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.Multicenter Adherence Study of Asthma Medication for Children in Korea
Chang Keun KIM ; Zak CALLAWAY ; Jungi CHOI ; Hyo Bin KIM ; Eun Mi KWON ; Yoon Seok CHANG ; Yeong Ho RHA ; Soo Jong HONG ; Jae Won OH ; Hyun Hee KIM ; Dae Hyun LIM ; Sung Won KIM ; Kang Seo PARK ; Yong Hoon CHO ; Hai Lee CHUNG ; Hee Ju PARK ; Sang Gun JUNG ; Im Joo KANG ; Myung Chul HYUN ; Moo Young OH ; Jin A JUNG ; Myung Sung KIM ; Jung Yeon SHIM ; Jin Tack KIM ; Young Yull KOH ;
Allergy, Asthma & Immunology Research 2019;11(2):222-230
PURPOSE: Adherence is a major component of successful medical treatment. However, non-adherence remains a barrier to effective delivery of healthcare worldwide. METHODS: Twenty healthcare facilities (secondary or tertiary hospitals) belonging to the Korean Academy of Pediatric Allergy and Respiratory Diseases (KAPARD) participated. Questionnaires were given to patients currently receiving treatment in the form of inhalant useor oral intake or transdermal patch for mild to moderate asthma. RESULTS: A total of 1,838 patients responded to the questionnaire. Mean age was 5.98 ± 3.79 years (range: 0-18 years). With help from their caregivers, the percentage of patients that answered “taking as prescribed” was 38.04% for inhalant users, 50.09% for oral medication users and 67.42% for transdermal users. Transdermal patch users had significantly greater adherence compared to the other 2 groups (P < 0.001). The 34.15% of inhalant users, 70.33% of oral medication users and 93.00% of transdermal patch users felt that their medication delivery system was “Easy” or “Very easy” to use (P < 0.001). “Method of administration” was deemed to be the most difficult part of the treatment regimen to follow, and 76.7% of patients preferred once-daily administration (i.e., “Frequency of administration”). CONCLUSIONS: Asthma medication adherence in young children was found to be better in the transdermal patch group. This may be due to requiring fewer doses and easy to follow instructions. From an adherence point of view, the transdermal patch seems more useful for long-term asthma control in children compared to oral or inhaled medicine.
Asthma
;
Caregivers
;
Child
;
Delivery of Health Care
;
Humans
;
Hypersensitivity
;
Korea
;
Medication Adherence
;
Transdermal Patch
3.Effects of an Internet-based informational video on preoperative anxiety in patients with colorectal cancer
Myung Jo KIM ; Heung Kwon OH ; Keun Chul LEE ; Hyun Hui YANG ; Bon Wook KOO ; Jebong LEE ; Min Hyun KIM ; Sung Il KANG ; Duck Woo KIM ; Sung Bum KANG
Annals of Surgical Treatment and Research 2019;96(6):290-295
PURPOSE: Surgery is the primary curative treatment for colorectal cancer; however, it remains a frightening procedure that can cause stress and pain in affected patients. Therefore, patients typically experience significant anxiety during the preoperative period, which has been associated with poorer outcome after surgery. This study aimed to evaluate the effect of an Internet-based informational video on preoperative anxiety level in patients with colorectal cancer.
