1.Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Jun Sung MOON ; Il Rae PARK ; Hae Jin KIM ; Choon Hee CHUNG ; Kyu Chang WON ; Kyung Ah HAN ; Cheol-Young PARK ; Jong Chul WON ; Dong Jun KIM ; Gwan Pyo KOH ; Eun Sook KIM ; Jae Myung YU ; Eun-Gyoung HONG ; Chang Beom LEE ; Kun-Ho YOON
Diabetes & Metabolism Journal 2023;47(6):808-817
Background:
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods:
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results:
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
2.Projections of Demand for Cardiovascular Surgery and Supply of Surgeons.
Jung Jeung LEE ; Nam Hee PARK ; Kun Sei LEE ; Hyun Keun CHEE ; Sung Bo SIM ; Myo Jeong KIM ; Ji Suk CHOI ; Myunghwa KIM ; Choon Seon PARK
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S37-S43
BACKGROUND: While demand for cardiovascular surgery is expected to increase gradually along with the rapid increase in cardiovascular diseases with respect to the aging population, the supply of thoracic and cardiovascular surgeons has been continuously decreasing over the past 10 years. Consequently, this study aims to achieve guidance in establishing health care policy by analyzing the supply and demand for cardiovascular surgeries in the medical service area of Korea. METHODS: After investigating the actual number of cardiovascular surgeries performed using the National Health Insurance claim data of the Health Insurance Review and Assessment Service, as well as drawing from national statistics concerning the elderly population aged 65 and over, this study estimated the number of future cardiovascular surgeries by using a cell-based model. To be able to analyze the supply and demand of surgeons, the recent status of new surgeons specializing in thoracic and cardiovascular surgeries and the ratio of their subspecialties in cardiovascular surgeries were investigated. Then, while taking three different scenarios into account, the number of cardiovascular surgeons expected be working in 5-year periods was projected. RESULTS: The number of cardiovascular surgeries, which was recorded at 10,581 cases in 2014, is predicted to increase consistently to reach a demand of 15,501 cases in 2040—an increase of 46.5%. There was a total of 245 cardiovascular surgeons at work in 2014. Looking at 5 year spans in the future, the number of surgeons expected to be supplied in 2040 is 184, to retire is 249, and expected to be working is 309—an increase of −24.9%, 1.6%, and 26.1%, respectively compared to those in 2014. This forecasts a demand-supply imbalance in every scenario. CONCLUSION: Cardiovascular surgeons are the most central resource in the medical service of highly specialized cardiovascular surgeries, and fostering the surgeons requires much time, effort, and resources; therefore, by analyzing the various factors affecting the supply of cardiovascular surgeons, an active intervention of policies can be prescribed for the areas that have failed to meet the appropriate market distributions.
Aged
;
Aging
;
Cardiovascular Diseases
;
Delivery of Health Care
;
Economics, Medical
;
Foster Home Care
;
Health Policy
;
Health Services Needs and Demand
;
Humans
;
Insurance, Health
;
Korea
;
National Health Programs
;
Surgeons*
;
Thoracic Surgery
3.Development of Models for Regional Cardiac Surgery Centers.
Choon Seon PARK ; Nam Hee PARK ; Sung Bo SIM ; Sang Cheol YUN ; Hye Mi AHN ; Myunghwa KIM ; Ji Suk CHOI ; Myo Jeong KIM ; Hyunsu KIM ; Hyun Keun CHEE ; Sanggi OH ; Shinkwang KANG ; Sok Goo LEE ; Jun Ho SHIN ; Keonyeop KIM ; Kun Sei LEE
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S28-S36
BACKGROUND: This study aimed to develop the models for regional cardiac surgery centers, which take regional characteristics into consideration, as a policy measure that could alleviate the concentration of cardiac surgery in the metropolitan area and enhance the accessibility for patients who reside in the regions. METHODS: To develop the models and set standards for the necessary personnel and facilities for the initial management plan, we held workshops, debates, and conference meetings with various experts. RESULTS: After partitioning the plan into two parts (the operational autonomy and the functional comprehensiveness), three models were developed: the ‘independent regional cardiac surgery center’ model, the ‘satellite cardiac surgery center within hospitals’ model, and the ‘extended cardiac surgery department within hospitals’ model. Proposals on personnel and facility management for each of the models were also presented. A regional cardiac surgery center model that could be applied to each treatment area was proposed, which was developed based on the anticipated demand for cardiac surgery. The independent model or the satellite model was proposed for Chungcheong, Jeolla, North Gyeongsang, and South Gyeongsang area, where more than 500 cardiac surgeries are performed annually. The extended model was proposed as most effective for the Gangwon and Jeju area, where more than 200 cardiac surgeries are performed annually. CONCLUSION: The operation of regional cardiac surgery centers with high caliber professionals and quality resources such as optimal equipment and facility size, should enhance regional healthcare accessibility and the quality of cardiac surgery in South Korea.
