs are important in effective management of COVID-19 in patients with epilepsy.
3.Prevalence and Public Awareness of Sleep Apnea Syndrome in South Korea
Keun Tae KIM ; Hea Ree PARK ; Jae Wook CHO ; Jee Hyun KIM ; Su-Hyun HAN ; Hye-jin MOON ; Seo-Yong LEE ; Yong Won CHO ;
Journal of Sleep Medicine 2022;19(3):133-138
Objectives:
In South Korea, a significant number of patients with obstructive sleep apnea have benefited from the insured continuous positive pressure for sleep apnea as of 2018. However, there is limited information on public awareness of sleep apnea syndrome in the country. A nationwide survey was conducted to evaluate the current status of public awareness on the diagnosis and treatment of sleep apnea.
Methods:
We conducted an online survey using structured questionnaires on symptoms and knowledge of diagnosis and treatment modalities for sleep apnea. A total of 4,000 participants aged 21 to 69 were proportionally allocated according to the residential area, gender, and age group.
Results:
The STOP questionnaire, a screening tool for sleep apnea, revealed that 1,044 (21.6%) scored ≥2 points, 327 (8.1%) scored ≥3 points, and 64 (1.6%) scored 4 points. However, only 19 of the 1,044 patients were being treated for sleep apnea, and 13 had been using continuous positive airway pressure. For the diagnosis of sleep apnea, 1,318 participants (33.0%) responded that polysomnography was necessary. For sleep apnea treatment, 1,954 (48.9%) participants responded that lifestyle modification was the treatment of choice, while 1,036 (25.9%) chose continuous positive pressure.
Conclusions
Although one-fifth were at high risk for sleep apnea, this disorder is still underestimated. Therefore, publicity and support are needed to improve public awareness of sleep apnea.
4.NF-κB signaling regulates cell-autonomous regulation of CXCL10 in breast cancer 4T1 cells.
Won Jong JIN ; Bongjun KIM ; Darong KIM ; Hea Young PARK CHOO ; Hong Hee KIM ; Hyunil HA ; Zang Hee LEE
Experimental & Molecular Medicine 2017;49(2):e295-
The chemokine CXCL10 and its receptor CXCR3 play a role in breast cancer metastasis to bone and osteoclast activation. However, the mechanism of CXCL10/CXCR3-induced intracellular signaling has not been fully investigated. To evaluate CXCL10-induced cellular events in the mouse breast cancer cell line 4T1, we developed a new synthetic CXCR3 antagonist JN-2. In this study, we observed that secretion of CXCL10 in the supernatant of 4T1 cells was gradually increased during cell growth. JN-2 inhibited basal and CXCL10-induced CXCL10 expression and cell motility in 4T1 cells. Treatment of 4T1 cells with CXCL10 increased the expression of P65, a subunit of the NF-κB pathway, via activation of the NF-κB transcriptional activity. Ectopic overexpression of P65 increased CXCL10 secretion and blunted JN-2-induced suppression of CXCL10 secretion, whereas overexpression of IκBα suppressed CXCL10 secretion. These results indicate that the CXCL10/CXCR3 axis creates a positive feedback loop through the canonical NF-κB signaling pathway in 4T1 cells. In addition, treatment of osteoblasts with conditioned medium from JN-2-treated 4T1 cells inhibited the expression of RANKL, a crucial cytokine for osteoclast differentiation, which resulted in an inhibitory effect on osteoclast differentiation in the co-culture system of bone marrow-derived macrophages and osteoblasts. Direct intrafemoral injection of 4T1 cells induced severe bone destruction; however, this effect was suppressed by the CXCR3 antagonist via downregulation of P65 expression in an animal model. Collectively, these results suggest that the CXCL10/CXCR3-mediated NF-κB signaling pathway plays a role in the control of autonomous regulation of CXCL10 and malignant tumor properties in breast cancer 4T1 cells.
Animals
;
Breast Neoplasms*
;
Breast*
;
Cell Line
;
Cell Movement
;
Chemokine CXCL10
;
Coculture Techniques
;
Culture Media, Conditioned
;
Down-Regulation
;
Macrophages
;
Mice
;
Models, Animal
;
Neoplasm Metastasis
;
Osteoblasts
;
Osteoclasts
5.Review of regulatory management on standards and specifications for veterinary medical devices in Korea.
