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.The Association Between Fall History and Physical Performance Tests in the Community-Dwelling Elderly: A Cross-Sectional Analysis.
Jin Chul KIM ; Jinmann CHON ; Hee Sang KIM ; Jong Ha LEE ; Seung Don YOO ; Dong Hwan KIM ; Seung Ah LEE ; Yoo Jin HAN ; Hyun Seok LEE ; Bae Youl LEE ; Yun Soo SOH ; Chang Won WON
Annals of Rehabilitation Medicine 2017;41(2):239-247
OBJECTIVE: To evaluate the association between baseline characteristics, three physical performance tests and fall history in a sample of the elderly from Korean population. METHODS: A total of 307 participants (mean age, 76.70±4.85 years) were categorized into one of two groups, i.e., fallers and non-fallers. Fifty-two participants who had reported falling unexpectedly at least once in the previous 12 months were assigned to the fallers group. Physical performance tests included Short Physical Performance Battery (SPPB), Berg Balance Scale (BBS), Timed Up and Go test. The differences between the two study groups were compared and we analyzed the correlations between fall histories and physical performance tests. RESULTS: SPPB demonstrated a significant association with fall history. Although the BBS total scores did not show statistical significance, two dynamic balance test items of BBS (B12 and B13) showed a significant association among fallers. CONCLUSION: This study suggests that SPPB and two dynamic balance test items of the BBS can be used in screening for risk of falls in an ambulatory elderly population.
Accidental Falls
;
Aged*
;
Cross-Sectional Studies*
;
Humans
;
Mass Screening
3.Biomechanical Analysis of Operative Methods in the Treatment of Extra-Articular Fracture of the Proximal Tibia.
Seong Man LEE ; Chang Wug OH ; Jong Keon OH ; Joon Woo KIM ; Hyun Joo LEE ; Chang Soo CHON ; Byoung Joo LEE ; Hee Soo KYUNG
Clinics in Orthopedic Surgery 2014;6(3):312-317
BACKGROUND: To determine relative fixation strengths of a single lateral locking plate, a double construct of a locking plate, and a tibial nail used in treatment of proximal tibial extra-articular fractures. METHODS: Three groups of composite tibial synthetic bones consisting of 5 specimens per group were included: lateral plating (LP) using a locking compression plate-proximal lateral tibia (LCP-PLT), double plating (DP) using a LCP-PLT and a locking compression plate-medial proximal tibia, and intramedullary nailing (IN) using an expert tibial nail. To simulate a comminuted fracture model, a gap osteotomy measuring 1 cm was created 8 cm below the knee joint. For each tibia, a minimal preload of 100 N was applied before loading to failure. A vertical load was applied at 25 mm/min until tibial failure. RESULTS: Under axial loading, fixation strength of DP (14,387.3 N; standard deviation [SD], 1,852.1) was 17.5% greater than that of LP (12,249.3 N; SD, 1,371.6), and 60% less than that of IN (22,879.6 N; SD, 1,578.8; p < 0.001, Kruskal-Wallis test). For ultimate displacement under axial loading, similar results were observed for LP (5.74 mm; SD, 1.01) and DP (4.45 mm; SD, 0.96), with a larger displacement for IN (5.84 mm; SD, 0.99). The median stiffness values were 2,308.7 N/mm (range, 2,147.5 to 2,521.4 N/mm; SD, 165.42) for the LP group, 4,128.2 N/mm (range, 3,028.1 to 4,831.0 N/mm; SD, 832.88) for the DP group, and 5,517.5 N/mm (range, 3,933.1 to 7,078.2 N/mm; SD, 1,296.19) for the IN group. CONCLUSIONS: During biomechanical testing of a simulated comminuted proximal tibial fracture model, the DP proved to be stronger than the LP in terms of ultimate strength. IN proved to be the strongest; however, for minimally invasive osteosynthesis, which may be technically difficult to perform using a nail, the performance of the DP construct may lend credence to the additional use of a medial locking plate.
Biomechanical Phenomena
;
Bone Nails
;
Bone Plates
;
Fracture Fixation, Internal/*instrumentation
;
Fractures, Comminuted/physiopathology/*surgery
;
Humans
;
Models, Anatomic
;
Tibial Fractures/physiopathology/*surgery
4.Optimal Parameters for Sutures Tied to a Post during Anterior Cruciate Ligament Reconstruction: Thread Numbers, Knot Numbers, Suture Techniques and Stitch Numbers: An Experimental Laboratory Study Using Porcine Tendon.