Anxiety
;
Cognition Disorders
;
Colorectal Neoplasms
;
Depression
;
Humans
;
Internet
;
Observational Study
;
Outcome Assessment (Health Care)
;
Postoperative Complications
;
Preoperative Period
;
Prospective Studies
;
Social Media
4.A useful additional medial subbrow approach for the treatment of medial orbital wall fracture with subciliary technique
Seung Min KIM ; Cheol Keun KIM ; Dong In JO ; Myung Chul LEE ; Ji Nam KIM ; Hyun Gon CHOI ; Dong Hyeok SHIN ; Soon Heum KIM
Archives of Craniofacial Surgery 2019;20(2):101-108
BACKGROUND: To date, a variety of surgical approaches have been used to reconstruct the medial orbital wall fracture. Still however, there is still a controversy as to their applicability because of postoperative scars, injury of anatomical structures and limited visual fields. The purpose of this study was to introduce a useful additional medial subbrow approach for better reduction and securement more accurate implant pocket of medial orbital wall fracture with the subciliary technique. METHODS: We had performed our technique for a total of 14 patients with medial orbital wall fracture at our medical institution between January 2016 and July 2017. All fractures were operated through subciliary technique combined with the additional medial subbrow approach. They underwent subciliary approach accompanied by medial wall dissection using a Louisville elevator through the slit incision of the medial subbrow procedure. This facilitated visualization of the medial wall fracture site and helped to ensure a more accurate pocket for implant insertion. RESULTS: Postoperative outcomes showed sufficient coverage without displacement. Twelve cases of preoperative diplopia improved to two cases of postoperative diplopia. More than 2 mm enophthalmos was 14 cases preoperatively, improving to 0 case postoperatively. Without damage such as major vessels or extraocular muscles, enophthalmos was corrected and there was no restriction of eyeball motion. CONCLUSION: Our ancillary procedure was useful in dissecting the medial wall, and it was a safe method as to cause no significant complications in our clinical series. Also, there is an only nonvisible postoperative scar. Therefore, it is a recommendable surgical modality for medial orbital wall fracture.
Cicatrix
;
Diplopia
;
Elevators and Escalators
;
Enophthalmos
;
Fracture Fixation
;
Humans
;
Methods
;
Muscles
;
Orbit
;
Orbital Fractures
;
Visual Fields
5.Myxoma arising from the parotid gland
Seung Min KIM ; Cheol Keun KIM ; Soon Heum KIM ; Myung Chul LEE ; Jee Nam KIM ; Hyun Gon CHOI ; Dong Hyeok SHIN ; Dong In JO
Archives of Craniofacial Surgery 2019;20(3):186-190
Myxomas can be divided into two groups: those derived from the facial skeleton, and those derived from external skeletal soft tissue. Soft tissue myxomas of the head and neck are uncommon, with fewer than 50 cases reported. In any form and location, myxoma of parotid gland is rare. We report a case of myxoma arising from the left superficial lobe of the parotid gland with good long-term follow-up after superficial parotidectomy with tumor excision. A 49-year-old man was referred to our department of plastic and reconstructive surgery with a painless palpable mass that had persisted in the left mandible angle region for 2 years. Excision of the facial mass and superficial parotidectomy with facial nerve preservation were performed. The biopsy result was myxoma. Long-term follow-up for 22 months showed favorable results without evidence of recurrence but with temporary facial nerve weakness right after the surgery. Myxoma should be considered as a differential diagnosis when benign tumor of the parotid gland is being considered.
Biopsy
;
Diagnosis, Differential
;
Facial Nerve
;
Follow-Up Studies
;
Head
;
Humans
;
Mandible
;
Middle Aged
;
Myxoma
;
Neck
;
Parotid Gland
;
Plastics
;
Recurrence
;
Skeleton
;
Soft Tissue Neoplasms
6.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
7.Clinical and Radiological Changes after Microfracture of Knee Chondral Lesions in Middle-Aged Asian Patients
Jong Keun KIM ; Rupesh VAIDYA ; Su Keon LEE ; JeongSeok YU ; Jae Young PARK ; Du Hyun RO ; Myung Chul LEE ; Hyuk Soo HAN
Clinics in Orthopedic Surgery 2019;11(3):282-290
BACKGROUND: Although microfracture is widely accepted as an effective treatment option for knee chondral lesions, little is known about the deterioration of clinical outcomes and radiological progression in middle-aged patients. Therefore, this study was conducted to evaluate the clinical and radiological changes after microfracture of knee chondral lesions in middle-aged Asian patients. METHODS: A total of 71 patients were included in the study. They were between the ages of 40 and 60 years and underwent arthroscopic microfracture for localized full-thickness cartilage defects of the knee from January 2000 to September 2015. The recovery status of chondral lesions was assessed by using the magnetic resonance observation of cartilage repair tissue (MOCART) score in postoperative magnetic resonance imaging (MRI). Clinical and radiological results were reviewed, and survival rate with conversion to arthroplasty or osteotomy as an end point was evaluated. RESULTS: The mean age of the patients at surgery was 51.3 ± 4.7 years (range, 40 to 60 years), and the mean follow-up period was 7.2 ± 2.6 years (range, 1.0 to 17.4 years). The MOCART scores of 32 patients at mean postoperative 2.1 years showed three cases (9%) of full recovery, two cases (7%) of hyperplastic recovery, 23 cases (70%) with more than 50% filling, and four cases (14%) with less than 50% filling. Clinical scores improved significantly at 1 year after surgery (p < 0.05); however, the scores deteriorated over time after postoperative 1 year, and the mean values reached preoperative levels at postoperative 10 years. Significant radiological progression of arthritis (Kellgren-Lawrence grade) was observed at 5 years after surgery. Four patients underwent total knee arthroplasty during follow-up. CONCLUSIONS: Most patients showed more than 50% of defect filling at 2 years after surgery on MRI. Clinical results of microfracture of knee chondral lesion showed the best improvement at postoperative 1 year but gradually worsened thereafter until postoperative 10 years. Radiological progression of arthritis was observed from 5 years after surgery.