Kyoung Mook KANG ; Tae Won KIM ; Oh Ryun KWON ; Hea Jung PARK ; Soo Min CHO ; Chung Hyun KIM ; Myoung Heon LEE ; Jin San MOON
Korean Journal of Veterinary Research 2017;57(2):71-78
Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
Equipment and Supplies
;
Equipment Safety
;
In Vitro Techniques
;
Indicators and Reagents
;
Korea*
;
Licensure
;
Magnets
;
Needles
6.Effect of intraperitoneal CO₂ concentration on postoperative pain after laparoscopic cholecystectomy.
Ji Won CHUNG ; Kyu Sik KANG ; Sang Hyun PARK ; Chun Sook KIM ; Jin Hun CHUNG ; Sie Hyeon YOO ; Nan Seol KIM ; Yong Han SEO ; Ho Soon JUNG ; Hea Rim CHUN ; Hyung Youn GONG ; Hae Il JUNG ; Sang Ho BAE ; Su Yeon PARK
Annals of Surgical Treatment and Research 2017;93(4):181-185
PURPOSE: This study set out to identify the association between the intraperitoneal CO₂ concentrations and postoperative pain by dividing the participants into a control group and 2 experimental groups receiving irrigation (1 L and 2 L), and directly measuring their intraperitoneal CO₂ concentrations with a CO₂ gas detector. METHODS: A total of 101 patients, American Society of Anesthesiologists physical status classification I and II patients aged 18–65 years were enrolled in the study. Group 1 did not receive irrigation with normal saline, while groups 2 and 3 were administered irrigation with 1 L and 2 L of normal saline, respectively, after laparoscopic cholecystectomy. Intraperitoneal CO₂ concentrations were measured with a CO₂ gas detector through the port, and postoperative pain was assessed on a visual analogue scale at 6, 12, and 24 hours after surgery. RESULTS: The intraperitoneal CO₂ concentrations were 1,016.0 ± 960.3 ppm in group 1, 524.5 ± 383.2 ppm in group 2, and 362.2 ± 293.6 ppm in group 3, showing significantly lower concentrations in groups 2 and 3. Postoperative pain was significantly lower in group 3 at 6 hours after surgery, and in groups 2 and 3 at 12 hours after the surgery. However, there was no significant difference between the 3 groups in postoperative pain 24 hours after the surgery. CONCLUSION: This study found a causal relationship between the amount of normal saline used for irrigation and the intraperitoneal CO₂ concentrations in that irrigation with normal saline reduces pain on the day of the surgery.
Cholecystectomy, Laparoscopic*
;
Classification
;
Humans
;
Pain, Postoperative*
;
Saline Waters
7.A Comparative Study of Oral Cyclosporine and Betamethasone Minipulse Therapy in the Treatment of Alopecia Areata.
Yong Hyun JANG ; Sang Lim KIM ; Kyou Chae LEE ; Min Ji KIM ; Kyung Hea PARK ; Weon Ju LEE ; Seok Jong LEE ; Do Won KIM
Annals of Dermatology 2016;28(5):569-574
BACKGROUND: Various systemic agents have been assessed for the treatment of alopecia areata (AA); however, there is a paucity of comparative studies. OBJECTIVE: To assess and compare cyclosporine and betamethasone minipulse therapy as treatments for AA with regard to effectiveness and safety. METHODS: Data were collected from 88 patients who received at least 3 months of oral cyclosporine (n=51) or betamethasone minipulse therapy (n=37) for AA. Patients with ≥50% of terminal hair regrowth in the alopecic area were considered responders. RESULTS: The responder of the cyclosporine group was 54.9% and that of the betamethasone minipulse group was 37.8%. In the cyclosporine group, patients with mild AA were found to respond better to the treatment. Based on the patient self-assessments, 70.6% of patients in the cyclosporine group and 43.2% of patients in the betamethasone minipulse group rated their hair regrowth as excellent or good. Side effects were less frequent in the cyclosporine group. CONCLUSION: Oral cyclosporine appeared to be superior to betamethasone minipulse therapy in terms of treatment effectiveness and safety.
Alopecia Areata*
;
Alopecia*
;
Betamethasone*
;
Cyclosporine*
;
Hair
;
Humans
;
Pulse Therapy, Drug
;
Self-Assessment
;
Treatment Outcome
8.A Case of Infective Endocarditis caused by Abiotrophia defectiva in Korea.