Jae Ang SIM ; Suk Won CHOI ; Chang Soo CHON ; Won Seok KIM ; Yong Seuk LEE ; Beom Koo LEE
The Korean Journal of Sports Medicine 2014;32(1):14-19
We evaluated the conditions required for sutures tied to a post for tibial fixation during anterior cruciate ligament (ACL) reconstruction. Harvested porcine tendon was used as a graft material and nonabsorbable suture was used for sutures. Samples were tested for ultimate tensile load and elongation according to thread numbers, knot numbers, suture techniques and stitch numbers. As thread numbers were increased, ultimate tensile load was increased and elongation was decreased. However, more than 4 strands of threads provided the sufficient ultimate tensile load more than 454 N of normal ACL for daily activities. As knot numbers were increased, ultimate tensile load was increased, but elongation was decreased. In terms of failure mode, unraveling occurred 100% in 3 and 4 knots, 81.2% in 5 knots, 54.5% in 6 knots, and 0% in 7 knots. Suture techniques and stitch numbers didn't significantly affect the ultimate tensile load and the elongation. For sutures tied to a post for tibial fixation in ACL reconstruction, more than 4 threads, more than 7 knots, and more than 4 stitches provide adequate ultimate tensile load and elongation.
Anterior Cruciate Ligament
;
Anterior Cruciate Ligament Reconstruction*
;
Knee
;
Suture Techniques*
;
Sutures*
;
Tendons*
;
Transplants
5.Safety and Efficacy of Modern Insulin Analogues.
Hye Jin YOO ; Keun Yong PARK ; Kang Seo PARK ; Kyu Jeung AHN ; Kyung Wan MIN ; Jeong Hyun PARK ; Sang Ah CHANG ; Bong Soo CHA ; Dong Jun KIM ; Yong Seong KIM ; Tae Keun OH ; Suk CHON ; Il Seong NAM-GOONG ; Mi Jin KIM ; Hye Soon KIM ; Young Sik CHOI ; You Hern AHN ; Sora LEE ; Sei Hyun BAIK
Diabetes & Metabolism Journal 2013;37(3):181-189
BACKGROUND: A1chieve(R) was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart. METHODS: Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints. RESULTS: Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7+/-15.9 to 72.5+/-13.5) while the mean body weight was slightly increased (0.6+/-3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%+/-2.2%, 2.5+/-4.7 mmol/L, and 4.0+/-6.4 mmol/L, respectively. CONCLUSION: The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
Biphasic Insulins
;
Body Weight
;
Diabetes Mellitus, Type 2
;
Drug Toxicity
;
Fasting
;
Glucose
;
Hemoglobins
;
Humans
;
Incidence
;
Insulin
;
Insulin Aspart
;
Insulin, Isophane
;
Insulin, Long-Acting
;
Patient Selection
;
Plasma
;
Quality of Life
;
Republic of Korea
;
Treatment Outcome
;
Insulin Detemir
6.Korean Addiction Treatment Guidelines Series (I) : Development of Korean Guidelines for the Treatment of Alcohol Use Disorder.
Bo Hye LEE ; Hyun Soo KIM ; Jeong Seok SEO ; Young Chul SHIN ; Seon Wan KI ; Sung Gon KIM ; Keun Ho JOE ; Kye Seong LEE ; Sam Wook CHOI ; Young Hoon CHON ; Sung Won ROH ; Hong Seok OH ; Hong Gyun YOON ; Chang Woo HAN ; Sun Jin JO ; Dai Jin KIM ; Ae Ran PARK ; Soo Bi LEE ; Hae Kook LEE
Journal of Korean Neuropsychiatric Association 2013;52(4):263-271
OBJECTIVES: The aim of this study is to develop Treatment Guidelines for Alcohol Use Disorder-the Korean Addiction Treatment Guidelines-using the Adaptation method. METHODS AND PROCEDURES: As the Adaptation method of Guidelines, the ADAPTE Manual, which is developed by ADAPTE collaboration is applied. In Part 1 : preparatory work prior to the beginning of Adaptation is performed. In Part 2 : the core phase of the Adaptation in which we searched the guidelines and performed a systematic review of the literature. The two guidelines (of the AU and the UK) are selected by gone through the methodological quality and currency evaluation for guidelines. And, in order to choose the proper recommendations, the contents were evaluated with regard to the applicability and acceptability of guidelines to the domestic. Finally, in Part 3 : the adapted guideline is reviewed externally, with review and plan update. Therefore, in this way, the Korean Guidelines for Treatment of Alcohol Use Disorder, comprised of 55 recommendations, was developed. CONCLUSION: In this study, Korean Guidelines for Treatment of Alcohol Use Disorder were developed by application of the Adaptation method of ADAPTE. These are the first evidence-based Korean Guidelines for Treatment of Alcohol Use Disorder, which were modified and accepted in accordance with Korean circumstances within the range not damaging the validity of the treatment worth, and it is expected to contribute to improvement in quality and efficiency enhancement of Korean treatment of Alcohol Use Disorder.