Delivery of Health Care
;
Education
;
Gangwon-do
;
Health Facilities
;
Health Services Accessibility
;
Humans
;
Korea
;
Quality of Health Care
;
Thoracic Surgery*
4.The Association Between Treatment Frequency and Treatment Outcome for Cardiovascular Surgeries.
Ji Suk CHOI ; Choon Seon PARK ; Myunghwa KIM ; Myo Jeong KIM ; Kun Sei LEE ; Sung Bo SIM ; Hyun Keun CHEE ; Nam Hee PARK ; Sung Min PARK
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S20-S27
BACKGROUND: This study analyzed the association between the volume of heart surgeries and treatment outcomes for hospitals in the last five years. METHODS: Hospitals that perform heart surgeries were chosen throughout Korea as subjects using from the Health Insurance Review and Assessment Service. The treatment outcome of the heart surgeries was defined as the mortality within 30 postoperative days, while the annual volume of the surgeries was categorized. Logistic regression was used as the statistical analysis method, and the impacts of the variables on the heart surgery treatment outcomes were then analyzed. RESULTS: The chance of death of patients who received surgery in a hospital that performed 50 or more surgeries annually was noticeably lower than patients receiving operations from hospitals that performed fewer than 50 surgeries annually, indicating that the chance of death decreases as the annual volume of heart surgeries in the hospital increases. In particular, the mortality rate in hospitals that performed more than 200 surgeries annually was less than half of that in hospitals that performed 49 or fewer surgeries annually. CONCLUSION: These results indicate that accumulation of a certain level of heart surgery experience is critical in improving or maintaining the quality of heart surgeries. In order to improve the treatment outcomes of small hospitals, a support policy must be implemented that allows for cooperation with experienced professionals.
Heart
;
Humans
;
Insurance, Health
;
Korea
;
Logistic Models
;
Methods
;
Mortality
;
Quality of Health Care
;
Thoracic Surgery
;
Treatment Outcome*
5.Imbalance in Cardiovascular Surgery Medical Service Use Between Regions.
Myunghwa KIM ; Seok Jun YOON ; Ji Suk CHOI ; Myo Jeong KIM ; Sung Bo SIM ; Kun Sei LEE ; Hyun Keun CHEE ; Nam Hee PARK ; Choon Seon PARK
The Korean Journal of Thoracic and Cardiovascular Surgery 2016;49(Suppl 1):S14-S19
BACKGROUND: This study uses the relevance index to understand the condition of regional medical service use for cardiovascular surgery and to identify the medical service use imbalance between regions. METHODS: This study calculated the relevance index of 16 metropolitan cities and provinces using resident registration address data from the Ministry of Government Administration and Home Affairs and the 2010–2014 health insurance, medical care assistance, and medical benefits claims data from the Health Insurance Review and Assessment Service. We identified developments over the 5-year time period and analyzed the level of regional imbalance regarding cardiovascular surgery through the relative comparison of relevance indexes between cardiovascular and other types of surgery. RESULTS: The relevance index was high in large cities such as Seoul, Daegu, and Gwangju, but low in regions that were geographically far from the capital area, such as the Gangwon and Jeju areas. Relevance indexes also fell as the years passed. Cardiovascular surgery has a relatively low relevance index compared to key types of surgery of other fields, such as neurosurgery and colorectal surgery. CONCLUSION: This study identified medical service use imbalance between regions for cardiovascular surgery. Results of this study demonstrate the need for political intervention to enhance the accessibility of necessary special treatment, such as cardiovascular surgery.