Arthritis
;
Arthroplasty
;
Arthroplasty, Replacement, Knee
;
Asian Continental Ancestry Group
;
Cartilage
;
Follow-Up Studies
;
Humans
;
Knee
;
Magnetic Resonance Imaging
;
Osteotomy
;
Survival Rate
;
Treatment Outcome
8.A score for decision making during percutaneous coronary intervention in acute myocardial infarction patients with multivessel disease
Hae Chang JEONG ; Joon Ho AHN ; Min Chul KIM ; Doo Sun SIM ; Keun Ho PARK ; Young Joon HONG ; Ju Han KIM ; Myung Ho JEONG ; Ki Bae SEUNG ; Kiyuk CHANG ; Youngkeun AHN
The Korean Journal of Internal Medicine 2019;34(2):324-334
BACKGROUND/AIMS:
The optimal percutaneous coronary intervention (PCI) strategy in patients with acute myocardial infarction (AMI) with multivessel disease (MVD) is uncertain. This study was designed to develop a novel and simple tool for assessing an individualized and optimized PCI strategy in AMI patients with MVD.
METHODS:
In total, 5,025 patients with AMI from nine centers at two universities were enrolled in the prospective Convergent Registry of Catholic and Chonnam University for Acute Myocardial Infarction (COREA-AMI) registry from January 2004 through December 2009. From among them, we selected 2,630 patients with MVD who were treated by culprit-only or multivessel (MV) PCI. We investigated major adverse cardiac events (MACEs) during a 1-year clinical follow-up. Using a subgroup analysis, we extracted variables for use in the culprit only versus multivessel revascularization (CONVERSE) score, which showed a preference for MV PCI rather than culprit-only PCI for treating MVD.
RESULTS:
The CONVERSE score was constructed using eight independent variables (1 point for each variable): age > 65 years, hypertension, diabetes mellitus, high Killip class (III or IV), low left ventricular ejection fraction (≤ 50%), low creatinine clearance (≤ 60 mL/min), high level of high-sensitivity C-reactive protein (≥ 2.0 mg/L), and left anterior descending artery or left main as the nonculprit vessel. The incidence of MACEs increased linearly with the CONVERSE score. The receiver operating characteristic curve showed that the cutoff value was 3 points.
CONCLUSIONS
The results suggest that patients with a CONVERSE score of 3 or more should undergo MV PCI.
9.Investigating the Feasibility of Targeted Next-Generation Sequencing to Guide the Treatment of Head and Neck Squamous Cell Carcinoma.
