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.Four Novel Synthetic Tryptamine Analogs Induce Head-Twitch Responses and Increase 5-HTR2a in the Prefrontal Cortex in Mice
Arvie ABIERO ; In Soo RYU ; Chrislean Jun BOTANAS ; Raly James Perez CUSTODIO ; Leandro Val SAYSON ; Mikyung KIM ; Hyun Jun LEE ; Hee Jin KIM ; Joung-Wook SEO ; Min Chang CHO ; Kun Won LEE ; Sung Yeun YOO ; Choon-Gon JANG ; Yong Sup LEE ; Jae Hoon CHEONG
Biomolecules & Therapeutics 2020;28(1):83-91
Tryptamines are monoamine alkaloids with hallucinogenic properties and are widely abused worldwide. To hasten the regulations of novel substances and predict their abuse potential, we designed and synthesized four novel synthetic tryptamine analogs: Pyrrolidino tryptamine hydrochloride (PYT HCl), Piperidino tryptamine hydrochloride (PIT HCl), N,N-dibutyl tryptamine hydrochloride (DBT HCl), and 2-Methyl tryptamine hydrochloride (2-MT HCl). Then, we evaluated their rewarding and reinforcing effects using the conditioned place preference (CPP) and self-administration (SA) paradigms. We conducted an open field test (OFT) to deter-mine the effects of the novel compounds on locomotor activity. A head-twitch response (HTR) was also performed to characterize their hallucinogenic properties. Lastly, we examined the effects of the compounds on 5-HTR1a and 5-HTR2a in the prefrontal cortex using a quantitative real-time polymerase chain reaction (qRT-PCR) assay. None of the compounds induced CPP in mice or initiated SA in rats. PYT HCl and PIT HCl reduced the locomotor activity and elevated the 5-HTR1a mRNA levels in mice. Acute and repeated treatment with the novel tryptamines elicited HTR in mice. Furthermore, a drug challenge involving a 7-day abstinence from drug use produced higher HTR than acute and repeated treatments. Both the acute treatment and drug challenge increased the 5-HTR2a mRNA levels. Ketanserin blocked the induced HTR. Taken together, the findings suggest that PYT HCl, PIT HCl, DBT HCl, and 2-MT HCl produce hallucinogenic effects via 5-HTR2a stimulation, but may have low abuse potential.
3.Guidelines for the Surgical Management of Oral Cancer: Korean Society of Thyroid-Head and Neck Surgery
Young hoon JOO ; Jae keun CHO ; Bon seok KOO ; Minsu KWON ; Seong keun KWON ; Soon young KWON ; Min su KIM ; Jeong kyu KIM ; Heejin KIM ; Innchul NAM ; Jong lyel ROH ; Young min PARK ; Il seok PARK ; Jung je PARK ; Sung chan SHIN ; Soon hyun AHN ; Seongjun WON ; Chang hwan RYU ; Tae mi YOON ; Giljoon LEE ; Doh young LEE ; Myung chul LEE ; Joon kyoo LEE ; Jin choon LEE ; Jae yol LIM ; Jae won CHANG ; Jeon yeob JANG ; Man ki CHUNG ; Yuh seok JUNG ; Jae gu CHO ; Yoon seok CHOI ; Jeong seok CHOI ; Guk haeng LEE ; Phil sang CHUNG
Clinical and Experimental Otorhinolaryngology 2019;12(2):107-144
Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to provide guidance on the implementation of a surgical treatment of oral cancer. MEDLINE databases were searched for articles on subjects related to “surgical management of oral cancer” published in English. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. The quality of evidence was rated with use RoBANS (Risk of Bias Assessment Tool for Nonrandomized Studies) and AMSTAR (A Measurement Tool to Assess the Methodological Quality of Systematic Reviews). Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. Additional directives are provided as expert opinions and Delphi questionnaire when insufficient evidence existed. The Committee developed 68 evidence-based recommendations in 34 categories intended to assist clinicians and patients and counselors, and health policy-makers. Proper surgical treatment selection for oral cancer, which is directed by patient- and subsite-specific factors, remains the greatest predictor of successful treatment outcomes. These guidelines are intended for use in conjunction with the individual patient's treatment goals.