Colorectal Surgery
;
Daegu
;
Gangwon-do
;
Gwangju
;
Insurance, Health
;
Neurosurgery
;
Seoul
6.The First Clinical Trial of Beta-Calcium Pyrophosphate as a Novel Bone Graft Extender in Instrumented Posterolateral Lumbar Fusion.
Jae Hyup LEE ; Bong Soon CHANG ; Ul Oh JEUNG ; Kun Woo PARK ; Min Seok KIM ; Choon Ki LEE
Clinics in Orthopedic Surgery 2011;3(3):238-244
BACKGROUND: Porous beta-calcium pyrophosphate (beta-CPP) was developed to improve the fusion success of posterolateral lumbar fusion (PLF). The possibility of accomplishing PLF using a mixture of porous beta-CPP and iliac bone was studied. This paper reports the radiologic results of PLF using the beta-CPP plus autograft for lumbar degenerative disease as a bone graft extender. METHODS: A prospective, case-matched, radiographic study evaluating the results of short segment lumbar fusion using a beta-CPP plus autograft was performed to compare the efficacy of beta-CPP plus autograft with that of an autograft alone for short segment lumbar fusion. Thirty one consecutive patients (46 levels) underwent posterolateral fusion with pedicle screw fixation and additional posterior lumbar interbody fusion. In all patients, 3 mL of beta-CPP plus 3 mL of autogenous bone graft was placed randomly in one side of a posterolateral gutter, and 6 mL of autogenous iliac bone graft was placed on the other. The fusion rates, volumes of fusion masses, and bone absorption percentage were evaluated postoperatively using simple radiographs and 3 dimensional computed tomography (3D-CT) scans. RESULTS: The control sides treated with an autograft showed significantly better Lenke scores than the study sides treated with beta-CPP at 3 and 6 months postoperatively, but there was no difference between the two sides at 12 months. The fusion rates (confirmed by 3D-CT) were 87.0% in the beta-CPP group and 89.1% in the autograft group, which were not significantly different. The fusion mass volumes and bone absorption percentage at 12 months postoperatively were 2.49 mL (58.4%) and 1.89 mL (69.5%) for the beta-CPP and autograft groups, respectively, and mean fusion mass volume was significantly higher in the beta-CPP group. CONCLUSIONS: beta-CPP combined with an autograft is as effective as autologous bone for grafting during instrumented posterolateral spinal fusion. These findings suggest that beta-CPP bone chips can be used as a novel bone graft extender for short-segment posterolateral spinal fusion.
Adult
;
Aged
;
*Bone Substitutes
;
*Bone Transplantation
;
Calcium Pyrophosphate/*administration & dosage
;
Female
;
Humans
;
Ilium
;
Imaging, Three-Dimensional
;
Lumbar Vertebrae/radiography/*surgery
;
Male
;
Middle Aged
;
Spinal Fusion/*methods
;
Tomography, X-Ray Computed
7.Outcomes of Pancreas Transplantation: Single-Center Experience in Korea.
Duck Jong HAN ; Song Cheol KIM ; Jae Berm PARK ; Young Hoon KIM ; Kwan Tae PARK ; Jung Ja HONG ; Hea Seon HA ; Ju Hee JUNG ; In Koo KIM ; Kun Choon PARK ; Pyung Chul MIN
Korean Journal of Medicine 2011;80(2):167-178
BACKGROUND/AIMS: Pancreas transplantation (PT) as the ultimate treatment for insulin-dependent diabetes has been the subject of debate clinically. Marked improvements in patient and graft survival, and decreases in postoperative morbidity have been achieved due to technical refinements, improved immunosuppressants, and better postoperative management. Here, we report our 18-year experience with PT performed at our institute. METHODS: All recipients who underwent deceased donor or living donor PT between July 1992 and December 2009 were included. We reviewed the medical records, including operation records, progress, and laboratory findings during follow-up. Graft and patient survival were analyzed using the Kaplan-Meier method. RESULTS: In total, 119 cases of pancreas transplantation were performed between July 1992 and December 2009 at our institute. Indications for pancreas transplantation were type I diabetes in 93 (78.2%) patients and type II diabetes in 16 (13.4%) patients. The transplanted pancreas was obtained from a deceased donor in 108 cases (90.8%) and a living donor in 11 cases (9.2%). Median follow-up duration was 39.3 months posttransplantation (range 0~176 months). Overall graft survival rates at 1, 5, and 10 years were 81.6%, 63.4%, and 57.1%, respectively. Following the introduction of tacrolimus as an immunosuppressant in 1999, graft survival at 1, 5, and 10 years was 89.1%, 72.9%, and 66.2%, and overall patient survival at 1, 5, and 10 years was 93.0%, 86.0%, and 86.%, respectively. CONCLUSIONS: Considering the quality of life and long-term patient survival, PT is an effective treatment strategy in non-obese diabetic patients requiring insulin regardless of the type of diabetes.
