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.Changes in Clinical Characteristics of the Patients Who Received Endoscopic Sinus Surgery according to 10 Year Temporal Difference: A Retrospective Observational Study.
In Yong RYU ; Chul KWON ; Tae Kyung KOH ; Kun Hee LEE ; Joong Saeng CHO ; Sung Wan KIM
Journal of Rhinology 2016;23(2):81-84
BACKGROUND AND OBJECTIVES: Endoscopic sinus surgery (ESS) was introduced to Korea in the 1980s and has since developed rapidly. There have been many changes in ESS over this period. Thus, in this paper, we explore trends in the clinical characteristics of ESS. SUBJECTS AND METHOD: We retrospectively reviewed patients who underwent the ESS at 000 Hospital performed by a single surgeon at a 10-year interval. By comparing 106 patients who underwent ESS in 2003 and 108 patients who underwent ESS in 2013, we investigated changes in ESS in terms of the target group of surgical indications, CT scores, range of operation and complications. RESULTS: With regard to surgical indications, the proportion of patients who underwent surgery due to nasal polyps in 2013 (32.4%) was lower than in 2003 (59.4%), while the proportion of patients undergoing fungal sinusitis surgery in 2013 (13.9%) was higher than in 2003 (0.0%). In terms of preoperative CT evaluation, Lund-Mackay scores for the maxillary sinus, ethmoid sinus, and ostiomeatal unit were lower in 2013 than in 2003. The proportion of ESS performed only in the maxillary sinus in 2013 (20.0%) was higher than in 2003 (10.0%). CONCLUSION: According to this study, the range and extent of sinusitis was favorable in 2013 compared to in 2003. The group of patients requiring treatment for only maxillary sinus disease accounted for a larger proportion of patients in 2013 than in 2003.
Ethmoid Sinus
;
Humans
;
Korea
;
Maxillary Sinus
;
Methods
;
Nasal Polyps
;
Observational Study*
;
Polyps
;
Retrospective Studies*
;
Sinusitis
3.Effect of Non-Steroidal Anti-Inflammatory Drugs on Cystoid Macular Edema in Diabetic Patients after Cataract Surgery.
Chang Hyun KOH ; Sung Kun CHUNG
Journal of the Korean Ophthalmological Society 2013;54(3):427-431
PURPOSE: The present study analyzed the effect of non-steroidal anti-inflammatory drugs (NSAIDs) on cystoid macular edema in diabetic patients after cataract surgery. METHODS: Among 105 eyes of 84 diabetic patients, 43 patients who were administered Pranopulin(R) (JW pharmaceutical, Korea) starting 3 days before surgery comprised the experimental group. The control group included 41 patients who were not given Pranopulin(R). The results consisted of macular thickness measurements and total macular volume which were quantified by optical coherence tomography (OCT, Carl Zeiss Meditec). RESULTS: Macular thickness of the experimental group was 7.72 +/- 13.04 microm at postoperative 1 month, 7.15 +/- 13.62 microm at postoperative 2 months and was significantly thinner than in the control group (p < 0.05). Macular volume of the experimental group was 0.33 +/- 0.49 mm3 at postoperative 1 month, 0.31 +/- 0.43 mm3 at postoperative 2 months and was also significantly smaller than in the control group (p < 0.05). CONCLUSIONS: Using NSAIDs prophylactically before cataract surgery can effectively reduce the risk of postoperative cystoid macular edema in diabetic patients.
Anti-Inflammatory Agents, Non-Steroidal
;
Cataract
;
Eye
;
Humans
;
Macular Edema
;
Phacoemulsification
;
Tomography, Optical Coherence
4.Interactions of Dopamine D1 and N-methyl-D-Aspartate Receptors are Required for Acute Cocaine-Evoked Nitric Oxide Efflux in the Dorsal Striatum.