Advisory Committees
;
Bias (Epidemiology)
;
Carcinoma, Squamous Cell
;
Counseling
;
Expert Testimony
;
Humans
;
Mouth Neoplasms
;
Neck
;
Republic of Korea
4.Guidelines for the Surgical Management of Laryngeal Cancer: Korean Society of Thyroid-Head and Neck Surgery.
Soon Hyun AHN ; Hyun Jun HONG ; Soon Young KWON ; Kee Hwan KWON ; Jong Lyel ROH ; Junsun RYU ; Jun Hee PARK ; Seung Kuk BAEK ; Guk Haeng LEE ; Sei Young LEE ; Jin Choon LEE ; Man Ki CHUNG ; Young Hoon JOO ; Yong Bae JI ; Jeong Hun HAH ; Minsu KWON ; Young Min PARK ; Chang Myeon SONG ; Sung Chan SHIN ; Chang Hwan RYU ; Doh Young LEE ; Young Chan LEE ; Jae Won CHANG ; Ha Min JEONG ; Jae Keun CHO ; Wonjae CHA ; Byung Joon CHUN ; Ik Joon CHOI ; Hyo Geun CHOI ; Kang Dae LEE
Clinical and Experimental Otorhinolaryngology 2017;10(1):1-43
Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to develop clinical practice guidelines for the surgical treatment of laryngeal cancer. This Task Force conducted a systematic search of the EMBASE, MEDLINE, Cochrane Library, and KoreaMed databases to identify relevant articles, using search terms selected according to the key questions. Evidence-based recommendations were then created on the basis of these articles. An external expert review and Delphi questionnaire were applied to reach consensus regarding the recommendations. The resulting guidelines focus on the surgical treatment of laryngeal cancer with the assumption that surgery is the selected treatment modality after a multidisciplinary discussion in any context. These guidelines do not, therefore, address non-surgical treatment such as radiation therapy or chemotherapy. The committee developed 62 evidence-based recommendations in 32 categories intended to assist clinicians during management of patients with laryngeal cancer and patients with laryngeal cancer, and counselors and health policy-makers.
Advisory Committees
;
Consensus
;
Counseling
;
Drug Therapy
;
Glottis
;
Humans
;
Laryngeal Neoplasms*
;
Neck*
5.Negative Effect of Rapidly Resorbing Properties of Bioactive Glass-Ceramics as Bone Graft Substitute in a Rabbit Lumbar Fusion Model.
Jae Hyup LEE ; Hyun Seung RYU ; Jun Hyuk SEO ; Do Yoon LEE ; Bong Soon CHANG ; Choon Ki LEE
Clinics in Orthopedic Surgery 2014;6(1):87-95
BACKGROUND: Bioactive glass-ceramics have the ability to directly bind to bones and have been widely used as bone graft substitutes due to their high osteoconductivity and biocompatibility. CaO-SiO2-P2O5-B2O3 glass-ceramics are known to have good osteoconductivity and are used as bone graft extenders. METHODS: This study aimed to evaluate the effects of the resorbing properties of glass-ceramics in bone fusion after producing and analyzing three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with high osteoconductivity that had enhanced resorption by having an increased B2O3 content. The three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with B2O3 contents of 8.0, 9.0, and 9.5 weight % were designated and grouped as P20B80, P10B90, and P5B95, respectively. Glass-ceramic types were tested for fusion rates and bone formation by employing the lumbar 5-6 intertransverse process fusion model in 51 New Zealand male rabbits. Bioactivity was assessed by soaking in simulated body fluid (SBF). RESULTS: In vitro study results showed sufficient hydroxycarbonate apatite layer formation occurred for P20B80 in1 day, for P10B90 in 3 days, and for P5B95 in 5 days after soaking in SBF. For the rabbit lumbar spine posterolateral fusion model, the autograft group recorded a 100% fusion rate with levels significantly higher than those of P20B80 (29.4%), P10B90 (0%), and P5B95 (14.3%), with high resorbing properties. Resorbing property differences among the three glass-ceramic groups were not significant. Histological results showed new bone formation confirming osteoconductivity in all three types of glass-ceramics. Radiomorphometric results also confirmed the resorbing properties of the three glass-ceramic types. CONCLUSIONS: The high resorbing properties and osteoconductivity of porous glass-ceramics can be advantageous as no glass-ceramics remain in the body. However, their relatively fast rate of resorption in the body negatively affects their role as an osteoconductive scaffold as glass-ceramics are resorbed before bony fusion.