Follow-Up Studies
;
Graft Survival
;
Humans
;
Immunosuppressive Agents
;
Insulin
;
Korea
;
Living Donors
;
Medical Records
;
Pancreas
;
Pancreas Transplantation
;
Quality of Life
;
Tacrolimus
;
Tissue Donors
;
Transplants
8.Posterior Lumbar Interbody Fusion Using New Hydroxyapatite Block: Comparison with Metal and PEEK Cages.
Jae Yoon CHUNG ; Bong Soon CHANG ; Choon Ki LEE ; Jae Hyup LEE ; Chang Bae KONG ; Jin Sup YEOM ; Kun Woo PARK ; Hyuk Ju MOON
Journal of Korean Society of Spine Surgery 2009;16(4):243-250
STUDY DESIGN: This is a retrospective study OBJECTIVES: This study compared the clinical outcomes of posterior lumbar interbody fusion (PLIF) using hydroxyapatite blocks with PLIF using a metal or poly-ether-ether-ketone (PEEK) cage. SUMMARY OF THE LITERATURE REVIEW: There are few reports on the clinical outcomes of PLIF using a hydroxyapatite block for treating lumbar degenerative disease. MATERIALS AND METHODS: The 27 PLIF cases (62 units, HA block) that were followed up for 1-year were compared with 13 cases using a metal cage and 13 cases using a PEEK cage. Pedicle screw fixation was performed for all the cases. If the local bone is deficient, then an additional bone graft with autogeous iliac bone or bone substitute was used. The visual analog scale(VAS) for low back pain and radiating pain, the Oswestry disability index (ODI), the intervertebral height and the halo sign around the cages and pedicle screws were comparatively analyzed. RESULTS: The mean VAS score for low back pain before PLIF and using the HA block, the metal cage and the PEEK cage was 7.5, 8.3 and 6.2, respectively, and this was 3.3, 2.9 and 4.8 after PLIF (P<0.05 with using the HA block and the metal cage (Wilcoxon test). The mean VAS score for radiating pain before PLIF was 7.9, 8.3 and 8.5, respectively, and the VAS score was 3.5, 3.1 and 3.9, respectively, after PLIF (P<0.05 for all cases, Wilcoxon test). For the ODI, the means before PLIF were 60.3, 51.2 and 53.8, respectively, and they changed to 30.5, 24.9 and 29.7, respectively, after PLIF (P<0 .05 for all cases, Wilcoxon test). On the X-ray images, there was no halo sign greater than 2 mm near the pedicle screws or greater than 1 mm near the cages and no breakage of the HA block. No additional bone graft was needed for the PLIF using the HA block and local bone. There was no statistically significant differences among the groups (P>0.05, One-way ANOVA). CONCLUSION: PLIF using a HA block showed improvements, including the back pain, and the ODI was satisfactory and this didn't fall below those ODIs of using metal or PEEK cages. Although a HA block may have higher tendency to break, there was no breakage at the 1-year follow up.
Back Pain
;
Bone Substitutes
;
Durapatite
;
Follow-Up Studies
;
Ketones
;
Low Back Pain
;
Polyethylene Glycols
;
Retrospective Studies
;
Transplants
9.Inter- and Intra-observer Reliability of MRI for Lumbar Lateral Disc Herniation.