Cooperative Behavior
7.Huge Hepatocellular Carcinoma Abruptly Developed within 3 Months.
Sang Hyuk LEE ; Byung Ik KIM ; Chang Uk CHON ; Ki Bae BANG ; Eun Haeng JEONG ; Jeong Yeon SEO ; Eun Hye PARK ; Ji Soo SEOL
Yeungnam University Journal of Medicine 2012;29(1):48-53
Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related deaths in South Korea. To decrease its mortality rate, its early detection is very important. Screening for HCC detection has been accepted as the management modality for patients with chronic liver disease. Reported herein is a case involving the marked rapid growth of HCC detected at an advanced stage in a screening test with a 3 months interval. A 49-year-old male patient with chronic hepatitis B was admitted to the hospital due to a liver mass detected on CT scan. The patient underwent a first CT scan 3 months earlier, and no tumor was detected. Follow-up CT scan was performed and showed a 9.1 cm HCC with portal vein thrombosis. Percutaneous liver biopsy was performed, and the diagnosis of hepatocellular carcinoma was confirmed. In the pertinent guidelines, the recommended screening interval for HCC is 6-12 months, but the screening interval and additional diagnostic methods should be considered due to the variation in the HCC growth rate according to the patient's clinical characteristics.
Biopsy
;
Carcinoma, Hepatocellular
;
Early Detection of Cancer
;
Follow-Up Studies
;
Hepatitis B, Chronic
;
Humans
;
Liver
;
Liver Diseases
;
Male
;
Mass Screening
;
Middle Aged
;
Portal Vein
;
Republic of Korea
;
Thrombosis
8.Effect of Nonalcoholic Fatty Liver Disease on the Development of Type 2 Diabetes in Nonobese, Nondiabetic Korean Men.
Chang Wook CHON ; Bum Soo KIM ; Yong Kyun CHO ; Ki Chul SUNG ; Ji Cheol BAE ; Tae Wan KIM ; Hyun Sun WON ; Kwan Joong JOO
Gut and Liver 2012;6(3):368-373
BACKGROUND/AIMS: We have a limited understanding of the effect of nonalcoholic fatty liver disease (NAFLD) on the development of type 2 diabetes. METHODS: The study subjects included male who had received biennial medical check-ups between 2005 and 2009 and who had been diagnosed with fatty liver disease. The subjects with sustained NAFLD (FL, n=107) and sustained non-NAFLD (NFL, n=1,054) were followed to determine the development of type 2 diabetes. RESULTS: In the FL group, there were more subjects with impaired fasting glucose (IFG), type 2 diabetes and high HOMA-IR than there were in the NFL group during the 5-year follow-up period (32.7 vs. 17.6%, 1.9 vs. 0.3%, 17.9 vs. 5.2% respectively, p<0.05). The FL group showed a higher risk than NFL group for abnormal glucose metabolism as determined using IFG (odds ratio [OR], 2.13; confidence interval [CI], 1.36 to 3.35), type 2 diabetes (OR, 7.63; 95% CI, 1.03 to 56.79) and high HOMA-IR (OR, 3.25; 95% CI, 1.79 to 5.91) and metabolic parameters such as body mass index (OR, 3.35; 95% CI, 1.87 to 6.02), triglyceride (OR, 3.05; 95% CI, 1.92 to 4.86) and fasting blood sugar (OR, 2.18; 95% CI, 1.39 to 3.41). CONCLUSIONS: Sustained NAFLD appears to be associated with an increased risk for the development of type 2 diabetes and deterioration of metabolic parameters in non-obese, non-diabetic Korean men.