Animals
;
Bone Resorption
;
Bone Substitutes/adverse effects/*therapeutic use
;
Ceramics/adverse effects/*therapeutic use
;
Electric Conductivity
;
Lumbosacral Region/*surgery
;
Male
;
Rabbits
;
Spinal Fusion/*methods
6.Clinical Characteristics of Idiopathic Pulmonary Fibrosis Patients with Diabetes Mellitus: the National Survey in Korea from 2003 to 2007.
Yu Jin KIM ; Jeong Woong PARK ; Sun Young KYUNG ; Sang Pyo LEE ; Man Pyo CHUNG ; Young Hwan KIM ; Jae Ho LEE ; Yong Chul KIM ; Jong Seon RYU ; Hong Lyeol LEE ; Choon Sik PARK ; Soo Tak UH ; Young Chul LEE ; Kwan Hyung KIM ; Young Joon CHUN ; Young Bum PARK ; Dong Soon KIM ; Yongjin JEGAL ; Jin Hwa LEE ; Moo Suk PARK ; Sung Hwan JEONG
Journal of Korean Medical Science 2012;27(7):756-760
Evidence suggests that diabetes mellitus (DM) is associated with idiopathic pulmonary fibrosis (IPF). According to the new IPF guidelines, high-resolution computed tomography (HRCT) is an essential means of diagnosing IPF. We investigated the relationship between IPF and DM in patients treated between 2003 and 2007. Newly diagnosed IPF patients in large university teaching hospitals in Korea were enrolled from January 2003 to December 2007. We retrospectively analyzed 1,685 patients using the interstitial lung disease (ILD) registry. In total, 299 IPF patients (17.8%) also had DM. The mean age of our subjects was 68.0 +/- 9.4 yr. HRCT showed significantly more reticular and honeycomb patterns in IPF patients with DM than in IPF patients without DM (P = 0.014, P = 0.028, respectively). Furthermore, significantly higher incidences of hypertension, cardiovascular diseases, and other malignancies (except lung cancer) were found in IPF patients with DM than in IPF patients without DM. In conclusion, IPF patients with DM are more likely to have the usual interstitial pneumonia (UIP) pattern, including reticular and honeycomb patterns, on HRCT than are those without DM.
Aged
;
Cardiovascular Diseases/epidemiology/etiology
;
Diabetes Mellitus, Type 2/*complications
;
Female
;
Humans
;
Hypertension/epidemiology/etiology
;
Idiopathic Pulmonary Fibrosis/complications/*diagnosis/radiography
;
Incidence
;
Male
;
Middle Aged
;
Neoplasms/epidemiology/etiology
;
Registries
;
Republic of Korea/epidemiology
;
Retrospective Studies
;
Tomography, X-Ray Computed
7.The Effect of Angle on the Position of the Catheter Tip in Paramedian Approach of Thoracic Epidural Catheterization.
Choon Gun RYU ; Ho Geol RYU ; Chul Joong LEE ; Jae Hyon BAHK
Anesthesia and Pain Medicine 2007;2(4):262-265
BACKGROUND: Thoracic epidural analgesia is the mainstay of postoperative pain control after thoracotomy. Usually the epidural catheter is blindly inserted and secured without confirming the tip position. The purpose of this study was to determine the influence of epidural approach angle on the position of the thoracic epidural catheter tip. METHODS: 129 patients scheduled for thoracotomy were enrolled. Patients were randomized into two groups: narrow angle group and wide angle group. The epidural needle was inserted at the skin of T8-9 level in both groups. In the narrow angle group the epidural space was approached at T7-8, whereas in the wide angle group the epidural space was approached at T6-7. After epidural space confirmation, a B-D nylon multi-hole epidural catheter was threaded 8cm into the epidural space. The epidural catheter tip position was assessed using a small amount of radiocontrast dye under fluoroscopy. RESULTS: The mean (95% confidence interval) position of the catheter tip was the mid-body of T5 (T5-6 - T5 upper body) in the narrow angle group and T3-4 (mid-body of T4-T3 lower body) in the wide angle group (P = 0.037). CONCLUSIONS: When approaching the thoracic epidural space by a wide angle, we can place the epidural catheters at a higher level because of a straighter threading.