Dong Kun LEE ; Sung Min AHN ; Yoon Bo SHIM ; Wei Choon Alvin KOH ; Insop SHIM ; Eun Sang CHOE
Experimental Neurobiology 2011;20(2):116-122
Alterations in nitric oxide (NO) release in response to psychostimulants in the striatum cause a plastic change contributing to the development and expression of addiction. In this study, regulation of NO efflux evoked by acute cocaine in the dorsal striatum was investigated using real-time detection of NO in vivo. We found that acute systemic injection of cocaine (20 mg/kg) increased NO efflux, which was reduced by the intrastriatal infusion of the dopamine D1 receptor antagonist, SCH23390 (7.5 nmol), and the dopamine D2 receptor agonist, quinpirole (5 nmol). Increased levels of NO efflux by acute cocaine were also reduced by the intrastriatal infusion of the N-methyl-D-aspartate (NMDA) receptor antagonists, MK801 (2 nmol) and AP5 (2 nmol). These findings suggest that interactions of dopamine D1 receptors and NMDA receptors after acute exposure to cocaine participate in the upregulation of NO efflux in the dorsal striatum.
Benzazepines
;
Cocaine
;
Dizocilpine Maleate
;
Dopamine
;
Glutamic Acid
;
N-Methylaspartate
;
Nitric Oxide
;
Plastics
;
Quinpirole
;
Receptors, Dopamine D1
;
Receptors, Dopamine D2
;
Receptors, N-Methyl-D-Aspartate
;
Up-Regulation
5.Prevalence and clinical characteristics of microalbuminuria in Koreans: a population-based cross-sectional study.
Eun Ran KIM ; Ki Chul SUNG ; Chang Uk CHON ; Chang Hee KWON ; Young Lyul KOH ; Hyun Jong LEE ; Sung Kun PARK ; Do Young LEE ; Ji Ho YUN ; Byung Jin KIM ; Bum Soo KIM ; Jin Ho KANG ; Man Ho LEE ; Jung Ro PARK ; Seung Ho RYU
Korean Journal of Medicine 2006;70(6):617-626
BACKGROUND: Microalbuminuria (MA) is independent predictor of cardiovascular disease and it cause mortality regardless of the presence of diabetes (DM) and hypertension (HTN). However, few published studies on this topic have been reported in Korea. Therefore, we investigated the MA prevalence and relationship between MA, insulin resistance and cardiovascular risk factor. METHODS: A total of 5,915 (3,053 men and 2,852 women) health screen examinees were enrolled in this study. We measured the anthropometric and biochemical parameters of the atherogenic indexes. RESULTS: The MA prevalence was 7.7% in all participants. The prevalence of MA in the men and women was 9.5% and 5.7%, respectively. Elevated levels of serum fasting glucose, serum fasting insulin, HOMA index, total cholesterols, LDL cholesterol, TG, Body Mass Index (BMI) and the systolic and diastolic blood pressure were significantly associated with MA. The results of multiple logistic regression analysis about MA showed that frequent drinking, low BMI, newly diagnosed DM and elevated levels of HOMA index and blood pressure were significantly associated with MA prevalence. Also, excluding newly diagnosed diabetic and hypertensive subjects, the MA prevalence was 5.7% (6.9% in men, 4.7% in women) and in multiple logistic regression analysis, the MA prevalence significantly increased in the individuals with pre-HTN rather than in the normotensives. CONCLUSIONS: The MA prevalence was 7.7% in all subjects. Except the newly diagnosed diabetic and hypertensive subjects, it was 5.7%. The MA prevalence was significantly increased in the individuals with pre-HTN rather than in the normotensives and MA was related with insulin resistance.
Blood Pressure
;
Body Mass Index
;
Cardiovascular Diseases
;
Cholesterol
;
Cholesterol, LDL
;
Cross-Sectional Studies*
;
Drinking
;
Fasting
;
Female
;
Glucose
;
Humans
;
Hypertension
;
Insulin
;
Insulin Resistance
;
Korea
;
Logistic Models
;
Male
;
Mortality
;
Prehypertension
;
Prevalence*
;
Risk Factors
6.Experience of Extracorporeal Shock Wave Lithotripsy with Electroconductive Lithotriptor (ECL, EDAP- Sonolith Praktis) in 703 Patients with Urinary Calculi.