Seohyun PARK ; Hea Won ANN ; Jin Young AHN ; Nam Su KU ; Sang Hoon HAN ; Geu Ru HONG ; Jun Young CHOI ; Young Goo SONG ; June Myung KIM
Infection and Chemotherapy 2016;48(3):229-233
Abiotrophia defectiva, a nutritionally variant streptococci can cause bacteremia, brain abscess, septic arthritis and in rare cases, infective endocarditis, which accounts for 5-6% of all cases. A. defectiva is characteristically difficult to diagnose and the mortality, morbidity and complication rates are high. Here, we discuss a case of infective endocarditis caused by A. defectiva. A 62-year-old female had previously undergone prosthetic valve replacement 6 years prior to admission. She developed infective endocarditis after tooth extraction. Her endocarditis was successfully treated with antimicrobial therapy and mitral valve replacement surgery. This is the first case of infective endocarditis caused by A. defectiva reported in Korea. This case shows that A. defectiva could be considered as a causative organism of infective endocarditis in Korea.
Abiotrophia*
;
Arthritis, Infectious
;
Bacteremia
;
Brain Abscess
;
Endocarditis*
;
Female
;
Humans
;
Korea*
;
Middle Aged
;
Mitral Valve
;
Mortality
;
Tooth Extraction
9.Fecal Transplantation using a Nasoenteric Tube during an Initial Episode of Severe Clostridium difficile Infection.
Yong Duk JEON ; Namki HONG ; Jung Ho KIM ; Se Hee PARK ; Sung Bae KIM ; In Ji SONG ; Hea Won ANN ; Jin Young AHN ; Sun Bean KIM ; Nam Su KU ; Kyungwon LEE ; Dongeun YONG ; June Myung KIM ; Jun Yong CHOI
Infection and Chemotherapy 2016;48(1):31-35
The incidence of Clostridium difficile infection is increasing worldwide, and its severity and resulting mortality are also on the rise. Metronidazole and oral vancomycin remain the treatments of choice, but there are concerns about treatment failure and the appearance of resistant strains. Furthermore, antibiotic therapy results in recurrence rates of at least 20%. Fecal transplantation may be a feasible treatment option for recurrent C. difficile infection; moreover, it may be an early treatment option for severe C. difficile infection. We report a case of severe C. difficile infection treated with fecal transplantation using a nasoenteric tube during an initial episode. This is the first reported case of fecal transplantation using a nasoenteric tube during an initial episode of C. difficile infection in Korea.
Clostridium difficile*
;
Clostridium*
;
Incidence
;
Korea
;
Metronidazole
;
Mortality
;
Recurrence
;
Treatment Failure
;
Vancomycin
10.Alopecia Areata in the Elderly: A 10-Year Retrospective Study.
Yong Hyun JANG ; Kyung Hea PARK ; Sang Lim KIM ; Hyun Jung LIM ; Weon Ju LEE ; Seok Jong LEE ; Do Won KIM
Annals of Dermatology 2015;27(4):411-416
BACKGROUND: Alopecia areata (AA) is an organ-specific autoimmune disease that typically occurs in young adults. AA in the elderly is relatively rare, thus little data have been reported. OBJECTIVE: This study aimed to understand the clinical characteristics of AA in the elderly. METHODS: We performed a 10-year retrospective study of AA in the elderly who visited our dermatologic clinic from January 2002 to December 2011. A clinical review of medical records and telephone interviews were performed by two dermatologists. RESULTS: Among 1,761 patients with newly diagnosed AA, 61 (3.5%) were older than 60 years at the first visit. Among those who completed a telephone interview, 74.3% (26/35) had less than 50% of scalp-localized hair loss. There was no association between the extent of AA and hair graying (p=0.679). Favorable therapeutic response was observed in 62.9% (22/35) of cases. CONCLUSION: AA in the elderly shows mild disease severity and favorable treatment response. There is no association between graying and the extent of AA. However, the influence of aging on the pathogenesis of AA in the elderly deserves further investigation.
Aged*
;
Aging
;
Alopecia Areata*
;
Alopecia*
;
Autoimmune Diseases
;
Hair
;
Humans
;
Interviews as Topic
;
Medical Records
;
Retrospective Studies*
;
Young Adult

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