Analgesia
;
Analgesia, Epidural
;
Catheterization*
;
Catheters*
;
Epidural Space
;
Fluoroscopy
;
Humans
;
Needles
;
Nylons
;
Pain, Postoperative
;
Skin
;
Thoracic Surgery
;
Thoracotomy
8.Multivessel Coronary Revascularization with Composite LITA-RA Y Graft.
Sub LEE ; Oh Choon KWON ; Moo Sung KO ; Ki Sung PARK ; Jae Kean RYU ; Jae Suk JANG
The Korean Journal of Thoracic and Cardiovascular Surgery 2006;39(5):359-365
BACKGROUND: Arterial grafts have been used to achieve better long-term results for coronary revascularization. Bilateral internal thoracic artery (ITA) grafts have a better results, but it may be not used in some situations such as diabetes and chronic obstructive pulmonary disease (COPD). We evaluated the clinical and angiographic results of composite left internal thoracic artery-radial artery (LITA-RA) Y graft. MATERIAL AND METHOD: Between April 2002 and September 2004, 119 patients were enrolled in composite Y graft for coronary bypass surgery. The mean age was 62.6+/-8.8 years old and female was 34.5%. Preoperative cardiac risk factors were as follows: hypertension 43.7%, diabetes 33.6%, smoker 41.2%, and hyperlipidemia 22.7%. There were emergency operation (14), cardiogenic shock (6), left ventricle ejection fraction (LVEF) less than 40% (17), and 17 cases of left main disease. Coronary angiography was done in 35 patients before the hospital discharge. RESULT: The number of distal anastomoses was 3.1+/-0.91 and three patients (2.52%) died during hospital stay. The off-pump coronary artery bypass (OPCAB) was applied to 79 patients (66.4%). The LITA was anastomosed to left anterior descending system except three cases which was to lateral wall. The radial Y grafts were anastomosed to diagonal branches (4), ramus intermedius (21), obtuse marginal branches (109), posterolateral branches (12), and posterior descending coronary artery (8). Postoperative coronary angiography in 35 patients showed excellent patency rates (LITA 100%,and RA 88.5%; 3 RA grafts which anastomosed to coronary arteries <70% stenosed showed string sign with competitive flow). CONCLUSION: The LITA-RA Y composite graft provided good early clinical and angiographic results in multivessel coronary revascularization. But it should be cautiously used in selected patients.
Arteries
;
Coronary Angiography
;
Coronary Artery Bypass
;
Coronary Artery Bypass, Off-Pump
;
Coronary Vessels
;
Emergencies
;
Female
;
Heart Ventricles
;
Humans
;
Hyperlipidemias
;
Hypertension
;
Length of Stay
;
Mammary Arteries
;
Pulmonary Disease, Chronic Obstructive
;
Radial Artery
;
Risk Factors
;
Shock, Cardiogenic
;
Transplants*
9.Evaluation of Osteosynthesis in CaO-SiO2-P2O5-B2O3 Glass-ceramics by Posterolateral Fusion of Rabbit Lumbar vertebrae.