Chang Ho LEE ; Sung Kun KOH ; Hyoung Jin KIM
Korean Journal of Urology 2005;46(4):375-381
PURPOSE: We analyzed the therapeutic results of 703 cases of urinary calculi treated using an EDAP-Sonolith Praktis, an electroconductive lithotriptor (ECL). MATERIALS AND METHODS: Between January 2000 and June 2004, 703 patients meeting the study inclusion criteria were treated with an EDAP-Sonolith Praktis. The site and size of the stones, session, auxiliary procedure, success rate, causes of failure, complication, efficiency quotient (EQ) and retreatment were analyzed. RESULTS: The records of 703 patients, in whom urinary calculi were treated by extracorporeal shock wave lithotripsy, using an EDAP-Sonolith Praktis, were retrospectively reviewed. The success rates were 99.3, 92.5, 66.7 and 12.5% for stone sizes < or=9, 10-19, 20-29 and > or=30mm, respectively, with an overall success rate of 95.3%. The EQ, mean number of session and retreatment rate were 0.71, 1.7 and 30.6%, respectively. As auxiliary procedures, double-J stenting, ureteroscopic stone removal and open surgery were performed in 6, 15 and 1, respectively. The complications were gross hematuria, flank pain, steinstrasse, nausea and fever, which were successfully controlled by conservative treatment. CONCLUSIONS: EDAP-Sonolith Praktis, an ECL, is an efficient and safe outpatient procedure for initial urinary calculi treatment.
Fever
;
Flank Pain
;
Hematuria
;
Humans
;
Lithotripsy*
;
Nausea
;
Outpatients
;
Retreatment
;
Retrospective Studies
;
Shock*
;
Stents
;
Urinary Calculi*
7.A Multi-center Study for Birth Defect Monitoring Systems in Korea.
Jae Hyug YANG ; Yon Ju KIM ; Jin Hoon CHUNG ; Moon Young KIM ; Hyun Mee RYU ; Hyun Kyong AHN ; Jung Yul HAN ; Soon Ha YANG ; Ahm KIM ; Hyun Se KIM ; Pyo Jong LEE ; Sung Soo KIM ; Young Ju KIM ; Kyung Sim KOH ; Jong Chul SHIN ; Yong Kun CHO ; Bo Hyun YOON
Journal of Korean Medical Science 2004;19(4):509-513
The aim of this study was to establish a multi-center birth defects monitoring system to evaluate the prevalence and the serial occurrence of birth defects in Korea. Ten medical centers participated in this program. A trained nurse collected relevant records from delivery units and pediatric clinics in participating hospitals on a monthly basis. We observed 1,537 cases of birth defects among 86,622 deliveries, which included live births and stillbirths. The prevalence of birth defects was 1.8%, and the sex distribution of the birth defect cases was 55.2% male and 41.6% female. The highest proportion of birth defects was in the cardiovascular system (17.5%), followed by birth defects involving in the genitourinary system (15.6%). Chromosomal anomalies were detected 30.0 per 10,000 births. Of these chromosomal anomalies, Down syndrome was most frequently observed. This study led to an establishment of a multi-center active monitoring system for birth defects. To better understand the serial occurrence of birth defects in Korea, it is necessary to increase the number of participating hospitals and to launch on a nation-wide multi-center study.
Abnormalities/*epidemiology
;
Child
;
*Chromosome Aberrations
;
Female
;
Humans
;
Korea/epidemiology
;
Male
;
*Population Surveillance
;
Pregnancy
;
Pregnancy Outcome
;
Research Support, Non-U.S. Gov't
8.Left Hand Mirror Writing Following a Left Temporo-Parietal Lobe Infarction.
Jee Hoon ROH ; Seong Beom KOH ; Youn Seon CHOI ; Sung Wook YU ; Min Kyu PARK ; Kun Woo PARK ; Dae Hie LEE
Journal of the Korean Neurological Association 2004;22(2):138-141
Mirror writing is the simultaneous process of reversing individual letters and composing word strings in the reverse direction. This phenomenon appears rarely only after brain damage. We present the case of a 65-year-old, right-handed man with mirror writing following a left temporo-parietal lobe infarction. He preferred to write in the mirror direction with his left hand, but he did not show any visual-spatial disturbance and allochria. We think that damage to the dominant writing program of the brain, releases the normally suppressed contralesional writing program and this uninhibited program induces the mirror writing.