Seong Wan KIM ; Jin S YEOM ; Seong Kyu PARK ; Bong Soon CHANG ; Dong Ho LEE ; Jae Hyup LEE ; Kun Woo PARK ; Eun Seok SEO ; Choon Ki LEE
Clinics in Orthopedic Surgery 2009;1(1):34-39
BACKGROUND: The authors analyzed inter- and intra-observer agreement with respect to interpretation of simple magnetic resonance T1- and T2-weighted axial and sagittal images for the diagnosis of lumbar lateral disc herniation, including foraminal and extraforaminal disc herniations. METHODS: Forty-two patients in whom lumbar lateral disc herniation was suspected or confirmed by simple magnetic resonance imaging at one institute between May 2003 and December 2004 were included. The magnetic resonance images consisting of T1- and T2-weighted axial and sagittal images, and these were reviewed blindly and independently by three orthopaedic spine surgeons in a random manner. The images were interpreted as positive or negative for lateral disc herniation on 2 different occasions 3 months apart. Results were analyzed using Cohen's kappa statistic, and strengths of agreements were determined using the Landis and Koch criteria. RESULTS: The kappa values for inter-observer agreement averaged 0.234 (0.282, 0.111, and 0.308 respectively) on the first occasion, and 0.166 (0.249, 0.111, and 0.137 respectively) on the second occasion, with an overall mean value of 0.200. Thus, the strength of agreement was only slight-to-fair according to the Landis and Koch criteria. Kappa values for intra-observer agreement averaged 0.479 (0.488, 0.491, and 0.459 respectively), indicating moderate agreement. CONCLUSIONS: The present study indicates that simple magnetic resonance imaging is not a reliable imaging modality for diagnosing lumbar lateral disc herniation. Another imaging study with improved diagnostic values should be developed to diagnose this pathologic finding.
Aged
;
Aged, 80 and over
;
Female
;
Humans
;
Intervertebral Disk Displacement/*pathology
;
Lumbar Vertebrae/*pathology
;
*Magnetic Resonance Imaging
;
Male
;
Middle Aged
;
Observer Variation
;
Single-Blind Method
10.Differential Diagnosis between Tuberculous Spondylitis and Pyogenic Spondylitis.
Ki Hyoung KOO ; Hyeok Jin LEE ; Bong Soon CHANG ; Jin Sup YEOM ; Kun Woo PARK ; Choon Ki LEE
Journal of Korean Society of Spine Surgery 2009;16(2):112-121
STUDY DESIGN: This is a retrospective study OBJECTIVES: We wanted to make the early differential diagnosis between tuberculous spondylitis and pyogenic spondylitis according to the clinical and MRI findings. SUMMARY OF THE LITERATURE REVIEW: Making an early differential diagnosis between tuberculous spondylitis and pyogenic spondylitis is essential to start prompt and proper treatment. However, the clinical symptoms and MRI findings of both these illnesses can vary considerably. MATERIAL AND METHOD: Ninety-five patients (49 men and 46 women, mean age: 54.5) who were treated from January 2001 to February 2007 and whose diagnosis was confirmed by laboratory or pathological studies were retrospectively reviewed. 50 patients with tuberculous spondylitis and 45 patients with primary pyogenic spondylitis were included. The patients with combined infection or an uncertain diagnosis were excluded. We compared the medical records and MRI findings between the different groups of patients. RESULTS: The patients with tuberculous spondylitis were younger (48.2 years vs. 61.5 years, respectively) and they had a longer symptom duration (4.3 months vs 1.8 months, respectively). The erythrocyte sedimentation rate (ESR) and the C-reactive protein (CRP) level were significantly higher in the patients with pyogenic spondylitis (71.3/49.6 mm/hr and5.74/2.98 mg/dl, respectively). A high fever above 38 degree was more frequent in the patients with pyogenic spondylitis. Intraosseous abscess, epidural abscess, a well-definded paraspinal abscess, focal enhancement and severe destruction of the vertebral body on MRI were more frequent in the patients with tuberculous spondylitis. Four parameters such as a symptom duration longer than 3 months, no fever higher than 38 degree, a well-defined paravertebral abscess and an intraosseous abscess were selected. 42 patients in the tuberculous group had 3 or more of these four parameters. The sensitivity and specificity of these combined 4 parameters were 84% and 97.8%, respectively, for making the differential diagnosis between these 2 maladies. CONCLUSION: These diagnostic criteria might be useful to discriminate between tuberculous spondylitis and pyogenic spondylitis even without definite laboratory or pathological results.
Abscess
;
Blood Sedimentation
;
C-Reactive Protein
;
Diagnosis, Differential
;
Epidural Abscess
;
Female
;
Fever
;
Humans
;
Male
;
Medical Records
;
Retrospective Studies
;
Sensitivity and Specificity
;
Spondylitis

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