Jae Hyup LEE ; Kun Woo PARK ; Kwang Sup SONG ; Hyun Seung RYU ; Jun Hyuk SEO ; Kug Sun HONG ; Hwan KIM ; Bong Soon CHANG ; Choon Ki LEE
Journal of Korean Society of Spine Surgery 2005;12(1):1-11
STUDY DESIGN: A comparative in vivo study between ceramics with different compositions. OBJECTIVES: To compare the biodegradation and osteoconduction properties of CaO-SiO2- P2O5- B2O3 glass-ceramics and Cerabone(R)-AW. Summary of Literature Review: Bioglass ceramics can be used as bone graft substitutes. However, no study has been undertaken to investigate the possibility of CaO-S i O2-P2O5-B2O3 glass-ceramics as a bone graft substitute. MATERIALS AND METHODS: Porous CSPB2 implants (44.07% CaO, 40.28% SiO2, 8.1% P2O5 and 5.0% B2O3), porous CSPB3 implants (43.76% CaO, 43.41% SiO2, 4.05% P2O5 and 7.5% B2O3) and porous Cerabone(R)-AW were prepared by the polymer sponge method. Single-level posterolateral spinal fusions were performed on sixty New Zealand white male rabbits. The animals were divided into four groups (9 of autograft, 17 per 3 kind of porous implant group) according to the implant material used: autograft, CSPB2, CSPB3 and Cerabone(R)-AW. Radiographs were performed every two weeks. All animals were sacrificed 12 weeks after surgery. Manual palpation and uniaxial tensile strength were determined. The proportion of the area occupied by the ceramics in the final compared to the initial radiographs was calculated. Decalcified and undecalcified histological sections were evaluated by light microscopy. RESULTS: Fifty one rabbits were evaluated. The union rates were 100 (9 out of 9), 80 (8 out of 8), 81.1 (9 out of 11) and 90.9% (10 out of 11) in the autograft, Cerabone(R)-AW, CSPB2 and CSPB3 groups, respectively. The proportion of the area occupied by Cerabone(R)-AW (90.8 % +/- 14.0) was significantly higher than for CSPB2 (73.1% +/- 11.5) and CSPB3 (73.5% +/- 10.0)(p=0.0011). The mean values of the tensile strengths of Cerabone(R)-AW (214. +/- 57.3N), CSPB2 (214. +/- 57.3 N) and CSPB3 (217 +/- 70.1 N) were not significantly different (p>0.05). CONCLUSION: CSPB2 and CSPB3 had similar tensile strengths and fusion rates of the fusion masses as those of Cerabone(R)-AW; however, they degraded more rapidly than Cerabone(R)-AW. These findings suggest that CSPB2 and CSPB3 grafts can be used as a more ideal new bone graft substitutes than Cerabone(R)-AW.
Animals
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Autografts
;
Bone Regeneration
;
Ceramics
;
Humans
;
Lumbar Vertebrae*
;
Male
;
Microscopy
;
New Zealand
;
Palpation
;
Polymers
;
Porifera
;
Rabbits
;
Spinal Fusion
;
Tensile Strength
;
Transplants
10.Evaluation of Osseointegration in Dense Ceramics Using Rabbit's External Fixation Model.
Jae Hyup LEE ; Dong Ho LEE ; Jae Hag LEE ; Hyun Sik GONG ; Young Joon AHN ; Hyun Seung RYU ; Jun Hyuk SEO ; Kug Sun HONG ; Hwan KIM ; Bong Soon CHANG ; Choon Ki LEE
Journal of Korean Orthopaedic Research Society 2003;6(2):151-162
PURPOSE: To evaluate the osseointegration of different dense ceramics. MATERIALS AND METHODS: Twenty-eight New Zealand white male rabbits were divided into 4 groups by implant materials: Cerabone(R)-AW, CaO-SiO2- B2O3 glass ceramics (CS10B), CaO-SiO2- B2O3 glass (CS5B glass) and Cerabone(R)- A W + A l2O3 glass ceramics. We implanted the dense ceramics into the tibia of rabbits with external fixator and checked the radiographs every 4 weeks. The union rate, histology and SEM were evaluated 8 weeks after surgery. RESULTS: The union rates were 85.7% (6 of 7) in Cerabone(R)-AW, 85.7% (6 of 7) in CS10B, 71.4% (5 of 7) in CS5B glass and 28.6% (2 of 7) in Cerabone(R)-AW+Al2O3 by simple radiographs. The union rates of Cerabone (R)-AW and CS10B were statistically higher than that of Cerabone(R)-AW+Al2O3 (p=0.031). Histologically, the Cerabone(R)-AW had fused with tibia without biodegradation, CS10B, CS5B glass had fused with tibia in some portion but resorbed in others. Cerabone(R)-AW+Al2O3 had not fused with bony tissue. CONCLUSION: We confirmed the osseointegration and insolubility of Cerabone(R)-AW. We also confirmed the osseointegration and partial solubility of CaO-SiO2-B2O3 glass ceramics. These findings suggest that Cerabone (R)-AW can be used as an insoluble artificial bone and CaO-SiO2-B2O3 glass ceramics as biodegradable bone replacement materials.
Bone Substitutes
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Ceramics*
;
External Fixators
;
Glass
;
Humans
;
Male
;
New Zealand
;
Osseointegration*
;
Rabbits
;
Solubility
;
Tibia

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