Aged
;
Brain
;
Functional Laterality*
;
Hand*
;
Humans
;
Infarction*
;
Writing
9.The Effects of Dopamin D-1 Agonist (SKF-38393) on Expression of Substance-P & Enkephalin mRNA in the Striatum of Hemiparkinsonian Rat Model.
Seung Hwan LEE ; Do Young KWON ; Sung Wook YU ; Seong Beom KOH ; Min Kyu PARK ; Hyun KIM ; Kun Woo PARK ; Dae Hie LEE
Journal of the Korean Neurological Association 2003;21(5):527-533
BACKGROUND: The selective D1 dopamine agonist has been known to play a stimulatory role in substance-P synthesis in the striatum, but its effect on the enkephalin mRNA expression has not been well known in the striatum of unilateral 6-hydroxydopamine(OHDA)-lesioned rat. So we investigated the effect of selective D1 dopaminergic agonist on substance-P, enkephalin mRNA expression in the striatum with different time interval. METHODS: The lesioned rats were divided into two groups (treated and non-treated). Each group was subdivided according to time course after lesioning (2nd, 4th and 8th week). Dopamine 1 receptor agonist, SKF-38393 (5 mg/kg/ip) and the same volume of saline was injected to treated and nontreated group respectively. The levels of enkephalin and substance-P mRNA were determined by in situ-hydridization and the expression of mRNA levels were compared between the groups. RESULTS: The expression of striatal enkephalin mRNA was increased on lesioned side in all groups. Especially, SKF-38393 enhanced the striatal expression of enkephalin mRNA after lesioning 2nd week. After lesioning 4th week and 8th week, the effect of SKF-38393 was not significant. The striatal expression of substance-P mRNAs was significantly decreased on the lesioned side, especially at the 2nd weeks. This decrement of substance-P mRNA was reversed by SKF-38393 at the 2nd week. CONCLUSIONS: These data show that the selective D1 agonist SKF-38393 have an agonistic effect on direct pathway but antagonistic effect on indirect pathway in early course of Parkinsonian rat model.
2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine
;
Animals
;
Dopamine
;
Dopamine Agonists
;
Enkephalins*
;
Models, Animal*
;
Rats*
;
RNA, Messenger*
10.The Effects of Dopamin D-1 Agonist (SKF-38393) on Expression of Substance-P & Enkephalin mRNA in the Striatum of Hemiparkinsonian Rat Model.
Seung Hwan LEE ; Do Young KWON ; Sung Wook YU ; Seong Beom KOH ; Min Kyu PARK ; Hyun KIM ; Kun Woo PARK ; Dae Hie LEE
Journal of the Korean Neurological Association 2003;21(5):527-533
BACKGROUND: The selective D1 dopamine agonist has been known to play a stimulatory role in substance-P synthesis in the striatum, but its effect on the enkephalin mRNA expression has not been well known in the striatum of unilateral 6-hydroxydopamine(OHDA)-lesioned rat. So we investigated the effect of selective D1 dopaminergic agonist on substance-P, enkephalin mRNA expression in the striatum with different time interval. METHODS: The lesioned rats were divided into two groups (treated and non-treated). Each group was subdivided according to time course after lesioning (2nd, 4th and 8th week). Dopamine 1 receptor agonist, SKF-38393 (5 mg/kg/ip) and the same volume of saline was injected to treated and nontreated group respectively. The levels of enkephalin and substance-P mRNA were determined by in situ-hydridization and the expression of mRNA levels were compared between the groups. RESULTS: The expression of striatal enkephalin mRNA was increased on lesioned side in all groups. Especially, SKF-38393 enhanced the striatal expression of enkephalin mRNA after lesioning 2nd week. After lesioning 4th week and 8th week, the effect of SKF-38393 was not significant. The striatal expression of substance-P mRNAs was significantly decreased on the lesioned side, especially at the 2nd weeks. This decrement of substance-P mRNA was reversed by SKF-38393 at the 2nd week. CONCLUSIONS: These data show that the selective D1 agonist SKF-38393 have an agonistic effect on direct pathway but antagonistic effect on indirect pathway in early course of Parkinsonian rat model.
2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine
;
Animals
;
Dopamine
;
Dopamine Agonists
;
Enkephalins*
;
Models, Animal*
;
Rats*
;
RNA, Messenger*

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