Sun Min LIM ; Sang Hee CHO ; In Gyu HWANG ; Jae Woo CHOI ; Hyun CHANG ; Myung Ju AHN ; Keon Uk PARK ; Ji Won KIM ; Yoon Ho KO ; Hee Kyung AHN ; Byoung Chul CHO ; Byung Ho NAM ; Sang Hoon CHUN ; Ji Hyung HONG ; Jung Hye KWON ; Jong Gwon CHOI ; Eun Joo KANG ; Tak YUN ; Keun Wook LEE ; Joo Hang KIM ; Jin Soo KIM ; Hyun Woo LEE ; Min Kyoung KIM ; Dongmin JUNG ; Ji Eun KIM ; Bhumsuk KEAM ; Hwan Jung YUN ; Sangwoo KIM ; Hye Ryun KIM
Cancer Research and Treatment 2019;51(1):300-312
PURPOSE: Head and neck squamous cell carcinoma (HNSCC) is a deadly disease in which precision medicine needs to be incorporated. We aimed to implement next-generation sequencing (NGS) in determining actionable targets to guide appropriate molecular targeted therapy in HNSCC patients. MATERIALS AND METHODS: Ninety-three tumors and matched blood samples underwent targeted sequencing of 244 genes using the Illumina HiSeq 2500 platform with an average depth of coverage of greater than 1,000×. Clinicopathological data from patients were obtained from 17 centers in Korea, and were analyzed in correlation with NGS data. RESULTS: Ninety-two of the 93 tumors were amenable to data analysis. TP53 was the most common mutation, occurring in 47 (51%) patients, followed by CDKN2A (n=23, 25%), CCND1 (n=22, 24%), and PIK3CA (n=19, 21%). The total mutational burden was similar between human papillomavirus (HPV)–negative vs. positive tumors, although TP53, CDKN2A and CCND1 gene alterations occurred more frequently in HPV-negative tumors. HPV-positive tumors were significantly associated with immune signature-related genes compared to HPV-negative tumors. Mutations of NOTCH1 (p=0.027), CDKN2A (p < 0.001), and TP53 (p=0.038) were significantly associated with poorer overall survival. FAT1 mutations were highly enriched in cisplatin responders, and potentially targetable alterations such as PIK3CA E545K and CDKN2A R58X were noted in 14 patients (15%). CONCLUSION: We found several targetable genetic alterations, and our findings suggest that implementation of precision medicine in HNSCC is feasible. The predictive value of each targetable alteration should be assessed in a future umbrella trial using matched molecular targeted agents.
Biomarkers
;
Carcinoma, Squamous Cell*
;
Cisplatin
;
Epithelial Cells*
;
Head*
;
Humans
;
Korea
;
Molecular Targeted Therapy
;
Neck*
;
Precision Medicine
;
Statistics as Topic
10.Hindfoot Endoscopy for the Treatment of Posterior Ankle Impingement Syndrome: A Comparison of Two Methods (a Standard Method versus a Method Using a Protection Cannula).
Eung Soo KIM ; Chang Rak LEE ; Young Jun KIM ; Sang Myung ROH ; Jae Keun PARK ; Heui Chul GWAK ; Sun Gyu JUNG
Journal of Korean Foot and Ankle Society 2018;22(1):26-31
PURPOSE: The purpose of this study is to compare the clinical results between two different methods of hindfoot endoscopy to treat posterior ankle impingement syndrome. MATERIALS AND METHODS: Between January 2008 and January 2014, 52 patients who underwent hindfoot endoscopy were retrospectively reviewed. Two methods of hindfoot endoscopy were used; Group A was treated according to van Dijk and colleagues' standard two-portal method, and group B was treated via the modified version of the above, using a protection cannula. For clinical comparison, the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, time required to return to activity, and the presence of complications were used. RESULTS: There was no statistically significant difference in the AOFAS scores at the final follow-up, and there was also no statistically significant difference in the times for the scores to return to the preoperative level. There were no permanent neurovascular injuries and wound problems in either group. CONCLUSION: Use of protection cannula may provide additional safety during hindfoot endoscopy. We could not prove whether protection cannula can provide superior safety for possible neurovascular injury. Considering the possible safety and risk of using additional instrument, the use of this method may be optional.
Ankle*
;
Catheters
;
Endoscopy*
;
Follow-Up Studies
;
Foot
;
Humans
;
Methods*
;
Retrospective Studies
;
Talus
;
Wounds and Injuries

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