Blood Glucose
;
Body Mass Index
;
Diabetes Mellitus, Type 2
;
Fasting
;
Fatty Liver
;
Follow-Up Studies
;
Glucose
;
Humans
;
Male
9.Comparison of Infliximab and Infliximab/Azathioprine for Maintenance Therapy in Korean Patients with Luminal Crohn's Disease.
Hyun Sun WON ; Dong Il PARK ; Chang Uk CHON ; Hyo Sun SEOK ; Tae Wan KIM ; Woon Je HEO ; Chang Kyun LEE ; Chang Soo EUN ; Dong Soo HAN ; Suck Ho LEE
Intestinal Research 2011;9(3):189-195
BACKGROUND/AIMS: The benefits and risks of concomitant immunomodulators with infliximab maintenance therapy in patients with luminal Crohn's disease (CD) have not been adequately evaluated. We studied the influence of immunomodulator discontinuation in patients in remission with infliximab therapy through a restrospective case-control study. METHODS: Medical records of 37 patients with luminal CD who received infliximab at four medical centers were retrospectively analyzed. We compared clinical and follow-up data of patients who were treated with infliximab alone with that of patients with combination therapy. RESULTS: Among 37 patients, 31 (83.7%) were treated with infliximab plus azathioprine and six (16.2%) were treated with infliximab alone. Of the 31 patients receiving combination maintenance therapy, 26 (83.9%) were in complete remission after 12 months, as compared with five of six patients (83.3%) receiving infliximab alone. No significant difference was observed in remission rate between two groups (P=0.735). In total, 16.1% of patients in combination therapy and 16.7% in infliximab alone group reported side effects (P=1.000), but serious adverse events such as reactivation of tuberculosis were noted in only one patient in combination therapy group. CONCLUSIONS: Concomitant immunomodulators did not improve efficacy in patients with luminal CD who received scheduled infliximab maintenance.
Antibodies, Monoclonal
;
Azathioprine
;
Case-Control Studies
;
Crohn Disease
;
Follow-Up Studies
;
Humans
;
Infliximab
;
Immunologic Factors
;
Medical Records
;
Phenobarbital
;
Retrospective Studies
;
Risk Assessment
;
Tuberculosis
10.The Clinical Results Using the Second Look Arthroscopic Findings and MRI after Allogenic Meniscal Transplantation.
Je Gyun CHON ; In Soo SONG ; Jun Beom KIM ; Hyun Yoon JEONG ; Chang Soo LEE
Journal of the Korean Knee Society 2009;21(1):35-44
PURPOSE: The purpose of this study was to evaluate the clinical results and the changes of allogenic meniscal transplantation by using the second look arthroscopic findings and the MRI changes after surgery. MATERIALS AND METHODS: From July 1997 to February 2007, among the patients that underwent allogenic meniscal transplantation, we chose 25 patients who underwent secondary arthroscopic evaluation. 16 of these 25 patients were men and 8 were women. Secondary arthroscopic evaluation was done without MRI in 3 cases. The mean age was 36.1 yr and the average follow up period was 28 months. Biopsy by the secondary arthroscopic evaluation was done in 2 cases. We evaluated the clinical results by the Lysholm knee scoring scale, the Knee Society Score (KSS) system and the Hospital for Special Surgery (HSS) knee score. RESULTS: Second-look arthroscopy after allogenic meniscal transplantation revealed that 23 cases seemed normal at the probing procedure. 5 cases showed a decreased posterior horn size. The MRI findings and secondary arthroscopic findings matched in all cases. The clinical Lysholm score improved from preoperative 65.4 points to postoperative 80.6 points, the Knee Society Score (KSS) improved from preoperative 64.6 points to postoperative 82.6 points, the functional score improved from preoperative 70.2 points to postoperative 85.6 points and the Hospital for Special Surgery (HSS) knee score improved from preoperative 66.4 points to postoperative 82.5 points (p=0.000). The function after surgery improved on all the tests and this was proved by paired t-tests. CONCLUSION: Allogenic meniscal transplantation showed good results on the second look arthroscopy and the follow-up MRI and according to the clinical functional outcome. We think that confirmation through arthroscopy after follow-up MRI for the patients with clinical knee problems seems to be necessary.
Animals
;
Arthroscopy
;
Biopsy
;
Female
;
Follow-Up Studies
;
Horns
;
Humans
;
Knee
;
Male
;
Transplants

Result Analysis
Print
Save
E-mail